English

Population Reports
Series B
Number 4
July 1982
INTRAUTERINE DEVICES
Popul lion Information Program , The Johns Hopkins University, Hampton House, 624 North Broadway, Baltimore, Maryland 21205, USA
I U OS: An Appropriate Contraceptive for Many Women
Editors' Summary. About 60 million women worldwide are
currently using intrauterine devices (IUDs), including over 40
mi llion in the People's Republic of China. The total number of
users has remained relatively stable in rece nt years. IUD use in
most developing countries has not increased as rapidly as the
use of oral contraceptives and voluntary sterilization. In Eu­
rope, however, where IUDs are readily available from commer­
cial sources, they have become increasingly popular. Despite
recent reports of pelvic inflammatory disease WID) and other
infection s associated with IUD use in some women, the IUD is
an ex tremely effective, safe, and appropriate method of family
planning for many women. It is especially suitable for women
who are not exposed to sexually transmitted diseases and who
have already borne children.
The life-tabl e event rates per 100 women, by which IUDs are
usually evaluated, are approximately as follows after one year
of use in large, multi cen ter studies:
Pregnancy 0.5-5
Expulsion 5-15
5- 15
Removal for bleeding/pain 3-9
Removal for other medical reasons
Removal for personal reason s 1-6
Thus, continuation rat es one year after insertion tend to range
from SO to 85 percent-high rates for a reversible method.
Usage Shifts to Copper IUDs
Some shift in usage occurred in the late 1970s from the unmedi­
cated Lippes Loop to copper-releasing IUDs and, to a lesser ex­
tent, to IUDs that release progestins into the uterine cavity .
Copper devices have now captured much of the market in the
United States and W estern Europe and amount to about two­
thirds of the supplies provided by donor agencies to many de­
veloping countries. In China, however, unmedicated devices,
usually metal rings or other, locally developed IUDs, are still the
rule. Unlike other IUDs, Chinese devices rarely have tails, or
strings-a practice th ilt some think may minimize the risk of in ­
fection but makes confirm ation of the I U D's presence as well as
removal more difficult.
Whether the trend toward copper devices reflects fundamental
improvements in performance or more aggressive marketing of
the copper devices, especially in Europe , is not entirely clear.
On one hand, copper devices have some advantages. Com­
pared with the Lippes Loop, some of these devices
• are less likely to be expelled,
• produce less menstrual blood loss,
• are better tol erated by women without children ,
• are more likely to stay in place after postpartum or postabortion insertion.
On the other hand , overall co ntinuation and effectiveness rates
differ only slightly between copper IUDs and Loops and among
the various copper devices. Continuation rates often vary more
among different research centers than among different devices.
The major disadvantages of copper IU Ds are
• possible need for replacement in several years or when
the copper is exhausted,
• limited availability, especially of the newer devices,
• cost , which , for government programs, may range from 2
to 20 times the cost of the Lippes Loop, depending on th e
device, the packaging, and the size of the order.
Paradoxically, several of the copper T devices that have per­
formed well in comparative trials are less widely marketed and
used than other copper devices, such as the Cu-7, Nova T, and
Multiload, that have not been included in as many comparative
studies.
Progestin-releasing IUDs have the advantage of reducing men­
strual bleeding well below pre-insertion levels. This could be an
important asset where many women are anemic. On the other
hand, these devices cost even more than copper IUDs, defi­
nitely need replacement after one to two years, produce more
midcycle bleeding and spotting, and are associated with a
higher rate of ectopic pregnancy.
In general, two decades of IUD research have demon strated
that an improvement in anyone facet of IUD performance of­
ten adversely affects some other facet. For example, reducing
the size of a device to minimize pain or bl eeding has raised
pregnancy rates.
Recently attention has focused on pelvic inflammatory disease
WID), which is caused by organisms from the 'l ower genit al tract
th at ascend to the uterus and fallopian tubes. PID is frequ ently
CONTENTS
Comparing IUD Performance . . . . . . . . . . ••. . . 8-103 D istribution and Us . . . . . .... . .... , . . . . . . . , . 8-108 Insertion and Removal .. . " .. . . .. . . .... , . . .. . 8- 111 Bleeding . . . . . . . . . . . . . . . . . . . . . . .. . . .. . . . . . B·116 Iniection . . . . . .. . • . • , .. .. . . • .. . . , • . . .. • ... B· 121 Pregnancy . . . .. ..
. . ... . . . ....•••. . .• . . . . B- 124 ProdUd and Packaging Is Uf'S .. . . . .. •• . . . . • .. . B· 126 Bibliography. . . . . . . . . . . .. . . .. . .. ... ... . . . . 6· 129 Volum e X, Number 4
This issue of Population Reports was prepared by
Laurie Liskin, M.A., with assistance by Gordon Fox, on
the basis of published and unpublished materials, cor­
respond ence, and interviews. Comments and additional
material are welcome.
kon S lield , which was involved in most of the deaths, was
withd Iwn from the market. Since these w drnings in t e
mid -1 70s, only two septic abortion deaths lave bee n re­
portee among IUD users in the US. Any Dalkol1 Shield still in
place hould be removed , since that device may also bp as 0­
ciate with higher risk of PID.
The assistance of the following reviewers is appreciated:
Ronald Burkman, Willard Cates, Jr. , J. Jarrett Cl inton,
Lynda Cole, C.C.A. de Nooyer, David Edelman , Larry L.
Ewing, Michael J. Free, Ronald Gray, A. T. Gregoire, John
Guillebaud, Robert Hatcher, Louis Hellman, Susan
Holck, Douglas Huber, Louis Keith, Theodore M. King,
Richard C. Leidenfrost, Jack Lippes, Harold A. Nash,
Howard Ory, Gordon Perkin, Malcolm Potts, R.T.
Ravenholt, Allan Rosenfield, Patrick J. Rowe, Pramilla
Senanayake, Irving Sivin, Robert Snowden, J. Joseph
Speidel, Michael Spence, Bruce Stadel, Tabitha
Standley, Howard Tatum , W.A.A. Van Os, Martin
Vessey, Jane Walker, Lars Westrom, Robert Wheeler,
and Andrew Wiley. Some reviewers read portions of the
manuscript; others, all.
Healt
possit
amon
amon
tectio
other
rates
lead t
Population Reports (USPS 063·1501 is published bimonthl y «anuary,
March, May. July, September, November) at 624 North Broadway, Bal·
timore, Maryland 21205, USA, by the Population Iniormation Program oi
The Johns Hopkins Uni versity and is supported by the United States
Agency ior International Development. Second class postage paid at
Baltimore, Maryland. Postmaste r to se nd address changes to Population
Reports, Population Information Program , The John s Hopkins Unlver·
sity, 624 North Broadway, Baltimore, Maryland 21205, USA.
Durir the 1980s attention shou ld probably focus less on Ihe
searc for an ideal device and more on the need for fami ly pl.lO­
ning J rograms to:
• i entify suitable candidates for IUDs,
• I ' courage better health service support for IU D in. N­
I n and follow-up,
• ," ake the newer IUDs more widely avail able to i ndi id­
I lis and national programs.
Population Reports IS designed to provide an accurat ' nd authoritativ
overview of important developments in the populallon li eld. It does not
repreSt' nt official statements of policy by The Johns Hopkins University or
the US Agency ior I nternational Development.
Phyllis T. Piotrow, Ph.D " Director; Walter Stender, A, sociate Director;
Ward Rinehart , Editor.
due to sex ually tran smitted diseases or to infection fol lowing in­
duced abortion or complications of childbirth. Recent studies
in developed countries suggest that PID occurs about 50 per­
cent more often in IUD users than in women using no contra­
ception. It is about two or three times as common in IUD use rs
as in users of oral contraceptives or barrier methods, which pro­
vide some protection against PID. The risk is greatest for
women who are exposed to sexually transmitted diseases. Thu s
PID may be of little concern where sexually transmitted
diseases are rare as in China but of more concern elsewhere.
Even one or two episodes of PID can cause infertility by perma­
nently blocking the fallopian tubes. Therefore, young women
shou ld be fully coun seled on th e risks of PID and the possible
effects of sexually transmitted diseases before choosing an IUD
or other contraceptive.
When PID is diagnosed, it shou ld be treat ed immediately with
broad-spectrum antibiotics to minimize tubal damage. Most
clinicians recommend removin g an IUD if infection·does not
respond to antibiotics within 24 to 48 hours. There is little rea­
son to remove and reinsert unmedicated IUDs routinely in
asymptomatic women, however, since there is no evidence
that this would help prevent infection .
If pregnancy occurs with an IUD in place, the dangers of infec­
ti on and spontaneous abortion are multiplied. Spontaneous
abortion occurs about three times more often when an IUD is
in place. The ri sk of septic abortion also is increased. In the US
in 1972-74 septic first and second trim ester abortions with
IU Ds in place caused 17 deaths. Physician s were then warned
to remove an IUD immediately in case of pregnancy; the Dal ­
8-102
personnel and IUD users also need to be alert to Ihe
lity of ectopic pregnancy. About one in 10 pregnancie s
IUD users is ectopic compared with a ut one i n 125
nonusers. This is because IUDs provid exceller t p'o­
, against uterine pregnancies but less a 'ainst tubal or
2xt rauterine pregnancies. It is also possi Ie that higher
f PI D or noninfectious tubal changes among IU uS ' rs
higher rates of ectopic pregnancy after l ng-term uSt ,
Issues for the 1980s
DuriR the 1970s attention focused on develol ing and testi ng
new I ) Ds to minimize or prevent the problem of pregnam:y,
expul on, bleeding, and pain. Improvements have b en
made but some of the problems associated wit h IUDs- d as
incre, ,ed bleeding and infection-remain difficu lt to preve r t.
The i ,portance of identifying suitable candidates for IU D Li se
is bet >ming increasingly clear, since it has not proved possi­
ble tl ' develop IUDs that will suit all women. For examl l ,
despi a decade of resea rch, no IUD is ideal for nu lliparo us
wom n or for postpartum inse rtion . Also, for some w on en
the ri k of infection and subseq uent infertility may be u c­
cept a }Iy high . Thus, just as the best candidate for oral .onl ra­
cepti' es is a young woman who does not smoke or face a rll 'h
risk 0 cardiovascular disease, so the best ca nd idate for ,In IU D
may ,e a woman in a stable marital relation 'hip or an oller
wom n who has already borne children.
For a y woman, the quality of health servio's clearl y inil u­
IUD acceptability and safety. Skillful Insertion of the
IUD t any time in the menstrual cycle that i ~ conver'ien l to
the ~ oman, sympathetic counseling on init , I probll~m , or
side , . ects, and prompt attention to any suspected infecti on
or pr, 'nancy probably make more difference I han the typ of
devic . With careful training, paramedical personnel can In­
sert IU Ds as well as physicians can, and th 'y can prO\ ide
mud of the necessary support.
ence~
Finall , the newer medicated devic es are not now availabl ' in
most level oping countries or in the US, despite consi de rable
clini c II experience with some of them. More attention to in ­
terna :onal di stribution mechanisms, possibly more coop ra­
tion I etween public and commercial organi za tions, and I cal
prodl etion of IUDs in some developing count ries may be nec­
essar to insure th at those who want to use these new IL Ds
willl _ able to obtain and afford them.
If th e
tribut
cade
unw,
small
challenges are met, IUDs can make a ubstanti al co n­
n to worldwide contraceptive use duri g the next d e­
Compared with the well-documented health ris k ot an
lted pregnancy, the risks associated w ith IUD use are
and the benefits, substantial.
End of Editors' Summa ry.
POPULAT ION REPORTS
I
I
•
•
• I
While the origins of intrauterine contraception date back to an­
tiq ~lity, IUDs have been widely used only in the last 20 years.
The first generation of modern IUDs, the unmedicated, or inert
devices such as the Lippes Loop, were designed and first pro­
duced in the late 1950s following the development of polyeth­
ylene, a biologically inert plastic. Polyethylene can be molded
into any configuration and will retain its "memory" -that is,
resume its original shape after being bent or straightened. In the
1970s medicated, or bioactive IUDs were developed. These
devices carry substances such as copper or hormones. Effort is
continuing to design IUDs that will resist expulsion, reduce
bleeding, be more appropriate for nulliparous women , and, in
the case of medicated devices, remain effective longer.
The IUD is a highly effective method of contraception. In large
multicenter clinical trials of different devices pregnancy rates
ranke from 0.5 to about 5 per 100 women per year (see Popu­
lation Reports, IUDs-Update on Safety, Effectiveness, and
Research, 8-3, May 1979). The most recent US survey of contra­
ce 9tive effectiveness among married women showed a preg­
nancy rate of 4.8 per 100 IUD users in the first year. 8y compari­
son , the pregnancy rate for oral contraceptives was 2.5 per 100
users (151).
In developing countries where women are not accustomed to
taking a pill every day, IUDs often have lower pregnancy rates
than orals (579,588). For example, using World Fertility Survey
data from five Latin American countries, Noreen Goldman and
colleagues estimated that the unplanned pregnancy rate in the
12-month interval after marriage or a previous birth was 5 per­
cent for women who had used an IUD at some time during that
period , compared with 8 percent for OC users, 18 percent for
con,d om users, and 40 percent for those using no contraception
(577).
In addition to pregnancy rates, other standard measures of IUD
performance are rates of expulsion, removal for pain and bleed­
ing, and removal for other medical reasons. In the first year of
use roughly 5 to 15 percent of women expel their IUDs, most
within the first three months. Prolonged menstrual bleeding
andl or pain cause about another 5 to 15 percent to have their
IUDs removed within the first year. Pelvic infection and persis­
tent vaginal discharge are the other major medical reason s for
discontinuation. In the first year after insertion about 3 to 9 per­
cent of IU Ds are removed for these reasons. Removals for per­
sonal reasons range from less than one to about 6 percent. Thus
overall continuation rates are approximately 50 to 85 percent
after 12 months (see Population Reports, IUDs-Update on
Safety, Effectiveness, and Research, 8-3, May 1979).
Most problems occur within the first three months after inser­
tion. After that , occasional complications of IUD use include
pelvic inflammatory disease (pID), which may lead to infertility,
and septic abortion if the IUD remains in place during preg­
nancy. Also, the risk of ectopic pregnancy seems to increase
with the duration of IUD use, although it is not clear whether
IUD users face greater risk than women using no contracep­
tion. After more than 20 years of observation, there is no evi­
dence that IUDs initiate or promote cervical, endometrial , or
any other type of cancer (191,511).
In developed countries two decades of research suggest that
the IUD is most suitable as a contraceptive method for older
women who have had children . IUD effectiveness is greatest
and the incidence of complications is lowest among older,
parous women. For example, in one clinical trial, among
women age 25 and over the pregnancy rate after four years of
use of the TCu-380A, a T-shaped IUD with 380 square mm of
copper surface, was only 1.0 per 100 users. By contrast, the rate
for women age 20 to 24 was 3.2 and for women under 20, 3.7
(439). Also, rates of PID are lower in older women, and rates of
expulsion and removal for bleeding and pain decline with par­
ity. In the UK one study found that in women age 30 and over
the rate of PID after almost three years of IUD use was only 1.2
per 100 women compared with 6.3 for women age 20 to 24
(49).
Comparing the Lippes Loop and Copper IUDs
The Lippes Loop, one of the first modern unmedicated devices,
is the best known and most widely used device in developing
countries other than China . The Loop is available in four
types-from the smallest, A, to the largest, D. Since they have
been so widely studied , the Lippes Loops C and D serve as the
standard for evaluating other IUDs. Copper was first added to
IUDs in the 1970s. These IUDs proved to be highly effective
even though they are smaller than the Loop .
The IUDs available are roughly equal in contraceptive effec­
tiveness. In comparative studies pregnancy rates for the Loops
and early copper devices are within the same range-from 0 to
3.8 per 100 women at one year after interval in sertion (see
Table 1). In three of four countries where the Population Coun­
cil organized studies, pregnancy rates for the Loop were slightly
lower than for the TCu-200 (434). A multicenter randomi zed
trial of almost 3,000 women , conducted by the World Health
Organi zation (WHO), reports the largest difference between
devices. The 18-month pregnancy rates for the Loop and the
Cu-7 were similar-3 .7 and 3.8, respectively-but lower for the
newer TCu-220C-l .7-which has copper on the arms and the
stem of a plasti c T (551) (see photos, pp. B-118-120).
Over 40 million Chinese women use IUDs-three-quarters of the
world's users. Here a gynecologist instructs commune family plan­
ning workers about the steel ring IUD. In China these community
workers routinely insert IUDs. (China Recunstructs/Guan Zongzeng)
POPULATION REPORTS
Although there is considerable variation among research cen­
ters, expulsion rates are somewhat lower with the copper T
IUDs than with the Loops, while rates of removal for bleeding
and pain are virtually the same. Expulsion rates for the TCu-200
were significantly lower than for the Loop in three of four devel­
oping countries where the Population Council conducted trials
(434) (see Table 1, p. B-1 04). Pooled data from noncomparative
8-103
Table
1.
Performance of Unmedicated and Copper-Bearing
IL
)s,
Selected Comparative Trials,
1972-1980
vent Rates (per 100 Women)
Author, Date,
& Ref. No.
Place
Devices
Studied
No. of
Women
Accide l al
Pregnar y
Expulsion
Bleeding
IPain
Co ntinuation
Rate
INTERVAL INSERTIONS-12-MONTH RATES
Edelman et al.
1977 (107)
Chile
Khan et al.
1979c (231)
Medel et al.
1978c (300)
Sivin 1976 (434)
Bangladesh
Chile
Colombia
Iran
Korea , Rep, of
Thailand
Tacla & Baeza
1978c (473)
Tatum 1972c
Chile
US
(477) Lippes Loop
TCu-200
Cu-7
Li ppes Loo p
TCu-220C
Lippes Loop
TCu-200
Lippes Loop
TCu-200
Lippes Loop
TCu-200
Lippes Loop
TCu-200
Lippes Loop
TCu-200
Lippes Loop
TCu-200
Lippes Loop
TCu-200
0
481
821
504
125
121
295
471
749
775
447
719
951
1,050
610
1,996
200
200
S06
978
C
0
0
D
3,8"
23'
3.4,1
- 17,7",b*_ _ - -- 11 ,6 a,b* _ _- - -1O,6a,b* _ _ -
0
0
1,5
2,7
1,8
2,5
11,1·
6,7a
6.4
6,3
5.3
3,8 *
1.4
2,6
0.4
1,0
7.4
9,2
8,6
6,0 *
10,0
6,7 *
10,8
8,6
10,3
5,6
1.7
1.0
2,2
2,1
2,1
1.S
15,2 a
24,6 a
2,2
1,8
8,3
8,1
110
12.4
18,2
19,7
2,7
4,3
NA
NA
NA
1.6
3,3
7,6
4,5
59,5
58.4
86.6
82,9
78.4
78,6
78,2
71.5
65 ,5
68,7
80,8
81,9
76,3
73,3
73.4
83,2
70,6
69,2
68,6
67,5 d
63.3
42,Sd
45,5
50,8"
72,6
69.4d
54,9
60.2
55,3
INTERVAL INSERTION-24-MONTH RATES
Medel et al.
1978c (300)
Sivin 1976 (434)
WHO 1980c
(551) Chile
Lippes Loop D
TCu-200
Colombia
Lippes Loop
TCu-200
Iran
Lippes Loop
TCu -200
Korea, Rep, of
Lippes Loop
TCu-200
Thailand
Lippe s Loop
TCu-200
Brazil, Egypt,
Lippes Loop D
Hungary, India, TCu-22OC
Philippines,
Cu-7
Thailand , USSR,
UK, US
2.3
3.7
3,1
3,8
2,7
36
1.0
1,3
2,5
1.8
3,7
1.7'
3,S'
8,1
8,0
7,4
4,3 *
9,1
10,2
11 .7
8,1 *
12,2
8,3 *
NA(
5,0
3,1
11 ,2
11,6
20.4
22.5
27,0
28,3
4,1
6,S
7,9 a
3,9 a
6,5 a
172
172
4,7
0
10.6
2.5 *
16.9
14.3
57.4
71 ,9 *
2,358 8 [
5,S'
2.2'
53
NA
NA
43,2
50.6
43.3
4.?-
1.8'
3.3'
NA
NA
295
471
749
775
447
719
951
1,050
610
1,996
e
} 2,98g [
NA'
6,3
POSTABORTION INSERTIONS-12-MONTH RATES
Khan et al.
1979c (231) Bangladesh
Lippes Loop C
TCu-22OC
POSTABORTION INSERTIONS-24-MONTH RATES
WHO 1980c Cuba, Hungary, Lippes Loop D
(551) TCu-22OC
India, Rep .
of Korea,
Cu-7
Singapore, UK,
Yugoslavia,
Zambia
Chile , Egypt,
Li ppes Loop D
Philippines,
TCu-220C
Singapore,
Cu-7
UK, Zambia
NA
~
]
} 1,060
h
not available
'Reported as a statisti cally significant diffe rence, Some studies do not report
tests of significance.
aC ross event rates; all other studies report net event rates,
blncludes all medical removal s
cRandomized study
8-104
[
-49
-49
-49
ctTCu-2C continuation rates exclude women having devic rem oved aftE . 2
years (" e to uncertainty about it s effective lifetime , Net r..tes for thi, typ' of
removi
Colombia 1,1%; Iran 12.4%; So uth Korea 0.3%; 1 hailand 0,10'10,
"Muitip, aus women
'Rates Ie Cu-7 and Lippes Loop 0 are reported only as higher than for TCu-22 )C,
glnsertit 5 immediatel y following legal induced abortion
hlnserti( S immediately following illegal induced or spontaneous abortion
POPULATION REPORTS
I
studies of over 6,700 women in 14 countries, conducted by the
International Fertility Research Program (IFRP), also show sig­
nificantly less expulsion with copper devices than with the Lip­
pes Loop. These poolled data show that rates of removal for
bleeding and pain also were lower with the copper devices.
Twb randomized IFRP studies directly comparing the IUDs,
however, found little difference (79). Other studies also report
that removals for bleeding and pain occur just as often or more
often with some copper devices than with the Loop (231 , 434 ,
473).
Th major advantages of copper IU Os over the Lippes Loop are
(1) less menstrual blood loss, (2) better tolerance by low-parity
women (300, 434) , (3) lower expulsion rates after postpartum
or postabortion insertion as well as after interval insertion (see
p. B-111), and (4) smaller inserter tubes. These advantages may
be partly due to the size and shape of th e copper devices. They
must be weighed against three major drawbacks of copper
devices: (1) higher price (see p. B-127) , (2) limited availability in
many areas, and (3) the recommended requirement for peri­
odic replacement as the copper diminishes. While copper de­
vices are a suitable alternative to the Lippes Loop, they are not
necessarily preferable for all women or in all circumstances.
Comparing Copper IUDs
The first copper IUDs emp'loyed copper wire wrapped around
th e vertical stem of the plastic device (see photos, pp. B-118­
120). They are:
TFu-200-200 square mm of copper,
Cu-7-200 square mm of copper,
Multiload-250 or 375 square mm of copper.
The TCu-200, commonly referred to as the copper T, is increas­
ingly used in developing countries. The Multiload is widely
used in Western Europe and in Indonesia . Unlike other copper
devices, the Multiload comes in four sizes, and one size is avail­
able with 375 square mm of copper as well as 250 . The Cu-7 is
the most widely used copper device in the UK and in the US,
where the TCu-200 was approved by the US Food and Drug Ad­
mi ~ istration only in 1979 and where other copper devices are
not available. The devices with 200 or 250 square mm of copper
have life spans of two to three years, according to manufac­
turers' recommendations. The Multiload-cu 375 has a recom­
mended life span of three years but is estimated to remain ef­
fective for at least five years (578).
Four other T-shaped devices have since been designed for a
longer life span and greater contraceptive effectiveness. They
are:
TCu-380A-two solid copper sleeves on both th e transverse
arms and copper wire on the stem, totaling 380 square mm
of copper surface,
TCu-380Ag-like the TCu-380A, but the copper wire on the
stem has a silver core,
TCu-220C-seven solid copper sleeves on the stem and
arms, totaling 220 square mm of surface,
Nova T-200 square mm copper wire with a silver core (see
photos, pp. B-118-120).
Copper sleeves were placed on the arms of the TCu-220C and
both TCu-380 IUDs to provide a greater surface area of copper
in the uterus and to bring the copper closer to the uterine fun ­
dus. This placement is thought to improve contraceptive ef­
fectiveness, since most implantations of the fertilized ovum
occur high in the uterus (438). Unlike copper wire, copper
sleeves do not fragment in utero and thus may retain their ef­
fectiveness longer. The core of silver in the TCu-380Ag and in
the Nova T is intended to reduce fragmentation of the copper
POPULATION REPORTS
wire. The Nova T has an estim ated life span of over 10 years;
the TCu-380A, of 6 to 10 years; the TCu-380Ag, of 10 to 15
years; and the TCu-220C , of 20 years.
Of these four IUDs, only the Nova T is generally available . It
was developed in Finland and is distributed by several Euro­
pean firms. The Nova T is widely used in Western Europe and to
a lesser extent in some Eastern European countries, Canada ,
Latin America, South Africa , and Taiwan (580). The TCu-380A
is being manufactured and distributed in Canada by Ortho
(317) . The TCu-220C is manufactured by Promotora e Impor­
tadora PEISA and a modified version , by Biotech Laboratories,
both of Mexico (see photos, p. B-119). The modified device is
used in the Mexican national family planning program.
Randomized comparative trials with three of the newer
devices-the Nova T, the TC u-220C and the TCu-380A-sug­
gest that they prevent pregnancy more effecti vely than the
TCu-200, the standard for compari son in evaluating copper
IUDs (see Table 2, p. B-106). In one Population Council com­
parative study, the 24-month pregnancy rate for the TCu-200
was 5.6 and the rate for the TCu-380A was 1.0. Similarly, in
another trial the 24-month pregnancy rate for the TCu-200 was
5.0 and for the TCu-220C, 1.8 (438). Even slightly lower
pregnancy rates are an important consideration because
pregnancy with an IUD in place constitutes not only a con­
traceptive failure but also a potential medical complication (see
p. B-124).
With these newer copper devices, greater effectiveness and
longer life may be offset by increased side effects, however.
Removals for bleeding and pain were significantly more com­
mon with the TCu-380A than with the TCu -200 (438). Other
studies also report lower pregnancy rates but more frequent
removal for bleeding and pain with both the TCu-380A and
IUD inserters and insertion methods vary but are less important to
successful insertion than the skill of the operator_ Inserters and
IUDs are arranged here by overall diameter at insertion, from
smallest (top) to largest. Diameter affects discomfort on insertion.
B-105
Table 2.
Performance of Copper-Bearing IUDs, Selected Ra' domized Comparative Trials, 1975-198 1
Author, Date,
& Ref. No.
12·MONTH RATES
Cooper et al. 1976
(81)
Jain 1975 (214)
Ladehoff et al. 1961
(243)
Luukkainen et al.
1979 (287)
Prema et al. 1979 1
(372 )
Place
US
US
Denmark
Denmark, Fin land,
Sweden
India
Roy et al. 1979
(399)
US
Sivin & Stern 1979
(438)
US, Canada
Tatum 1975 (476)
US, Canada
Thiery et al. 1980
(492)
Belgium
24-MONTH RATES
Allonen et al. 1960
(15)
Jain 1975 (214)
Lefebvre et al. 1979
(261)
Lim et al. 1962
(273)
McCarthy et al.
1962 (295)
McCarthyet al.
1962 (296)
Royet al. 1979
(399)
Sivin & Stern 1979
(438)
Thiery et al. 1980
(492)
36-MONTH RATES
Nygren et al. 1961
(336)
Roy et al. 1979
(399)
48-MONTH RATES
Nielsen et al. 1982
(322)
Devices
Studied
TCu·22OC
TCu-300
TCu-200
Cu-7
TCu-200
Multiload 250
Nova T
TCu·200
TCu-200
TCu-220
TCu-380A
Soonawala Y
TCu-22OC
TCu·300
TCu· 380A
TCu-200
TCu-22OC
TCu-200
TCu-380A
TCu- 200
TCu-300
TCu -200
TCu- 380A
TCu -200
TCu- 22OC
TCu-200
Multiload 250
Denmark, Finland, Nova P
Sweden
TCu·200 a
US
TCu-200
Cu-7
Canada
TCu -200
TCu-300
TCu-200
TCu-300
Singapore
Multiload 250d
Multiload 375
Singapore
Cu-7
Multiload 250
Singapore
Cu-7
TCu-22OC
Multiload 250
US
TCu-22OC
TCu -300
TCu-380A
US, Canada
TCu-200
TCu-22OC
TCu-200
TCu-380A
Belgium
TCu-200
Multiload 250
vent Rates (~er 100 Women)
Bleeding
No. of Accidental
IPain
Infection
Women Pregnancy E· pulsion
483
516
1,839
1,831
116
124
741
780
250
227
281
119
903
498
391
1,0 14
1,097
1,851
1,679
2,479
2,394
2,772
2, 199
2,196
2,198
730
664
0.9
1.1
1.5 ,
2.8
0.9
0.8
0.7
1.8
0 .9
0
0
0
1.1 a
1.5a
0.5 a
744
786
1,839
1,831
537 b
495 b
449 c
462
274 d
1.4 ,
3.8
3.8
4.5
2.2
3.9
5.1
2.7
1.8a
275 d
299
192
200
200
200
903
498
391
1,014
1,097
1,851
1,679
730
664
tNot randomized
8-106
2.1·
4.3 a
4.2a
9.8·'
0.6"*
4.0a
2.6 a
2.6 a
1.0a
5.7
5.0
10.0 ,
19.5
6.1
5.7
5.3
3.7
2.9a
1.8a
15.6a
3.7a'
16.9a•
8.5 a,
2.3 a
14.4
9.3
8.4
10.0
12.2
7.4
10.5
11.0
4.3
5.5
10.6
7.8
15.6a
10.2 a*
16.3"
10.3
11.5
11 .5
14.2
12.0
10.1
10.7
11.8
8.0
8.9
1.4·
2.3 a
16.0
13.7
12.6
14.3
15 .1
17.0
16.6
13.3
8.5·
12.2a
12.4a
10.7a
5.0
1.8
5.6
1.0 *
1. 2a
1.1 a
9.0
9.8
8.3
9.5
3.1 a
1.2'
13.3·
14.4 a
12.6a
27.6 a
19.7a'
27.1a
16.1
17. 1
18.9
23.7 *
1. 9a
3.8a
.
8.1a
89"
8.7 a
Denmark, Finland, Nova T
Sweden
TCu-200
US
TCu-22OC
TCu-100
TCu-380A
746
783
903
498
391
2.0
4.8 *
3.4'
4.3·
1.0"
7.0
5.2
1O.0a
11.5·
13.2a
19.9
17.9
32.3a
28.5 a
29.7 a
Denmark, Finland,
Sweden
746
783
2.2
5.0 *
7.6
6.4
22.9
21.5
Nova T
TCu-200
NA ~ not available
'Reported as statistically Significant difference. Some studie s do not report
signifi cance.
2.1
0.9
3.1
1.0 *
2.9
2.6
3.2
1.1*
1.5
0.6
1.0"
0.5 a
3.7
3.1
8.8 ,
15.5
2.6
7.5
4.2
4.6
4.6
4.1
7.1
4.1
5.7a
4.9a
5.2a
7. 1
8.0
7.1
7.1
9.4
9.6
5.9
5.7
6.1
6.7
2.7a
1.2a
'Cross I
hNull ip,
CMult ip
dPostab
Other
Medical
Continuatio
Rate
-----{). 9 - ­
- - 2.1 - ­
--3.4-­
--4.0­
0
4.3
1.6
0
1.8
1.5
1. 7
2.2
NA
0
NA
0
NA
0
NA
122
- - 1 . 6' -­
--2.7a_­
- - 3 . 5 a- ­
- -3 . 6 - ­
- -2 3 - ­
- -2.8- ­
- - 3 .0 ­
- - 2. 8 - ­
--3.9-­
- - 2 . 5 -­
- - 2. 8 - ­
- -2.3­ --2.1-­
0.2a
NA
O.la
NA
71 ."
63.7
66.1
72 6
76 .
72 . 1
72. ,
73 .'i
70.8
69 !
68.9
68 8
73.2
74.1
77.\)
77. 9
93 .1
94.4
--6.1- ­
0.9
2.9
0.7
2.9
3. 1
1.0
2.3
0.8
- -7.2"-­
--7.2a_­
- -7.6a- --101"- ­
- -5.4 a- - - 4.7a_­
- - 6 . 7 a- --4.4"-­
- - 5 . 9a- ­
--9.6"-­
- - 5 .0 ­
- - 4. 0 ­
- -4.3- ­
- - 4 .7- ­
NA
0.2'
O. la
NA
64.7
65 5
58 5
46.3
62 . 1
59. 1
53 .0
58 3
NA
NA
61.9
71 .4
NA
NA
NA
51.8
57.5
50.
55.9
597
50.0
50.1
90.0
89.5
1.7
25
3.1
2.6
- - 6 . 4 a- ­
- -7.8' - ­
- - 1 3.3 a*- ­
48.8
509
43.0
41 .1
378
2.6
2.5
2.4
2.4
74 r )
79.7
73. I
63.tl
73 1)
76,
77.B
75 8
77. 1
--~.9--
3.4
3.7
2.1
4.5
43 2
42 <I
tes; all othe r studies report net rates.
ous women
ous women
<1ion insertions; all other stu dies involve interval ins. rtions.
POPULATION REPORTS
TCu-220C than with the TCu-200 (372 , 399, 476). One re­
searcher suggests that this may occur because the copper
sleeves reduce the flexibility of these devices (399). Despite dif­
ferences in some event rates, however, continuation rates are
simiilar for all copper devices.
Stu~ies
in several countries with the Multiload-cu 250 and 375
show pregnancy rates of less than 1.0 at one year (243 , 280,
446, 515, 518, 519, 520, 547). In randomized comparativ~
trials, however, the pregnancy rates for the Multiload-cu 250
wf> \e similar to the rates for the TCu-200 and the Cu-7 (243,295,
492? and higher than the pregnancy rates for the TCu-220C
(296). Preliminary results of a trial comparing the Multiload-cu
375 with the TCu-380Ag show similar and low event rates for
both devices (78). One of the first copper device~ , the Cu-7,
often has been preferred for null'iparous women because ihe
diameter of the inserter tube is small (see photo, p. B-118). Ran­
domized comparative trials with other devices have found that
the lCu-7 has higher pregnancy and expulsion rates than the
TCu-200, the TCu-220C , or the Multiload 250 (214, 295 , 296,
551 ) (see Table 2). A drawback of the Cu-7 is that the threads
can become looped over the upper arm of the device during in­
sertion. Later, if the threads descend, the woman may think that
the IUD is being expelled (187).
Th J Population Council considers its second generation copper
devices-TCu-220C, TCu-380A, and TCu-380Ag-superior to
the TCu-200 and plans no further developmental research on
new copper devices (317). All three of the new copper devices,
however, may be more difficult to manufacture and distribute
tha ~ the Lippes Loop and TCu-200. None of the newer Ts has
yet been approved by the United States Food and Drug Ad­
mini stration (USFDA). Therefore, they cannot be supplied by
the United States Agency for International Development (USAID),
which has been the major provider of IUDs to developing­
country family planning programs. Because of differences be­
twe~n the USFDA and the manufacturer over the design of the
ste~ of the TCu-220C, the Population Council has not applied
for USFDA approval for this device. USFDA approval of the
TCu-380A is expected shortly. Approval for the TCu-380Ag
may be requested in 1983 (317). More manufacture in develop­
ing countries for local use may eventually be possible (see
p. B-126).
Neither the Multiload-cu 375 nor the Nova T has been evalu­
ated to the same extent as the other T devices or the Lippes
LOOfl. Data from international randomized comparative trials
of the Multiload conducted by WHO and other agencies have
not yet been published. Also, neither device has been used in
the ~S. European reports to date and the increased usage in
Europe suggest, however, that the performance of these de­
vices may be comparable to that of the other new copper
devices.
A family planning worker in Pakistan describes the IUD and other
contraceptive methods. The IUD is a good choice for older, parous
women because pregnancy, expulsion, and infection rates are low.
(UNICEF/Wolf)
with duration of use. In some studies rates declined significantly
after the first and second years (438, 570).
Perhaps these devices continue to be effective because enough
copper remains to prevent pregnancy . In studies in China,
Chile, and Sweden, between 50 and 70 percent of the copper
on the TCu·200 and Cu-7 devices remained intact after four to
five years of use (248, 568, 570). After 60 days, copper in utero
dissolves steadily at an estimated rate of about 45 mcg per day
(172). At this rate, a device with 200 square mm of copper
would have a life span of six years (146). Another study found
that the rate of dissolution very slowly decreases over time and
after two years of use averages 25 mcg of copper per day (308).
Individual variation in the rate of dissolution is wide and may
depend on the composition and quantity of uterine secretions
(237, 498) and the Quality of the copper (237).
Deposits of calcium salt and other organic materials form on
some IU Ds after less than one year of use (148, 149, 217, 394,
429). Some researchers argue that these deposits can block the
release of copper and so impair contraceptive effectiveness
(147, 319). Available evidence does not support this view (158,
436)' since pregnancy rates do not increase with duration of use
(148, 149). And , according to some studies, after an initial
decline, the release rate of copper remains fairly constant over
time (236, 245 , 248, 467, 498). Concern has been expressed
about the fragmentation of copper wire in utero (498). The frag­
ments are microscopic in size, and to date there have been no
reports of harmful effects (146).
Life Span of Copper Devices
A major disadvantage of copper devices with 200 or 250 square
mm of copper wire without a silver core-the TCu-200, Cu-7,
and Multiload-cu 250-is the current recommendation by regu­
latory agencies that they be replaced every two to three years.
This adds to the programmatic and personal costs of IUDs and
also may expose the woman to the risks associated with reinser­
tion. Recently, several researchers have challenged this recom­
mendation (157, 445), More than 10 studies have shown that
the e devices effectively prevent pregnancy for at least four
years (107, 139, 199, 238,247, 322,438, 491, 551 , 568, 569,
570, 578). No studies show any increases in pregnancy rates
POPULATION REPORTS
Steroid-Releas'i ng IUDs
IUDs that release a steroid such as progesterone or levonor­
gestrel are now in use or being tested. Delivered locally in the
uterus, the effective doses of steroid are substantially lower
than doses required for oral administration, and systemic side
effects are less frequent (356, 419). The steroid-releasing de·
vices appear to perform about as well as the first copper IUDs.
The Progestasert, a T·shaped device containing 38 mg of pro­
gesterone with a daily release rate of 65 mcg, is the only steroid­
releasing device currently marketed. In three recent compara·
B-107
tive trials,. pregnancy and continuation rates for the Progestasert
were similar to those of the Nova T, the TCu-200, and the Cu-7
(131,244,362).
The main advantage of the Progestasert is that it significantly re­
duces the volume of menstrual blood loss and so increases
serum iron levels. Thus it may be a good choice for women who
experience heavy bleeding. The Progestasert increases the
number of days of bleeding and spotting, however. As a result,
it is removed for bleeding just as often, or more often, than
other devices. The Progestasert may also relieve dysmenorrhea
(see pp. B- 116- 11 7).
The recommendation for replacement every 12 months limits
the value of the Progestasert for many family planning pro­
grams. A new device, containing 52 mg of progesterone and
also releaSing an average of 65 mcg per day, was tested in a
multicenter WHO trial. The trial was stopped after pregnancy
rates began to increase at 20 to 22 months (396).
Both WHO and the Population Council are testing other
T-shaped devices that release the progestin levonorgestrel. The
WHO device, which contains 10 mg of levonorgestrel, has a re­
lease rate of 2 mcg daily and an estimated life span of 10 years
(551, 552). The release rate was set very low to avoid any
possibility of systemic effects. No data on the performance of
this IUD are yet available.
The Population Council initially developed two devices­
the first containing 43 mg of levonorgestrel released at a rate of
20 mcg daily; the second containing 56 mg released at a rate of
30 mcg daily. A comparative trial of these two devices and the
Nova T reported 2-year pregnancy rates of 0.6 with the lower­
dose levonorgestrel deVice, 0 with the other, and 3.3 with the
Nova T (284, 329). The greater effectiveness of the levonorges­
trel devices may be offset by more side effects. About 20 per­
cent using either of the levonorgestrel devices had them
removed for amenorrhea or other hormonal side effects. Cum­
ulative rates of removal for bleeding and pain were similar for
all three devices (284,329). The continuation rate for the Nova
T was higher than the rates for the levonorgestrel devices-65.2
per 100 women compared with 56.2 and 52.1 at two years
(284). A modified levonorgestrel device with 60 mg of
levonorgestrel, releasing 20 mcg daily, is now being tested by
The Population Council (437) (see photo, p. B-120).
Research is now underway to find other steroids suitable for in­
trauterine release. IUDs with the natural estrogen estriol pre­
vent pregnancy in animals (29,97,98). Clinical trials in women
have just begun (96). In the Netherlands, Willem van Os is de­
veloping a Multiload device that releases the progestin deso­
gestrel (517). Devices with the progesti n dehydroretroproges­
terone were ineffective. Five pregnancies occurred in the first
500 woman-months of use (420). WHO stopped research on a
norethisterone-releasing IUD because high doses were re­
quired to reduce menstrual blood loss (552).
Despite new designs and the use of different bioactive agents,
none of the newer devices has proved to be markedly superior
to all others in overall performance and continuation rates. Fur­
thermore, the design changes that improve one aspect of per­
formance often diminish another aspect (228). Moreover, vari­
ations in the populations under study, insertion procedures,
skill and training of the providers, and methods of counseling
and following up users all can affect performance as much or
more than the characteristics of a particular device. Difierences
among studies or among study centers testing the same device
are often greater than differences among devices in one study
B-108
(586).
montltinuati
B-1 06~
clini ctional
n seven studies of the TCu-200, for ex.l mple, the 12­
pregnancy rates ranged from 0.9 to 3.2 and th e con­
In rates, from 69 to 93 per 100 women b ee Table 2, p.
Also, pregnancy rates as low as those r ported in sm ) 1I
trials often are not attained when an lU I is used In r a­
Irograms. As Lynda Cole and David Edel an co m.:lud
Fur ler studies and research are required to eval uate the r la­
tivf merits of different types of IUDs for use in diff rent popula­
tior
Factors other than even I rates influence l Ie best IU D
che ce for a given subject and a given program. I is dou btful
tha lny one type of IUD is best for all women. (7'J)
Data w m the World Fertility Survey (WFS), Contra eph 'e
Preval nce Surveys (CPS), and other surveys ofertility s ggt
that t e number of women using IU Os has remaine lai"ly
stable It about 60 million in recent years (see Table 3). M ore
than t l o-thirds of all IUD users are in the People's R pu blic
of Ch la (see Figure 1)' where about 35 percent of arrled
womt 1 of reproductive age use IUDs (72). By cont rast, in
most eveloping countries 5 percent or fewer of the w omen
surve ;d used IUDs. Only in South Korea and Venezu la , 0
surve show as many as 10 percent of marri ed women usmg
IUDs 65, 521). In some developing countries the per :enta e
of we en usi ng I U Os has stayed roughly con tant w hile l e
perce tage using the pill and sterilization has inc reased; th u~ a
Tabl( 3. Estimated Number of IUD Users Worldwide, 1 81
Region
Estimated No.
of IU D USt rs
Estimated % of
MWRA Using IUD, (in 1, 000. /
ASIA China
Indial subcontinent
Other \sia
All re, on
35 1
3
13 42,100
1, >DO
2, 000
45, 900
AFRI( Tropic I Africa
0.5 300
LATlI' AMERICA & CARIBBEAN Brazil
All ot r
All r€) o n
0.5 3
2.2 80
1,000
1,800
MID[ E EAST & NORTH AFRICA All ret on
2
aoo
25 7
6
5
7
6
600
7, 100
2,600
1,000
200
11.700
2
6,500
6
3
35
11 .700
18,200
42,100
60,:>00
DEVE OPED COUNTRIES Scand avia
Other Europe
US & Canada
Japan
Austr••lia & New Zealand
All r ,on
TOTA l S Devel ping countries, exc .ding China
Oevel ,ped countries
Worl( excluding China
Chin
World
8.7
MWRi - married women of reproducti ve age
POPULAT ION REPO TS
Figure 1. Distribution of IUD Users Worldwide,
by Region, 1981
drawal , from 33 percent in 1972 to 22 percent in 1976, and
also by declines in the use of periodic abstinence and con­
doms. The percentage of married French women using oral
contraceptives rose from 11 to 27 percent in the same period
(266, 505) .
~--- Europe 13%
~.=:!!!!!
=::
=
us &
Canada 4'.(,
lapan, Austra lia,
}
19%
1
& New Zealand 2%
:ii:~~eO~::~
&
North Africa 1.5%
latin America &
Caribbean 3%
The availa bility and promotion of several copper IUDs may
be responsible for increased IU D use in Europe . In Sweden
copper IUDs were introdu ced in 1972, following publicity
about the adverse effects of orals in the late 1960s and early
1970s. It is estimated that the number of Swedish women us­
ing IUDs nearly doubled in the yea r following the introduc­
tion of copper IUDs-from 59,000 in 1971 to 103,000 in
1972-and reached 294,000 by 1977 (302).
11 °..(:,
Donor Agency Supplies
Asian
Cou ntries 6%
sm II r percentage of all contraceptors now use IUDs (see Table 4) (65). In northern Europe, however, a substantial in­
CrEo';)Se in IUD use occurred in the 1970s. In China IUD use appears to have increased in the past 10
yea rs. About half of al l Chinese contraceptors now use IUDs
(72). Fo r the last decade IUD inse rtions have con Siste ntly been
the most common of the "four planned birt h operations" ­
which also include vasectomy, tubal ligat ion, and induced
abor ion (72). Between 1971 and 1978, 94 million IUDs were
inserted (72) . In Taiwan , government estimates indicate that
aboLt 25 percent of married women are using IUDs (333). A
hig~ proportion of married women in Vietnam also are re­
ported to use IUDs-about 27 percent (561).
Surveys indicate little ch ange in IUD use in deve loping co un­
tries, and program sta tistics suggest no change or possible
declines. In 12 developing countries with successive surveys
ove~ the last decade-Barbados, Colombia, Costa Rica ,
Jam aica, South Korea, Mexico, Panama, Paraguay, Singapore,
Syria, Thailand , and Trinidad and Tobago- the percentage of
women using IUDs remained about the sa me (see Table 4). In
South Korea surveys show a decline in the percentage of con ­
traceptors using IUDs-from 25 percent in 1974 to 18 percent
in 1979 (see Table 3), The decline was more than matched by
the increase in voluntary sterilization from 14 percent to 38 per­
cent of contraceptors (65 , 310).
In most developing countries the great majority of IUDs are
supplied by various national and international donor agencies
that purcha se large quantities at the lowest possible price and
ship them to government and private programs. In the last
three years about 10 million devices were provided by eight
agencies, according to shipment statistics (see Tabl e 5). This
figure is consistent with estimates based on survey data of 6.5
million current IUD users in developing countries excluding
China. The US Agen cy for International Development (USAID)
supplied 2 million IUD s in 1979 and about half a million in
both 1980 and 1981. The United Nations Fund for Population
Activities (UNFPA) provided about 2 million to 36 countries in
1981.
USAID supplied nearly 2.9 million IUDs directly to Egypt , In­
donesia, and Chile between 1979 and 1981-nearly 90 per­
ce nt of ali USAID IUD shipm ents in that period-and also sup­
plied smaller quantities of IUDs to 29 other countries. Family
Figure 2. Increases in IUD Use Among Married Women of
Reproductive Age (MWRA) in Europe, 1970-1978
Service statisti cs show a mixed pattern. The number of first in­
sertions performed by government family planning programs
has Id eclined in Bangladesh , South Korea, and Sri Lanka; re­
mair~ ed stable or fluctuated moderatel y in Indonesia, India,
and aiwan; and remained stable but accounted for a smaller
perce ntage of new contraceptors in Thailand , Mexico, and
Egypt (333, 334).
By contrast, in northern Europe surveys of married women
show a dramatic increase in IUD use in some countries during
the 1970s (see Figure 2). In Finland between 1971 and 1976,
IUD use increased ninefold, from 3 to 28 percent. In France,
IUD use rose from one percent to 12 percent between 1972
and 1976. In Norway 29 percent of married women used
IUDs in 1977, and in Sweden, 16 percent in 1981 (332,479).
I
In creaSing IUD use in Europe appears to be part of the general
moderni za tion of European co ntraceptive practice. In France,
for example, the rise in IUD use was accompanied by a
decline in the percentage of married women using with-
POPULATION 'REPORTS
Belgium
Denmark
1971
1977
Finland
1972
1978
France
1970
1976
United
Kingdom
Sources: Belgium: Cliquet et 01. (76, 77); Denmark: United NJtions (505)'
Schmidr (415); Finland: Un ited Nations (505), Riihinen et al. (383); France:
United Nations (505), Leridon & Sardon (266) ; United Kingdom: Bone (44).
Dunnell (103),
B-109
Table 4.
Percentage of Married Women of
Re
as Reported by Representative Sample
% Using
Region & Place
AFRICA
Kenya
Lesotho
Mauritius
Senegal
ASIA & PACIFIC
Bangladesh
Fiji
Hong Kong
Indonesia
Korea, Rep. of
Malaysia
Nepal
Pakistan b
Philippines
Singapore
Sri Lanka
Thailand
% of
Contraceptors
Using
IUDs'
Ref.
No.
Date of
Survey
Any
Method
227
272
192
272
1977-78
1977
1975
1978
7
7
46
4
1
0
2
0
66
66
197
66
66
310
66
66
66
66
571
571
66
66
310
1975-76
1974
1977
1976
1974
1979
1974
1976
1975
1978
1973
1977
1975
1975
1978
8
41
71
26
37
54
33
2
5
36
60
71
32
36
53
1
5
3
6
9
10
1
0
1
2
3
3
5
7
4
30
47
3
4
11
9
31
43
41
31
47
1
0
1
0
0
2
0
1
0
64
45
48
51
66
65
66
32
34
44
18
31
27
25
40
55
51
0
9
8
1
20
16
17
8
7
9
9
10
8
7
19
3
9
5
4
5
IUD
urveys, 1970-1981
% Using
Reg
In
& Place
Mexico
LATIN AMERICA & CARIBBEAN
Barbados
104
1971
1981
86
Brazil
Bahia
390
1980
Paraiba
390
1980
Pernambuco
390
1980
Piau;
310
1979
Rio Grande
390
1980
do Norte
Sao Paulo
1978
310
Colombia
1976
66
310
1978
1981
86
Costa Rica
1976
66
310
1978
1981
86
Dominican Republic
66
1975
EI Salvador
1978
310
Guadeloupe
70
1976
Guatemala
310
1978
Guyana
1975
66
Haiti
204
1977
Honduras
86
1981
Jamaica
66 1975-76
310
1979
1976
Martinique
70
8
5
5
6
3
3
3
1
6
1
2
2
2
3
10
3
4
4
13
12
4
23
24
18
3
0
20
6
5
4
16
19
8
Note: Data (rom Contraceptive Prevalence Surveys (86, 310, 390) exclude
douLhc, abstinence, and " other" (rom total contraceptive us('rs; data (rom
World Fertilit y Surveys (66, 70, 171 , 204, 22 7, 272, 499, 521) include th 5e
methods.
Note: Women surveyed are currently in union (Latin America & Caribbean) or
married (elsewhere), age 15- 44 or 15- 49. Exceptions are: AFRICA : Lesotho, (ecund, nonpregnant (includes users of voluntary sterilization); Mauritius, evermarried, age < 50; Senegal, (ecund , nonpregnant (in cl udes users of voluntary
sterili zation); Sudan, fecund, nonpregnant (includ es userS of voluntary sterilization); LATIN AMERICA & CARIBBEAN Barbados 1971 , all wom en 15-45;
Costa Rica 1976, age 20-44; Haiti, fecund , nonpregnant (includes users of
voluntary sterilization); Panama 1976, age 20 - 44; Puerto Rico, ever-married;
Trinidad & Tobago 1970, ever in union ; Trinidad & Tobago 1977, fecund , nonpregnant (includes users of voluntary sterilization) ; Venezuela, fecund, nonpregnant (include- users of voluntary sterilization); MIDDLE EAST & NORTH
AFRICA : Syria 1978, fecund , nonpregnant (includes USerS of voluntary sterilization); Turkey, fecund , nonpregnant (includes users of voluntary sterilization);
DEVELOPED COUNTRIES: Belgium 1971, age 30-34; Belgium 1975-76, age
16- 44; Bulgaria, (ecund, nonpregnant (includes users of voluntary ster'ilization),
in first marriage, age < 45; Canada, all women ; Czechoslovakia 1970, age
8-110
roductive Age Using IUDs,
Panam
Paragu y
Peru
Puerto ico
Trinid a & Tobago
VenezL la
% of
Co n tra­
cept ors
Using
IU D s·
Ref.
No.
Date of
Survey
Any
Method
66
310
66
310
310
66
66
374
179
499
521
1976-77
1978
1976
1979-80
1977
1979
1977-78
1974
1970
1977
1977
33
41
55
61
24
39
31
61
40
61
60
3
J
6
8
3
0
4
17
15
25
5
23 c
23
32
50
2
2
0
0
1
7
4
15
88
87
76
62
66 c
95
67c
75 c
77c
75 c
64 c
2
4
2
5
14
18
3
10
MIDDI EAST & NORTH AFRICA
1981
Egypt
86
1976
Jordan
66
272
1978
Sudan ,"orth)
412
Syria
1973
272
1978
Tunisi; (Jendouba)
310
1979
Turkey
171
19 78
DEVEL )PED COUNTRIES
Belgiur (Flemish only) 76
77
Bulgarl
272
64
Canad
Czech , lovakia
505
272
Denm. k
505
415
Finlan. '
505
383
France
505
266
Hunga r"y'
202
Italy
118
272
Japan
506
Nether nds
265
Norwa
332
Polanc
505
272
Roma r d
506
Spain
456
479
Swede
UK (E I land & Wales) 44
103
US
505
125
311
Yugosl via
272
1971
1975-76
1976
1976
1970
1977
1970d
1975
1971
1977
1972
1978
1977
1976-77
1979
1974
1975
1977
1972
1977
1978
1977
1981
1970
1976
1970
1973
1976
1976
88
73
77 c
78
67"
66c
71c
57 c
75
57 c
50
62 c
75 c
76
65 c
70
68
58
IlD
6
7
4
4
3
6
1
4
3
!8
1
12
10
3
14
5
4
29
1
8
0
1
16
4
7
5
7
6
5
IS
17
7
6
14
1~
8
2
1
3
22
8
2
4
2
8
~1
19
4
13
4
]7
2
I
13
4
18
7
6
39
1
10
0
26
5
8
7
10
9
9
< 50; (
sterili za
1975, '
18-54;
use r o
all WO II
(i nclud,
lands,
pregna,
age < 50
zation)
echoslovakia 1977, (ecund, nonpregnant (include< users o( \ " Iun' ary
on), in first marriage, age < 45; Denmark 1970, age 18- 49; ~n mark
18-49; Finland 1971 , age 18-54; Finland 1977, in first nHrr tge
ranee 1972, ever-married, age <45; France 1978, fecund li nel l es
voluntary sterilization), age 20-44; Hungary, age
40; Italy 1'176-77,
'n age 18-64; Italy 1976, age 18-64; Italy 1979, f cund, nonpreg, ant
users oi voluntary sterilization), in nrst marriage. dge < 45; Nether­
arried continuousl y since 1963-1973, all "ges; No ay, (ecuf1 d, roon­
(excludes users o( voluntary sterilization), age 1 ~44; Poland I' 72,
; Poland 1977, fecund, nonpregnant (includes user; o( voluntil')! st. rili­
In first marri age, age < 45 ; Romania , in first marri ~e; Spain ieel d,
.Ionpre 1ant (includes users of voluntary sterilization); Sweden, all wornen 18e
20- 44; OK 1970, age 16-40; US 1970, ever-married , age 45; Yugo lavia Iecund, , Inpregnant (includes users o( voluntary sterilizatiorl , in first mMri. ge.
age <
' Figure
bpaki st,
menti,
'Excluo
d
Denm
1re not derivable from preceding columns due to r undinll.
- -Respondents were d, ked about use only after they spont, lneo 'sly
led method in knowledge section o( survey.
, sterilization
k 1970- Excludes central municipalities of Copenh 3~en .
POPULATION REPO
TS
Planning Internation al Assistance (FPIA), with USAID funds,
provided nearly one million IUDs, primarily to the Philip­
pines, Mexico, Peru , and Turkey. The Intern at ional Planned
Parenthood Federation (lPPF), largely with USAID funds, pro­
vided about 1.6 million IUDs to its affiliated private family
planning programs in 80 countries. About half went to Chile
and Colombia. The numbers of IUDs sent by UNFPA to spe­
cific countries are not available, but India and Vietnam were
thelmajor recipients in 1979-81.
Types of Devices Used
No data are available on the number of each type of IUD cur­
rently in use. Organon International B.V. , which manufac­
tures the Multiload through its subsidiary, Multilan S.A., has
estimated the 1979 world sa les by type of device (see Figure
3). By thi s estimate, copper IUDs accounted for 80 percent of
Nohh American and 90 percent of West European IUD sales,
but for only about 10 percent of IUDs sold or distributed in
developing countries excluding China (83). Most IUDs in
Chiha are stainless steel rings. Small numbers of copper de­
vices and plastic devices are being used in certain areas and
studied in clinical trials (72). Plans are being made to produce
TCu-220Cs in China (350).
As a result of public sector distribution, the use of copper
IUDs in developing countries has probably increased signif­
icantly since 1979. The major donor agencies supp lyi ng the se
cou ntries have shipped increasing proportions of copper IUDs
in the last three years. USAID, for example, shipped two to
thr~e times as many TCu -200 devices as Lippes Loops in 1980
and 1981 (507)
USAID policy is to supply only con traceptives that have been
approved by the United States Food and Drug AdministrJtion
(USFDA) for US use. As ot' July 1982 the only available devices
approved for US use were the Lippes Loop, the Saf-T-Coil , the
Cu-7, the TCu-200, and the Progestasert . To date USAI D has
sup li ed the Lippes Loop and the TCu-200.
Figure 3, Estimates of Market Shares by IU D Type, 1979
~:---------------:---=-=
Developin
g
countries
except China
L..-_ _ _ __ _
I
~--------~:,I
....
~,.-- ., ~r
'J
I I
.'.
.
I
,
-
~......
__
~
_~ ;
-
•
_ .
..
China
Western
Europe
I
I
Eastern
L..-_ __ _ _ __ __ __ _ _ _ _ __ _ __ _ _
I Europe
~
Table 5, Deliveries of IUDs by Major Donor Agencies,
1979-1981 (in 1,000s)
Subtotal "
Plastic
D
Steel
,ouree' adapted Irom L.
r usen ,
POPULATION REPORTS
Copperbearing
•
Progestin­
releasing
rganon Internat ional 8 V. (83)
22
6
97
53
29
NA
44
44
201
40
50
110
294
58
199
111
94
50
121
633
Subtotal"
127
50
108
32
1,170
317
1,296
182
582
32
10
2,102
149
246
179
207
10
791
107
337
26
156
165
791
96
534
126
171
187
1,114
352
1, 117
331
534
361
2,695
1,189
35
2
4
NA
1,230
126
56
272
3
NA
457
256
73
49
220
598
1,571
164
324
7
220
2,286
NA
NA
68
68
2,198
NA
369
505
236
NA
594
NA
592
516
188
NA
165
10
2,065
LATIN AMERICA & CARIBBEAN
USAID bilateral
IPPF
FPIA b
Pathfinder
PAHO
Subtotal"
MIDDLE EAST & NORTH AFRICA
USAID bilateral
IPPF
FPIAb
Pathfinder
WHO
Subtotal'
EUROPE
WHO
AGENCY TOTALS
USAID bilateral
UNFPA c
IPPF
FPIA b
Pathfinder
WHO
PAHO
SIDA
10
11
3,329
-­
Total"
485
2,000c
701
327
211
370
187
110
4,391
3,277
2,OOOc
1,662
1,350
633
370
361
131
9,784
Note: USAID bilat eral aid is provided directly to nalional progr,)ms. Supplies
purchJ..<ed by USAID ,Iso are di stributed by FPIA, IPPF, and Pathfinder. .1 Sum of year column, may not ef1 ual tOlal due 10 rounding. bFPIA ligures are for fi s al year, . eNo regional breakdown is availahle for UNFPA. Source" US Agency for International Developmen t (USAID) (507); Uniled Na· tions Fund for Population ,\ctivili s (U FPA) (28. 264); Internation.,1 Planned Parenthood Federation (IPPF] (60); Filmily Planning International Assistance (FPIA) (15b); Palhfinder Fund (102); World Healt h Organization (WHO) (320); Pan American Health Orgilni 7.al ion (PAHO) (455); Swedish International Devf'l· opment Au thority (SIDAI (469). I
..
~
o
Total"
339
102
165
NA
10
616
830
30
310
NA
USAID bilateral
IPPF
FPIA b
WHO
SIDA
,.
World
1981
ASIA & PACIFIC
""7
r::j
30
58
14
25
NA
11
138
USAID bilateral
IPPF
FPIA b
Pathfinder
WHO
SIDA
!'
[
1980
AFRICA
North
America
World
except China
1979
Region
'---r""'­
.
I
••
•
.
'
.
'
.
.
.
Proper insertion of an IUD is important. Insertion can affect all
major events that determine success of use-pregnancy, ex­
pulsion, bleeding, pain , perforation, and infection. While
there are seve ral different te chniques for inse rting IUDs, with
each the skill of the operator is critical. IUDs can be inserted
safe ly at any time during the menstrual cycle as well as after
childbirth or abortion. Expul sion rates are higher after early
postpartum insertion but not after first trimester abortion.
B-1 11
Insertion techniques vary depending on the type of device. All
IUDs should be inserted as high as possible in the uterine cav­
ity to guarantee the most effective protection against preg­
nancy and to reduce the likelihood that uterine contractions
will cause expulsion. The Lippes Loop is inserted by the "push­
out" technique . The tube containing the device is inserted in
the uterus about 4.5 cm beyond the external cervical os, and
the IUD is pushed out by a plunger. Copper devices such as
the TCu-200 use the withdrawal technique. The tube contain­
ing the device is inserted up to the uterine fundus. The tube is
withdrawn while an inner rod holds the IUD in position. Then
the rod is withdrawn. The Multiload and Progestasert are in­
serted like the T devices, but the inserter tube does not contain
an inner rod. In the case of these two IUDs, the arms of the de­
vice do not fit within the tube but are pressed against the out­
side of the tube as it passes through the cervix. The withdrawal
method is thought to cause fewer fundal perforations than
the " push-out" technique (25, 21 1, 392, 475, 511). (See box,
p. 8-115 .)
Timing of Interval Insertion
Established practice has been to limit insertion of IUDs ill
women who are neither postpartum nor postabortion to dur­
Table 6.
Author, Date,
& Ref. No.
6-MONTH RATES Aznar et al. 1980
(27) IFRP 1981 (209)
Sobrevilla et al.
1980 (45 1)
Thiery et al. 1980
(492) WHO 1980 (553) 12-MONTH RATES
Aznar et al. 1980
(27)
Sobrevilla et al.
1980· (451)
Thiery e\ al. 1980
(492)
Thiery & Van der
Pas 1982 (490)
WHO 1980 (553)
ing or
ortly after menses, because insertion as thought to
be eas' r and safer at that time (543). This resl riction is not
justifie\ Recent studies of about 10,000 wom en show th t
there i~ 0 one preferable time for insertion (106 . 542). In a S
study, \ hen IU Ds were inserted after the 18th day of the c yel f',
rates 0 pregnancy and removal for bleeding and pain we re
higher, b ut rates of expulsion and pelvic infection were low. r
than w h in sertion around the time of menses. ates for o th, r
medi c- removals during the first two months Jfter ins rti on
w ere II est when IUDs were inserted from th 11th to t ile
17th d. y of the cyele (542). All differences wer small, hm ­
ever. , not her study found no differences in event rat 5
whetht IUDs were inserted during menses or at any o th er
time (1 16). Thus, for a woman who is reasonal' ly sure . h e IS
not pr nant , the best time to insert an IUD is wf en she com s
to a he Ith center to request it.
Postpartum Insertion
For wo en who deliver in hospitals or health c _nters, I D i f! ­
sertion In the early postpartum period (after del ivery b t b ',
fore & -harge) is a safe and convenient procedu re . The ri sks o f
infectic 1, perforation, or heavy bleeding are no greater than It
Performance of IUDs After Immediate Postpartu
Place
Mexico
19 countri es Colombi a Belgium
Belgium, Chile,
EI Salvador,
Hungary, UK,
West Berlin
Mexico Colombia
Belgium
Belgium
Belgium , Chi le,
EI Salvador,
Hungary, UK,
West Berlin
Devices
Studied
Various standard IUDs
Delta Loop
(modifi ed
Lippes
Loop D)
Delta T
{modi fied
TCu-2200
TCu-220C
Lippes Loop
TCu -200
Multiload-cu 250
Lippes Loop
TCu postpartum
Cu-7
Various standard IUDs
Lippe s Loop
TCu-220C
TCu-200
Multi load-cu 250
TCu-200
Multiload-cu 250
Multiload-cu 375
Lippes Loop D
TCu postpartum
Cu-7
Insertions, Selected Studies, 1980-1982
Event Rates (~er 100 Women)
No. of Accidental
Bleeding
Women Pregnancy E pulsion
IPain
Infection
Other
Medical
Continuatio
Rate
1,008
0.4
175
3.4
2,908
0.5"
13.7"
2.5"
---{). 9 " -
NA
1,549
0.1 J
10.6"
4.4"
- -1.3"- -
NA
0
08
0
1.5 c
7.3
1.6
1.3
2.3
5.9
9.4"
7.4"
41.3 c
39.4 c
31. 1c
0.8<'
1.0"
3.5
3.5
18
3.0
2.8
0
0.4"
0
0.4"
- - 6.7- - -4.0--- - D.9 - -
92 .8
88 I
85.0
81l .8
48. 1
.14.
64,6
28
23.5
5.5
1.9
1.7
0.5 a
2.4"
3.4
1.8
0
12.1
5.6
7.2
7.8'
3.6
11.2"
9.9"
52
3.1
4.6
44.1 '
41 .3c
34.8 c
274"
522 b
269
293
272
287
282
1,008
274 0
522 b
269
293
136
135
134
272
287
282
not avaIlable 'Reported as stati stically significa nt; not all siudi es report tesls of S'gnif,cance. 'Gross rates; all other studies report net rales. " 14 % ofTCu·22o( and 12% of Lippes Loop insertions were postabortion; remaind er were one
' Excl udes 37 women whose IUDs were expelled within first 48 hours.
.
1.8"
3.6"
5.7
2.4
4.8
4.6
8.7
5.2
0.9
1.2
0.5
07
3.4
5.3
0
0.4"
0
0.9"
0
0
0
0
0
0.8
- - 9.0--- -5.C)--- -1.8- -
75." 61.
82.1
82 _77. 2
77. ,
82 .2
81l .
84 4
39. 1
46 q
52 ~
NA •.
8-112
to
I +
days po;tpolrtum.
POPU LATION RE PO RTS
I
WHAT THE IUD USER SHOULD KNOW For many women the IUD is an excellent contrac eptive. It is
highly effective and does not require day-to-day action such
as taking a pill or monitoring signs of fertility. During breast­
feeding, unmedi cated and copper IUDs do not affect milk
volume or composition. IUDs are not appropriate for all
women , however. The risks of PID , ectopic pregnancy, and,
in some cases, subsequ ent infertilit y are greater than with
other methods. Thus every potential IUD user needs in­
formed and sympathetic counseling telling her what th e
ri sks and benefits are and how they may apply to her.
Medical contraindications to IUD use, as listed in the 1981
IPPF Medical Policy Statement, include:
• current or past PID ,
• known or suspected pregnancy,
• history of ectopic pregnancy,
• gynecological bleeding disorders before the establish­
ment of a defi.nitive diagnosis,
• suspected malignancy of the genital tract,
• congenital uterine abnormalities or fibro ids that pre­
vent proper IUD placement (211 ).
Other medical factors that might contraindicate IUD use ,
depending on individual circumstances and the judgment of
health care personnel and potential user are:
• anemia,
• nulliparity,
• blood coagulation disorders,
• severe cervical stenosis,
• heavy menstrual flow ,
• severe primary dysmenorrhea,
• for copper-bearing IUDs, copper all ergy or Wilson ' s dis­
ease (a rare inherited disorder of copper excretion) (211).
and the National Family Planning Association of Great Bri­
tain conclud ed, after reviewing research results, that dia­
betes is not a contraindication to IUD use (82,211).
In addition , a woman using an IUD should know :
• how to check for IUD strings and to return for follow -up
care if she cannot locate th e strings or if she misses
a period ,
• common side effects of IUD use such as increased
bleeding and cramping,
• the need to seek medical attention if any signs or symp­
toms of infection appear-fever, pelvic pain and ten­
derness, unusually heavy bleeding, severe cramping,
or heavy discha rge,
• the fact that pregnancy with an IUD in place may be ec­
topic and that abdominal pain and amenorrhea can be
signs of ectopic pregnancy,
• that if pregnancy occurs with an IUD in place, even if a
woman wants to continue her pregnancy, she should
seek medical attention. The device should be removed
imm ediatel y if possible . If not possible, she should be
warned of the risk and symptoms of septic abortion .
• the type of IUD,
• the recommended time for replacement of a medi­
cated IUD.
C
IUD users should be reexamined within three months after
insertion , if possible, to ensure proper placement of the de­
vice . Annual check s also are useful to be sure the device is
still properly placed. Women who have passed menopause
should have their IUDs removed, since narrowing and shrink­
ing of the uterus may make later removal difficult (225).
Unmedicated IU Ds can be used for long periods of time, but
devices with 200 square mm of copper have a manufac­
For the nulliparous w oman who plans to have children even­
turers' recommended lifetime of only two . to three years.
tually, IUD use raises special issues. IUD users are more
The IUDs with more copper have longer lifespans, and the
likely to develop PID than other women, and every epi sode
Progestasert has a one- year li fespan. If a woman ha s forgot­
of PID carries some possibility of tubal obstruction and infer­
ten whi ch IUD she has and when it should be replaced , the
tility. For this reason many clinicians believe that nullipa rou s
color of the cervical threads may give some clu e (see de­
women should not use IUDs (115, 183, 198, 316, 450). In
scri ptions, pp. B-118-120)' but colors have not been standard­
any case, nulliparous women should receive special coun­
ized, and some manufacturers may change thread color.
seling be fore they choose an IUD (49, 504). All women
Regulatory agencies have cautiously limited manufacturers
should know that the risk of contracting PID is greatest for
to
recomm end ing lifespans of several years at most. Never­
tho e who are young, have multiple sexual partners, and are
theless, copper IUDs they may be effective longer (see
frequently exposed to sexually tran smitted diseases . Each
p. B-1 07). Thus routine removal <l nd reinsertion aft er three
w oman can then consider whether th e benefits of IU D use
years may in fact not provide greater protection against
outweigh the risks.
pregnancy but instead m<ly expose the user to the higher risk
of PID, perfor<l tion , and other complications tllat occur
Women with diabetes may al so need special attention if they
use an IUD. Som e studies have report ed higher pregnancy
most frequently soon after insertion. Two devices particu­
rates and different endometrial reaction s among diabetic
• larly associated with serious problems, the Dalkon Shield
women USing IUDs (149,250, 464), while others have found
and th e Mazlin Spring, should be removed in any case and
no difference (260, 544). The Medical Advisory Panel of I PPF
replaced by other devices or other forms of contraception.
six week s after childbirth or at a time unrelated to pregnanc y
(30, 208, 392, 393, 488). Expulsion rates tend to be high , how­
ever. In Santiago, Chile, the 3-month ex pulsion rat e for 1,142
women fitted with lCu-200s between eight hours and si x days
after delivery was 32 compared with 5 to 15 for interval inser­
tion (see p. B-103) (259) . IUDs inserted immediately after de­
livery of the placenta are also frequently expelled . In a WHO
POPU LATION REPORTS
multicenter trial the 12-month expulsion rates following post­
placental insertion w ere 44 for the Lippes Loop D and 35 per
100 women for the Cu-7 (553) (see Table 6).
To try to minimize expulsions, both the International 'Fertility
Research Program (IFRP) and the Population Council have
modified IUDs especially for postpartum insertion. IFRP has
B-113
modified the Lippes Loop D and the TCu-220C (calling them
the Delta Loop and Delta T) by attaching chromic catgut
sutures to the upper arms of the devices. It was expected that
the sutures would embed in the endometrium and hold the de­
vice in place during uterine involution. The sutures slowly
dissolve in the uterus over a 6-week period (206, 257). In ran­
domized trials of postplacental insertion comparing the modi­
fied devices with standard devices, the Delta Loop had a sig­
nificantly lower 6-month expulsion rate than the standard
Loop-16 versus 22. By contrast, the expulsion rates for the
Delta T and the unmodified TCu-220C were very similar-both
about 12 (78). IFRP is currently developing new models of the
Delta Loop and Delta T with projections made of a slowly bio­
degradable copolymer. These projection s are expected to
keep their shape and strength in utero better than catgut su­
tures (541) (see photo, this page).
'!"he Population Council has developed the Postpartum T, a
T-shaped copper-bearing device with additional arms extend­
ing 2 cm upward and outward from the lower end of the stem. A
WHO trial reports a high 12-month expulsion rate of 41 (553).
Careful postpartum insertion technique may be more impor­
tant in reducing expulsions than the design of any particular
IUD (see box, p. B-115). For example , in seven centers where
IFRP researchers performed 1,350 postplacental in se rtions of
the Delta Loop or Delta T, 3-month expulsion rates ranged
from zero to 19 per 100 (78) . This wide variation suggests dif­
ferences in insertion technique and skill. Earlier studies docu­
mented similar variation among centers with interval inser­
tion s (39, 40, 304) . Some investigators-Michael Thiery, for
one-report low expulsion rates regardless of the device or the
time of insertion (488, 490, 492) . In a WHO multicenter trial of
postplacental insertion, the Santiago, Chile, center reported
the lowest expulsion rates. At that center manual examination
was performed after each insertion. If the device was palpable,
and thus incorrectly placed, it was immediately removed and
reinserted (553).
It is not clear whether insertion by hand or with instruments
leads to better placement. When manual insertion wa s com­
pared with insertion using a special 30 cm-Iong flexible in­
serter, there was no difference in expulsion rates (78, 258).
Unpublished data suggest that risk of uteri rie perforation may
be greater in lactating women than in non lactating women
when IUDs are inserted at approximately six weeks or more
after delivery (462) Although confirmation of thi s finding is
necess, ry, it suggests that lactating women may r qui re
special lttention in using IUDs, as they do in using steroidal
contral !ption (see Population Reports, Breast-reeding, Fert"­
ity and Family Planning, )-24, November-Decerll ber 198 1).
Postabortion Insertion
IUDs c n be inserted immediately after first tri mester spont.!­
neous Ir induced abortion. Recent studies in both develop d
and dE l eloping countries confirm earlier findi r gs that mfe '­
tion , p rfo ration, expulsion, bleeding, and pregn ncy rat -s ar
no higl e r when IUDs are Inserted after first trim ester abortil n
than at r interval insertions (20,74,143,231, 82,516 551 ,
568). I Os inserted after second trimester abort r ns, ho\\ev r,
are 5 i 'l 10 times more likely to be expelled Ihan aft r fi ~t
trimest r abortion, accordi ng to a recent W HO multicent r
trial (5 1) .
Comp, ative studies suggest that event rates aft T postaborti( n
inserti( differ among devices. Complications \ ere mo re fre­
quent .... ith the Lippes Loop than with the TCu-2()0, TCu -220 _,
and C\ 7 in several studies (74, 143,231 , 395, 551) (see Ta Ie
1, p. B 104). In the WHO trial, however, the 2-y~ar expulsi< r1
and pr gnancy rates for the Lippes Loop D w re significantly
higher han the rates for the TCu-220C but sim ilar to th rates
for th f CuI Based on these results, the WH Special PI O­
gramn' , of Research , Development and Researc h Train ing i n
Huma Reproduction recommends the TCu- 220C for po t ­
aborti.l use (551).
Postcoital Insertion
IUD il ,ertion shortly after one or more acts of unprotecte d n­
tercou -e may prevent pregnancy by interferi n : with the im ­
planta on of the fertilized ovum in the uterus (42 , 150, 2; 6,
503). r 0 'pregnancies occurred after insertion 0 1 the Cu-? in-l2
wom
up to five days after unprotected intl rcourse. H Jf­
monal ;tudies indicated that fertilization had occurred i 15 of
the w men (503), In a study of 299 women, no pregnJnc es
were Ibserved after postcoital insertion of the TCu- 200 or
Cu-7. n sertions took place up to seven days aft r unpro ecti'd
interc< rse (276), Postcoital IUD insertion do 5 not produce
the si( €-effects of nausea and vomiting that onen occur WIth
POStCl tal use of hormones, although, where genital infectio n
is pre ent , it may increase the risk of pelvil inflam at ry
diseas (PID) (150, 162, 368, 370), Postcoital insertion off :r
the a antage of providing an effective contin uing met hod of
contr3 eption (398). IPPF is now recommendirlg postcoItal n­
sertior of copper IUDs when " there is concern about the oral
admin tration of oestrogen-containing preparati0ns. , ." (21 1).
Measuring the Uterus
An IUD with a new modification especially for postpartum inser­
tion has been developed by IFRP. Projections made of a slowly bio­
degradable copolymer on the arms of a TCu-J80Ag are intended to
help keep the device in place during uterine involution.
B-114
Some researchers believe that pregnancy, expul sion, heil y
bleed Ig, and pain can be minimized by more carefu l m
surem nt of the endometrial cavity and selecti n of the ppro­
priate ' sized IUD (6, 11, 181 , 241, 242, 495) Several small
studi
report that side-effects are more freq uent in women
whos( uterine measurements are outside the normal range of
about .5 to 8 cm from the external os to the fundus (1 1, 1 :5,
220, 47, 486) . New instruments have been develored 10
meaSl re more precisely the length of the elldometri .1I c IV­
ity-tl Hasson Wing Sound I (6, 180, 181)-and both len\.11 h
and \, dth-the Hasson Wing Sound II and th Cavim ter (6,
182, 41 , 495). The usefu Iness and practicali ty of these in­
strum nts for developing country programs is not ci f' ar,
Altho gh more accurate measurement could i entify won n
with -'y small or very large uterine cavities, who would be
POPU LATION REPORTS
Instructions for IUD Insertion With all IUDs, manufacturers' instructions for insertion
should be followed exactly. IUDs and instruments inserted
into the endocervical canal and uterus should be sterile.
The following steps are recommended in the 1978 US Food
and Drug Administration ' s Second Report on Intrauterine
Devices (511):
1. Administer analgesics and sedatives if needed. Use atro­
pine if there is reason to expect syncope (temporary loss of
consciousness). For parous women IU D insertion usually
involves brief discomfort rather than pain, but there is great
individual variation .
Q. Insert a specu,l um into the vagina and inspect the cervix
and vaginal walls.
. . If possible, take a Papanicolaou cervical smear and a
for gonorrhea.
~ulture
I
4. Perform a bimanual examination to determine the size,
shape, position, and mobility of the uterus and to rule out
malignancy or inflammation of adjoining organs.
5. Reinsert the speculum and swab the endocervix and va­
ginal walls with an antiseptic solution.
6. Use intracervical anesthesia or a paracervical block at
this time if necessary. This may be helpful for nulliparous
women, women with cervical stenosis, or women who may
xperience syncope.
I
7. Place a tenaculum on the cervix and apply gentle traction
to straighten and stabilize the uterus. This will minimize
bleeding and risk of perforation.
IFRP Instructions for Postpartum Insertion
The International Fertility Research Program (I FRP) recom­
mends the following technique for immediate postplacen­
tal insertion of an IUD in its clinical tri~ls (207):
1. Grasp the anterior lip of the cervix at the 12 o'clock posi­
tion with a sterile ring forceps (ovum or sponge-holding for­
ceps) (see Figu re A).
2. With a second sterile ovum or ring forceps grasp the IUD
(see Figures Band C) and close the lock of the forceps. Slip
the distal portion of thE' string between the fourth and fifth
fingers to keep the string straight.
3. Insert the IUD through the cervical canal. When the
IU D reaches the fundus, the operator will feel resistance .
Place one hand on the abdomen and palpate the fundus to
confirm that the IUD is placed as high in the uterine cavity
as possible.
4. Once the IUD has reached the fundus, release the ring
forceps that holds the IUD, separate the blades, and gently
withdraw the forcers from the uterine cavity. During this
procedure the strings of the IUD should not move. If more
of the strings becomes visible, the IUD has dropped from
its fundal placement. It must then be removed and rein­
serted.
5. Following removal of the ring forceps that held the IUD,
release the ring forceps that has been grasping the cervix.
6. Trim the strings 1.5 cm from the external os.
8. Insert a uterine sound to determine the direction and
size of the endocervical canal and internal os and the posi­
tion and depth of the uterus. Sounding should be done
gently to avoid perforation. If any obstruction is en­
countered, the IUD should not be inserted. If the uterus is
smaller than 6.5 cm in depth, consider using a smaller than
standard IUD.
9. Insert the IUD, following the manufacturer's instruc­
tions, up to the uterine fundus, with only the strings re­
maining in the endocervical canal. An IUD should not re­
main in the inserter tube longer than two minutes or the
IUD will not resume its shape.
I
more likely to experience side effects, the measuring devices
are expensive and not designed for reuse (495). In addLtion,
health centers may not have a wide range of IUDs available,
and only a few devices come in several sizes.
Removal
Usually IUDs can be easily removed by pulling on the strings.
Sometimes problems occur, however. When the strings are
not visible or when perforation is suspected, clinicians have
several options. Many IUDs in the uterus can be removed with
simple hooks, alligator forceps, or other forceps with narrow
jaws (13, 21, 159, 187, 427, 487) (see photo, p. B-126). Threads
that have been drawn into the uterus can be retrieved by
vacuum aspiration (161, 167, 233). If these methods fail, or if
the device has perforated the uterus, curettage or other
surgi al procedures such as laparotomy or laparoscopy may be
necessary to remove it (167, 431, 504).
POPULATION REPORTS
- - -~------
A
B
c
If facilities are available, diagnosis of uterine perforation can
usually be confirmed by hysterography (x-rays of the uterine
cavity after instillation of a contrast medium), by hysteroscopy
(direct visualization of the uterine cavity with a fiberoptic in­
strument), or by ultrasound techniques. Otherwise, inserting a
sound or a second IUD into the uterine cavity and taking
lateral and anteroposterior x-rays of the pelvi S can help to
locate a displaced device by making clear the position of the
uterus (see photo, p. B-116) (25, 167, 187, 303, 566).
Some devices should be removed promptly when they are
found outside the uterus. Copper devices cause severe adhe­
sions (25, 233, 344 , 373, 476, 504, 566). Closed devices such
as the ring or bow are more likely than others to obstruct or
perforate the bowel (233), IPPF and others favor removal of
progesterone devices as well , since they can produce intra­
peritoneal irritation (162 , 233). With regard to open , unmedi­
cated IUDs such as the Lippes Loop and Saf-T-Coil , some
8-115
researchers believe that they should be removed to avoid po­
tential complication s if they are found outside the uteru s (25,
106, 229, 454,566). Others suggest that they can remain in the
abdominal cavity as long as the user has no symptom s (233 ,
275).
Insertion by Nurse-Midwives and Paramedicals
Nurse-midwives and paramedicals can master the technical
skills necessary for IUD insertion. They may also establi sh a
close rapport with clients that can improve acceptance of
IUDs (109,247,279, 300,349, 378, 433 , 551,559, 567, 569).
Recent WHO studies in the Philippines and Turkey found that
nurse-midwives and physicians were equally able to identi fy
contraindications and complications of IUD use and that ex­
pulsion , pregnancy, and removal rates were similar after inser­
tion by nurse-midwives and by physicians (551). In China fe­
male barefoot doctors in every commune routinely insert and
remove IUDs (572).
Female paramedical personnel may increase the acceptance
of IUDs because women in many cultures prefer these work ­
ers to male physicians (14,380, 413). These women also tend
to be more accessible to clients. The WHO study in the Philip­
pines found that, although expulsion rates after insertion by
nurse-midwives and physicians were similar, nurse-midwives
performed reinsertions for 55 percent of their client s who ex­
pelled IUDs, compared with the physicians' 31 percent. The
nurse-midwives were more successful because they followed
up their clients more frequently than physicians (551).
In some countries auxiliary health personnel are now perform­
ing insertions in women's homes. In the Philippines over 60
percent of the IUD insertions performed by health personnel
of the Bohol project were done in clients' homes (413).
Training programs for paramedical personnel are now being
developed and evaluated. After reviewing the results of two
small programs in the Philippines and Turkey, A. Akin and col-
Women choosing a contraceptive method need accurate and sym­
pathetic counseling in terms they can understand . A pamphlet
designed by PIACT de Mexico to explain IUD use to non literate
women shows that the IUD fits in the uterus as if in a pear.
B-116
made the following recommendations tor other trai ll ­
rams:
technical reference manual adapted t(1 local neecls
)uld be used as the basis for the trainin f.\ program.
Iching physical examination and IUD in, ertion i, m Q ~t
SL r cessful with a ratio of two or three trolinee s p r i 1­
st u ctor.
• T e training should focus on managem nt of norm II
c, es, but all trainees should be given ver clear critell a
f . recognizing contraindications and co plicati ons f
IL D use.
• T linees should perform at least 50 to 60 ) lpervisE',1 p\ 1­
vi examinations before working on their own.
• T linees should perform at lea st 10 to 15 IUD ins rtiolls
u dersupervision (14).
The pi llgrams in the Philippines and Turkey h ve now be. 11
expanl ed, and further evaluation of training, performcl n(
and th extent of supervision needed is undeJ\~ ay (552) .
league'
ing pr
• A
sl• TI
Increa ed bleeding, often accompanied by pa in in the 10,;\ r
abdon ~ n or lower back , is the most frequent problem . I L 0
use. R' Jughly 5 to 15 percent of women have their IUDs r' ­
moved within the first year because of blee ing and pa n.
Three ypes of bleeding changes occur:
• g _ater volume of menstrual blood flow ,
• II 1ger menstrual period s,
• n dcycle, or intermenstrual bleeding or sp tling.
These c hanges may cause both inconvenien p and pnssille
healt risks for IUD users.
Both, ')pper and unmedi cated IUDs increase the vol ume of
blood loss during menses, but copper device~ c.ause t 5S n­
creasr Normal menstrual blood loss in healt h women aver­
ages a lout 35 ml per cycle (178, 212, 538). Wil unmeui led
devic( ., blood loss appro ximately doubles c mpared w ith
prein ~ rtion levels. Average increases range from 20 to 50 rnl
(132, 65, 166, 170, 190, 191 , 212). With the Cu-7 and TCu- 200
devici <;, blood loss increases by about 50 perce nt, or 10 to 30
ml , a ()ve preinsertion levels (166, 191 , 212, 249, 27U, 2 1,
290). he smaller increase in blood loss is prob bly bec •.lus of
the sr aller surface area of these devices, not the add itio n of
COpP( (164,191). Heavy blood loss-over 80 I-also DCC rs
less f equently with copper IUDs than wit il unmed ica ed
IUDs In a Briti sh study 25 percent of the Cu-7 users ~ x ­
periel lCed heavy blood loss compared with 5_ to 60 perc ' nt
of thr Lippes Loop users. Before insertion 10 to 15 percenl o f
all W( nen experienced heavy blood loss (166, 309).
Unlik unmedicated and copper I U Os, pro estin-relea 5lng
devic 5 reduce the volume of blood loss by as m uch as 40 er­
cent I 10, 164, 284,285, 329,406). In fact , the experim e tal
devic 5 with higher doses of progestin cause amenorrh ea in
some omen (284, 327, 329). In several studi s the Proge ta­
sert , so reduced the incidence of dysmenorrhea pail iul
men, uation) by as much as one-third (136, 565, 59 1), , nd
the I( \/onorgestrel IUD, which releases 20-3 mcg per dcly,
even '11ore (283). A recent WHO study, however, found no
signif ant difference between the Cu-7 and the Progf'sta . rt
in tht reduction of dysmenorrhea (361).
AIIIL s tend to prolong menstrual bleeding, often in the for m
of sp' ting, or very light bleeding (565 , 591). Copper devices
POPU LATION REPORTS
may prolong menstrual bleeding more than unmedicated de­
vices. In a group of parous British women, for example, the
sixth menstrual period after insertion lasted on average 1.2
days longer than before IUD insertion for Cu-7 users. For Lip­
pes Loop users, the sixth postinsertion menstrual period lasted
0.4 days longer-an 8 percent increase. Adding copper to the
Lippes Loop lengthened the duration of flow by two days-a
36 percent increase over preinsertion levels (164).
Progestin-releasing devices, while reducing the volume of
blood loss, increase the total number of days of bleeding and
the incidence of midcycle bleeding even more than other de­
vices (164, 188, 244 , 397,511). This difference may decrease
with length of use (188, 329,554) . An increase in the number
of days of bleeding may be less acceptable to women than an
increase in the volume of bleeding (555, 556). In four of five
comparative trials, removal rates for bleeding and pain with
progestin-releasing IUDs were similar to or higher than with
copper or unmedicated devices (131, 244, 284, 329, 362, 554).
Risk of Anemia
The most serious problem that may result from increased
menstrual blood loss is iron-deficiency anemia. About 50 per­
cent of nonpregnant women in developing countries are al­
ready anemic (549) , and many more are on the borderline .
Repeated pregnancies contribute to anemia in many women.
While common sense suggests that increased menstrual blood
loss could lead to anemia or make existing anemia worse, stud­
ies designed to evaluate the impact of IUDs on iron levels have
not produced conclusive results. In Malaysia, Mexico, and
Chile studies 6 and 12 months after IUD insertion showed de­
clines in transferrin saturation and serum ferritin levels (140,
5S1 )-signs of iron loss-and declines in hemoglobin (132 ,
140) and hematocrit (123)-signs of iron deficiency. Several
other studies, however, in India and Latin America, found no
change in various indicators of anemia after 12 months of use
(123, 366, 371 , 385, 386, 584). These studies involved women
using un medicated and copper devices (366, 385, 386) and , in
Mexico, women already moderately anemic (385, 386). By
contrast, among women using progestin-releasing devices,
hemoglobin and average serum ferritin levels increased com­
pared with preinsertion levels (188, 324 , 385, 386, 551).
In developed countries, where anemia is much less prevalent,
researchers also report conflicting results. Some studies show a
decline either in plasma ferritin or in hemoglobin levels after
IUD insertion (63,163, 165, 212,309,404), while others show
no effect (249,270). Recently a US case-control study of almost
4,000 women found that IUD users were at no greater risk of
being hospitalized for severe vaginal bleeding than women us­
ing barrier methods or no method. Among those hospitalized
for heavy bleeding, those who were anemic were no more likely
to use IUDs than those who were not anemic (200).
Limiting Bleeding
Why IUDs cause increased menstrual bleeding is not com­
pletely clear. Mechanical stress to the endometrium caused by
pressure from the IUD or by distortion or displacement of the
device may interfere with the normal blood clotting mecha­
nisms of the endometrium (106, 220, 315, 428). I nsertion of an
IUD leads to a higher concentration of plasminogen activators
(ehzymes that break down proteins and activate the dissolu­
tion of blood clots) in the endometrium. These enzymes in­
crease fibrinolytic activity and prevent blood clotting, leading
to greater blood flow (46, 106, 189, 249, 251, 252, 271, 404,
428). There is some evidence that menstrual bleeding in IUD
users begins early-several days before the end of the luteal
POPULATION REPORTS
MECHANISMS OF ACTION Even though IUDs have been widely used for over 20
years, the precise mechanisms by which they prevent
pregnancy are still unknown. In animals the mode of ac­
tion of an IU D varies from one species to another (511).
In humans several different mechanisms of action ap­
pear to be at work.
All IUDs stimulate an inflammatory, or foreign-body re­
sponse in the uterus, which in turn causes cellular and
biochemical changes in the endometrium and uterine
fluids. These changes are believed to be responsible for
the contracept,ive effect (174, 234, 511). After IUD in­
sertion numerous polymorphonuclear leukocytes ap­
pear in the endometrium and 'uterine fluids, foi l owed by
foreign-body gi ant cells, mononuclear cells, plasma
cells, and macrophages (168,312, 313, 408,409). These
ce ~ ls may consume the spermatozoa or the fertilized
ovum by the process of phagocytosis.
Another theory, not necessarily incompatible, is that
changes in the endometrium , perhaps stimulated by the
inflammatory reaction, delay the normal cyclic changes
of the endometrium , making it inhospitable to implanta­
tion at the time the fertilized ovum ar-ri ves (47,195,216,
426, 560, 564). No evidence has emerged, however,
that unmedicated or copper IUDs cause any fundamen ­
tal changes in hormonal function (173, 234, 367).
Medicated IUDs, in addition to producing an inflam­
matory reaction , have local effects that may playa part
in their contraceptive action. While copper affects the
uterus, its precise role in preventing pregnancy is not
known . Copper interferes with enzymes in the uterus
(347), with the amount of DNA in endometrial cells
(174) , with glycogen metabolism (389), and with estro­
gen uptake by the uterine mucosa. Copper increases
the inflammatory reaction (307) and may increase con­
tractions of the uterine muscle layer, thus preventing
implantation (254). Also, copper ions alter the biochem­
ical composition of cervical mucus. This may affect sperm
motility, capacitation, or survival (23, 222, 234, 379).
IUDs containing progesterone interfere with the normal
hormone-regulated cycle of the endometrium (357, 418).
By maintaining high progesterone levels in the uterus
and, consequently, relatively low estrogen levels, these
devices keep the endometrium in a state in which im­
plantation is unlikely to occur (419) . The small amount of
progesterone released by Progestaserts-65 mcg per
day-seems not to affect the ovaries and is not detectable
in blood serum (419) . By contrast, IUDs releasing an
even smaller amount of the stronger synthetic progestin
levonorgestrel-12 mcg per day-sometimes prevent
ovulation (327) .
phase . This may be because the endometrium in an IUD user
is less sensitive to progesterone and thus begins to slough off
before progesterone levels decline to the point that normal1ly
leads to menstruation in nonusers. Ovarian function is un­
changed, however (51, 122, 293, 335) ,
Research is underway to identify drugs that will reduce mens­
trual bleeding when administered either orally or through the
B-117
Figure 4. Lippes Loop Description: One of the first of the modern IUDs and for years the
standard, the Lippes Loop is the most widely used IUD in developing
countries outside of China. Injection-molded of alathon-20 poly­
ethylene, it comes in four types, the smallest designated A (left); the
largest, 0 (right) . The Loop was the first IUD to incorporate barium
sulfate for radiopacity and the first IUD to have a tail. Developer: Jack Lippes (US) Date marketed: 1962 Distributors: Finishing Enterprises, US; Ortho Pharmaceutical Cor­ poration, US. Length: A, 26.2 mm; B, 25.2 mm; C, 27.5 mm; 0, 27.5 mm. Width: A, 22.2 mm; B, 27.4 mm; C, 30.0 mm; 0, 30.0 mm . Tail : Two threads; A, blue; B, black; C, yellow; 0, white. Inserter type: Push-out Inserter diameter: 4.7 mm Areas of major use: Worldwide Figure 6. Cu-7, or Gravigard
Description: The Cu-7 has copper wire with a surface area of 200
square mm wrapped around its stem . The plastic component is injec­
tion-molded of polypropylene homopolymer with barium sulfate added for radiopacity. Developers: Jaime Zipper and Harvey Abramson (Chile) Date marketed: 1974 Distributor: G.D. Searle & Company, US Length: 36 mm Width: 26 mm Tail: One blue thread Effective life: USFDA-approved, 3 years Inserter type: Withdrawal type; can be used for push-out insertion if desired. Inserter diameter: 3.07 mm Areas of major use: Australia, Canada, Europe, Mexico, US B-118
Figure 5. af-T-Coil
Descript h, : Injection-molded of ethylene vinyl acet a te copolymer
with bari m sulfate added for radiopacity, the Saf-T-Coil com in
three size . the 25-S (left), the 32-S (not shown), and th 33-S (ri ht).
Develope Ralph R. Robinson (US)
Date mar eted: 1965
Distribut..,: Schmid Laboratories, US
Tail : Two reen threads
Length: 2 oS, 20 mm; 32-S, 30 mm; 33-S, 32 mm.
Width: 2: S, 25 mm; 32-S, 29 mm; 33-S, 37 mm.
Inserter t· pe: Retract over plunger
Inserter d . meter: 25-S, 3.76 mm; 32-S and 33-S, 4.5 mm .
Areas of I ajor use: Worldwide
Figure 7. I Cu-200, or Gyne T, and TCu-200B
Descripti n : Injection-molded of polyethylene with barium su lfat£"
added fOl radiopacity, this device was the first medica h"llIUD t ·ted
for contr eptive use. The copper wire wrapped about the ste of
the IUD « poses 200 square mm of surface area. The TCu-200B has a
ball at th. tip of the stem; the TCu-200 does not (not snown).
Develope ;: Howard Tatum (US) and Jaime Zipper (Chile)
Date mar eted: 1972
Distributllfs: Finishing Enterprises, US; G. D. Searle & Co., US ; AB
Kabi, Sw den; Huhtamaeki Oy, Leiras Pharmaceuti( als, Finla nd;
OutokulT' lu Oy, Finland ; Ortho Canada; Ortho Ph.lrmaceu li aI,
Ltd ., UK; ~ hering AG, West Germany.
Length: 3 mm
Width: 3: mm
Tail: Two hreads; color varies.
Effective ie: USFDA-approved , 3 years
Inserter t e: Withdrawal
Inserter ' J meter: 4.4 mm
Areas of !'lajor use: Worldwide
POPULATI
'\J REPORT
Figure 8. TCu-220C and T modified 220 Cu, or Cobritec Description: Of the same T shape as the TCu-200, the TCu-220C has sevf n solid copper collars, or sleeves-two on the transverse arm and five on the stem. With a total exposed copper surface of 220 square mm, this device has a longer effective life than the TCu-200. The T modified 220 Cu (right) has an enlarged round end on the bot­ tom of the stem and on the two transverse arms. Developer: Population Council Date marketed: 1980 Distributors: Promotora e tmportadora PEISA, Mexico; Biotec Lab­
oratories, Mexico (modified version). Length: 36 mm Width: 32 mm Tail: Two threads; TCu-22OC, blue or white; T modified 220 Cu, translucent. Inserter type: Withdrawal. (A new inserter being introduced for the T modified 220 Cu will allow personnel to load and cock the inserter without touching the IUD.) Inserter diameter: TCu-22OC, 4.4 mm; T modified 220 Cu (old in­
serter), 4.7 mm; T modified 220 Cu (new inserter), 4.5 mm. Effktive life: Developer's estimate, 15-20 years ArJas of major use: Mexico Figure 9. TCu-380A and TCu-380Ag
The TCu-380A carries two sleeves of solid copper on the transverse
arm and a coil of copper wire around the stem. In the 380Ag, which is
not yet available commercially, the copper wire has a silver core to
keep the copper from fragmenting. This lengthens the effective life of
the device. Total exposed copper surface area is 380 square mm.
Developer: Population Council
Date marketed: 1982
Distributors: Ortho Canada; Outokumpu Oy, Finland (investiga­
tional use only).
Length: 36 mm
Width: 32 mm
Tail: Two white threads, formerly blue.
Inserter type: Withdrawal
Inserter diameter: 4.4 mm
Effective life: TCu-380A, developer's estimate, 6-10 years; approved
in Canada, 30 months. TCu-380Ag, developer's estimate, 10-15
years.
Area of major use: Canada
Figure 10. Multiload-cu 250 and Multiload-cu 375 Description: Copper-releasing devices with 250 square mm of cop­ per wire around the stems of the Multiload-cu 250 models and 375 square mm on the Multiload-cu 375. The arms are flexible plastic ser­
rated fins that help to hold the device in place. The Multiload-cu 250 comes in four sizes: the standard size, a smaller size ("Mini"), a model with standard-sized fins but a shorter vertical shaft ("Short"), and a larger size ("Maxi"). The Multiload-cu 375 (lower right) is available only in the standard size. Developer: W. A. A. van Os Da.te marketed: 1974 Distributors: Multilan S.A., Switzerland; Organon International B.V., Netherlands; G.D. Searle Ltd. of Canada; Parke Davis, Italy; Laboratoires CCD, France. Width: Standard and Short, 16-20.5 mm; Mini, 12-13 mm; Maxi, 21-25 mm. Tail: Two threads; Standard (250 and 375), translucent; Mini and Short, black; Maxi, blue. Inserter type: Withdrawal (no plunger) Width of device during insertion (fins remain outside inserter tube): Standard and Short, 12 mm; Mini, 9 mm; Maxi, 14 mm. Effective life: Multiload-cu 250, manufacturer's recommendation, two years; Multiload-cu 375, manufacturer's recommendation, th ree years. Areas of major use: Western Europe, Indonesia. POPULATION REPORTS
B-119
Figure 11. Nova T, or Novagard Description: Injection-molded of polyethylene with barium sulfate added for radiopacity. The copper wire wrapped about the vertical stem of the device exposes 200 square mm of copper. The wire con­ tains a silver core to extend the effective life of the device. Developers: US Patent No. 3,937,212 assigned to Outokumpu Oy Date marketed : 1979 Distributors: Huhtamaeki Oy, Leiras Pharmaceuticals, Finland; Outokumpu Oy, Finland; AB Kabi, Sweden; Schering AG, West Ger­
many. Length: 32 mm Width: 32 mm Tail: Two white threads Inserter type: Withdrawal Inserter diameter: 3.6 mm Effective life: Manufacturer's estimate, at least 10 years. Areas of major use: Europe, Canada, South Africa, Taiwan. Figure 13. LevonorgestrellUD 20
Description: Uses the Nova T shape, but w"ith a capsule on the stem.
The core of the capsule contains a mixture of silicone rubber and the
progestin levonorgestrel. This device is undergoing clinical trials and
has not yet been marketed. The model currently being tested con­
tains 60 mg of levonorgestrel released at a rate of 20 meg per day.
Developer: Steroid Research Laboratory (Finland) with Population
Council
Length: 32 mm
Width: 32 mm
Tail: Two white threads
Inserter type: Withdrawal
Inserter diameter: 4.5 mm
Effective life: Developer's estimate, at least 7 years.
B-120
Figure 1 . Progestasert Intrauterine Contraceptive Sys em Descrip n: Uses the same T shape as the TCu-200. progestero ne i silicone lil base is released to the uterus at the rate of &5 meg p r day through the wall of the ethylene vinyl acetate copolymer stem. The reservo i in the stem contains 38 mg of progesterone. The tram.ver arm is Sl id copolymer. Develop or: Alza Corporation, US Date m, keted: 1976 Distribu rs: Alza Corporation, US; Grunenthal GM BH, West Ge ­
many; ~ mpthorne Medical Supplies, New Zealand; Polcrome Ltd., UK; Ret rdati S.A., Italy; Theraplix Division, Rhone Poulenc Sant , France. Length : 6 mm Width : :I l mm Tail: Tw black threads Inserter ype: Modified withdrawal, automatic load ing; inserter 5 curved I mimic the curve of most uterine cavities b t pliable to ht others. Width I device during insertion (arms remain ou tside insertion tube): 8 m. EffectiVE life: USFDA-approved, one year; France, 18 months. Areas of 'TIajor use: US, Western Europe. Figure 1
The mo
a single I
Both cor
Flower (:
and the
mm of CI
Chinese IUDs widely used IUDs in China are 2 tailless stain less steel rings, g of coiled wire (1) and the mahua ring (2), a double coil in many sizes. Two IUDs in regional use are the Cant0l1 ,with flexible plastic petals that move as the uterus moves, hanghai Copper V200 (4), silicone plastic and 200 squar per wire on a flexible wire frame. POPULATI Q
REPORT.
IU D itself. WHO has been testing eight nonsteroidal antiin­
flammatory drugs that are taken orally. Preliminary results
show ,In average reduction in blood loss ranging from 26 to 35
percent with three of these compounds-indomethacin , flu­
fenamic acid , and alcofenac. These drugs offer some relief
from menstrual pain as well and cause few side effects (551).
O ji her prostaglandin synthetase inhibitors, such as naproxen ,
to fenamic acid, and mefanamic acid, also alleviate dysmenor­
rhea and decrease blood loss (61, 90, 128, 563). Prostaglandin
synthetase inhibitors may present various long-term risks, how­
ever (19).
IUDs are now being developed that release antifibrinolytic
agents (205, 484). These agents-epsilon aminocaproic acid
(EACA) and tranexamic acid (AMCA) - are known to be effec­
tive orally in reducin g blood loss (62, 240, 330, 331). WHO is
currently working on IUDs that release diamidines, drugs that
may reduce both bleeding and fertility (552). As yet it is un­
cl rt ain whether any of these devices can be manufactured
cHeaply enough for widespread use or if important improve­
ments in performance will result.
\' !I . :- j
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,
.
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t
:
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.
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I
Studies in the US and Sweden find that IUD users are about 1.5
times, or 50 percent more likely to develop PIO than sexually
active women using no contraception at all (59, 535). In the US
Women' s Health Study, involving 4,900 women , current IUD
users were 1.6 times as likely to be hospitalized with PIO as
women using no contraception and 4.5 times as likely as oral
contraceptive users (59). A higher risk of PIO persisted for about
12 months after the device was removed. In Lund , Sweden,
from 1970 to 1974 the rate of PIO in women age 20-29 was 5.2
per 100 woman-years for IUD users compared with 3.4 for sex­
ually active women using no contraception and 0.9 for oral
contraceptive users (535, 536). Other recent studies in devel­
oped countries have found the relative risk of developing PIO
ranges from 1.5 to 10 for IUD users compared with women us­
ing various other methods of contraception or no method (see
Table 7). Despite the apparently higher risk for IUD users, in
multicenter WHO studies comparing different IU~s, rates of
removal for PIO are low-usually less than one per 100 women
after two years (551).
'
1
R cently new attention has focused on pelvic inflammatory dis­
ea e. PIO is a common health problem. In the US and northern
EJrope about one to two percent of women of reproductive age
contract PI D every year (12, 117, 253, 535). In some developing
countries PIO is widespread , but the exact incidence is un­
known (314). PIO is caused largely by sexually transmitted infec­
ti on . In developing countries PIO also occurs after childbirth ,
induced or spontaneous abortion, and genital tuberculosis.
PID in the fallopian tubes (salpingitis) can cause adhesions or
complete tubal obstruction. Thus ectopic pregnancy or infertil­
ity may occur even after only one episode (177, 219, 531, 534,
535, 539). For example, in a Swedish study of 415 women with
a history of salpingitis, 21 percent were infertile, compared with
3 percent in a comparison group with no history of salpingitis .
Ectopic pregnancy was six times as common among the
women who had had PIO as among the controls (534).
IU D users, particularly young women who are exposed to sex­
uil ily transmilled diseases, are more likely to develop PIO than . n?nusers. All women who develop PIO require prompt treat­
ment with antibiotics, and those using an IU~ may need to have the device removed.
The relationship between IUD use and PIO is difficult to quan­
ti fy for at least two reasons: imprecise criteria for diagnosis of
tHe disease and lack of a standard reference group for com­
p1ri on with IU 0 users (56, 93, 115, 124, 407, 424 , 535). Pelvic
i+ lammatory disease is a general term for infection of the upper
genital tract, including the uterus, fallopian tubes, and ovaries.
Many cases are asymptomatic and difficult to diagnose, even
ith laparoscopy (114, 535, 552). Moreover, both oral con­
traceptives and barrier methods protect against PIO (59, 117,
121.346, 400,407 , 536). Thus, the estimated relative risk of PIO
with IUD use is higher if IUD users are compared with women
using these methods rather than with women using no con ­
traception. In addition , most studies do not take account of the
POPULATION REPORTS
number of sexual partners, the frequency of intercourse, or his­
tory of salpingitis- all important risk factors in PID. Further­
more, in some areas women most exposed to sexually trans­
mitted diseases may have been most likely to have had IUDs
inserted. These risk factors vary in different communities and
are difficult to identify.
It is not clear whether PIO in IUD users takes a more severe
form than in nonusers. Formation of an abscess in the fallopian
tubes or ovaries is one of the most severe forms of pelvic infec­
tion. Many of the reported cases of tubo-ovarian abscesses have
involved IUD users (91 , 105, 138,141,142,226, 281,318,421 ,
485). While most tubo-ovarian abscesses are bilateral, several
studies have found that IUD users were more likely to have uni­
lateral abscesses (138, 141 , 573). Other studies report no dif­
ference (105, 117, 421).
Whether PIO is more likely to occur with longer IUD use is also
unclear, since studies report conflicting results (59, 224, 527).
Unpublished data from the Contraceptive Evaluation Branch of
the US National I nstitutes of Health suggest that women using
IUDs for five or more years may experience more severe but
not more frequent episodes of PI 0 (462).
In developed countries PIO in IUD users, as in nonusers, occurs
most frequently among women under age 25 (49, 59, 121 , 286,
342 , 345, 551 , 552). For example, among 871 nulliparous Brit­
ish women fitted with the Cu-7, the life table rates for PIO after
30 months of use were 14.2 for women age 16 to 19 and 1.2 for
women age 30 to 49 (49). Younger women may have more sex­
ual partners than older women and thus be more exposed to
sexually transmitted diseases (49, 59, 114).
Studies on the role of parity are inconclusive. Some researchers
have found that the rate of PIO is higher in IUD users who have
never been pregnant or borne children than in other women
(11 7, 348, 535, 540). Others find no difference (59, 253, 286,
345, 346).
Mechanisms of Infection
PIO develops when microorganisms from the lower genital
tract ascend into the uterus and fallopian tubes. Several
physiological factors have been suggested as accounting for the
association between IUDs and PIO:
• sterile inflammatory reaction in the fallopian tubes and the
endometrium,
• increased volume and duration of menstrual bleeding,
B-121
• ascent of bacteria along the IUD tail ,
• introduction of bacteria into the uterus during insertion.
Since 1976 six studies of women undergoing sterilization in de­
veloped and developing countries have shown that chronic,
non bacterial inflammation of the tubes is more common in
IUD users than in nonusers (34,115,292, 364,443,552). This
inflammation may reduce resistance to the growth of patho­
geniC organisms (115,443) . Also, IUDs can cause small ulcera­
tion s in the endometrial wall that could allow bacteria to enter
underlying tissue, thus increasing the ri sk of infection (312).
Increased bleeding associated with IU D use may illso enhance
bacterial growth (184, 474, 557). Bacteria are more likely to
enter the endometrium during menstruation, when the cervical
mucus lug is absent, and most species of bacteria multipl y
rapidly 1 the presence of blood (113). PID, pa rticularly ono­
coccal i fection , occurs more often just after mf'nses th an at
other tir es in the menstrual cycle (117, 119, 184, 196, 297, 557).
The tail f the IUD is a potential route of infecti on. Ce rvica
bacteria can ascend into the uterus along the tail c.f the IU D . II
Britain, ichard Sparks and colleagues studied w men under·
going h\ ,terectomy. They found bacteria in the uterine ca itie_
of 12 of 4 women using IUDs with monofilament tails and in all
three \\ )men using Dalkon Shields with multi tll ament l aib
There", _re no bacteria in the uterine cavities 01 five wo e
who hal used tailless Dalkon Shields or of 50 n nusers ( 57
458).01 le r studies suggest that multifilament tail more re d i l ~'
Table 7. Pelvic Inflammatory Disease (PID) and IUDs,
Author, Date,
& Ref. No.
Place
Study
Design
~
lected Recent Studies, 1979-1981
Description of Participants
Findings Burkman & Women's
Health Study 1981
(57, 59.341)
US
Multicenter
case-control
1,447 cases
hospitali zed
with PID;
3,453 controls
-Rei ive risk for IUD users was 1.6 times higher th " n for non­
co r raceptors; 4.5 times higher than for pill users; U times
hi gl er than for users of barrier methods.
-Ris~ higher for Dalkon Shield . lower for Cu-7 and
LiPI 25 Loop .
Flesh et al. 1979
(124)
US
Case-control 163 cases
hospitalized
with acute
sa lpingitis;
222 control s
-Sigr
use
-Eth
salr
iicantly more cases (25%) than controls (14 ", ) were ILD
. (Unadjusted relative risk = 2.1)
c group, number of sexual partners, and hi sll) ry of
ngitis affected risk.
Kaufman et al. 1980
(224)
Canada,
Israel,
US Multicenter case-control 44 case s
hospitali zed
with PID;
259 controls
-Agf
?: 5
-ReI.
T-C
..ldjusted relative risk for all IUD users: 6.5; f r IUD us.>
, ears = 12.9; for < 5 years = 5.7.
ive risk by device: Cu-7
.1.8; Lippes Loop = 7.9; Saf·
il = 9.2; Dalkon Shield = 12.3.
Larsson et al. 1981
(253)
Sweden
Cohort 996 IUD users;
176 nonusers
-No vidence that copper IUDs increased the ri sk of PID ill dll
use , in users with a history of PID, or in long-te m users.
Osser et al. 1980
(346) Sweden
Case-control
690 cases
hospitali zed
with acute
salpingitis;
690 controls
- ReI. ive ri sk for current IUD use rs = 2.1.
-No ignificant difference in frequency of PID bet\ een ever·
and 'lever-pregnant users.
Paavonen &
Vesterinen 1980
(348) Finland
Case-control
144 cases
hospitalized
with acute
salpingitis;
229 control s
-Si gr i icantly more cases (58%) than controls (31 %1 were I D
use . (Unadjusted relative risk = 3.0)
-Rei. ive risk for IUD users was 2 times higher than for women
usir no cont race ption or a method other than the pill.
Ryden et al. 1979
(407) Sweden
Cohort 672 women with
gonorrhea; 85
used IUDs, 342
used hormonal
methods, 245
used neither
_24°;
part
tho'
wor
neit
Vesseyet al. 1981
(527) UK
Cohort 17,032 women ;
- Inci
woman-years of
observation :
use rs = 20,482,
ex-users = 4,210,
Ac u
nonusers = 65,259.
Chr
(101 developed
Oth
PID)
Westrom 1980
(535) Sweden
Cohort All women age
20-29 in Lund,
Sweden, 1970-74
(5 71 developed
PID)
nce of PI D per 1,000 woman-years:
Current
User. of
IUD
Ex-IUD
OC~ &
Users
Users
Di agnos is
Barr"ers
e definite
1.51'
0.48
0.1+
0.54'
0.95'
O. 3
nic definite
r
0.54
0.48
O.
'Si ~ ificantly different from rate for OC and barrier user
(p < 0.05)
-Inci
All
N
E\
OC
Barr
Sexi
Sexl
Note: Earlier studies are reported in Population Reports. IUDS-Update on Safet y. Effectiveness. and
B-122
of IUD use rs had PID complicating the gonclrrhea. com­
I with 9% of users of hormonal methods and 15% of
using neither IUDs nor orals. Difference bel ween
,en using IUDs for more than 3 weeks and t l1Qse llsing
.er IUD nor orals is not statistically significant
~ nce
of PID per 1,000 woman-years of method use:
52
ve r-pregnant
118
r-pregnant
34
sers
9
'r method users
14
Illy active, no method
34
lIy inadive. no method
0
JD users
·;;earch, B-3. May 1979. Table 15, p. 8·68.
POPULATI O
REPORTS
permit bacteria to ascend than monofilament tails (440, 481 ,
482, 483). One hypothesis is that the sheath of the Oalkon
Shield tail may deteriorate during use. This would expose the
inner filaments, which are made of highly absorbent nylon ,
providing a suitable surface for bacterial growth (291) .
changes in IUD design involve tradeoffs, however. For exam­
ple, IUDs releasing synthetic progestins reduce the volume of
bleeding and possibly PIO but may increase other compli ca­
tions such as ectopic pregnancy or systemic side effects.
In ·several studies the Oalkon Shield, which is no longer on the
m rket, has been linked with an increased risk of inflammation
or PIO (34, 105, 124, 141,485, 527) , although other researchers
have found no difference among types of IU Os (115 , 117, 142).
Preliminary unpublished data from the US Women's Health
study suggest that long-term Oalkon Shield users are at least
five times more likely to be hospitalized for a first episode of
PIp than long-term users of other devices (57, 341). Whether
thF multifilament tail or other features of the device are in­
volved is not clear.
Treatment
o
the IUDs currently on the market or being studied, no signifi­
cant difference has been found in PIO rates. These studies in­
volve unmedicated and copper devices, including the Lippes
Loop, Saf-T-Coil, Cu-7 , and TCu-200 (59, 124, 253, 527, 536,
551) . It is possible that progestin-releasing devices cause fewer
inflammatory changes or infections than other devices. In one
study of 113 women undergoing sterilization, none of the 13
women using the Progestasert showed any signs of inflamm a­
tion or infection; approximately half of those using various
unmedicated and copper devices had nonbacterial inflamma­
ti on and about half had normal tubes (115) . In Finland, with
levonorgestrel IUDs Tapani Luukkainen and Carl Nilsson re­
port only three removals for infection in over 15,000 woman­
months of use (284). The infection rate may be low because
levonorgestrel reduces both the volume and total days of men­
strual bleeding. Also, levonorgestrel causes thickening of the
cervical mucus, which could prevent bacteria from entering
th e uterus (283). Larger, comparative studies would be neces­
sary to confirm these findings.
Prevention
So far, research on ways to prevent pelvic infection among IUD
users has been extremely limited. In addition to clinical guide­
lines that might limit IU~ use to women at low risk of develop­
ing PIO, two approaches have been considered:
• better steriliz ation and insertion techniques,
• modified devices either without tails or releasing sub­
stances that minimize infection.
Better sterili zation and insertion techniques might be useful
because bacteria from the cervix and vagina are introduced
into the uterus when an IUD is inserted (59, 115, 338, 345, 346,
497). Currently, IFRP is sponsoring studies on different chemi­
cal disinfectants for sterilizing IUDs (see p. B-128), and research
is continuing on IU~ strings that release an antiseptic into the
cervical canal (255). These measures cannot eliminate all infec­
ti on, however, since many women develop PIO months after
insertion (117 , 121 , 253, 286, 348) .
Modified devices, including devices without tails, might reduce
the incidence of infection. So far, however, only one (111) of
five small studies comparing devices with and without tail s has
found a lower rate of infection in women with tailless devices
(53, 111 , 210, 262, 546). Moreover, there would be other prob­
I ms. With tailless IU~s, women would not be able to check
vvhether the device was in place, and health personnel would
have difficulty removing it in case of pregnancy . Thu s substan­
tial redesign might be necessary.
Other modifications are possible, including devices that release
various progestins, antibiotics or other substances (589). Most
POPULATION REPORTS
Prompt recognition and treatment of PIO may reduce tubal
damage and subsequent problems such as infertility and ec­
topic pregnancy (100). PIO is sometimes difficult to diagnose,
however (114, 213, 535). Common symptoms include any or
all of the following: abdominal pain, adnexal tenderness, pain
with cervical manipulation, fever, and discharge fwm the
vagina and cervix. Some women have only mild symptoms.
Others may be entirely asymptomatic (535).
PIO involves a number of di,(ferent organisms (73, 114), which
vary in different communities (7) . Thus, unless tests can be car­
ried out to identify the specific organism, a broad-spectrum an­
tibiotic is necessary (see box, p. B-124). Gonorrhea frequently
causes PIO, but among IU~ users nongonococcal PIO is also
common (117, 253, 346, 348). Nongonococcal PIO is often
caused by Chlamydia trachomatis and mycoplasmas (7, 114,
155). In Sweden and the US the most common aerobic (oxy­
gen-requiring) organisms found in PIO are Escherichia coli Pro­
teus, Staphylococcus epidermidis, and Hameophilus influen­
zae. Commonly observed anaerobes (which develop in the
absence of oxygen) include Bacteroides, Clostridium , Pep­
tocOCCU5, and Peptostreptococcus (155). In both IUD users and
nonusers, the first episode of PIO is often caused by a sexually
transmitted infection or by complications of induced abortion
or childbirth . After one episode of PIO, the fallopian tubes seem
to be more vulnerable to reinfection. Thus, succeeding epi­
sodes are more often cau sed by anaerobic organisms normally
found in the genital tract (114, 153, 535).
Some US and European physicians recommend that , once PIO
has been diagnosed in an IUD user, the device should be re­
moved immediately and antibiotics should be administered
(100, 142, 187, 403,463). Others recommend that the device
be removed only if the woman does not respond quickly to an­
tibiotics (305, 452 , 511 , 512). A randomized Swedish study
compared the two treatment methods and found that removal
of the IUD did not significantly influence the rate of recovery
from acute PIO (452) . A recent medical policy statement from
the International Planned Parenthood Federation (IPP F) recom­
mends removal of the IUD if improvement does not occur
within 48 hours after the start of antibiotic treatment (211).
Actinomyces
Recently attention has focused on a particular anaerobic organ­
ism-actinomyces-which can cause the serious but very rare
pelvic infection known as actinomycosis. Actinomyces organ­
isms, which are difficult to identify and culture (41, 71 , 218,
282, 299), have sometimes been found on the cervical smears
of IUD users but rarely on the smears of nonusers (24, 48, 94,
101, 130, 175, 472 , 513). A recent study suggests, however, that
actinomyces organisms normally inhabit the genital tracts of
many women who do not use I U Os. Using a sensitive detection
technique, researchers examined 50 women and found that ac­
tinomyces were present in 44 percent of the women with I U Os
and in 27 percent of those without (85). The presence in the
genital tract of organisms re sembling actinomyces does not
necessarily indicate infection . The majority of women with
such organisms are asymptomatic (24, 130, 175, 176, 218,472),
and reported cases are few (155, 478).
B-123
Whether the presence of actinomyces in the genital tract of
IUD users, without other signs or symptoms of infection, re­
quires treatment has not yet been resolved. Some clinicians
believe that IUDs should be removed if actinomyces-like or­
ganisms are seen on cervical smears and then reinserted only
after negative cervical smears have been obtained (31, 48, 89,
169,289, 461 , 513). Others suggest that IUDs should not be re­
moved from asymptomatic women but that these women
should be closely watched for signs of infection (1, 24 , 472J.
Women with actinomyces-like organisms often remain asymp­
tomatic after many months of continued IUD use (24, 85 , 221).
All agree, however, that when pelvic tenderness or other symp­
toms of infection are present , the IUD should be removed, and
antibiotics effective against actinomyces organisms-penicillin
and tetracycline (31 , 155, 289, 442) - should be administered
(24 , 31 , 175, 289). Adne xal masses usually require surgery
(1, 442J.
To minimize the possibility of infection from actinomyces-like
organisms, some researchers have gone so far as to recom­
mended routine removal and reinsertion of all IUDs every three
years (54, 387, 391 , 416). Since the likelihood of harboring
these organisms increases with the length of IUD use (24, 48,
101,176, 353, 391,416), it is assumed that removal would dis­
rupt bacterial growth.
rics-Gy ecology Device Section of the Obstetri ~ -Gynecology
and Ra iologic Device Panel of the US Food ,md Drug ,A, ­
ministr, ion Advisory Committee (512), by the
tional M ed i­
cal Con ittee of the Planned Parenthood Feder(ltion of Amer­
ica (58~ , and by the International Medical Adv l~ory Pa nel d
IPPF (2 I). Moreover, since the ri sk of PID, perioration, and
other c~ ' m plications is highest in the first few mont hs after I ser­
tion , re lsertion may increase rather than remO\ to! PID ri . k (1,
186). In ~ 1981 statement on IUDs, the IPPF pan -I conclude
pon
soci a
dural
fectic
port I
shou
free i
."
.. " -
,-
J..
t
.
inical infection wilh aClinom ycosi s is a very mall com­
t of the total spectrum of pelvic inflammatory dis ase a5­
~d with IUDs, and the exi stence of a relationslt p betwe n
In of use of an IUD and development of actinomycosi s in­
I is not conclusive. Current data therefore pro\l de no sup­
r the sugge ..tion that inert devices such as the Li ppes Loop
be replaced at regular intervals in those wom'n who are
)m significant side-effects. (211)
'.
II
.
.
,
I
'.
.
-"
.
"':
_
-
-
" .
T
11
I
I
,
_."'---
~
The prevailing view, however, opposes routine removal and re­
insertion (120, 186, 211, 352, 453J. For exam pie, routi ne
removal is opposed by the medical advisory panel of the UK
Family Planning Association and the National Association of
Family Planning Doctors of Great Britain (120)' by the Obstet-
The I U [ is one of the most effective contraceptt ve met ho d ~
Pregnar y rate s range from less than one to about five per 1011
women per year (see p. B-103J. If a pregnanc\ does (K CU r
with an UD in place, however, complications may result , anc
medical attention is required. Early removal of the IU D wi l l
improvE a woman's chances of safe pregnancy iln d deli\'ery
but eve after removal the risk of spontaneous c1bortion wil l
still be I lgher than for a nonuser. A pregnancy in an IUD use
is more kely to be ectopic than a pregnancy in a nonuser bu t
whethel IUDs actually Increase the risk of ectopIC pregnrl nc
or simp fail to prevent as effectively JS they pr vent ut rin!
pregnan y it is not clear.
Antibiotic Therapy For PI D
Uterine Pregnancies
What is the best antibiotic for treating PID? There are nQ
reliable clinical signs to distingui sh gonococcal from
nongonococcal PID. Thus, when laborJtory facilities for
identifying specific causative organisms are not avail­
able, an antibiotic effective against a wide range of
pathogens is necessary. For mild to moderate cases of
unspecified PID, a recent WHO report on sexually trans­
mitted diseases recommends tetracycline. The dosage
should be 500 mg taken orally, four times a day, for 10
days (548). Severe cases of PID with pelvic abscesses
and, at times, peritonitis, usually involve anaerobic or­
ganisms (35). Recommended antibiotics include tetra­
cycline, metronidazole, clindamycin, kanamycin , or
gentamicin, usually given intravenously (10, 35 , 381 ,
470, 537).
For treatment of gonococcal PID on an outpatient basis,
the US Centers for Disease Control (CDC) suggest tetra­
cycline 500 mg taken orally, four times a day, for 10
days, in addition to either 500 mg ampicillin or 500 mg
amoxicillin, taken on the same regimen (508). For hospi­
talized patients penicillin G, tetracycline, amoxicillin, or
metronidazole are recommended (10, 508, 381). Preg­
nant women should not take tetracycline. Other an­
tibiotics, including procaine penicillin , ampicillin, and
amoxycillin, can be safely used (508).
In all cases, the woman's sexual partner should also be
treated with antibiotics to prevent reinfection and re­
currence of PI D.
B-124
If pregn ncy occurs with an IUD in place, that pregnan cy i
more li~ -Iy to end ina spontaneous fi rst or sec nd trim (:'ste
abortior than pregnancy in a nonuser. About 51) percent 0
uterine Hegnancies spontaneously abort if the c evi e is nOI
remove! (16, 201 , 235, 430, 450, 465, 480, 52J, 524, 528)
This is a out three to five times the rate of spont. neous abor
tion for )ther women (201 , 232, 523). In some , tudies ove
half of tl _ spontaneou s abortions in IUD users 0 ( urred in th
second imester of pregnancy (269, 465). A re nt US
se­
control ~ udy of 539 cases found that pregnant w m en wit h an
IUD in lace were 26 times as likely as women without an
IUD to xperience a septic second trimester s pontan eo u~
abortion (126). Complications of any second tri ester a or­
tion Jre , sually more serious than those of an early abort io n.
Removir ..: the IUD early in pregnancy cuts the E'xcess ri s 01
spontan( us abortion at least in half (16, 45 • 480) and,
accordi n to one study, eliminates any excess ri k of sec nd
trimestel abortion. I n a US study the relative risk f nonsepti
second imester spontaneous abortion for IUD users com­
pared w h nonusers dropped from 10.3 to 1.5 if the IUD Nas
removec and the risk of septic spontaneous abortion , from
26.4 to 2 (126).
The risk
becam e
there W E
and se '
women '
posed th
A. H. Rc
)i septic second trimester abortions with IUDs tirst
pparent in the early 1970s. From 1972 tl lrough 1 74
e 50 reported deaths in the US associated with ~ rst
nd trimester spontaneous abortion ; 17 of tl'ese
ere IUD users (69). One device, the Dal kon Shi -' d,
ee times the risks of other devices (69). In 1974 the
)ins Company, manufacturers of the Dal kon Shield,
POPULATIOI
REPORTS
date on Safety, Effectiveness, and Research, B-3, May 1979).
One explanation for this difference, first offered in 1970 by
Hans Lehfeldt and Christopher Tietze, is that IUDs provide
more protection against uterine pregnancies than aga inst tu­
bal or other extrauterine pregnancies (263).
A South Korean family planning worker demonstrates a Lippes
Lqop and inserter. In Korea 20 percent of contraceptors use IUDs.
(USAID)
withdrew the device from th e market. Th e US Food and Drug
Adm inistration and the Robin s Company instructed doctors to
r move any type of IU D from women who became pregnant
(5, 388). Since 1974 on1ly two US women using IUDs have
died from septic spontaneous abortion (67, 68). IPPF recom­
mends that all women still using Dalkon Shields should have
these devices removed even if th ey are not pregnant (2 11) . Re­
cent reports of higher PID rates among women who used
Dalkon Shields reinforce thi s recommendation (see p. B-123).
More recently, it has also been suggested that IUDs may in­
crease the risk of ectopic pregnancy by affecting th e fallopian
tube s. Epidemiologic evidence for thi s hypothesis comes from
studie s showing increasing rate s of ectopi c pregnancy with
longer IUD use (343, 435, 479). For example, in th e US Wom­
en's Health Study, involving over 4,000 women, IUD users
with no history of ectopic pregnancy or PI D who had used
IUDs for 25 months or more had 26 tim es greater risk of ec­
topic pregnancy than women who had lIsed IUDs for less than
25 months. The risk persisted for one year after the IUD was
removed. Researchers suggest that a duration-of-use effect
could be caused by th e gradual development of non bacterial
inflammatory changes in the tubes (343) (see p. B-122). In US
studies of various copper T devices, the chance of ectopic
pregnancy in the first and seco nd years of use was 1.1 per
1,000 women; in the third and fou rth years, 2.6 per 1,000
(435). By contrast, no duration-of-use effect was found in the
Oxford/FPA study, and the rate of ectopic pregnancies in IUD
users remained fairly constant at 1.2 per 1,000 women per
year (526).
All IUD cannot be easily removed from a pregnant woman
when the strings are not visible. Probing the uterus to locate
tHe strings or to remove a tailless device may disrupt the
pregnancy. In this case, the IUD must be left in place if the
woman wants to continue the pregnancy (106, 233). Close
s pervision is essential , since sepsis may develop rapidl y, with
only mild early symptoms (69, 75). When sepsis is suspected,
antibiotic therapy and immediate uterine evacuation are man­
datory (106, 504) (see Population Reports, Complications of
Abortion in Developing Countries, F-7, July 1980).
Other epidemiologic evidence does not make clear whether
IUDs actively increase the ri sk of ectopic pregnancy. In the
Women's Heal th Study, even thou gh long-term IUD users
faced greater risk than short-t erm users, the risk of having an
ectopic pregnancy was no higher for long-term users than for
women who had never used IUDs. Thi s suggests that the IUD
has a possible protective effect at fi rst, which wears off with
time (343). Ectopic pregnancy rates among US women using
IUDs in Population Council studies were not clearly different
from estimated national rates of ectopic pregnancy among all
US women not using IUDs or oral contraceptives or steriliza­
tion (435).
Not only spontaneous abortion but also premature delivery,
stillbirth, and lower birth weights are more common if an IUD
is left in place during pregnancy (16,480, 524). For example,
the Oxford University/Family Planning Association (Ox­
ford/FPA) cohort study found that 14 percent of infants of
women who became pregnant with an IUD in place weighed
less than 2,500 gram s, compared with 9 percent of infants of
women using oral contraceptives and 2.4 percent of infants
whose mothers used other methods (524). This difference was
highly stati stically significant. There is no evidence, however,
that IUDs cause birth defects, even if the device remains in
place (106, 233, 306, 351, 363, 450, 524). Also, there is no
evidence that past use of an IU D leads to complications dur­
irjg a subsequent uterine pregnancy (126, 524).
Comparisons of ectopic pregnancy rates in IUD users and
other women (435, 522, 539) are difficult to interpret because
a satisfactory control group is hard to find. Oral contraceptives
virtually eliminate all risk of ectopic pregnancy, since they
prevent ovulation. Barrier methods of contraception may also
have a protective effect (343). Also, ectopic pregnancy rate s
vary widely in different populations depending on such factors
as previou s ectopic pregnancy, prevalence of pel vic infection ,
and age (127, 193, 219, 268, 343, 401, 414, 417, 466, 479).
IUD users have higher rates of PI D, however, and a history of
PID is known to increase the risk of ectopic pregnancy (see
p. B-121). For example, in Lund, Sweden, rates of ectopic preg­
nancy were four to six times higher in women with a hi story of
PID than in women with no history of PID (539).
Ectopic Pregnancies
While the physiological and epidemiological evidence on ec­
topic pregnancy and IUDs is still inconclusive, the clinical
significance is clear:
• If an IU D user conceives, the possibility of an ectopic
pregnancy must always be considered.
• All women using IUDs should know the symptoms of
ectopic pregnancy-abdominal pain , dark and scan ty
vaginal bleeding, or amenorrhea-and the importance of
getting prompt medical attention.
• Women already at high risk of an ectopic pregnancy-due
to previous PID, ectopic pregnancy, or tubal surgery­
should not use IU Ds if other methods are feas ible.
A link between ectopic pregnancy-the implantation of a fer­
ti lized ovum outside the uterus-and IUDs has been recog­
nized since 1929 (263). The link is still not completel y under­
stood, however.
One point is clear. When an IUD user becomes pregnant, the
pregnancy is more likely to be ectopic than pregnancy in a
nonuser. It has been estimated that in IU D users about one in
30 pregnancies, or 3 to 4 percent, is ectopic. In other women ,
about one in 125 pregnancies, or 0.8 percent, is ectopic (32,
55,306, 351 , 437, 438). (See Population Reports, IUDs-UpPOPULATION REPORTS
8-125
Table 8. Rates of Ectopic Pregnancy Among IUD Users,
by Type of IUD, Selected Studies, 1970-1981
Author & Date
POOlED DATA
Gibor & Pharris
1980
Sivin 1979
Snowden 1977
Ref.
No.
Type of IUD
137 Progestasert
435 Copper IUDs
448 Lippes Loop
Cu-7 & TCu -200
Tietze & Lewit 1970 497 Various unmedicated IUDs
USFDA 1979
510 TCu-200
Cu-7
Progestasert
Vessey et al. 1979
526 Lippes Loop
Saf-T-Coil
Copper IUDs
Others & unknown
COMPARATIVE STUDIES
Alza 1982
17 Progestasert
Plastic T
Diaz et al. 1980
95 5 sleroid-re leasi ng
Ts
TCu-200
Plastic T
131 Progestasert
Fylling & Fagerhol
1979
Nova T
Larsen et al. 1981
244 Progeslasert
TCu-200
Pizarro et al. 1977
362 Progeslasert
Cu-7
WHO 1979
554 Progestasert
Plastic T
WomanYears
of Use
Ectopic
Pregnan­
cies per
1,000
WomanYears
9,802
5.4
21,875
5,000
4,000
28,614
0.96
0.6
0.5
1.2
11 ,036
05
0.4
4.0
1.2
0.8
1.4
2.0
13,135
10,567
9,834
4,712
739
2,010
417
365
433
2.4(1*)
2.7( 1*)
11.5(5*)
93
49
'144
124
166
162
131
130
282
246
0.0
0.0
139(2*)
0.0
6.0(1*)
0.0
0.0
0.0
0.0
4.0(1*)
disconti
185,50
and gel
after IU
497). n
to reco
continu
ue the method in order to become pregnant 1106,
Among these women the return to fert ility is rap i ,
_rally over 70 percent conceive within 12 m nth ­
) removal (33, 50, 95, 215, 225, 230, 3:"5, 422, 43
. Oxford/FPA study found that some wom n w ere '10
er their fertility, but within two ye:l rs after di ~
t ion 92 percent of 258 women had given birth (5 25).
Only or
in Taiw;
for med
ave rage
tracepti,
30, the
IUD us
re sea rd
these fo
PID (21
. study, involving over 2,500 users of th Lippes Loop
1, has followed women whose devices w ere rem ove
'al as well as personal reasons. Based o n estimate of
ecundability and taking account of su equent con­
n, the analysis suggests that, among wOlll en over agO'
li kelihood of conception decli ned wit h duratio o '
Although no clinical evidence was a ailable, th.
' rs hypothesized that decreased fecund .l bility amon,
ner IUD users might have been due to h gher rat es 0 1
Much I
bleedin!
widely
matic is
have so
agencie'
mercial
publish ~
gramma
• ma
• cor
• the
• me
• she
I.
0 research has focused on clinical is' ues sue
a
pregnancy, and infection. The result have bee
~ ported in medical and scientific journ.: ls. Progr m
es relating to manufacture and distribution of IU D
far been the spec ial concern of a small numb r 0 1
and firms sponsoring product develol ,ment, om
les, or public sec tor distribution . Littl e in formati on i
I or available to the public on such i portant pro
c issues as:
ufactu ring capabilities in developing co ntries,
parat ive prices of different devices,
nerits of bulk versus individu al packagi ng of IU s
lods of sterilizing IUDs,
life of IUDs.
'Number of ectopic pregnancies
Manufacturing in Developing Countries
Differences Among Devices
Ectopic pregnancy rates may be higher with proge st in­
releasing IUDs than with other types (see Table 8). Poo led
clinical trial s of the Progestasert show a rate of about 5 ectop ic
pregnancies per 1,000 woman-years (17, 137). By contrast,
the rate for unmedicated devices reported by the Population
Council Cooperative Statistical Program is 1.2 (497). For cop­
per devices, Population Council studies show a cumulative
rate of 0.96 (435). Compari sons such as this, involving dif­
ferent studies with different populations, may be unreliabl e,
however, since risk factors for ectopic pregnancy vary widely
(26,37,133,3 55,3 58). Comparative tria ls have found that the
Progestasert had a hi gher ectopic pregnancy rate than the
Nova T (131) and the TCu- 200 (244), but the same rate as the
Cu-7 (362). There was no difference between the Progestasert
and its plastic component without progesterone (17, 554) . A
sma ll comparative trial found a higher ectopic pregnancy rate
with va rious experimental progestin-releasing IUDs than with
the TCu-200 or an unmed icated plastic T (95). A greater risk of
ectopic pregnancy with progestin-releasing IUDs is plausible,
since another progestin contracepti ve, the mini-pill, has
shown higher than expected ectopic pregnancy rates (38, 45 ,
278, 444).
Subsequent Fertility
The effect of IUD use on su bsequent fe rtility has not been fully
evaluated, since most studi es invol ve only IUD users who
B-126
IUDs an I in serters are currently produced in sev ral dev ~lop
ing cou tries, including China , India, and M e ico . Lippe
)
The IUD
tional D(
needed f
tains (tor
five iodit
(bottom
uterine I
sounds,
one IUD
Back-up Kit, distributed by the US Agen
for Intema·
elopment (USAID), contains all the back-up equipmenf
insertion of IUDs and follow-up of users. ~ach kit m n·
row, from left) one pan with five covers, one forcep jar,
cups, two dozen sterile disposable su rgeon's gl yes,
w, from left) one speculum, one sponge forceps, fivf­
aculum forceps, one scissors, five grad uated uleri nf­
e endometrial biopsy curette (for retrieving lost tails),
moval forceps, and one IUD removal hook . (USAID)
POPULATI O
REPORTS
Loops have been manufactured in India throughout most of
the l<lst decade. Copper T devices are being produced in Mex­
ico and are slated for production in Brazil , China, India, and
Indonesia (52).
IUD production can range from assembly and packaging of
components purchased from other manufacturers to full-scale
plastic molding, production of all components, assembly, pack­
aging, and sterilization (129, 575). The technology of IUD pro­
duction is unique among contraceptive technologies in that it
is available from both the private and public sectors, allowing
a variety of technology transfer arrangements (575).
The decision about which components are produced locally
an8 which are imported depends upon local capabilities on
one hand and barriers to imports on the other. The best strategy
for starting IU D production may be to begin with assembly and
packaging operations and build up. For developing countries
with sufficient demand for IUDs, it may be most feasible to
make the plastic body of the IUD and the plastic inserter and
flange in a local factory while the IUD tail and copper and pack­
aging components are imported (129). Local contractors may
be able to carry out blending of the plastic materials, mold
repair, quality-control analyses, and, sometimes, plastic in­
jection molding and gas sterilization of individually packaged
devices.
The cost of setting up production of sterilized, individually
packaged copper IUDs (such as the TCu-220C or TCu-380Ag)
in <l developing country is estimated at $2-3 million (US). The
costs of actually producing IUDs in a developing country are
more variable. Salaries and wages; tariffs, duties, and taxes on
imported materials; availability of local energy sources; and
ta}fes all may have significant effects on production costs. Ac­
cording to an overview prepared by the Program for the Intro­
duction and Adaptation of Contraceptive Technology (PIACT),
efficient operation requires production of at least one million
IUDs per year. If the facility is also manufacturing other pro­
ducts, however, it may efficiently produce fewer IUDs, since
the other products will absorb some of the fixed costs (575).
Quality control in the manufacturing process can be a serious
problem. Where inadequate materials, incomplete blending
of plastic, or poor manufacturing techniques are used, the
IUDs may be of inferior quality-for example, too brittle­
which could injure the user and jeopardize the reputation of a
family planning program. This has occurred in some countries
where small-scale operations have produced IUDs illegally
(5 2). Current efforts to establish IUD manufacturing are con­
centrated on large countries with the appropriate labor force
and, in some cases, governments committed to assisting the
fledgling enterprise.
Table 9. Commercial Wholesale and Public Sector Prices of IUDs Charged by Selected Distributors, 1982 Device
Lippes
Loop D
POPULATION REPORTS
Finishing Enterprises, US Onho, US TCu-200
TCu-22OC T modified
220 Cu
TCu-380A
Cu-7
Multiloadcu 250
Nova T
Progestasert
$90.00 box of 6.
Individual sterile
packages.
Finishing Enterprises, US Searle, US Prices
IUD prices vary greatly. Manufacturer's prices range from
$0.12 (US) each for bulk-packaged , nonsterile Lippes Loops
purchased by public sector programs to $20-$27 for an in­
dividually packaged, sterile TCu-200 or Cu-7 purchased by a
commercial distrilbutor (see Table 9). For the individual
woman , an IUD may be obtainable free of charge through a
family planning program or may cost as much as $50-$100
from a private physician (333). Prices of the devices are in­
fluenced by such factors as:
• raw material and production costs,
• licensing agreements,
• public or private sector sales,
• quantity purchased,
• local requirements, duties, regulations, and patents.
Distributor
Price (in US$)
Commercial
Public
Wholesale
Sector
$0.12-$0.22 depending on or­
der size. Bulk
packaging only.
$47.82 box of 6
in US. Price to
USAI D: $37.50
for unsterilized
package of 100
with 10 reusable
inseners.
$0.85-$1.55 depending on or­
der size. Price to
USAID and
UNFPA for Idrge
orders under an­
nual contracts:
$0.81. Individual
sterile packages.
$20-$27 each.
Individual sterile
packages.
Promotora e
Imponadora
PEISA, Mexico
Individual sterile pack with insener: $1.80
Bulk-packed:
$1.08; I nsener:
$.10. Orders
larger than
10,000 units:
prices
negotiable.
Biotec
About $4.32; de- About $1.10;
depends on
Laboratories,
pends on
quantity. Indi­
Mexico
quantity. Individual steri Ie
vidual sterile
packages.
packages.
Onho, Canada $16 each. Individ­
ual steril e
packages.
Searle, Canada $12 - 14 each. In­
dividual sterile
packages.
$20-$27 each. In­
Searle, US
dividual sterile
packages.
Prices depend
Multilan,
Prices deter-
on size of order
Swit zerland
mined by local
distributor. Inand local con­
dividual sterile
ditions. 1981
packages.
price to WHO:
$2.32 each. In­
dividual sterile
packages.
Outokumpu
Prices depend on Prices depend
on quantity
Oy, Finland
quantity and
local conditions. and local condiIndividual sterile tions. 1981
packages.
price to WHO:
about $2 each.
Individual steri Ie
packages .
$8.40. Individual
Alza, US $12 .90-$15.80;
depends on
sterile packages.
quantity. Individ­
ual sterile
packages.
Note: Individual sterile package includes inserter.
Sources: Data (rom distributors: Alza Corporation (529), Biotec Lclboratori("
(402), Finishing Enterprises (264), Multilan S.A. (500), Ortho Canada (5761
Ortho Pharmaceutical (340) , Outokumpu Oy (580), Prom0tora e Importadora
PEISA (921. Searle Canada (58 7), Searle Pharmaceuticals (432); data from pur­
chasers: WHO (3 20) .
8-127
Raw materials cost far less than production. In the US the
plastic content is usua lly no more than $0.003 per device .
Altogether the nonmeta ll ic material s, including threads and
barium sulfate to make the device radiopaque, cost about
$0.008. The seven copper sleeves used fo r a TCu-220C cost
about $0.15, si nce they require special manufacture (574).
How mu ch manufacturing and packaging add to the cost
depends on the amount of individual handling required . For
example, TCu-200s normally cost more than Lippes Loops
(see Table 9) because more labor is involved in winding the
copper wire onto the device , providing individual inserters,
and assembling the device and inserter (264).
Licen si ng agreements also can affect price. The Population
Council , fo r example, in negotia tin g agreement s for manufac­
ture and distribution of the IU Ds it has developed , requires
that public sector prices to developing countries rema in low.
As a result , public sector prices are sometimes very much less
than private sector prices. For example, for a sterile, singly
packed TCu -200 the public sector price can be as low as
$0.81 , while the wholesale commercial price is $20 to $27.
For a Progestasert, developed and produced by the Alza Cor­
poration , the public sector price is $8.40, while the wholesale
commercial price is between $12.90 and $15.80 (see Table 9).
In the public sector, price depends to some extent on the size
of the order. By contrast, in the comme rcial sector, import
dut ies, regulations, d istributor's mark-up, patents, and promo­
tional expe nses influence the final price. In general, the mar­
keting si tuation in each country, includin g the extent of com­
petit ion , strongly influences the final price.
Bulk and Individual Packaging
IUDs could theoretically be packaged in three different ways:
bulk nonsterile packages, indi vi du al sterile packages, and
bulk sterile packages . Lippes Loops di st ributed by Ortho Phar­
maceutical Corporation and TCu-220Cs distributed by Pro­
motadora e Importadora PEISA, a Mexican fir m, are available
in either bulk nonsterile packages or in individual sterile
packages . Finishing Enterprises, a US firm , produces Lippes
Loops only in bulk, nonsterile packs. All other IUDs are
available only in individual sterile pack. No IU Ds are currently
distributed in bulk sterile packs.
Three considerations affect choice of packaging: safety, cost,
and convenience. Conventional medical practice dictates that
IUDs should be sterile before in sertion, just as ste ri le technique
is normally used with any pelvic procedure. Nevertheless, in
the process of passing the IUD through the vagina and cervix,
some microorganisms are like ly to be introduced into the
uterus (581). Thus, sterilization of IUDs reduces the risk of con­
tamination but cannot eliminate it.
Is factory-sterilization preferable to chemical sterilization in the
field? Limited data suggest that the choice makes no difference
in rat es of pelvic infection (365, 437). Factory-sterilization,
however, can help to assure that all IUDs used are sterilized
properly and can eliminate variation in sterilization technique
that would occur if the devices were sterilized in the field in­
stead (3 17). Bulk-packed, sterile IUDs would present new
problems, however. Unless all the IUDs were inserted shortly
after th e bulk package was opened, the remaining devices
could become contaminated (264, 317, 437). Moreover,
health personnel could be misled by a package that is labeled
sterile even though it has been opened and may be con­
taminated. As a result, they might fail to sterilize the IUDs
B-1 28
chemic
packed
these il
siderinE:
IUDs v.
sterile I
lIy before insertion (264, 317). In ad ition , bulk­
.i ppes Loops are provided with reusabl e inserte rs, but
erters should be steri lized before each re-use. Con­
these problems, o rga ni za tion s that wanl presteri lized
)uld probably be wisest to use individu. Ily pach: .lged
l D s.
How m ch does sterile packaging add to the co t of an IUD '
The ad< ·d cost of individual ste ril e packages is <l lmost a negl ­
gible p, t of the total cost for cop per Ts because he exte nsi ve
individl Ii handling required in manufacturing and assem b lin'
these dt "Vices accounts for so much of the cost (264). For Lippes
Loops, owever, which require far less handling and are usu­
ally bul -packed, the addition of individual stenle packdgin ~
would I obably increase the cos t by 250 to 300 percent 1264 . .
In som!
conven
health
more e
steriliza
numbel
easilya'
settings, indi vid ually sterili zed IU Ds are clearly mor !
-nt and easier to use th an bulk-packed IUDs. Tra\ li n -\
ersonnel, for example, can use sterile-packed IUD;
ily than bulk-packed IUDs, which req lJ ire chem iCal
on . On the other hand, in clinics that p( rform a larg •
of IUD insertions, bulk-packed IUDs mi "ht be used 3 ;
individually sterile-packed IUDs.
Current y, for copper devices, sterile, individual f ckaging ha>
proved Iractical. Research on methods of chem cally st ril i?­
ing cop er IUDs is still in the preliminary stages. Furthermor
in the ii Id, bulk-packed copper Ts could be diffi, ult to 10dd i 1
the insE ' ters. Shipment of assembled but nonste r Ie copppr 1-;
and ins! 'ters could result in confusion over whe tr er they wer· ­
sterile ( 4).
IPPF su
bulk-pa
IPPF ha
has an,
tion to I
personr
plies both individually packed, sterile TCu-200s an, I
ked Lippes Loops to its affiliates aroun the worla .
suggested that field sterilization of bulk-packed IU D
Ivantage. It mi ght offer an opportunity tn draw ,M el' ­
e importance of sterile tech nique and h Ip in trainin .;
·1 not to handle steril ized IUDs (423).
Methods of Sterilizing IUDs
For bull packed un medicated IUDs, cold sterili - tion in an ti­
microbi I chemicals is the usual method of steril ization . Se\,­
eral dift rent methods have been used , and no ingle antim i­
crobial , ~ent is clearly established as the best. IPPF recommend
immers l)n for 20 minutes in an aqueous iodine 1:2,500 01 ­
tion or
isopropyl alcohol 75 percent (233). VvHO su gv. st,
immers · n for 24 hours in benzalkonium chloridl~ 1 :750 r fo ­
lD mim es in aqueous iodine 1: 2,500 (154). Robert Snm del'
and col agues recommend three methods: \oV,lshing in 0. 1
percent )enzalkonium chloride and soaking in the sa me olu ·
tion for ~4 hours; soaking in 0.1 percen t benzalkonium chlo ·
ride fo r IX hours and then rin sing in the same sol l ion; or oak
ing for ve minutes in diluted iodine or in an iodine-i odi d,.
mi xtu re with 0.04 percent elemental iodine, and then ri si n ~.
in steril( water (450). Inserters should be sterilized in the amI
way as IU Ds.
Recent
chlorinE
ods of (
eliminal
esearch by IFRP suggests that formaldehydes and
liberating compounds may be more effective eth
)Id-sterilizing unmedicated IUDs. These compound ...
d bacterial spores as well as the two bacteria t e ~ted
Esc heric ia coli and Staph ylococcus aureus. By con trast, ben·
za lkonil n chloride did not eliminate bacteri al spores ant
some VE ~etative bacteria (3).
For cop er IUDs, factory sterilization is preferred (350). Re
searc h i~ underway to find methods of cold sterili zation for us/­
when t~ sterile packaging has been contaminated or if copper
POPULATI
N REP
P:
IUDs were provided in bulk, nonsterile packages. Iodine solu­
tions are not the first choice because they can corrode copper
(4). IFRP tests identified three compounds as meriting further
study-one compound liberating formaldehyde and two liber­
ating alkaline glutaraldehydes (501 , 502). In the next phase of
the study, these three sterilizing agents will be tested under the
working conditions prevailing in family planning clinics in de­
veloping countries (4). USAID has offered to make available
Sporicidin, one of the alkaline glutaraldehyde solutions (545) .
Cold sterilization has several disadvantages. Many compounds
are effective only against some forms of bacteria. As noted,
benzalkonium chloride (marketed in the US as Zephiran Chlo­
ride Aqueous Solution) is ineffective against bacterial spores
and some vegetative bacteria (3). A widely used alkaline gluta­
raldehyde compound (marketed in the US as Cidex Formula 7)
is effective against Escherichia coli on copper IUDs but not on
polyethylene IUDs (3) . Also, IUDs must be soaked for as long
as 24 hours prior to insertion . Another major problem is the
need for sterile water, either to flush the chemical residue from
the IUD, to dilute the antimicrobial. compound before use, or
both. Flushing is important because most antimicrobial com­
pounds are skin irritants, and formaldehyde is also an eye and
re piratory tract irritant (3) and is carcinogenic ,in rodents (43,
323,471). Some compound s are unstable and can be used for
only a few weeks after be,ing opened (3).
Storage
How long can IUDs be stored before insertion? No one know s,
but normally both the polyethylene and copper used for most
devices are inert and durable. If protected from ultraviolet light
and extremes of heat and cold-especially repeated cycles of
heat and cold-IUDs do not appear to change significantly for
years.
Tests on sterile-packed TCu-200 IUDs conducted by the Popu­
lation Council in cooperation with the Ortho Pharmaceutical
I. ANQI YMOU5.
Adinom~'c~ s in IUD u ~rs: management.
pn!\ienlion sparks COnirover!iy. Contracept ive Technology Up­
d. , 2(3),29.)2, March 1981.
2. ANONYMOUS. Bacterial infection (rom aCtinomyces, though
be a problem among 'jOm e IUD users. Fami ly
Pl do"l1Ing Pe rspect ives 12(6): 306- 307. November-December
fJ re', is found to
198\>
·3 . A, ONYMOUS. Cold·steri l1z-alion of copper IUDs. PIACf
Product News 4(1 ): 2-3. March 1982 .
4. ANONYMOUS. Continuing IU D research. Network 2(2) : 4.
January ' 98' .
5.
NO NYMOU S. FDA inveStigating IUDs after deaths reported .
FDA DruK Bull etin 4(2): 10. 1974.
6. ANO NYMOUS. New probe for accurate IUD fit slated (or
m.H'ket Ihis fall.
Contracepl;ve Technol<>b'Y Updalc 2(10) :
134-136. October 1981.
7. ANONYMOUS. Pathogen is of pelvic i nflammatory disease.
8rift~ h Med tcal JoumaIH6178): 1588-1589. June 16, 1979 .
8. ANO NYMOUS. Progestasert IUO and ectopic pregnancy .
FDA Drug Bulleti n 8(6): 37. December 1976-lanuary 1979.
9. ~ N ON YMOUS. Tatum makes a case for the tail-less IUD. Con­
tracept ive Technology Update 2(10) : 132- 134. October 1981.
10. ANONYMO US. Treatment of sexually transmitted diseases.
M roical letter 24(605): 29-34. Minc h 19, 1982.
11 . ABDAlLA. M.l" KAMAL. I.. OSMAN, M.1.. BAYAD. M.A..
IBRAHAM, 1.1.. ASKALANI . H .• and BAD RAOUl. M .H .H. Dimen­
sion<J1 and archlt cdural disproportion between the IUD and the
uterine cavity: a cause of complications. Contraceptive Delivery
SyStEms 2(1} : 31 -35. January 1981.
1'-. A DLER M.W. Tr~ n(h for gonorrheJ and pelvic inflammatory
di sease in Engl.,m d and Wales and for gonorrhea in a defined
popu iation . Americ.1n Journ,,1 of Obstetrics and Gynecology
138( 7. PI. 21, 901·904. D.... ember 1. 1980.
13. AKERlUND . M.. PAP DE PESTENY. M.. and SOLftEIM. f. A
simple and effective methc.xf for retrieving retracted threads of in­
Ir,lute-fine contraceptive devices. Briti§.h Journal of Family Plan­
mng 7(4): 10)-106. January 1982.
POPULATION REPORTS
Corporation found no significant changes in devices stored for
18 months at 5° C, 24°C (room temperature). 37° C, or 50°C
(317). No tests have been reported on IUDs stored for longer
periods or in fluctuating climates.
Repeated extremes of heat and cold-such as might occur in
railroad cars, ships, or warehouses in hot climates-might
change the shape or reduce the memory of the polyethylene in
IUDs (298) . Exposure to ultraviolet radiation-from the sun or
fluorescent lights-can similarly affect polyethylene (265, 298).
The packaging might also be affected. After a long period of
storage, individually packed IUDs might no longer be sterile.
Currently one distributor of Lippes Loops, Ortho Pharmaceu­
tical, lists expiration dates of three years from the time of manu­
facture on its products. Part of a corporate policy of date­
stamping all products, the dating is intended to indicate the
difficulty of guaranteeing that the device will remain stable
over prolonged periods under varied storage conditions (340).
Few cases have been reported of damage to IU Ds from pro­
longed storage, however, and none have involved the Lippes
Loop (545).
In conclusion , the contraceptive benefits and many medical is­
sues associated with IUDs have been well-researched over the
last two decades. In addition to the Lippes Loop, several cop­
per-releasing and other devices have been proven safe, effec­
tive, and suitable for national family planning programs. The
major problems in expanding use of IUDs in developing coun­
tries tend to be programmatic rather than scientific: identifying
women at high risk of pregnancy and low risk of PID or other
complications, who are the best candidates for IUD use; assur­
ing the attention of well-trained and sympathetic health per­
sonnel both for insertion and for follow-up; and providing a reg­
ular supply of high-quality devices at affordable prices. Solving
problems of supply and distribution will probably require much
cooperation between donor organizations, commercial manu­
facturers, and government regulatory and service agencies.
·14. AKIN, A .. GRAY, R.H .• and RAMOS, R. Training auxiliary
nurse-midwives to provide IUD se rvice:; in Turkey and the Phi iip­
pines. Studies in Family Planning 11(5): 178-187. May 1980.
15 . AlLONEN. H .• lUUKKA1NEN. T.. NI ELSEN , N. ·C.. NYGREN ,
K.-G" and PYORALA. T. Two-year rates for Nova T and Copper T
in a comparative study. Contraception 21(4): 321-333. April
1980.
16. AlVIOR, G.T .• Jr. Pregnancy outcome wirh removal of in­
trauterine device. Obstetrics and Gynecology 41 (6): 894-896.
June 1973.
17. AlZA CORPO RATION _ (Edopi<: pregnancies in comparative
trial of Proge ~a5eft and plastic 111 Pe rsonal commun ication , July
1. 1982. IS. AlZA CORPORATION. The ProgtMtasert: intrauterine pro­
geste rone contraceptive syS1em : relf!ase rated 65 fTlcgfday pro­
gegterone for one year: a new contraceptive. Palo ,\Ito, Califor­
nia, Alza Corporat ion, May 1976.62 p.
19. ANDERSSON , K.-E.. Side-effects of prostaglandin synthetase
inhibitors. Ad a Obstetricia et Gynecologica Sa ndinavil':a l Suppl.
B7), 101·104. 1979.
20_ANDOLSEK, L. Post -aoortum IUD insertion . In : Hafel:. ES E_
and Van 0::;. W .A .A. , eds.
Medic.att:'d intrauterin e devices:
physiological and clinical aspects. The Hague, Netherlands, M ar­
linus Nijhoff, 1980. p. 137-145.
21. ANSARl. A.H. and HOFFMAN. D. Retrieval of intr.wtt-rine
co ntraceptive device with missing tail by means of a plastic spiral
(urelle (Mi -Mark). American Journal of ObstetriCS ~ nd Gyne­
cology 142(8), 1061.1062. April 15. 1982.
22. AREf. 1.. EL·SHEIKHA, Z.. BADRAOUI . M.H.H .. and HAFEZ.
E.S.E. Fadors affecting IUD-induced menstrual bleeding. In:
Hafez. E.S.E. dnd Van Os. W.A.A. . eds . IUD pathology and
m.1nagement. Boston, G.K_ Hall, 1980. (Progres.. in Contracep­
tive Delivery Systems Vol. ) p. I()9..1 20.
24. AUBERT. I.M.. COBEAUX-CASTADOT. M.·I ., and BOR1A,
M.e. Actinomyces tn the endometrium of IUD u5t'ni. Contracep­
tion 21(6): 577-58 3. June 1980.
'2 5. AUDEBERT. A.I.M. and EMPERAIR E, I.e.
Pe lvic and ab­
dominal IUDs: pathophysiology, diagnOSis and managem ent. In:
Hafez, E.S.E. and Van Os, W .A .A .• eds. IUD p.1thology and
management. Boston , G .K_ Hall, 1980. (progr 5 in Contracep­
tive Delivery Systems Vol. 3) p. 159- 168.
26. AZNAR, R.• BERRY. e.L.O.. COOKE. I.D .. CUADROS , A..
GRAY. R., MCNICOL. G.P. , NEWTON . I.R.. PIZARRO, E.. ROWE .
P.I .. SHAW. S.T.. Ir.. WAGATSUMA. T.. WEBB. f .. and WilSON.
E. Ectopic pregndncy r.;ttes in IUD user;, llener] Britis h MI.."<1ical
Journal 1(61 IS): 785·786. March 25 . 1978.
27. AZNAR, R.. REYNOSO, l., MONTEMAYOR, C .• and GINER,
P~t-plact:' nt a l inse rtion of IUDs.
Contraceptive Deliwry
Systems 1(2): 143- 148. April 1980.
I.
28. BADHAJv1, D. (U nited Nations Fund for Population Aaivi ties
(UNFPA)) [UNFPA allocations for contracepti vpsJ Personal com­
munication, April 12. 1981.
29. BAKER, R,W .. TUTTLE. M.E.. LONSDALE. H.K.. and AYRES.
J.W . Development of an estriol-releasing intrauterine devic.e.
Journal of Pharma (!Utical Sciences 68(1): 20-26. January 1979.
30. BANHARNSUPAWAT, l. and ROSENfiELD. A.G. Immed iate
postpartum IUD insertion.
276-285. August 1971.
Obstetrio and Gynecology 38\2):
31. BARRrTT. I.M .. GROWDON . I.H .• and VANHooYDONK .
J.E_ Pelvic actinomycosis associated w ith intrautt:'finc onlracep­
live devices. Journal of the Tennessee Medical Association 74(n :
492-493. luly 1981.
32. BARRON. B.A., WEI NSTEI N, H.. and RICHART, R.M. An in·
vestigation of the effecu of the intrauterine contraceptive devi ce
based on a longitudinal study of a se li-selected sample of Bar­
badian women. American Journal of Obstetrics and Gynecology
2J. AREf. 1., HEfNAWI . F.• KANDll. 0 .. YACOUT, M.. and SAID.
124(7) , 723· 729. April I. 1976.
E. Effed of ML Cu250 IUD On menstrual blood loss and sperm
migration. In: Haft.·J:, E.S.L and Van Os, W.A.A.. eds. MedicJted
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VJn Os, W .A .A .• eds. Ml"dic.lted intrauterine devices: ph ~o­
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B-129
BE[RTHI IIZE N. R.I.c..'-I.. V,\N WIjCK. lAM..
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'4.
ESKES.
Pa. ho·
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au
35 .
Me.di cu l and su,giCJI nt.Jn.lgement of the
C1I1IIClI ()b<.,I~t ncs .100 Cynecology 24 (4):
IGNQ, .B,B.
()€,Ivlc Jbsci?SS.
""7-1197 December 198 1.
16. RERAI . V. An ~pi dernlo l ~iL.JI udy of wC('nl "pnds in ec ·
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82 775-iB l. October 1975.
37. BERGER . G.S .. KEITH . l. G.. and EDELMA N. f).A. IUDs . nd
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<.h. 'ltV,A.A.,
...ds.
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"it""t'o, Inlem..l tional J(>urn,)1 of C; yn~leColog.y dnd Obstell'i(..-> 8(6.
Pt .
11 , 926-94(>. Novembef 1970
as.
4 1. HHAGr\VAN .
any G UPTA. P.K C t'nll.l\ ad ill o m ~·ro'!>l "
Md Inlr"tJlJterine oonll.w:epIL\,(' dPvlces: cytoptJlhologic d i.1~;nosis
and d l niol ::-Igmhn ncc.
HumJ:n Patholo 'y 9(5)~ 567·578
SIoplembe r 1976.
42. BLAC K. T.R. L , GOW5TUCK. N.D .. ond SPENCF . ,\ . p"".
collJI tmmuterin(! devl{""p insertion further eva) lion.
C(, n­
tfiJ'-I'pctoo 2l{6l' 65' 656 . OeCP.Olbt r 1'100.
43. B CKWUl. M.. KA NG. H , THOMAS. A. ,ond loI FAN11'. P.
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I lyglf"fie
A... sodt,cion lo urnJI 4Z rn 34-4b. July 100 1.
44. BONE. M. f.l m. i~1 plJll ni/li sel'\'lces In England ;ll1d Wales.
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Progeslagcn-on ly, onlr ilCl.:"p1ton and lu bal
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presn.1OCles. (letter)
Femll,uy 16. Iq74
4li. BUN N R. I.. ilSONDr. K. ",\I)DON. M., HASSA [ IN .
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ble'{'(i.ng compllcallofl!l w tl h Intr .1 ut l 'nn(~ t;Onlroceptivc deviCl"S.
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47. llON'iEY. W,A.. Ir .. GlASSER. ' .R .. CLEWE. rH . NOYES.
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Endom cJriu' rC's.ponS(· !n I ~ in ~
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48. ROaN M.E. KIR K R , ~ .. and lJE GRMFF G UILLO UO, I.e.
P'!.iltnmo O"W bod ies ilnd !.Om~ o flPort un~ ic infe110ns de1ected In
Con1r{l cepl ive
cervir."'I1 sn i.I1S of wOrne n fi lle<i wlI h .a n IUD
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&9.
C. W"
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Controver·
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n Guadeloupe
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74. Cl IOWD HURY, N. N.R., MAN DAL. G.5."n<
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ClIQUfT. R.l .. V N HYFrE. E.. ond DEV EN,
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or
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80. COM81 ED R NG KOK HOSPi[Al GROtH
'~ raml
o( the
[IUO
Unpe
tnl('rn.:II I()(\;IJ
1980.
nd WRIG HT,
Oft pehic 1II11amnklt{IrY cti"'!.Jse In nulli parous WOnh?1") u.... ng ol
Copper 7 InlraLi l enn~ conH;-r ep!ivC' devll"'('. BntlSh M edlCdl Joor·
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SO. (3nUc/'IARD I.-G ., ALBERT, R., dlld I"l RSKU . I Uo,e of I h(>
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81. COOPER D.l.. MilLEN . ,\ .K.. an<I MISH[U D .R., Jr. The
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ne Co r.Ir3Cf'P­
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Cldn
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124 1 2 )~
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" l-tdnawl, F_
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88. DAHLB ERG. B., KU lLANDER. S., URSI NG
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56 BURK.rVI,\ N, R.T. Inlraut rinede icft
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.:.nd Ihl ' ri ..k o( pelvic
58. e URK,\<AN , R.. SCHLESSELMAN.
.. MCCAFFREY. L,
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{l9821. 14 " . (U npubll\hed)
"S9. BURJ<M,\ N. R. T. "'''' WOM F ' $ HFALTH ST DY. M "",,, ·
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1962..
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&1.
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N , R.T. Pelvic
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H ospital, Fe.r­
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100 p.
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473 . TACLA, X. and BAEZA, R. La T de cobrc y
lippeS loop:
cual es mejor para la mlljer chilena? Una muest sclecd onZldJ .
rrhe Copper T and the lipp€ ' s loop: w hich is bel
for th ~ Chi I·
ean woman? A select samplingllSPA. sum mary ir NG] Revista
Colombiana de ObSt tricia y Ginecologla 29(51 : 2 234. Septern ­
ber-October 1978.
501. TULIS. J.J. Feasibilit y of u!til1£ <1ldehyc-l .: di~'n eclJfIt (or t t \
fi eld sterilization of copper intra·uterine dr ices. l unt" l 19t 1.
24 p. (Unpubli shE'd)
502. TUlIS, J.J. Ident ify method of cold lerll izol,ion Clf copr intra-uterine devices. June 20. 1980. 40 p. Unpo!ltL5hech 503. TYRER, l.B. The Cu-7 and postCO!
contra eptit)" P
sented at the Annual Scientific Meeting Nf the As$O( )flon 11
Planned Parenlhood PhysiciJns, Philadelph .1. Pennsylv;l l'uL'l . C
tober 10-12, 1979. 16 p.
"S04. TYRER, l.B. Update on intrauterine d vices. Current Pr V­
lem s in Obstetrics and Gynecology 2(7): 1.... i. March 1
,
50S, UNITED NATIONS (UNI . DEPARTM NT OF ECO'"
:c
AND SOCIAL AFFAIRS . Fertility and fam tty plann ing In f uro \.:
around 1~70: a comparative 'lItudy of !"Ii ve nJ1lOnJI . urv~"
New York. UN, 1976. (Population Studies "' 0 . 58; ST15 .4 'SER. I
58) 180 p.
POPU LATICIN REPORT'S
506. UNITED NATIONS [UN). DEPARTMENT OF INTERNA­
TIONA L tCONOMIC AND SCX:.IAL AffAIRS. POPULATION DI ­
VISI ON . Variatio ns in l he !ncio 'nee of knowl£>dg~ and use of
conlraception : a comp.:uallYe anal ysis of VVodd Fen ilily Surv<.>y reo
sulls lor twenty devploping counln es . Pr~Jan;>d for United N a­
tion't Working Group on Campara.l ive Analysis oi World Fe ltilily
SurvPy DilIJ, 4t h meeting. Gen e v~ , Novem be r 18-21 . 1980. (U NJ
UN FPN W F-S.IVJl 9j 113 p.
507 UN ITED STATES. AGENCY FOR INTERNATIONAL DEVEL­
OPM ~N T [,\10) . Of FICE Of POP ULATION .
[AID-fi na n<:ed
deliverit?') lor IUDs by country (rroc~ sed by GSA), calendar yeM~
1968- 198 1 (in unib)}
Personal com m uni collion , February 25,
1982 .
'500. UNITED STATES. DEPARTMENT Of HEAlTH . EDUCA­
TION. AND WELF/\RE. CENHRS fO R 0 1 F.ASECON TROl. Go n­
orrhf'<l. CDC recommended treatment schedul • 'I Q79. Morbid­
ity JmJ MortalIty W eek ly Rep(Ht 28(2): 13-21 . ,.1nuary 19. 1979.
509. UNITED STATES. DEPARTMENT Of H t~LTH . EDUCA­
TION, AND WE LF/\R CENT[RS FOR DI S[AS CONTROl. Pel­
vi c- mn71 mmJtory d i~-Umtl'd Stat6, Morbidit y unci Mortalil y
W« kly Repo rt 28\51 ); 605-607 lanu.'Y •. 1980.
'SI O UN ITW STATES. D[I' ARTME NT O f II EALTH . EDUC.\­
TI ON. AND WELFARE. FOO D AND DRUG ALJMI NISTRATION.
Pros' :1Y'rt IUD tlnd et.."'10 PIC pr('gnancy. FDA DrllS Bulletin 8(6):
37. D ecember 1978-Ja nuary 1979.
' 511 .
IHD 5T H S. DEPARTMENT OF HEALTH. EDUCA­
TION. AND WflFARE. FOOD AND DRUG ?\[)MI N ISTRA TI O :-.J.
M£OI
L DEVI CE A N D DRUG ,\OVISORY CO.\1MITIn S ON
OBSTETRICS A t D GYNECOLOG Y, Sec,ond rt'f )(H1 on inlrJulcr­
in!! ( f}ll trcl c~ phve devices.. \OVJ~ hingtun. D.C. U.S. Govt~ rnmenl
Print ing O ffice. Decem be r !I)78. 102 p.
112. UNlTfD STATES. DEP,IRTM ENT OF HEALTH AND IIUM,\ N
StR\ I ES. FOOD NO DRUG ADMI NISTRATION !FOAl. Sum­
nlo.lry of minute'S: twenty· ninth mCC'ting obsr e t nc ~y n N: ol osy 'SeC ­
tion of the ob:.ICIn10-gynecology and radiologic devicf!') panel .
Wa ~hi n.~t(m. D.C.. FDA , Novt'rnbPr 10. 1980. 47 f.l. (Mim eol
· 535. W ESTRQIv1, l. In idem: , pr~ v i1l ence. and trends of acute
pelvic i nilaml'll<itory disease .lnd its o msequences in induSlriaJ­
ized (:ounIIie'S. .'\merican Journ.ll of O lJ1let ri and Gynecology
nBO . Pt 21 88O-HY2. December 1, 1980.
536. WESTROM . l. Pelvic inflJmmatory disease And t tw IUD. In·
ternal ional l ourn.J1 of G ynaC:.'Coiogy Jnd O bslecri(:s 1i151: 509·511 .
MJrch-Apri l 1980.
noc
515. Vi\ N KH S, I-I. E. , THIERY, M., VA N DER PAS , H., DELHE.KE ,
OS. WAA . f AUB ER. P.F.. DO." BR()WICl.. N., MM :'
L.. VA
DON J\lD, I.S.• HASP£lS. A.A., and DROCEi'DIlK. A. - Inleri m
insel1ion of the ML Cu 2.50 int rJutenn(' (Ontr<lCl"pl ive device.
ContrdCeptlve De!lvc ry Syst{!,l m 1121: 149-1 54. April 1980
516. VAN lITH. OA F.. DU PLESSIS-ALBLAS. M.. tl ERIDO. L..
VAN stH1E. K.J" <1 nd BEfKHU IZEN. W . Postabor1urn irnert ion of
Muh iiood IU D . Lt:!den, Nel h erl .1 nd ~, Cf:.'nter for Hum an Ref'H o­
dUCI ion. [19801. J) p .
51 7. V AN 0 $, \'II ,A.A. lSI. Eli Z Jbeth '~ 01 Groo te C;.)<.:t hui.:. Has­
plt.)I, r l.ldl k m, el herlands) [Th E' Multilooo and c.u rrem IUD rc­
£earch] Persona l comnluniGltio n. MiHCh 8. 1982
SIB. VAN OS. WA.A .. DE NooYER. CC. A.. BAKK ER. ..
BO M( RT. L RH tM REV. P.E.R .. and LOEN OGRS LCXlT. E. W.
!::v,lluJ.tion oj Ih(' ('o01bineO Multiload copp.'! r IUD (M lCu J5 0 nnd
1\1 LC u37SI_ Internatio nal Joorn,11 (Ii Fert ilil y 2J( 2) 152- 15S . 1978.
5 1~ .
VAN OS, W.A.A .. DE NOOY[ R. C C A.. and KLEIN HOUT . I.
Thc MultilOJd inl id-LJlerine contrclct'pl i\'e d{'vice. SOut h Afri Gln
Medial journal6Q{24): 938-940. Der l::'mber 12. 1981.
520. V , OS. WA A , DE NOOYER. CCA. RHtMREV . P.E.R..
BO , r RT , L.. and K SASIH, F. Ex pt'rience w ith Ihe cOInbineU
Multi lo.Jd CU 150 mod Is and MullilCl.1d CU 373 IUD. In: Kon­
gh-OS O t~ h,·tri Ginekologt Indonb td Ke 4, Idang I!miah . Yogy;l­
k;:i nJ. 10- 15 Juni 197t'J. Vol. 2, IYogy.akJr1a] P.O . Lu kma n, \1979] .
p.61-&3.
j 2J VFNEZUHA Of lClNA CENTRAL Of ESTADI STICA [ I, ­
FOR,,\- TICA .
Encue5tJ n.tcion., 1 de f~(u ndi dad: Venezuf>IJ
1977: dpe nd ice esL1dfsIICO. INa t l o n ~11 Ferti lity Survey: VeneZltel:J
1977 : Stali5l icdl appenri1x .J[SPA)
Carilcd ~ . Venezuela , 1980
~ \"'orld t-en llity SU(veyJ 799 f1
522. VI5S£Y. M.. DOLL R.. PETO. R., 10 1-INSON. B.. and \,vIG ­
GINS, P. A long-I rm follow-up il udy o( women u~in g different
mel hods of contraception: an interi m repo rt . lour nal of B i u~,~ J
$cit"' n<. e 8(4): 37)-427. October 1976.
523. VESSn·. M.P .. 10HNSON. B" DOll, R., and PETO, R. Oul·
come of pregnancy in wonWn u.:iing an inlrJUlerine device. lan­
cet 1(?85!tr. 495-498. M arc h 2J , 1974.
'~ 24 . VESS EY. /vi ., MEI SLl.R. l. , HAVEl. R.. and YEATIS. D. O UI
come (lj [If( 'Hnancy in wom en using differen t methods o( con­
trilcc-pt ion, British Journal 01 O bstetrics and GynaeL"Olugy 86(7):
548- 56. luly IQ79.
525. VE!iS('l'. M .P., WRIG HT, N .H., MCPI'IEKSON, K" and WIG­
GINS, p, Fe rt ili ty after ~loppj ng differf"nt met hods of contracep­
tion . B' l t i~ h Medical l ournal 1(61 08); 265- 267 . Feoruary 4, 1978.
526. VES5[Y, M .P.• YEATES, 0 ., and FlA VEL R. Ri.:.Jt of ectopic
prt:gn'l1lc..-y and duration 01 uS(' 1')f ,lfl i nfraulerine deV'iCC. Lancct
2(6 14 11 50 1.502. se",em be, S, 1 ~ 79 .
1
'527. VESSES , M.P.. YEATES, D. , FLAVEl. R.. and MCPHERSON,
K. PelVIC inil,lmrn i)fo ry dl~ 5e Jnd the intrJUl erinc d iCt : fi nd­
IngS if' . I.Hge co hort study. Brit ish Medic,l l Journal 282(62 671:
WESTROM , L. , and WIESE. J. Oinic..,11 c~ peti{:'n~ w uh the uteri l le
p(ogeste rone system 1Prosesrasect). Contracept!U1l 1l(5); 559·
5{4): 41-48. Ocloocr 1970.
' 539. WESTROM. L.. BENGTSSON. [.p... nd MARDH . P.-A . In­
cidence. Irc n(I.;;, ;lnd risks of cctopic pl1!gnanq' in ~ populJt iOn 01
w omen. Bnli sh Medi c.ll Journal 282 [625 7): 15-18 . J.'tnu,uy ,),
198 1.
540. W ESTROM , l .. BENGl'SSON , L. P., ,ond MARDH , P. ' .... The
r' k of pelvic tnf1.~m m.ltory disease in women u:,illg intr.)uterine­
contfJceptivf.· df'v ices as: compared 10 non-u:;el'5. L:J nCCI 2(7919);
22 1·224. luly 31. 1976.
54 1. W H EELER, R.C . [l n l l'rn~IJ ion,jJ 1 Fertility R~.Hch Prop,r~ml
[I U O research] Pe~n,ll co mln uni lion. December 14, 1981 .
'542.. WHI FE. M.K.. ORY. HW .. ROOKS, 1.0.. ,ond
ROCI-i ~ T.
I
'545, WILEY. A. [U nil l'd Sidl es Agency for Internatio na l Develop­
ml?nl i IIUD progrilm i..!o u (.~ : costS, packaalflg. Stc n\t/;)lio n, Jnd
sht! lf life ] Pe rson.11 commu nication, F~ bru ;l ry 11 . 1982.
S46. WIL LSO N. I.R.. LEDGFR, W.I ., BOL LI NGf R, C C . and AN ­
DROS, G./. Thp M argu lies intr, ut l:'rine contrJCepl ivE' device,
AIllf'r1Ul n l oumal of Ob$tet rics and Cynecology CJ 2( 1): 62·70 .
M.:ty 1, 1 96 ~.
547 WILSO N, J.
IntrJut erine co nt racept ion wi th the Cop ~ r 7
100 <ompdred wi lh the Mulu lood Cu 250. PrBellted Jt tht' 10th
V odd Congress on Fert il ity and Sterilily, Madrid, july 5- 1L 19B(l.
°548. WORLD HEALTH O RGAN IZATION [WHO[ . Nongonococ·
cal urethrilis dnd ot her se lected 5exu!1l1v tr JIlSmiued di 5ense1 of
pub lic h ' ahh 'Inport ~ n e
Geneva, ~IH(), 198 1. (TechniCd I
Report Se n", No. 660) 142 p.
549. WORLD HEALTH O RG/INIZATION [WHO [. DIVISIO N O F
FAMll Y H(A LTH. T he prevalCflce o( nul ritiollal .=!oot'mia in
w omen In devt!IOf-ling count ries : a li l~ri.lture revll:...... Gt::n~vd,
WHO . 1979. (FH EJ79.J I li B P
550. WORLD Hb \LTH ORGANIZATION [W HO[. SP ~C I A L PRO­
GRAMME o r R' SEA RCH . DEV[lOPM T I'm RES&IRCH
TRAINI N G Ii- H UMAN REPRO DUC'n O
n 3!Ost"$smenl of the
U p~~ l.oop D and the Copper T n IX. Genevd, \0 H O, flJ79 ,
p. IMim l'(l)
' 551. WO RLD HEALTH O RG ,INI ZAlION [WHO) . PEC IM PRO­
GRAMME Of RES<.-\RCH. DEVElOPME NT AND R L~£i\RCH
TRA INING IN HUM A N REPRO DUCTION , N i nth dnnual report.
Geneva, WHO, I 'JUG , 162 p.
' 552. WORLD HEA LTII ORG ANIZATIO N [WIIO). SPECI M PRO­
GRAM.\;1( OF R EA RCI-I. DEVFLOPM E IT AND R :;fJ\~CH
TRAINI NG IN l-lU MAN REPRO DU C 10
Genev,l . WHO, Novem ber 1981 . &7 p.
T nt h annual report.
5S3. WORLD Hr~\L 1 H ORGAN IZATI O N [WHO ). SPECIAl PRO­
GRAMM " Of RESEA RCH. () VHOPME NT AI I) RESfA RCH
TRilliN G IN II UMAN REPROD UCTION . T/ISK FO RCE ON I '
TRA UTERI NE DEVI CES FOR f FRTllI TY REG LATION. Com r ,rn­
live multic ntre t fiJI of Ihree IU D:. i n ~.rt ed immed iately (ollow ing
delivery o( Ihe pbC;f'nt.1. Cont raception nI t) : 9-1H. luly 1900.
554. WORLD HEA LTf l O RGA NIZAT ION IW~{O[_ TASK FO Ra
O N M£THO DS fOR Tfl( REG ULATi N O F IMPI ANT TIO N.
NEWTON, j .. SZONTAC H. F., LEFl[(lI. P.. and ROWE . P. A col ­
laboratl w , tudy of the progest erone IntrauLCri nl" d(~\'ice <Pro­
gestasc r1 ). Con".. ept ion 19(6); 575-589. Ju ne IQ79.
555. WO RlD HEA LTH ORGANIZATIO N. SP U Al PRO­
GRAMME O F RE [ARCH. DEV ElOPME T AND RESEA RCH
TRAINING IN HUMAN REPROD UCTIO ! . TASK FORa ON psy­
CHOSOCIAL RESEARCH IN FAMILY PL~ NNI 'G. A cros><ul­
tu ra l study of men-.tru 3tion: impli c;J t io n ~ for ont r3ceptivC' dcvd ­
opmcnl .lI1d use. Studies in F.. mily Pl;mning 1211}: 3-16. )anUJrl
198 1. S56. WORLD HEALTH ORGANI ZATION. SP ECIAL PRO­
GRAMME Of RESEA R H. DEVELO PM8
AND RES fARCH TRAINING IN HUMAN REPRODUCTION. TASK FOR EON PSY, CHOSOClA l RESEA RCH IN FAMilY PlA N NING. Women',
bleeding PJIt~r ns ; ability 10 r(,("el ll .)nd predk:t memotru.J1 e\ll;'n b .
Stud ies in f-Jmil y Pt,mning 12( 1): 17-27. I.MUdry 1981.
568. ZHANC, P. Fh c yeat'S expe rience with t he Copptr T 200 In
Snr.tn ghai: 856 ca
ConlfJ eption 22 (6): C;/j1 ·5 71. (x:ce(n be,r
1980.
569. ZIPPER. I.. M DEL. M .• GOl DSM ITIi . A.. ,nd EDElMA N,
Journ;a! 0(
L, OSO RI O. A _, and TaS \ NI 1. C. Fo ur )"e:ill"S elClX-...fentX wltf't
the Cu7 200 devlo-··~n d oul e tin e copper in fj ·rtility (ont-roi. Con·
1141Cept ion 1 il L 7- 15. Jiln u<1ry 1976.
ADDENDA
5 71. CHEN, "- I.. PAN G . S.L , and YAP, M .T. TIlf' '«ond nalion.ll
(~m l ly plann ing d nd pOpu liJt ion su rvey in )ing.lpore 1077, N tH} ­
mi; Jour na l Oi Sfng.lpofe 19{2t : 67· 71. Derem ~ r ]liN.
sn,
CH
• P.Birth planni nR. In. CQf11 mll l~l: >n St::hola riy
COOl munlC';i ll ion \YlI h t h ~ Peop'~ ' s: Republ
of Ch in,). Ruml
he.... bh In tht: People's R uhlte of Chind . W,I'l-hiflgto n, D, C.. U.
Governm €nt Printing otIice. 1980 (NIIl Pub! . N o . 61 -2124)
,I.
10>- 127.
57J . EDWA RDS. L L.• IV\ rOGI. S. P.. HUR LEY . S.K .. and HA K­
l " trJ1J t eti r~-df.\' 1 (·. r ·ldled hru.pil ali Z1lio ns,
v.J nces ill Planned P.lrenthood 1&(2): 65-70. 198 1.
A. SON, C.Y.
Ad ·
- 74. FREE, M . (Program tor Ihe Introduet io n J.nd dJpl ation o(
Co nlraa 'jlli ve Technology ,PIACT)I [L()(;dl prodVd!on of IU Ds.]
Personal communic,nion. M.lfch 5, 1982.
575. FREE. M.I ..
ENSTEIN . I.M.. MORROW. M.M"
dnd PERKI N.
G.""""
l oca l p rodUO lon of co nl race ptives in devc:IOVing coun ­
IOraft pmp<1YM for Donor ConferE' nce un Con l rac,; p ll'o-~
N ··(·ch III the 198O"s. \OVashln8ton, D. C.. ,,-by 24, 198Z] ISe.all le [,
P r o~ rJm for the Introductio n and AdapCdtion of C-onlri)"E'pt ivp
Tl?d'tl'lqlOSY (PIACfl. MdY 1981. 4J p. ( M in~eo)
tries.
576. GIBSO N " 'N .G . (O t1 ho D nada] [Productir.lf'I .:lod diSl ri bu­
l io n of the TC u-J80A. ) Pe rsona l commun1C:(ll io n. Mav 5, 1982 .
•577 . C OLDMAN , N " PEBlE'lr, A .R., .md WESiOFF, CF_ Pmb.l .
biht le>. of <.u n« ptio n i ll u tin Aml"tic.l _ P [~ nt f'd <II Ihe annual
(n t=<Imy, of the Popul.allon A.,SOCiati(JIl of 1\mef\G1, Arri! ) 0, 1982.
30p.
57R , H BER, A. and O tBR! H , E_ Pregrgncy fill es dUfl llS lo n8­
lerm use oj
OI'fJe-r IUDs.
ContraLe.pti vc D
,n\lery Sys!etm ](1l !
99-102. Arn11 982.
t;79. LA I
, J,E. Jnd l\l CA!\'' T/\R:\ . A.N. I·ina! report 0 11 111 <: l C) 7b
til io cwl Ac.l..t'pt<Jr Surve~. !M ani la], Ulll....~f'!, I ( y 01 the PhHII)fllnes
Po pulation In ':.l i lu l~. l uly 1980. 127 p.
"iSO. M!\KElJ\. S. [Outok (Jl1l pu O¥. Flnl.md) (Specl G11ior1S and
J l - ribuli(Jn of 0" ,1T .J Person:a l com munQh n, M.lY 2:1. 1962.
58 1 \;1I SHEU, D.R , 1<. B ~U. I.H.• GOOD , R.G.,
.10<'
" OYE R,
D_l. The inlfdutf'rine .~\'i cl: : J b.lC1f1riologie ilud y ot Ihl.! j . n(Jo­
mel nal cavil)'. Amerian louma l 01 0bsI !rIa .lnd ynec.oIogv
%fl] . 119-126. SeplUml r I, 1% 6.
582. PERKI N, G W .# G E STEIN. J. , Jild M O RRO\·\ ,
tracepti\ E!' uS(> in Chi flJ. PIAL! Product Nc.A\\·) 211): \-8.
.
Con ­
It( 80)
PLA
ED PARE TfIOOD FElJ RAT I()N O F "M ,~ I CA
01 medial stoll'ld.:udr, Ol nd Hui delines. New York.
PP FA. 1982.
584. Sf l,IW. ST. Ir. A, DRA DE. A. F.L.. PAIXAO DE SOlJZ,\ . I.,
583
IflPFA). M.JOllal
,\MCA ULJ\Y, LK" and RO W E. P. 1. Qua nt itaTive menw u,,1 and in
tt'rmefl rua l blood loss i n women USing L1Pf}e5 loop and C(lM)('f
T InlrJUler ine dllVldK Con t r~ pli o n 21(41: 343 -352. April 1980.
S8S . SKOUBY, SoD, and M0 1_'>TED -PEOERSEN. l. Int ra ul ~ril'lt:
c:olltr.)(ep!ive d~ices for di;Jhel ics. {l enNI t.." n<: 1 J(8278}· %8.
Apn124, 198 2,
-566 . 5N O WD EN. R. W hy I n intl?rn;ltio l\dl IU D 5(ofldtu d is nO(
prJs51ble IPPf M e.diClI Bulletin 1601: 2-4 . lune 1982..
':;87. SQUIRES. E..F. [Se arle Canada] [Muhiloads ilnd C'1Il.ldi.l n
distribution.] Persanu l communicatio n, M JY 10 , 1982.
538.
ULLIVA , I.. SUYONO, H.. BAHRJ\WI. W., and HAR­
1 C ADI , A, CootrJ(' pt ivp use-effecti veness in M ojokCrto Rt:·
geftC{, Indonf-'<;iJ: J co mpa.rison of regular p,.-og.-am ~ nd sped :! l
d rive acceptors. Swdit>'" ill Fami ly Planning 7(7): 186- 1%. Ju ly,
" ROSENA ELD. AG .. and
1976.
5H9. UNllED STATES CONG R ' S. O FFICE OF TE HNOLOGY
VARAKAI'vIIN, S. N urse-midwife inscrt lon or Ihe COpperT i n Thal ­
lJ.nd: performar,ce. acceptance. ,l nd progr.un m.1Hc effects. Stud­
ie'S in Family Plann ing 6(9): 237 -241. Seplember 1977.
ASSESSME
World populJ tio n ;) nd fert ility pl Anning tech"o lo
sf I he next 20 years . Wdslting1 on , O. '" . U S. (iovern n)CIlI
P ri nti n~ O Nic(l, Fcbr\J,J,ty 1982. (OTA ·H R- 15n 1 43 p.
'SS9. WRIGHT. i'o. H.. SUJPUL
.
;Jl. WEoLl S. W, CAMPODONICO. I., GU NTHER. A.. and RIED,
\ An ihomi('oSis Je! tracto genital fem('nino. [Actinomycosis o(
lhe f~ m J le genil JI trad _HSPA, ) ummary in ENG] Rev'isl a Chilena
t1~ Ob~ t 4; triti:t y Ginecologia 450 ): 141 · 146. 1980.
561. XIEM, N .T. HeaJth.~i n t eg rJt e~
J .o proJch 10 bmily planning
i n Viet Nclm. In :~t
. ~€
i . . ~.(' ilnd Soc.i.l l Cummis-­
s.io n fo r Asia and (.'
-1
p; JJlon Divisio n. Inven­
tory oj selt:cted I - I l l y r o.lnn; g ogram m ~ c.xpcnc nces in
- -- - - - --
KHOS I1:-.lEVI . P. t rfeol....e~ of Ihe Ira nian Juxi ri.ory midWife in
I D inst'ftion. Si udies in Fami ly Pltt nni ng 1(lJJ: 2 6' ~l 6). x'ph' RI­
b..- 1976.
-43 WHITl. M.K.. ROOKS . I.B .• STRAUSS. I. . KOCHAT RW ..
106. May 1976.
--
~17. AugUS! 198 1.
567. ZEIG IIAMI. E., lfICtl,\ MI. B.. EF'1 EK HARI. A.E.. dn"
570. ZIPPER. I.. MEDEL M.. PA"'FNE. L. RIVERA. \;1 ., TO RR ES.
560. WYNN. R.M. und S,A,WA RAG I, I. Effea.. oj Inlra-uterlne ann
oral cont r.:lCeptives on the ult rastructu re of lho hum ilO endo me­
trium. Journu l of Reproduction and Fert ili ty (Suppl. 8): 45-57.
1969.
POPULATION REPORTS
fi nd pJrti.11 uteri ne IJt.lrlor;)t\.on and embeddi ng iollow if\g insertion
at intrauterine d'vices. 2. D iagnosllc mdhods. PfeO.,.enlfon, ,md
manJgement. Obstetrlc:..tl.u1d G ynecologic-.l l urn'"Y 36( 8) : 40 1­
O.A . Six-year COOl luuo1fio n ra tes fo r C u -T~200 lisen..
Reproouctiv.:- Medrcine la [2)~ 95·97 Ff!.boJary 1977.
558 . WRIGHT, N.H . and LAEMML E. P. Acute pelvic inn,l mmd.­
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-
~~~~I~i~~~I~~~Z~!\~~., ~,~~ ~t~JE~:r~~ ld~~ti~~~~~i~Ir.~
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1977. "OSN 0092-9344 8-135
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