Reconstruction Breast

Breast
Reconstruction
For over 20 years,
Mentor Corporation
has been recognized
worldwide as a leading
manufacturer of the
highest quality breast
implants.
Be confident.
Be informed.
MAKE A GOOD DECISION.
There’s a lot to learn when you’re considering
breast reconstruction or breast replacement
surgery. This brochure is intended to help
you build a solid foundation of knowledge as
you begin this important process. It’s packed
with facts about the surgery itself, the latest
information about Mentor’s MemoryGel® and
saline breast implant options…and more.
For over 20 years, Mentor Corporation has been
recognized worldwide as a leading manufacturer of the
highest quality breast implants. We offer two basic
types: MemoryGel® and saline-filled breast implants.
Our rich history is filled with industry firsts,
innovative product designs and groundbreaking
research. While other manufacturers have come
and gone, Mentor has a record of continually
producing leading-edge, FDA-approved breast
reconstruction products. And, all of our
implants sold in the U.S. are manufactured
right here in the U.S.
TABLE OF
CONTENTS
1. 3.
7.
An Introduction
Breast Anatomy 101
What are the facts about breast reconstruction with implants?
13.
Which type of Mentor breast implant is right for you? Silicone gel or saline?
19.
Special Considerations:
Deciding on Breast Reconstruction
23.
27.
Selecting the Right Surgeon for You
The Surgical Procedure…
Facts and Factors
29.
31.
Important Safety Information
What are some of the considerations before reconstruction or implantation?
33.
Mentor Product Replacement
Policy and Limited Warranties
37.
Frequently asked questions about breast implants
Like all things in life–the
best decisions are made
when you base them on
your personal needs,
desires and expectations.
AN INTRODUCTION
Did you know that tens of thousands of
breast cancer survivors have chosen to have
breast reconstruction?
Is it the right choice for you?
Not every woman facing a mastectomy feels the
need for breast reconstruction, but for many women
it is an important next step in their recovery and
overall healing. What has changed over the years is
the number of options when it comes to choosing
breast implants and surgical techniques.
Most women are good candidates for
breast reconstruction. It’s true.
Some women want breast reconstruction after a
mastectomy because they feel a lack of wholeness
or a loss of femininity. For others, the reason is more
practical–they simply don’t like the hassle or worry
associated with wearing a breast prosthesis.
The best decisions are made when you base them
on your personal needs, desires and expectations.
Breast reconstruction procedures vary depending
on the results you desire along with your particular
situation and other physical and psychological
factors. Again, being informed about your options will
help you and your surgeon make the right choices.
Any breast reconstruction process will
require multiple procedures.
The actual number of surgeries and recovery time
will vary. Select a surgeon who is experienced in
breast reconstruction and encourage your general
surgeon to work closely with your plastic surgeon
for the best overall care.
{1}
Know the benefits…
and consider the risks.
There are other options for breast reconstruction
that do not involve breast implants. Be sure to ask
your surgeon for a detailed explanation of each
alternative to help you decide which reconstruction
option is most suitable for you and your lifestyle.
It’s essential to spend time with all the information
you have received before deciding whether to have
reconstruction surgery. A helpful tip–prepare a list
of questions after reading this brochure, and take
them along to your consultation with your surgeon.
Who will be on your “treatment team?”
During the course of your treatment for breast
cancer, there will be several different physicians who
will work hand-in-hand to plan your mastectomy
and reconstruction procedure so that you get the
best possible result. Your team should include:
Surgeon – He or she will perform the biopsy of
the breast tumor and the mastectomy
Pathologist – This surgeon studies the tumor
to determine the degree of malignancy
Medical oncologist – This specialist
administers anti-cancer drugs or chemotherapy
Radiation oncologist – He or she administers
radiation therapy
Plastic surgeon – This physician performs
your breast reconstruction
{2}
BREAST ANATOMY 101
The breast consists of milk ducts and glands,
surrounded by fatty tissue that provides its shape
and feel. The chest muscle (pectoralis major
muscle) is located beneath the breast. As most
women know, factors such as pregnancy (when
milk glands are temporarily enlarged), rapid weight
loss and the effects of gravity as you age combine
to stretch your skin, which may cause your breast
to droop or sag.
Pectoralis Major Muscle
Pectoralis Minor Muscle
Fatty Tissue
Milk Lobes, Glands
Milk Ducts
Nipple and Areola
Sof t Tissue
Ribs
What is a mastectomy?
When cancer is discovered in a woman’s breast,
a common form of treatment is a mastectomy.1
A mastectomy is the removal of breast tissue due
to the presence of a cancerous or pre-cancerous
growth. The amount of tissue removed during a
mastectomy procedure varies. There are several
types of mastectomies that can be performed. The
type that is best for you depends on many factors,
including the size and stage of your cancer, your
particular anatomy and your preferences. You will
discuss the mastectomy itself with your surgeon.
1
Berger, Karen and Bostwick, John III, M.D., lbid., pg. 51
Two of the most common mastectomy procedures
are the modified radical mastectomy and the simple
mastectomy. The modified radical mastectomy entails
removing the breast, its tissues, the nipple-areola and
the lymph nodes found in the armpit. This procedure
leaves the pectoralis major (the large muscle located
on the chest wall) intact.
The simple mastectomy involves the removal of only the
breast tissue and sometimes the lymph nodes. Breast
reconstruction can be performed after the modified
radical mastectomy or the simple mastectomy.
What are your reconstruction options?
One of the first decisions you’ll need to make
if you decide to have breast reconstruction is
whether to have immediate reconstruction, which is
performed at the time of the mastectomy; or delayed
reconstruction, which is performed weeks, months
or even years after your mastectomy. You and your
surgeon can thoughtfully decide which of these
options is best for you.
Your medical situation, breast shape and size,
general health, lifestyle and goals determine the
type of breast procedure that is available to you.
There are several ways to approach
breast reconstruction:
By the use of a prosthesis (a breast implant,
either silicone gel or saline-filled).
A tissue flap which is a combination of skin,
fat, and/or muscle that is moved from your
stomach, back, or other area of your body to
the chest, where it is shaped into a new breast.
A tissue flap also may be used to provide skin
or other tissue needed to make up for what was
removed at the time of surgery, or changed
following radiation treatment.
A combination of the two.
{4}
A MAJOR CONSIDERATION
It is likely you will undergo
additional surgeries to improve symmetry
and appearance – whether or not you have
reconstructive surgery with or without
breast implants. These additional surgeries
may be part of a several-stage reconstruction
of the removed breast, or may be to shape the
remaining breast to bring it into better balance
with the reconstructed one. Most commonly,
breast implants are inserted after a space has
been created for them using a temporary soft
tissue expander that can be placed at the time of
your mastectomy, or at a later time.
Nipple reconstruction is normally done as a
separate outpatient procedure after the initial
reconstruction surgery is complete. Because
the nipple and areola are usually removed with the
breast tissue during a mastectomy, the nipple is
usually reconstructed by using a skin graft from
another area of the body or from the opposite
breast. The area also may be tattooed to obtain a
better color match.
Can breast reconstruction be done
without implants?
Yes. In some patients, the breast may be
reconstructed by surgically moving an area of
skin, fat and muscle from one area of your body to
another. The section of tissue can be taken from
such areas as your abdomen, upper back, upper
hip or buttocks. This may be required to provide
enough tissue to match a large remaining breast,
or to replace tissue removed or damaged at the
time of your mastectomy or following radiation
therapy. Ask your surgeon about the non-implant
options that may be available to you.
WHAT ARE THE
FACTS ABOUT BREAST
RECONSTRUCTION
WITH IMPLANTS?
Your health and medical condition are important
factors your surgeon will use to decide if you are
an appropriate candidate for breast reconstruction.
The surgeon also may recommend breast
implantation of the opposite, uninvolved breast in
order to make them more alike, or he or she may
suggest breast reduction (reduction mammoplasty)
or a breast lift (mastopexy) to improve the symmetry
between your breasts. The goal is to help you feel
comfortable with your body.
Mastopexy involves removing a strip of skin from
under the breast or around the nipple to lift the
nipple and breast location and tighten the skin over
the breast.
Reduction mammoplasty involves the removal of
breast tissue and skin. If it is important to you not
to alter the unaffected breast, you should discuss
this with your surgeon, as it may affect the breast
reconstruction methods considered.
Tissue expansion
This method of breast reconstruction involves the
use of a tissue expander and a breast implant.
Stage 1: Placing the expander
A tissue expander is a balloon-like device made
from elastic silicone rubber. During a mastectomy,
the general surgeon removes skin and breast
tissue, leaving the chest tissues flat and tight.
To create a breast-shaped space for the breast
implant, a tissue expander is placed under the
remaining chest tissues.
The method: The tissue expander is inserted
unfilled, and over time sterile saline fluid is
added by inserting a small needle through the
skin and into the tissue expander’s filling port.
As the tissue expander fills, the tissues over the
expander begin to stretch, similar to the gradual
expansion of a woman’s abdomen during
pregnancy. The tissue expander creates a new
breast-shaped pocket for a breast implant.
A FEW FACTS:
Tissue expander placement is usually
done under general anesthesia in an
operating room.
The procedure may require a brief hospital
stay, or be done on an outpatient basis.
Typically, you can resume normal daily
activities after two to three weeks.
Mastectomy Incision
E xpander/Implant with
Remote Injection Dome
Tissue E xpander with
Integral Injection Dome
Final Result
Stage 2: Placing the breast implant
After the tissue expander is removed, the breast
implant is placed in the pocket. In reconstruction
following a mastectomy, a breast implant is
most often placed sub-muscularly. The surgery
to replace the tissue expander with a breast
implant (implant exchange) is usually done under
general anesthesia in an operating room. It may
require a brief hospital stay or be done on an
outpatient basis.
Tissue E xpander with
Remote Injection Dome
Tissue E xpander with
Integral Injection Dome
Mentor tissue expanders
Contour Profile® Tissue Expander
The Contour Profile® Tissue Expander is used to
expand the skin and create a shaped pocket for
implantation. This product is designed to expand
primarily in the lower portion of the breast, so the
resulting pocket will accommodate the implant
and slope like a mature breast. It also has an
integral injection dome that allows your surgeon
to add saline solution to the expander and
gradually stretch the breast tissue over several
months. Expansion is typically performed in an
office procedure.
For some patients, the secondary surgery for
the expander/breast implant exchange can
be avoided by using an implant that is postoperatively adjustable, or is a combination type
expander/mammary implant. In a simple office
procedure after your surgery, the fluid volume
of post-operatively adjustable implants can be
increased or reduced. This helps you to achieve
the final breast size you desire.
Smooth and Siltex® Spectrum®
Expander/Breast Implants
The Spectrum® functions as both a tissue
expander and a long-term saline breast implant.
It can be placed with minimal volume during your
initial surgery, with the fluid volume gradually
being increased over time, which expands the
breast’s tissues. This implant contains a fill tube
and remote injection dome that can be removed
when the final volume is reached. It is then left in
place as the long-term breast implant.
What about pain?
Good news–because the chest skin is usually
numb from the mastectomy surgery, you may not
experience much pain from the placement of the
tissue expander or the needle sticks that follow to fill
it with saline solution. However, you may experience
feelings of pressure, tightness and discomfort after
each filling of the expander. These feelings stop after
several days, once the tissue expands, but they
may last for a week or more. The tissue expansion
process typically lasts four to six months.
THE TECHNICAL DEFINITION OF
A BREAST IMPLANT:
A breast implant is a sac (implant shell) made
of silicone elastomer filled with either silicone gel
or saline, which is surgically implanted under your
breast tissue or under your chest muscle.
WHICH TYPE OF
MENTOR BREAST IMPLANT
IS RIGHT FOR YOU?
SILICONE OR SALINE?
MemoryGel® Breast Implants –
A trusted choice
MemoryGel® implants have been successfully
used and trusted for 20 years by millions of women
worldwide. Why? Because our implants feel
more like natural breast tissue–without
compromising reliability or safety. After
decades of research and testing, MemoryGel®
breast implants are now FDA approved for women
in the U.S. MemoryGel® implants come in either a
textured or smooth surface shell and are available in
a wide range of sizes and profiles to fit your body.
WHY THIS
PICTURE
MATTERS
TO YOU:
We have cut a
MemoryGel®
breast implant in half to demonstrate how
the gel material can hold together uniformly.
It does this because of a cohesive, gelatin-like
substance that acts as a solid rather than a liquid
maintaining its shape.
Smooth
Round Moderate
Profile
Smooth
Round Moderate Plus
Profile
Smooth
Round High
Profile
Siltex ®
Round Moderate
Profile
Siltex ®
Round Moderate Plus
Profile
Siltex ®
Round High
Profile
BEAUTIFUL BENEFITS:
MemoryGel® breast implants are
FDA approved
Each implant is filled with Mentor’s
proprietary cohesive gel
The gel filler holds together uniformly and
looks and feels like natural breast tissue
The implants have a set fill volume for
predictable results
MemoryGel® breast implants come in three
projection options: Moderate, Moderate
Plus and High Profile to give you the look
you want
They come in two shell surface options:
smooth and textured (Siltex®)
MemoryGel® implants are covered by
Mentor’s Standard or Enhanced Limited
Warranty and Lifetime Replacement Policy
{ 14 }
THE SAFETY OF SILICONE
BREAST IMPLANTS
After reviewing years of research concerning
silicone gel-filled breast implants, the Institute of
Medicine (IOM) found that “Evidence suggests
diseases or conditions such as connective tissue
diseases, cancer, neurological diseases or other
systemic complaints or conditions are no more
common in women with breast implants than in
women without implants.”
In November of 2006, the FDA approved
MemoryGel® silicone breast implants for breast
augmentation and reconstruction.
Mentor Corporation is committed to conducting
its own long-term, far-reaching clinical studies.
After almost two decades of research and
testing with surgeons and patients all over
the world, and Mentor’s clinical study results,
MemoryGel® breast implants became available
to women in the U.S. Mentor currently has
eight silicone gel breast implant clinical studies
in progress. More than 200,000 women have
participated in Mentor’s studies in order to
provide a significant body of clinical evidence
demonstrating the safety and effectiveness of
silicone filled breast implants. As we have for
many years, Mentor will remain committed to
providing objective information about breast
implant safety.
SALINE IMPLANTS:
FDA approved
These implants are filled with a saltwater
solution similar to the fluid that makes up
most of the human body
Our saline implants have a slightly firmer
feel than gel
They have a flexible fill volume that can be
adjusted during surgery
Three projection options: Moderate,
Moderate Plus and High Profile
They come in two shell surface options:
smooth and textured (Siltex®)
Our saline implants are covered by Mentor’s
Standard or Enhanced Limited Warranty and
Lifetime Replacement Policy
Mentor Saline Breast Implants –
Another Option
Mentor’s saline-filled breast implants also come
in a variety of shapes, sizes, profiles and surface
textures. Saline implants are inserted into the body
without fluid. Once placed, the implant is filled to the
pre-determined size. When the fill-tube is removed,
the implant will automatically seal itself.
Smooth
Round Moderate
Profile
Smooth
Round Moderate Plus
Profile
Smooth
Round High
Profile
Siltex ®
Round Moderate
Profile
Siltex ®
Contour Profile ®
Moderate
Siltex ®
Contour Profile ®
High
Mentor Spectrum®
Adjustable Saline Implants
An innovative line
of adjustable implants
Mentor’s innovative line of Spectrum® Breast
Implants makes the process easier because
the size can be adjusted after surgery. In fact,
Spectrum® implants are the only post-operatively
adjustable saline-filled breast implants that allow
your physician to adjust the size of your implant
for up to six months after your procedure.
Smooth
Round
Spectrum ®
Siltex ®
Round
Spectrum ®
Siltex ®
Contour Profile ®
Spectrum ®
HOW DO MENTOR’S SILICONE
AND SALINE IMPLANTS COMPARE?
MemoryGel® Breast Implants
Feel like natural breast tissue
Moderate, Moderate Plus and High profiles
Smooth and textured surfaces available in
a range of sizes
Saline Breast Implants
Various profiles for more options
Intraoperative sizing flexibility
Self-sealing valve
Post-operative adjustability with the
Spectrum® Implant
SPECIAL CONSIDERATIONS:
Deciding on Breast Reconstruction
Whether you decide to have breast
reconstruction will depend on your medical
condition, general health, lifestyle, emotional
state and breast size and shape. You should
consult your surgeon to discuss your personal goals
for breast reconstruction. For many women, the
support and perspective of family, friends, breast
implant support groups, and breast cancer support
groups can help you make the right decision.
What are the alternatives to breast
reconstruction?
Should you decide that breast reconstruction
surgery isn’t for you, there are still a few options.
You may or may not decide to wear an external
breast form (prosthesis) inside your bra. Breast
forms are available in a variety of shapes, sizes
and materials, such as foam, cotton and silicone.
Custom prostheses are also available to match the
size and shape of your breast.
What is the best time for your breast
implant reconstruction?
The answers below apply to reconstruction
following mastectomy, but similar considerations
apply to reconstruction following breast trauma
or reconstruction for congenital anomalies.
The breast reconstruction process may begin
at the time of your mastectomy (immediate
reconstruction) or months to years afterwards
(delayed reconstruction). This decision is made after
consultation with your cancer treatment team based
on your individual situation.
What are the advantages and
disadvantages of doing it immediately?
The pros: A potential advantage is that your
reconstruction begins at the time of your mastectomy.
This can save you money and require fewer days in
the hospital when you combine your mastectomy
procedure with the first stage of your breast
reconstruction.
Possible downside: There may be a higher
risk of capsular contracture, extrusion, and
other complications associated with immediate
reconstruction as a result of post-operative radiation
and chemotherapy treatment. Your initial operative
time and recovery period may also be longer.
Immediate reconstruction may involve placement
of a breast implant, but typically involves placement
of a tissue expander, which is used to recreate skin
that was removed during your cancer surgery. The
tissue expander is then eventually replaced with a
breast implant.
What about delayed reconstruction?
By waiting to have your reconstructive surgery
sometime after your mastectomy, you can delay
your reconstruction decision and surgery until
other treatments, such as radiation therapy and
chemotherapy, are completed. Delayed reconstruction
may be advisable if your surgeon anticipates healing
problems with your mastectomy, or if you just need
more time to consider your options.
What are some other personal
considerations?
There are true medical, financial and emotional
considerations when choosing between immediate
and delayed reconstruction. These should not be
taken lightly. You should discuss thoroughly with
your general surgeon, reconstructive surgeon and
oncologist, the options available in your individual case.
HERE IS A SUMMARY OF THE
DEFINITIONS OF YOUR OPTIONS
Immediate reconstruction means:
One-stage reconstruction with a breast implant
or a combination expander/mammary implant
(implant only).
Two-stage immediate reconstruction with a tissue
expander followed by delayed reconstruction
several months later with a breast implant.
Delayed reconstruction
Two-stage delayed reconstruction with a tissue
expander followed several months later with a
breast implant.
One-stage immediate breast implant reconstruction
Immediate one-stage breast reconstruction
may be done at the time of your mastectomy.
After the general surgeon removes your breast
tissue, the reconstructive surgeon will then place
a breast implant that completes the one-stage
reconstruction. In reconstruction following a
mastectomy, a breast implant is most often
placed sub-muscularly, which is underneath
the muscle of the chest wall.
Two-stage (immediate or delayed)
breast implant reconstruction
Breast reconstruction usually occurs as a twostage procedure, starting with the placement of a
breast tissue expander, which is replaced several
months later with a breast implant after enough
new skin has been created to obtain the best result.
The tissue expander placement may be done
immediately at the time of your mastectomy, or be
delayed until months or years later.
{ 21 }
Your general surgeon, breast
reconstruction surgeon, and
oncologist should work as a
team to plan your mastectomy
and reconstruction procedure
in order to help you get the
best possible outcome.
SELECTING THE RIGHT
SURGEON FOR YOU
If you are considering breast reconstruction and do
not have a reconstructive surgeon in mind, first, ask
your general surgeon for a referral. They can give you
the names of experienced, board-certified surgeons in
your area. Your general surgeon, breast reconstruction
surgeon, and oncologist should work as a team to
plan your mastectomy and reconstruction procedure
in order to help you get the best possible outcome.
Together, they will advise you on all aspects of surgery
and care based on your specific clinical needs and
desired outcome.
What kinds of questions should you ask
your reconstructive surgeon?
You’re likely to have lots of questions for your surgeon.
We’ve given you this list as a starting point. Make good
use of this section–remove these pages from this
booklet so you can have it handy for your consultation.
About the procedure
What are all my options for
breast reconstruction?
What are the possible risks and complications
for each type of breast implant surgery, and
how common are they?
{ 23 }
How many steps are there in each procedure,
and what are they?
How long will it take to complete
my reconstruction?
How much pain or discomfort will I feel, and
for how long?
How long will I be in the hospital?
Will I need blood transfusions, and can
I donate my own blood?
About the surgeon
How much experience do you have with
each procedure?
Do you have before-and-after photos I can
look at for each procedure? What results are
reasonable for me?
Can I talk with other patients about
their experience?
About the results
What if my cancer recurs or occurs in the
other breast?
Will reconstruction interfere with my
cancer treatment?
What will my scars look like?
What kind of changes in my implanted breast
can I expect over time?
What kind of changes in my implanted breast
can I expect with pregnancy?
What are my options if I’m dissatisfied with the
cosmetic outcome of my implanted breast?
When will I be able to resume my normal
activity (sexual activity or athletic activity)?
{ 24 }
About the cost
For staged reconstruction, what is the
estimated total cost of each procedure?
How much will my health insurance carrier
cover, especially any complication that may
require surgery?
About the implants
Who is the manufacturer of my
breast implant?
Does the manufacturer have a
product warranty?
{ 25 }
THE SURGICAL PROCEDURE…
Facts and Factors
Being empowered with credible information is
essential when it comes to your implant procedure,
your recovery and your results. Here are some of
the important factors you and your surgeon should
discuss:
The stage of development of the cancer when it
was discovered
The follow-up treatment that you will require
Your overall health
Your chest structure and overall body shape
Your healing capabilities (which can be affected
by smoking, alcohol and various medications)
Prior breast surgeries
Bleeding tendencies
Infections
Shifting of the implant
Scarring from the incision
Pre-disposition to develop a hardened capsule
around the implant
A FEW FACTS:
Reconstruction surgery is usually
performed on an inpatient basis in an
operating room when it begins at the same
time as your mastectomy.
Some of the stages, such as nipple
reconstruction, or placement of the implant
after soft-tissue expansion,
can be done as an outpatient procedure.
General anesthesia is most often used.
How is the incision site selected?
In reconstructive surgery, the incision placement
and length is decided by your surgeon and should
be communicated to you. It is largely influenced by
the type of cancer surgery that is planned for you.
What will recovery be like?
Depending on the type of surgery you have
(immediate or delayed), your post-operative
recovery period will vary. Possible complications
that may occur have been described throughout
this booklet. Ask your surgeon to advise you on
your specific post-operative care instructions.
IMPORTANT SAFETY
INFORMATION
Mentor MemoryGel® and Saline-filled breast
implants are indicated for breast augmentation
in women who are at least 22 years old for
MemoryGel® and at least 18 years old for Saline or for breast reconstruction. Breast implant surgery
should not be performed in women with active
infection anywhere in their body, with existing
cancer or pre-cancer of their breast who have not
received adequate treatment for those conditions
or are pregnant or nursing.
There are risks associated with breast implant
surgery. Breast implants are not lifetime
devices and breast implantation is likely not a onetime surgery. You may need additional unplanned
surgeries on your breasts because of complications
or unacceptable cosmetic outcomes. Many of the
changes to your breast following implantation are
irreversible (cannot be undone) and breast implants
may affect your ability to breastfeed, either by
reducing or eliminating milk production.
The most common complications with
MemoryGel® breast implants include reoperation,
capsular contracture, asymmetry, and breast pain.
A lower risk of complication is implant rupture,
which is most often silent (meaning neither you
nor your doctor will know you have a rupture).
The health consequences of a ruptured silicone
gel-filled breast implant have not been fully
established. MRI screenings are recommended
three years after initial implant surgery and then
every two years after to detect silent rupture.
The most common complications with Mentor
Saline-filled breast implants include reoperation,
implant removal, capsular contracture, wrinkling,
breast pain and deflation.
Contour Profile® Tissue Expanders are used for
breast reconstruction following mastectomy. This
expander is intended for temporary subcutaneous
or submuscular implantation and is not intended
for use beyond six months. You should not have
an MRI while the Contour Profile® Tissue Expander
is implanted. The device could be moved by the
MRI causing pain or displacement, potentially
resulting in a revision surgery. The incidence of
extrusion of the expander has been shown to
increase when the expander has been placed in
injured areas: scarred, heavily irradiated or burned
tissue, crushed bone areas or where severe
surgical reduction of the area has previously been
performed.
Detailed information regarding the indications,
contraindications, warnings, precautions and the
risks and benefits associated with Mentor breast
implants are provided in brochures available
from your surgeon (Important Information for
Augmentation Patients about Mentor MemoryGel®
Silicone Gel-Filled Breast Implants, Important
Information for Reconstruction Patients about
Mentor MemoryGel® Silicone Gel-Filled Breast
Implants and Saline-Filled Breast Implants,
Making an Informed Decision) or on line at
www.mentorcorp.com. It is important that you read
and understand this information when considering
Mentor breast implants prior to deciding on surgery.
Keep your breast implant ID card for
later reference
When you have breast augmentation, you will be
given a device identification card with the style and
serial number of your breast implant(s). This will be
given to you right after your surgery. It is important
that you keep a copy of this card because you may
need to refer to the information at a later date.
WHAT AR E SOME OF THE
CONSIDER ATIONS BEFOR E
R ECONSTRUCTION OR
IMPLANTATION?
Ask your surgeon about his or her surgical
experience and training. Surgeons expect questions
like these so you don’t need to feel shy about asking.
When choosing a surgeon who is experienced
with breast reconstruction, you should know the
answers to the following questions:
How many breast reconstruction implantation
procedures does he/she perform per year?
How many years has he/she performed breast
reconstruction procedures?
Has he/she obtained training certification from
Mentor to use its MemoryGel® breast implants?
Is he/she board certified, and if so, with
which board?
In which state(s) is he/she licensed to practice
surgery? Note that some states provide
information on disciplinary action and
malpractice claims/settlements to
prospective patients, either by request or
on the internet.
What is the most common complication he/she
encounters with breast reconstruction?
What is his/her re-operation rate with
breast reconstruction?
What is the most common type of re-operation
he/she performs?
{ 31 }
HEALTH INSURANCE
COVERAGE. Good news, most
carriers cover
reconstruction.
In general, private insurance
that covers medically necessary
mastectomies will also cover
breast reconstructive surgery.
Insurance coverage for re-operation
procedures or additional surgeon
visits following reconstruction may
not be covered, depending on the
policy. For example, a re-operation
may include temporary removal of the
implant to facilitate the oncologist’s
ongoing surveillance for breast
cancer recurrence.
Documentation: When you
talk to your health insurance
carrier, keep a record of your
conversations and all written
communications. Because
coverage policies vary and can
change over time, no guidance can
be given with respect to coverage
under any particular health plan. We
recommend that you contact your
health plan provider to obtain specific
information regarding its coverage
policies before deciding to proceed
with reconstructive surgery.
{ 32 }
MENTOR PRODUCT
REPLACEMENT POLICY AND
LIMITED WARRANTIES
Mentor proudly stands behind the products we
manufacture with a product replacement policy
and limited warranty programs. It’s important to
understand that when undergoing breast
reconstruction, breast implantation may not be a
one-time surgery.
Mentor’s Lifetime Product
Replacement Policy
Mentor’s Lifetime Product Replacement Policy
provides for the free lifetime product replacement
of its MemoryGel® and saline-filled breast implants,
worldwide. When implant replacement is required,
and the Mentor Product Replacement Policy
applies, Mentor will provide, throughout the
patient’s lifetime, the same or similar Mentor breast
implant at no cost. If a more expensive product is
requested, Mentor will invoice your surgeon for the
price difference.
Mentor Saline-Filled Breast Implants
Mentor Standard Advantage Limited Warranty
($1,200 financial assistance)
This warranty is free of charge to all patients who
are implanted with Mentor saline-filled implant
products. Here is an overview of the details:
Lifetime product replacement policy1
10 years and up to $1,200 financial assistance
for operating room, anesthesia, and surgical
charges not covered by insurance2
Free contralateral (opposite side) implant
replacement upon surgeon request
Non-cancelable terms
The Mentor Enhanced Advantage Limited
Warranty ($2,400 financial assistance)
This optional limited warranty is available for
saline-filled breast implant products and, to be
eligible, must be purchased for an enrollment
fee of $100 within 45 days from implantation 3 .
Here is an overview of the details:
Lifetime product replacement policy1
10 years and up to $2,400 financial assistance
for operating room, anesthesia, and surgical
charges not covered by insurance from the date
of implant2
Free contralateral (opposite side) implant
replacement upon surgeon request
Non-cancelable terms
Mentor MemoryGel® Breast Implants
Mentor is the first to offer the Premier Advantage
Warranty ($3,500 financial assistance)
It offers up to $3,500 in financial assistance.
Here is an overview of the details:
Effective for surgeries between May 1,
2009 and December 31, 20094
Lifetime product replacement policy1
This warranty applies to expenses occurring
from a confirmed rupture for up to 10 years
from the date of implant surgery
The warranty pays up to $3,500 financial
assistance2 for operating room, anesthesia, and
surgical charges not covered by insurance and
applies only to implant surgeries from May 1,
2009 to December 31, 20094
Free contralateral (opposite side) implant
replacement upon surgeon request
Non-cancelable terms
Please retain your records
With the Mentor Standard,
Enhanced, and Premier
Advantage Limited Warranties,
it’s important for you to maintain
your own records to ensure validation of your
enrollment. Your surgeon may only be required
to retain your records for a limited period of time
depending upon the laws of your state.
1
Lifetime Product Replacement Policy: Mentor will provide replacement
Mentor product of any size in the same or similar style as the originally
implanted product free of charge for the lifetime of the patient. Upon
surgeon’s request, a different implant style may be selected (subject to a
charge of the difference between product list prices). Refer to the Mentor
Advantage Limited Warranty for eligibility and program details.
2
Operating room and anesthesia charges to be given payment priority. In
order to qualify for financial assistance, you will need to sign a Release form.
3
One warranty payout per enrollment fee; enrollment in the program for
replacement device will require additional $100 enrollment fee.
4
Please note: If you had breast surgery prior to May 1, 2009 or have surgery
after December 31, 2009, your warranty coverage will be based on the
warranty in effect at the time of your original surgery.
FREQUENTLY ASKED
QUESTIONS ABOUT
BREAST IMPLANTS
For the most comprehensive information
about reconstructive surgery, we invite you
to visit www.YourBreastOptions.com
What is a breast implant?
When someone says “breast implant,” they are
describing a silicone shell that is filled with either
silicone gel or saline solution. Breast augmentation
and reconstruction surgeons insert these implants
under breast tissue or under the chest muscle to
create a fuller looking and feeling bust line.
MemoryGel® Breast Implants
MemoryGel® breast implants are the next
generation of silicone implants. They are prefilled with Mentor’s propriety cohesive silicone
gel. MemoryGel® breast implants hold safely and
uniformly together to deliver a “natural feel”
that closely resembles natural breast tissue.
Saline-filled breast implants
Saline-filled breast implants are silicone shells
filled with saline (a saltwater solution) that is very
similar to the bodies natural fluid which makes
up most of the human body. Saline implants are
inserted into the body without fluid and then filled
with the saline fluid through a fill-tube during the
surgery to adjust and achieve optimal volume.
Certain Mentor saline-filled breast implants also
allow for adjustments after surgery.
What is silicone?
Silicone is derived from silicon, a semi-metallic
or metal-like element that in nature combines
with oxygen to form silicon dioxide, or silica.
Beach sand, crystals and quartz are silica. Silica
is the most common substance on earth. Heating
silica with carbon at a high temperature can
produce silicon. Further processing can convert the
silicon into silicone, which can be a liquid, a gel or
a rubbery substance. Various silicones are used in
lubricants and oils, as well as in silicone elastomers.
Silicone can be found in many common consumer
items, such as chewing gum, nail polishes, suntan
and hand lotions, antiperspirants, bath soaps and
processed foods.
Are silicone gel-filled implants safe?
MemoryGel® implants have been successfully
used and trusted for over 20 years by millions
of women worldwide. Mentor currently has
eight silicone gel breast implant clinical studies
in progress. More than 200,000 women have
participated in Mentor’s studies in order to provide
a significant body of clinical evidence demonstrating
the safety and effectiveness of silicone filled breast
implants. As we have for many years, Mentor will
remain committed to providing objective information
about breast implant safety.
Good news from the scientific community
The Institute of Medicine, in a highly respected
study, concluded that, “There is no evidence that
silicone implants are responsible for any major
diseases of the whole body. Women are exposed
to silicone constantly in their daily lives.”
How is the silicone gel used today different
from the silicone used in years past?
Silicone gel-filled breast implants have undergone
changes in the last three decades to meet
increasingly sophisticated consumer expectations.
The very first silicone breast implants used thick
shells and contained firm gel. Then, a second
generation of implants with thinner shells and less
firm gel was introduced in the late 1970s to address
concerns of patients and surgeons who believed
that implants were too firm, palpable and visible.
In the mid 1980s, concerns related to rupture rates
of the second generation thinner-shelled implants
led manufacturers to introduce a third generation of
implants. The shell and gel of these third generation
implants are slightly thicker but still soft.
Today these third generation silicone gel filled breast
implants are typically referred to as cohesive gel
implants. Mentor’s products have kept pace with
the ever-evolving expectations of surgeons and
women who desire a soft gel to retain the natural
feel that resembles actual breast tissues.
Do Mentor breast implants include latex?
No. Because latex allergies are so common, Mentor
never uses latex in the manufacturing of any of its
breast implants.
Is there active platinum in breast implants?
The manufacture of silicone breast implant
shells and gel-filling materials uses platinum as a
catalyst. Because very small amounts of platinum
remain in the product following its manufacture,
concerns have been raised that platinum may
enter the body and cause adverse effects—either
by diffusing through the intact shell, or through an
implant rupture.
However, in 2006, the United States Food and
Drug Administration (FDA) released the following
conclusion about platinum:
“Based on the existing literature, FDA believes
that the platinum contained in breast implants
is in the zero oxidation state, which would pose
the lowest risk, and thus that the small amounts
of platinum that leak through the shell do not
represent a significant risk to women with silicone
breast implants.”*
*source: www.fda.gov/cdrh/breastimplants/platinum.html
{ 39 }
How much do breast implants weigh?
You can use this formula to estimate
the weight of your MemoryGel® and saline-filled
breast implants: 1 ounce = 30 cc’s.
Example: A 300 cc implant = 10 ounces
Implant weight will vary with implant size.
How do cc’s compare to cup size?
cc volumes do not accurately translate to bra
cup sizes.
How do breast implants affect mammography?
With breast implants, routine mammography
screening may be more difficult. The implant
may interfere with finding breast cancer during
mammography and generally requires additional
x-rays and more potential exposure to radiation.
If you are of the proper age for mammography
screening, you should continue to undergo routine
mammography screenings as recommended by
your primary care surgeon. When you do, be sure
to inform the mammography technician that you
have implants.
What is the average life expectancy of a
breast implant?
It’s important to know that breast implants don’t
last a lifetime. While implant duration varies from
woman to woman, implants need to be replaced
at some time. Replacement is often prompted by
choice, such as a desired size change, or implant
style change. Some women undergo breast implant
replacement because of a complication, such as
saline deflation or gel rupture.
Do implants influence the occurrence
of breast cancer?
Patients with breast implants have not been found
to be at a greater risk of developing breast cancer
than those without breast implants.
Should I be at my ideal weight before I have
a breast implant procedure?
You should be close to your ideal weight when you
have breast implant surgery. Why? Because women
who lose or gain a significant amount of weight
after receiving breast implants sometimes alter the
results in unpredictable and/or undesirable ways.
How long should I wait to resume exercise
and other strenuous activities after breast
reconstruction?
Your surgeon is in the
best position to answer
this question. Because
recovery periods vary from
woman to woman, he or
she will determine how much
downtime you may need and
when to resume normal activities.
Be sure to check with your surgeon
before returning to your workouts.
What affect does smoking have on
the healing process following surgery?
Smoking can compromise recovery a great
deal by causing the blood vessels to constrict,
reducing blood flow, and the oxygen it carries,
to the surgical area. Your tissues need this
blood and oxygen supply to heal properly.
When your blood supply is reduced, tissues
heal more slowly and irregularly.
That’s why surgeons ask patients to refrain
from smoking for one to five weeks prior to
and after surgery. It is important that you
ask your surgeon what his or her specific
recommendation for you would be.
{ 41 }
Are Mentor breast implants covered by
a warranty?
Your peace of mind is important to us. All Mentor
products come with Mentor’s Lifetime Product
Replacement Policy which provides for the free
lifetime product replacement of our gel-filled and
saline-filled breast implants, worldwide. When
implant replacement is required, and the Mentor
Product Replacement Policy applies, Mentor will
provide, throughout the patient’s lifetime, the same
or similar Mentor breast implant at no cost. If a more
expensive product is requested, Mentor will invoice
your surgeon for the price difference.
Mentor Saline-Filled Breast Implants
Mentor Standard Advantage Limited Warranty
($1,200 financial assistance)
This warranty is free of charge to all patients who
are implanted with Mentor saline-filled implant
products. Here is an overview of the details:
Lifetime product replacement policy1
10 years and up to $1,200 financial assistance
for operating room, anesthesia, and surgical
charges not covered by insurance2
Free contralateral (opposite side) implant
replacement upon surgeon request
Non-cancelable terms
The Mentor Enhanced Advantage Limited
Warranty ($2,400 financial assistance)
This optional limited warranty is available for
saline-filled breast implant products and,
to be eligible, must be purchased for an
enrollment fee of $100 within 45 days
from implantation 3 . Here is an overview of
the details:
Lifetime product replacement policy1
10 years and up to $2,400 financial
assistance for operating room, anesthesia,
and surgical charges not covered by
insurance from the date of implant2
{ 42 }
Free contralateral (opposite side) implant
replacement upon surgeon request
Non-cancelable terms
Mentor MemoryGel® Breast Implants
Mentor is the first to offer the Premier
Advantage Warranty ($3,500 financial
assistance)
It offers up to $3,500 in financial assistance.
Here is an overview of the details:
Effective for surgeries between May 1,
2009 and December 31, 20094
Lifetime product replacement policy1
This warranty applies to expenses occurring
from a confirmed rupture for up to 10 years
from the date of implant surgery
The warranty pays up to $3,500 financial
assistance2 for operating room, anesthesia,
and surgical charges not covered by
insurance and applies only to implant
surgeries from May 1, 2009 to December
31, 20094
Free contralateral (opposite side) implant
replacement upon surgeon request
Non-cancelable terms
With the Mentor Standard, Enhanced and Premier
Advantage warranties, it is important to maintain
your own records to ensure validation of your
enrollment, as it is possible your doctor may not
retain your records for the entire duration of the
limited warranty.
1
Lifetime Product Replacement Policy: Mentor will provide replacement
Mentor product of any size in the same or similar style as the originally
implanted product free of charge for the lifetime of the patient. Upon
surgeon’s request, a different implant style may be selected (subject to a
charge of the difference between product list prices). Refer to the Mentor
Advantage Limited Warranty for eligibility and program details.
2
Operating room and anesthesia charges to be given payment priority. In
order to qualify for financial assistance, you will need to sign a Release
form.
3
One warranty payout per enrollment fee; enrollment in the program for
replacement device will require additional $100 enrollment fee.
4
Please note: If you had breast surgery prior to May 1, 2009 or have surgery
after December 31, 2009, your warranty coverage will be based on the
warranty in effect at the time of your original surgery.
{ 43 }
Please visit www.loveyourlook.com/BreastImplants/breast-implant-warranty.aspx to learn
more about the terms of our Limited Warranties and
Product Replacement Policy.
YOU CAN ENROLL in the Enhanced
Advantage Limited Warranty by visiting
www.mentorcorp.com/enhancedadvantage.
Please review the complete limited warranties
for details and limitations of coverage. You may
receive a copy of the complete Mentor Advantage
and Enhanced Advantage Limited Warranties for
saline-filled and MemoryGel® breast implants by
writing or calling:
Mentor Consumer Affairs Department
201 Mentor Drive, Santa Barbara, CA 93111
(866) 250-5115 Option 3
We’re always here to help
For additional information or questions about Mentor
breast implants, please call 1-800-MENTOR-8.
The following list of resources may help you obtain
additional information so you can make an informed
decision about breast reconstruction.
Mentor Corporation
[email protected]
www.mentorcorp.com
www.loveyourlook.com
Institute of Medicine Report on the Safety of
Silicone Implants
www.nap.edu/catalog/9602.html
Food and Drug Administration
1-888-Info-FDA or 301-8230
www.fda.gov/cdrh/breastimplants/
You can find important information in the FDA breast
implant consumer handbook which is available
through the above phone number or website.
American Society of Plastic Surgeons
www.plasticsurgery.org/
Breast Reconstruction Resources
National Cancer Institute
1-800-4-CANCER www.cancernet.nci.nih.gov
American Cancer Society (Reach to Recovery)
1-800-ACS-2345 www.cancer.org
Women’s Information Network
Against Breast Cancer
866-2WINABC (866-294-6222) www.winabc.org
Breast Cancer Network of Strength™
(formerly Y-ME National Organization for Breast
Cancer Information and Support)
(800) 221-2141 www.networkofstrength.org
Books
LaTour, Kathy. The Breast Cancer Companion, From
Diagnosis Through Recovery: Everything You Need
to Know for Every Step Along the Way. Avon Books,
New York, 1993.
Bruning, Nancy. Breast Implants, Everything You
Need to Know. Hunter House, Inc. California, 1995.
{ 45 }
Important Safety Information:
Mentor MemoryGel ® and Saline-filled breast implants are indicated for
breast augmentation in women who are at least 22 years old for MemoryGel
and at least 18 years old for Saline - or for breast reconstruction. Breast
implant surgery should not be performed in women with active infection
anywhere in their body, with existing cancer or pre-cancer of their breast
who have not received adequate treatment for those conditions or are
pregnant or nursing.
There are risks associated with breast implant surgery. Breast implants are
not lifetime devices and breast implantation is likely not a one-time surgery.
You may need additional unplanned surgeries on your breasts because of
complications or unacceptable cosmetic outcomes. Many of the changes to
your breast following implantation are irreversible (cannot be undone) and
breast implants may affect your ability to breastfeed, either by reducing or
eliminating milk production.
The most common complications with MemoryGel breast implants include
reoperation, capsular contracture, asymmetry, and breast pain. A lower
risk of complication is implant rupture, which is most often silent (meaning
neither you nor your doctor will know you have a rupture). The health
consequences of a ruptured silicone gel-filled breast implant have not been
fully established. MRI screenings are recommended three years after initial
implant surgery and then every two years after to detect silent rupture.
The most common complications with Mentor Saline-filled breast implants
include reoperation, implant removal, capsular contracture, wrinkling, breast
pain and deflation.
Contour Profile ® Tissue Expanders are used for breast reconstruction
following mastectomy. This expander is intended for temporary
subcutaneous or submuscular implantation and is not intended for use
beyond six months. You should not have an MRI while the Contour Profile ®
Tissue Expander is implanted. The device could be moved by the MRI
causing pain or displacement, potentially resulting in a revision surgery. The
incidence of extrusion of the expander has been shown to increase when
the expander has been placed in injured areas: scarred, heavily irradiated or
burned tissue, crushed bone areas or where severe surgical reduction of the
area has previously been performed.
Detailed information regarding the indications, contraindications, warnings,
precautions and the risks and benefits associated with Mentor breast
implants are provided in brochures available from your surgeon (Important
Information for Augmentation Patients about Mentor MemoryGel Silicone
Gel-Filled Breast Implants, Important Information for Reconstruction Patients
about Mentor MemoryGel Silicone Gel-Filled Breast Implants and Saline-Filled
Breast Implants, Making an Informed Decision) or on line at www.mentorcorp.
com. It is important that you read and understand this information when
considering Mentor breast implants prior to deciding on surgery.
201 Mentor Drive
Santa Barbara, CA 93111 USA
(805) 879-6000
Customer Service: (800) 235-5731
Fax: (805) 967-7108
www.mentorcorp.com
© August 2009 Mentor 0809009 Rev B