A Birth-Control Comeback: The IUD

HEALTH & WELLNESS
A Birth-Control Comeback: The IUD
A Device More Effective Than Birth-Control Pills Seeks a New Market
By ANGELA CHEN
Dec. 16, 2013 7:06 p.m. ET
The IUD is making a comeback more than 30 years after a generation of women
was scared away from the birth-control device by the faulty Dalkon Shield.
This year, the U.S. Food and Drug Administration approved Bayer HealthCare
Pharmaceuticals' Skyla, the first new intrauterine device on the market in 13 years. Planned
Parenthood has launched a nationwide campaign in its clinics promoting a copper IUD as the
most effective form of emergency contraception. And in New Orleans, three-year-old startup
Bioceptive Inc. is engineering a one-step implantation device that its founders say will reduce
the time it takes a doctor to insert an IUD to less than two minutes, from a procedure that
currently can take five minutes to, at worst, an hour.
The Skyla IUD from Bayer is marketed to women who haven't had children. Saul Polamo
As of 2010, about 2.1 million U.S. women were using an IUD, the highest level since the early
1980s, according to the Guttmacher Institute, a reproductive-rights organization with offices in
New York and Washington, D.C. Of women using contraception, about 5% use an IUD, which
is still significantly less than the 27% who use the hormonal pill—the most popular method.
The IUD is 20 times more effective than birth control pills, the patch or vaginal ring, according
to a 2012 study published in the New England Journal of Medicine. That is because the IUD
virtually eliminates the risk of human error.
Researchers tracked nearly 8,000 women and found that, over three years, nearly 10% of
participants using the short-term birth control methods accidentally became pregnant. In
contrast, accidental pregnancy occurred for only 0.9% of women with an IUD.
IUDs on the market now differ in design from the Dalkon Shield. Today, IUDs are small, Tshaped devices that use either hormones or a copper material to prevent sperm from joining
with an egg.
Unlike the Dalkon Shield, they don't have multifilament strings, which can attract bacteria and
cause health complications. Common side effects include headache, cramps, spotting and
mood changes.
The IUD fell from favor in the late 1970s after the Dalkon Shield IUD became the target of
highly publicized lawsuits claiming it caused pelvic infection and infertility. Manufacturer A.H.
Robins Co. pulled the product from the market in 1974 after more than 300,000 Shield-related
lawsuits. The company paid billions to plaintiffs and filed for Chapter 11 bankruptcy in 1985.
IUD use began to pick up in the 1990s with the release of the nonhormone ParaGard from
Teva Women's Health Inc., owned by Teva Pharmaceutical Industries, Ltd. Bayer brought its
hormonal Mirena IUD to market in 2000.
Now pharmaceutical companies, policy makers and engineers are working to lower remaining
barriers, which they say include cost and misinformation.
After the Dalkon Shield lawsuits, gynecologists became cautious and didn't recommend IUDs
unless a woman was finished having children, says Eve Espey, a professor of gynecology at
the University of New Mexico and spokeswoman for the American Congress of Obstetricians
and Gynecologists, a trade group.
Studies have shown no connection between the new IUDs and pelvic infection or infertility,
says Dr. Espey.
The newest IUD, Skyla, is a smaller device marketed to women who haven't had children
before, says Marcy Funk, a spokeswoman for Bayer Healthcare, part of Bayer AG.
Skyla's smaller size can cause less pain and be more appropriate for women who haven't had
children, since they tend to have smaller uteruses, some doctors say.
The upfront cost of the IUD has been a barrier for some women, as it can range from $500 to
$1,000. Now, the Affordable Care Act's birth-control provision covers the cost of the device,
preliminary consultation and follow-up appointments. (There are caveats: Insurance from
houses of worship are exempt. Also exempt are select, "grandfathered" health-care plans that
existed before March 2010, says Mara Gandal-Powers, legal counsel for the National
Women's Law Center, a D.C.-based women's rights organization. She adds that 90% of this
group should be covered by the act by the end of 2014.)
Lauren Barry, a 26-year-old paralegal in San Diego, says her employer-provided insurance
covered all of her Mirena IUD, which she has had for a year. She previously took birth control
pills and used the NuvaRing, a hormonal contraceptive vaginal ring, but both made her
nauseated. The IUD is more cost-effective, she says, and she liked that she didn't have to
remember to take pills. But the first few months on it involved cramps and spotting and the
initial, 10-minute insertion was "incredibly painful, like one really, really bad cramp," she says.
Ben Cappiello, chief scientific officer at Bioceptive, is hoping to solve that problem. Mr.
Cappiello studied biomedical engineering at Tulane University, where he learned that the
complexity of the insertion process is partly responsible for the IUD's relatively low popularity.
"It takes a lot of expertise to do it perfectly every time, and in a lot of places the IUD isn't
offered because people don't know how to insert it," he says. The current procedure involves a
few separate medical devices, including the cervical tenaculum, which Mr. Cappiello describes
as "a sharp, prong-like tool that is used to pierce the tissue of the cervix and clamp it and pull
on it."
The company's device, currently called the Bioceptive Inserter, makes insertion a one-step
process using a suction-based method. The IUD is loaded into the device, which is inserted
into the patient. The company says it takes 90 seconds.
The group has done preclinical testing using both synthetic uterus models and tissue taken
from women who have had a hysterectomy. According to Mr. Cappiello, Bioceptive has several
patents and will be pursuing FDA approval in the U.S. in 2014, with the goal of the device
reaching the market in 2015.
While the IUD has traditionally been used for long-term family planning, the device is one of
the most effective forms of emergency contraception, says Deborah Nucatola. Dr. Nucatola is
senior director of medical services for Planned Parenthood, which launched the EC4U
campaign promoting the copper IUD ParaGard for this purpose.
Recent studies have shown that Plan B and other "morning after" pills are sometimes not
effective for overweight women. "Body mass has no effect on the effectiveness of the copper
IUD," says Dr. Nucatola. The device uses copper because its ions kill sperm. Data about the
effectiveness of the hormonal IUD as emergency contraception isn't available.
Nine U.S. clinics will receive $12,000 each through a grant from the William and Flora Hewlett
Foundation to record best practices in regard to educating women on the copper IUD for
emergency contraception, Planned Parenthood says.
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