— Ellen Hanrahan, a 36-year-old mother of two, was done
having children. To make sure, she had tiny metal coils
implanted inside her fallopian tubes, a relatively new form of
permanent birth control marketed under the brand name Essure.
later, Hanrahan began feeling a familiar form of fatigue —
one she’d experienced with her previous pregnancies.
Incredulous, she took a home pregnancy test. And then another.
"I panicked, called my husband and said, ‘We have a
problem,’" said Hanrahan, who was, indeed, 10 weeks
of researchers estimated Monday that as many as 9.6 percent of
women could become pregnant within 10 years of undergoing
hysteroscopic sterilization, or Essure. That is nearly four
times the estimated risk after a laparoscopic tubal ligation,
the more traditional method.
study, published in the journal Contraception, is the first to
compare the effectiveness of the two main choices offered to
women who seek a permanent form of birth control. About
345,000 American women undergo sterilization procedures each
year, with Essure an increasingly popular choice because it
does not require a surgical incision.
sterilization is very effective; the absolute risk of
pregnancy is low," said lead author Aileen Gariepy, an
assistant professor in the department of obstetrics,
gynecology and reproductive sciences at the Yale School of
Medicine. "But if … one method is not as effective,
that definitely needs to be part of the decision-making
process and not overlooked."
laparoscopic tubal ligation, a physician makes a small cut in
the abdomen, then blocks, ties or seals the fallopian tubes to
keep eggs and sperm apart. Essure also involves blocking the
tubes, but instead of using an incision the physician weaves a
catheter through the cervix to insert the coils. Scar tissue
then gradually forms a barrier.
manufacturer says clinical trials show the procedure is 99.83
percent effective at preventing pregnancy over a five-year
period when used according to approved instructions.
rate is for so-called perfect use. Gariepy’s team wanted to
estimate the effectiveness under real-world conditions, or
example, doctors don’t always insert the implants correctly,
and the fallopian tubes may not become fully blocked. Women
are directed to use an alternative form of birth control
before returning to the doctor’s office after three months
to confirm proper placement — a critical follow-up step that
some fail to carry out.
new study, the researchers used available published data —
including reported cases of post-Essure pregnancies — to
estimate what would happen to hypothetical groups of 100,000
women using a particular sterilization procedure, including
cases where problems occurred.
to their calculations, 96 of every 1,000 women who undergo
hysteroscopic sterilization, or Essure, would get pregnant
within 10 years. For laparoscopic tubal ligations, the
pregnancy risks were significantly lower: 24 to 30 pregnancies
per 1,000 women.
deserve to have this information, which differs from the data
provided by the manufacturer, said Dr. Cassing Hammond, an
associate professor of obstetrics and gynecology at
Northwestern University’s Feinberg School of Medicine who
was not involved in the study.
Essure offers advantages that may make it the right choice for
some women, he added. "If patients and providers are
assiduous during the first year of use, the hysteroscopic
Essure implant remains a very effective form of
sterilization," he said.
Healthcare, which purchased Essure manufacturer Conceptus in
June, said hundreds of thousands of women have benefited from
the procedure since it was approved for sale in 2002. But the
company also stresses that "no method of contraception is
100 percent effective and pregnancies have occurred in the
of mathematical model used by Gariepy’s team "is useful
in identifying future areas for clinical research," the
company said in a statement. Bayer "welcomes ongoing
evaluation and research of new innovations in
on the Essure site as "a quick 10-minute procedure that
can be performed right in your doctor’s office," the
technique allows women to return to normal activities within a
day or two.
hysteroscopic sterilization is effective only if both coils
are properly placed; estimates of the success rate on the
first attempt vary from 76 to 96 percent, according to the
unlike a laparoscopic tubal ligation, which is effective
immediately, hysteroscopic sterilization requires several
steps, including the three-month waiting period and followup
procedure, which is required by the U.S. Food and Drug
Administration. Previously published studies on Essure
primarily reported the outcomes in women who successfully
completed all of the steps, said Gariepy.
bottom line is we do see a higher pregnancy risk (with Essure),"
she said. "Any time there are multiple steps, there are
multiple opportunities for things to go wrong."
Foley, 26, of Drexel, Mo., said she had Essure implanted in
September 2012, used other contraception for three months but
didn’t return for the follow-up test, in part because state
Medicaid didn’t cover it. She said her fourth child is now
due in October.
having this procedure and knowing how low they state the
percentage is, I never thought in a million years I’d get
pregnant," said Foley, who plans to have a hysterectomy
after her baby is born.
options for long-term birth control include IUDs and
contraceptive implants, which both have a failure rate of less
than 1 percent after a year with typical use, according to the
Guttmacher Institute. The male sterilization method,
vasectomy, also comes in at less than 1 percent.
institute lists "tubal sterilization" at less than 1
percent, a figure consistent with Gariepy’s estimated
failure rates for laparoscopic tubal ligations at the one-year
mark. By contrast, her team estimated a 5.7 percent failure
rate for hysteroscopic sterilization, or Essure, after one
to a recent report on the benefits and risks of sterilization
by the American College of Obstetricians and Gynecologists,
about 50,000 women underwent Essure procedures between 1997
and 2005, and 64 unintended pregnancies were reported to the
manufacturer. Most of these occurred because patients failed
to use an alternative contraceptive until it had been
confirmed the tubes were blocked, the report said.
women say they became pregnant even after completing the
follow-up test, which involves injecting a special dye into
the uterus and using an X-ray to check whether it leaks past
of Prophetstown, Ill., had Essure inserted in April 2010 and
returned in July to confirm the procedure worked. Records
provided by Hanrahan state that her tubes were 100 percent
blocked, and she was told she could stop taking birth control
pills. Her daughter Leena was born in early 2012.
woman does become pregnant after Essure, the risks to the
mother and the fetus are unknown, according to the Essure.com
Cox, 42, became pregnant despite Essure and worried about the
coils moving or even puncturing her uterus. She recently was
able to confirm they are in the right place but still plans to
have a hysterectomy after the baby is born in order to remove
she originally wanted a tubal ligation but her doctor steered
her toward Essure. She had the procedure in September 2012,
and the three-month follow-up test confirmed her tubes were
fully blocked, according to records Cox provided. Her fourth
child is due in July.
pregnant with these coils in my body and there’s no study to
tell me it’s going to be fine," said Cox, who lives
near Sacramento, Calif.
doctor, Timothy Phelan, said he has been implanting Essure in
patients for seven years and Cox is the first to become
pregnant. "To me the biggest issue is whether the
follow-up test is reliable enough to confirm the tubes are
blocked," he said. "If the tubes are truly blocked,
how do they get pregnant?"
said her pregnancy was stressful and involved many scares.
to my age, pre-term labor and Essure, there were many
potential risks and most of them were unknown," she said.
"I do consider myself lucky to have survived the
pregnancy and have a healthy baby."
other women, she wishes more information was available to
families affected by unplanned pregnancy.
is a huge side effect, especially when women are led to
believe it’s not possible," she said. "We’re
left to wait and wonder and pray everything will turn out