Women who received a
metallic birth control implant are urging health regulators to pull the device
from the market, citing problems including severe pain, irregular bleeding and
weight gain.
The Essure implant
has been sold for more than a decade and is frequently pitched to women as the
only non-surgical option for permanent birth control. Manufacturer Bayer
estimates 750,000 women have received the device since 2002.
But since 2013, the
Food and Drug Administration has received thousands of complaints about the
device from women and doctors. While the product's label warns about pelvic
pain and bleeding immediately after the procedure, many women say these
problems persisted and were so severe they required invasive surgery to remove
the device.
The FDA convened a
panel of outside experts Thursday to review the device's safety and
effectiveness.
In often emotional
prepared remarks, women from throughout the U.S. described debilitating
symptoms which they attribute to Essure.
Elena Mendez
received her implant in February 2008 at the recommendation of her doctor. An
emergency room nurse in New York, Mendez said she liked the idea that she could
return to work after a quick, in-office procedure.
But soon afterward
Mendez began experiencing severe, constant pain, including during sex.
"Pain became my
norm every day," Mendez said. "This negatively impacted my marriage
and I could not be the mother my children deserved."
Essure consists of
two metallic coils inserted into the fallopian tubes, where they are intended
to spur scar tissue that eventually blocks sperm. Bayer sells the device as an
alternative to traditional procedures used to "tie the tubes," via
incision or other methods.
Essure's warning
labeling lists a number of potential risks, including that the device can slip
out of position or puncture the uterus, requiring surgery to remove.
Additionally, Essure is made of a nickel-titanium alloy that can cause allergic
reactions — such as itching and hives — in some patients.
But thousands of
women have attributed more severe problems to the implant, including chronic
pain, headaches, mood disorders, hair loss and irregular bleeding. Many of
those complaints have been shared through social media, including a Facebook
page called Essure Problems, which has more than 20,000 members.
The American College
of Obstetricians and Gynecologists, Physicians for Reproductive Health, and
Planned Parenthood Federation of America defended Essure.
"Today, Essure
is the only permanent contraception that can be performed non-surgically,
allowing women to avoid potential complications associated with surgery and
general anesthesia, especially those with certain medical conditions,"
they said in a joint statement.
"We urge the
FDA to recognize that restricting women's access to certain methods of birth
control will limit their choices and, in some cases, expose them to additional
risk."
Later Thursday the
FDA will ask its panel of experts to discuss whether use of the device should
be restricted to certain women. The panel's recommendations are not binding.
The dilemma
confronting the FDA is not a new one when it comes to medical devices.
Short-term studies
used to approve the device initially suggested it was safe and effective. But
real-world experience from thousands of women suggests Essure can cause
troubling side effects and may be less reliable than some other contraceptive
methods.
Three years ago a
similar FDA panel convened to review unforeseen problems with metal-on-metal
hip replacements. Those devices were thought to be more durable than older
ceramic models. But the panel said real-world data showed the devices actually
break down earlier than older implants, exposing patients to tiny, metallic
shards.
In the case of
Essure, the original company studies suggested the implant prevented pregnancy
in 97 percent of cases. But the studies only tracked 85 percent of women out to
a year and only 25 percent of women were followed for two years. Researchers
from Yale University said this drop-out rate "limited the evaluation of
adverse events and device safety," in an op-ed in this week's New England
Journal of Medicine.
"I think we
could do better for women by getting better information," Dr. Aileen
Gariepy of Yale School of Medicine said in an interview with The Associated
Press.
The advocacy group
Public Citizen also pressed for the device to be taken off the market.
"The device causes long-term, debilitating pain and other chronic adverse
effects in some users. Additionally, Public Citizen raised significant concerns
regarding how serious adverse events and patient satisfaction were assessed
during clinical testing of the device," the group said. by
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