By Thomas M. Burton
The Food and Drug Administration said it has received more than
5,000 complaints about adverse reactions--including some
deaths--among women who received a sterilization implant called
Essure.
The agency said that over 12 years, it received reports of four
deaths of women who used the device, as well as five reports of
deaths of fetuses in women who became pregnant despite the implant.
The device was cleared for U.S. marketing in 2002.
The FDA said it has scheduled a hearing for Sept. 24 to evaluate
the overall safety and effectiveness of the product.
Essure is a metal and polyester coil placed in a woman's
fallopian tubes that is designed to render her permanently sterile.
It is estimated that about 750,000 of the devices are implanted
world-wide. Bayer AG, which acquired the product in 2013 when it
purchased a majority interest in the manufacturer, Conceptus Inc.,
didn't immediately respond to requests for comment.
Bayer has previously said it "stands behind the safety and
efficacy of Essure."
The agency said most of the reports it has received were filed
since 2013 and were "voluntary reports, mostly from women who
received Essure implants." There also have been several lawsuits
over Essure filed against the manufacturer. Bayer said it "will
aggressively defend itself in court."
The FDA said that it plans to monitor the safety of the device
to "ensure it does not pose an increased risk to public
health."
"To date, we have found no conclusive evidence in the literature
indicating any new or more widespread complications definitely
associated with Essure occurring more than five years after Essure
placement," the agency said.
Of the 5,093 reports received by the agency, the most frequently
reported problems were pain or abdominal pain, irregular
menstruation, headache, fatigue and weight fluctuation. The agency
said some of the reports it has received, such as extreme fatigue
and depression, weren't including in the labeling, in post-approval
studies or in medical literature.
A Bayer website describes "rare reports of chronic pelvic pain
in women who have had Essure." It said, too, that there are "rare
instances" of an Essure implant migrating through the fallopian
tubes and requiring surgery.
Among the deaths reported to the FDA by individuals, one
resulted from an infection after the implant procedure, one related
to uterine perforation, another stemmed from surgery to remove the
device, and one was a suicide. Such reports are difficult to
interpret, partly because most of them are voluntary and because
causation isn't proven in the reports.
Installation of the device is done in a doctor's office by a
catheter that passes through the vagina through the cervix and
uterus. It is designed to cause tissue growth that will block the
fertilization of eggs.
Write to Thomas M. Burton at tom.burton@wsj.com
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