Study Raises New Concerns About Bayer Sterility Device
October 13 2015 - 6:59PM
Dow Jones News
By Thomas M. Burton
In the first large, controlled study of Bayer AG's sterility
device Essure, researchers found that women who have had it
implanted are 10 times as likely to need new operations as women
who got standard sterility surgery.
Women have spoken of debilitating pain and allergic reactions to
the Essure implants, including at a Food and Drug Administration
workshop last month. Some 750,000 or more women world-wide have
gotten the Essure implants, but it has been difficult to assess the
scope of the problem until this study.
"A more than 10-fold high occurrence of reoperation during the
first year following Essure-based surgery is a serious safety
concern," wrote researchers from Weill Medical College of Cornell
University.
Essure implants are inserted through the vagina and cervix into
a woman's fallopian tubes. There, they are designed to cause
inflammation and fibrous tissue growth that will block the pathway
between sperm and egg.
Reoperations don't always connote a safety issue, but the
doctors in the study noted that "most of the adverse events"
reported by a federal device safety database "were injuries that
would require a reoperation." Severe pelvic and abdominal pain, and
allergic reactions to nickel in the device, have been commonly
reported.
The report was statistically powerful, as it included the
records of 8,048 women who underwent the Essure procedure, and
44,278 others who got traditional surgery, known as tubal ligation.
The researchers evaluated the cases of patients with such
procedures in New York state between 2005 and 2013. Reoperations
one year afterward were the main outcome measured.
The study, run by Art Sedrakyan of Weill Medical College,
appeared online in the publication BMJ.
The FDA now is considering the safety record of the device after
receiving an onslaught of recent complaints--2,259 in 2014 and
1,363 through June 1, 2015.
Bayer acquired Essure through a 2013 acquisition of Conceptus
Inc., the original maker of the product.
Bayer said Tuesday that "Essure is a highly effective
birth-control option with a positive benefit-risk profile for women
who have completed their families and want permanent contraception
with a nonsurgical procedure." It said that more than a decade of
research, development and real-world experience "supports the
safety and efficacy of Essure."
This product poses the latest challenge for the medical-device
center at the FDA, which never insisted on a gold-standard,
randomized and controlled study prior to approving the device.
Often, as was the case with devices like metal-on-metal hip joints
that sometimes failed, the FDA has used an abbreviated process
requiring only that the new device be substantially like an older
one.
Essure's approval was different. It was in the most stringent
FDA category of medical devices when the FDA approved it in
2002--which often can mean a strenuous clinical study is called
for. But the agency didn't require that this study include a
control, or comparison group of patients who didn't get the device,
a fact that was sharply criticized by some panelists at the
workshop in September. Agency officials noted that the preapproval
study did include 600 patients and said it required Essure's maker
to do further study after approval.
There have been some lawsuits filed over Essure, but lawyers
said their numbers are small, largely because of a 2008 Supreme
Court decision called Riegel v. Medtronic. That case said that
because the FDA oversees the safety of medical devices, plaintiffs
generally are pre-empted from suing device makers under state
laws.
Write to Thomas M. Burton at tom.burton@wsj.com
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(END) Dow Jones Newswires
October 13, 2015 18:44 ET (22:44 GMT)
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