Hundreds of Women Petition FDA on Essure

Hundreds of people have written to FDA, with most asking the agency to pull Bayer's Essure permanent birth control from the market.

Marie Thibault

 

 

Hundreds of people have sent comments to FDA petitioning against Bayer HealthCare's Essure permanent birth control system. Most of the comments are from women who were implanted with Essure and allege the device caused significant side effects. 

The public comments were sent in response to an FDA notice scheduling a meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee for September 24. The panelists will discuss Essure, consider the risks and benefits based on scientific data, and make recommendations on future use, labeling, and, if necessary, any potential studies.

The Essure system, which Bayer acquired with its 2013 purchase of Conceptus, consists of nickel-titanium alloy inserts implanted hysteroscopically in a woman's fallopian tubes. Women undergo a confirmation test three months after implantation to ensure the fallopian tubes are blocked by tissue ingrowth around the inserts. Essure has had FDA approval since 2002. 

There have been more than 5000 complaints related to Essure submitted to FDA's Manufacturer and User Facility Device Experience (MAUDE) database between November 2002 and May 2015, according to FDA

Commenters give firsthand accounts of their troubles with Essure. Numerous women write about unexplained weight gain, pain, migraines, menstrual irregularities, and other complications, which started after Essure implantation. Some of the comments come from patients' loved ones, including sons, husbands, and cousins. One son writes that "I have seen Mother live everyday in pain and ER trips."

A Bayer spokesperson said in an e-mailed statement, "Bayer looks forward to an open and transparent discussion regarding Essure at the meeting of the Obstetrics and Gynecology Devices Panel on September 24, 2015. Bayer has been in regular communication with the FDA about the risk-benefit profile of Essure and the informational needs of both healthcare providers and patients.

"Patient safety is Bayer’s top priority. Given there has been a great deal of interest in the safety of Essure among some patients, we welcome this open dialogue with healthcare providers, patients, researchers, representatives from professional societies, and other members of the public to review and discuss available data regarding the benefits and risks associated with Essure.

"Bayer is strongly committed to women having access to safe and effective birth control options. The only FDA-approved non-surgical option for women who have completed their families and want permanent contraception, Essure is supported by more than a decade of science and real world clinical experience."

Catholic News Agency reported last month that a group of patients campaigning against Essure are planning a hunger strike outside the FDA building following the September 24 panel meeting. Pope Francis will be in Washington, DC the same day to address Congress, and the hunger strike is an attempt to ensure attention stays focused on FDA and Essure, as well as underscore the group's dedication to the cause, according to the article.

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Marie Thibault is the associate editor at MD+DI. Reach her at marie.thibault@ubm.com and on Twitter @medtechmarie

[Image courtesy of OHMEGA1982/FREEDIGITALPHOTOS.NET]

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