Essure Problems Continuing to be Reviewed by FDA, But No Action Likely Until February 2016

Following a recent FDA advisory panel meeting to review increasing reports of injuries and problems with Essure birth control implants, the federal health regulatory agency indicates that it does not anticipate announcing any actions until late February 2016.

The FDA issued an update on the status of its Essure safety review on November 24, indicating that the agency is continuing to work expeditiously to conduct an evidence-based review of available information and to determine what regulatory steps may be necessary.

The announcement comes following a meeting of the FDA’s Obstetrics and Gynecology Devices Advisory Panel on September 24, where concerns were raised by health experts and women who received the controversial Essure implant, with many calling for the FDA to recall Essure from the market due to the long-term risks associated with the device.

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“Presently, we are reviewing information from the panel meeting, the public docket, as well as additional medical literature and adverse event reports which have been published or received since the panel meeting,” the FDA statement reads. “In this review, we are focusing attention on the concerns identified by the public speakers and the feedback and recommendations provided by the panel.”

Essure is a female sterilization devices offered as an outpatient procedure for long-term birth control. During the surgery, a doctor inserts bendable coils into the fallopian tubes, passing through the vagina, cervix and uterus. The process causes scar tissue to form around the coils over several months, which blocks the tubes, preventing insemination.

In recent years, there have been growing concerns over the problems with of Bayer’s Essure procedure, with the FDA indicating earlier this year that it had received at least 5,093 adverse event reports involving the device since it was approved in November 2002. Most of those reports were voluntary from women who received the implants and later suffered Essure problems.

According to FDA adverse event reports, there have been at least 3,353 incidents involving abdominal pain from Essure, 1,408 involving menstrual irregularities, 1383 involving headaches, 966 were reports of fatigue, 936 were reports of weight fluctuation, and there were four reported deaths.

At the advisory committee meeting in September, a line of women testified about just such complications, urging the committee to recommend an Essure recall to the FDA. However, the advisory committee determined that better safety data is needed, including a patient registry and a new clinical study on safety and effectiveness. They also said Bayer should provide women with more detailed information about the risks of Essure before it is implanted, suggesting that women have review a checklist of possible complications and sign off on it before getting the procedure.

Congressman Mike Fitzpatrick, a Republican from Pennsylvania, has introduced the E-Free Act in the U.S. House of Representatives. If approved, it would revoke the pre-market approval given by FDA to Essure’s original developer, Conceptus, in 2002. This would require Bayer, who currently owns and distributes the birth control implant, to remove Essure from the U.S. market.


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