Problems With Essure Permanent Birth Control Coils To Be Provided to FDA By Bayer, and Made Publicly Available
Bayer has told federal regulators it is continuing to receive information about problems with the recalled Essure birth control coils through social media and other adverse event reports. However, the company will not have to release what those reports say for at least a year after receiving them, according to a recent FDA statement.
In an update on Essure postmarket activities issued on April 24, the FDA indicated it has sent a letter to Bayer, outlining its requirements for reporting additional postmarket adverse event information.
The agency’s letter grants a variance to Bayer, which gives the company a year to submit postmarket adverse event reports involving problems with Essure implants, which will then be posted by the agency on a publicly available website. The manufacturer requested the variance after it says it became aware of adverse event information about the implant on social media.
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“Bayer must process all reportable adverse events within one year of the variance, unless an extension is granted,” the FDA stated in an update to its Problems Reported with Essure webpage. “The FDA will make the events publicly available on this webpage at the pre-specified timepoints over the next year, starting in July 2020.”
Summary information from the reports will be put in the FDA’s Manufacturer and User Facility Device (MAUDE) database, and Bayer will have to provide quarterly and final analysis reports of the events, and must make those reports public.
The Essure device was a permanent form of birth control involving flexible coils inserted into the Fallopian tubes. It was used during a procedure designed to cause scar tissue to develop, which blocks the tubes and prevents insemination. However, the device was removed from the market amid reports thousands of women suffered painful and debilitating complications from Essure coils, including migration injuries, perforations, severe reactions and other problems.
Although Essure was recalled from the market in most countries in 2017, Bayer continued to sell the device in the United States until the end of 2018. In the face of mounting pressure and publicity about the injuries women were experiencing from Essure, the company announced in July 2018 that it was removing Essure from the US. market on December 31, 2018.
Following the decision, the FDA confirmed Bayer would be required to extend a post-market surveillance study and take other measures to ensure long-term Essure oversight well after production and sales have ceased.
Bayer currently faces more than 18,000 Essure lawsuits filed by women nationwide, each involving similar allegations that the permanent birth control coils resulted in painful and debilitating complications. Approximately 750,000 women worldwide have been implanted with the device, and Bayer has previously estimated that 70% of those have been implanted in women in the U.S.
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