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Federal regulators indicate that nearly all unused Essure devices have been removed from the market entirely and retrieved by the manufacturer, and hundreds of women who already received the permanent birth control implant have been enrolled in a study intended to evaluate the long-term complication risks.
An Essure recall was announced a year ago, and the FDA issued an update on the Essure market withdrawal last week, indicating that Bayer is only aware of 10 units that are unaccounted for, having either obtained or accounted for 99% of the Essure devices distributed before December 31, 2018, when U.S. sales were discontinued.
In addition to retrieving Essure devices, the agency indicates Bayer has finished the recruiting stage for ongoing postmarket studies, and will be monitoring at least 340 women who received the implant over a five year period, comparing the results to 788 women who elected to undergo laparoscopic tubal ligation.
“While Essure devices have not been sold in the U.S. for more than a year, the U.S. Food and Drug Administration (FDA) engaged directly with Bayer to help to ensure that previously sold but unused devices were returned to the company by the close of 2019,” Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the press release. “Efforts included Bayer proactively reaching out to health care professionals and facilities to return unused Essure devices so that they would no longer be available for implantation.”
The Essure device was a permanent form of birth control, involving flexible coils that are inserted into the fallopian tubes. It was used during a procedure that is designed to cause scar tissue to develop, which blocks the tubes and prevents insemination. However, the device was removed from the market amid reports that thousands of women were suffering 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.
The FDA noted that as of January 10, Bayer has enrolled 1,128 patients, with 340 women who received the Essure implant, and a control group of 788 women who instead chose to undergo laparoscopic tubal ligation. Originally a three-year study, the FDA ordered Bayer to extend the study to five years, in order to understand the long-term safety risks of the defunct birth control device.
Bayer currently faces more than 18,000 product liability complaints filed by women nationwide, each involving similar allegations that complications from the Essure coils. 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.