Essure Removed in 85% of FDA Adverse Event Reports Submitted in 2017 and 2018
Federal regulators continue to receive reports of problems from Essure birth control implants, indicating that 85% of adverse events submitted involve women who had Essure removed after experiencing complications from the device, which was recalled from the market last year.
The FDA issued an update to its review of Essure complication reports on November 4, indicating that there were 11,854 cases submitted in 2017 and another 6,000 in 2018, with the vast majority involving subsequent removal of Essure. The agency has not yet released the number of reports submitted this year.
The most common reason given for Essure removal was pain, which accounted for 60% of cases where the device was removed, according to the FDA’s analysis. The second most common reason, at 14%, was genital hemorrhage. Device dislocation migration and expulsion accounted for 12% of removal cases, followed by perforation at 11%, suspected allergy to metals at 4% of cases, and device breakage occurred in 3% of removal cases. However, the agency notes that most removal cases cited more than one reason.
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 last year. Amid 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 notes most of the reports were submitted by Bayer itself, and are linked to a growing number of Essure lawsuits filed by women who have experienced complications.
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.