Product News and Recalls

FDA Issues Follow-up Statement for Essure Patients

fda reports on postmarket Essure patientsThe FDA recently released an update to its tracking and post-market surveillance of Essure patients and the measures taken by Bayer since the corporation pulled the device from US shelves last year. The agency, according to a statement by the director of its Center for Devices and Radiological Health, “is committed to continuing to monitor the postmarket safety of the device for women who have the device implanted.”

Some may wonder where that commitment was when tens of thousands of women were filing reports of the incomprehensible pain they were enduring because of Essure devices. In the end, it wasn’t even the FDA that forced the device off the market. Having pulled Essure off shelves in every country in the world except for the United States, Bayer finally officially pulled the plug on US Essure sales the last day of last year amid increasing pressure from legislators, regulators, and experts in the medical community.

Rather than force the device off the market, the FDA even went so far as allowing Bayer to enforce its own compliance with a mandate to inform patients of Essure’s known safety issues. When asked about the lengths the FDA appeared to be going to avoid recalling Essure, the agency would itself acknowledge that its solutions for Bayer were “unique.”

Progress in the postmarket survey of Essure patients is described by the FDA as “adequate.” The study, mandated by the agency but conducted by Bayer, has been extended to five years from its original three. Just over 1,000 women are participating in the study that compares the long-term complications suffered by 329 Essure users with 673 who underwent laparoscopic tubal ligation; more commonly known as having one’s tubes tied. The FDA has promised to release interim results from the study at the end of this year.