FDA Outlines New Steps to Evaluate Long-Term Safety Risks of Essure

Since medical device company Bayer HealthCare announced it would halt sales of its permanent contraceptive Essure in July 2018, the FDA has taken new measures to evaluate the long-term safety risks of the device. Thousands of women have lodged complaints against Bayer citing painful, debilitating complications from Essure such as chronic pain, pregnancy, miscarriage, perforation of the uterus or other organs, and even death. FDA Commissioner Scott Gottlieb issued a statement outlining the regulator’s next steps to revise and strengthen the manufacturer’s postmarket surveillance study. The study will include monitoring women implanted with the device for five years instead of three to capture longer term information about device removals, requiring additional blood testing to detect inflammatory indicators, and requiring Bayer to submit more frequent reports to the FDA on the study’s progress and results.

Cases on behalf of thousands of women have been filed against Bayer, claiming the manufacturer did not warn patients of Essure’s potential severe complications. Grant & Eisenhofer is Co-Liaison Counsel and serves on the Plaintiffs’ Executive Committee leading the litigation. If you have experienced complications from an Essure implant, please call us at 888-985-7228 to speak confidentially with an attorney about your potential claim.

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