Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA activities related to the ongoing post-market review of Essure and FDA’s commitment to keep women informed

www.fda.gov/womens

 

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA activities related to the ongoing post-market review of Essure and FDA's commitment to keep women informed

"Some of my most important time as Commissioner is spent speaking directly to patients and their families about significant health issues that affect their lives, from the devastating opioid crisis to the current flu season. Overseeing a wide array of medical products, the U.S. Food and Drug Administration plays a vital role in providing consumers with up-to-date, evidence-based information to help them make the most informed medical decisions. The products we regulate touch people’s lives in meaningful ways. Last month I had the opportunity to meet with consumers who have been affected by the medical device Essure to listen and learn about their concerns. This device is used as a method of permanent birth control. The product’s manufacturer, Bayer, estimates that more than 750,000 women worldwide have received the device implant since it was first approved by global regulatory authorities. Some of the women I spoke to went on to develop significant medical problems that they ascribe to their use of the product. As a physician, I know that patients are uniquely positioned to provide feedback to the FDA about their experiences with currently available medical products, and I appreciated the thoughtful discussion. Ensuring the safety and effectiveness of medical products is paramount to the FDA and a core part of our consumer protection role. The FDA takes concerns about Essure very seriously." Read the full statement.