FDA Commissioner Scott Gottlieb vows to commit to market review of Essure
FDA Commissioner, Scott Gottlieb affirmed that FDA vows to commit itself to addressing women’s health issues by speaking directly to patients and their families about significant health issues that affect their lives ranging from the devastating opioid crisis to the current flu season.
U.S Food and Drug Administration plays a vital role in providing consumers with updates and evidence-based information to help them make thee most informed medical decisions.
Scott Gottlieb states “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.”
Since Essure’s approval in 2002, the agency has persisted to oversee the product’s safety and effectiveness by reviewing thee medical literature, clinical trial information, post-approval study data and medical device reports submitted to the agency. They have convened a panel of medical experts in the fall of 2015 to provide them with advice on how to better redress the concerns about the device, such as patients who experienced abdominal pain, abnormal uterine bleeding and device migration.