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.
I would like to outline the steps we’ve taken, to date, regarding this product, and the additional steps that are underway. I also want to reiterate my commitment to regularly communicating with patients and physicians about this device as more information is made available and additional steps are taken.
Since Essure’s approval in 2002, the agency has continued to monitor the product’s safety and effectiveness by reviewing the medical literature, clinical trial information, post-approval study data and medical device reports submitted to the agency. We convened a panel of medical experts in the fall of 2015 to provide us with advice on how we could better understand concerns about the device, such as patients who experienced abdominal pain, abnormal uterine bleeding and device migration.
In February 2016, we ordered the manufacturer of Essure, Bayer, to conduct a postmarketing (522) study to better evaluate the safety profile of this device when used in the real world. We also required a boxed warning to be added to the product labeling as well as a Patient Decision Checklist. The aim is to help make certain that a woman considering Essure receives and has full access to information about the benefits and risks of this type of device prior to undergoing treatment with this product.
As part of the FDA’s ongoing efforts to monitor Essure adverse events, we continue to review medical device reports submitted to our public database and provide updates about our ongoing analysis of the reports on our website. At the current time, the FDA is actively evaluating a significant collection of new medical device reports submitted to FDA on the Essure device. Of the nearly 12,000 reports received in 2017 for Essure, the majority were sent to the FDA in the last quarter of the year.
Detailed Statement enhanced here http://snip.ly/tyywq