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

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Mar 07, 2018, 02:43 ET

SILVER SPRING, Md., March 7, 2018 /PRNewswire-USNewswire/ -- 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.

Most of this new information comes from cases that were made available by plaintiff attorneys as part of litigation against the product sponsor. We appreciate any opportunity to receive additional information about the safety of this product. We're working to evaluate whether these cases reflect new safety concerns, as well as the extent to which they represent entirely new reports to the FDA or may have been reported in a prior safety filing. More than 90 percent of the reports in 2017 mentioned issues involving potential device removal, which the FDA is further investigating. Some of the reports do not indicate when or if the device was removed, based on the information submitted. In short, we're actively working to gain more information on these new reports and to better understand reasons for the device removal. The FDA will be following up on many of these individual reports to gather this additional information.

We'll provide updates on our evaluation of this data. The FDA will use the new information to continue to inform our assessment of the benefits and risks of Essure. We also rely on peer-reviewed medical studies to inform our thinking on Essure. Those peer-reviewed, published study results have been generally consistent with our previous assessments on the product's safety profile.

While the FDA continues to believe that Essure may be appropriate for some women based on our current information, the agency also recognizes that serious problems have been associated with its use. We're continuing to monitor adverse events reported to our database, as well as other data sources, such as the postmarketing (522) study, and will communicate publicly on any new findings or concerns.

We also will continue to consider regulatory options that appropriately balance the benefits and risks for the Essure device as new information becomes available. The agency is committed to continuing to communicate publicly on this issue, to share what we learn, and help women make informed decisions.

For more information:

Essure: FDA activities
Essure product labeling
Patient decision checklist

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Deborah Kotz, 301-796-5349 [email protected]
Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration