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Statement from FDA Commissioner Scott Gottlieb, M.D., on manufacturer announcement to halt Essure sales in the U.S.; agency's continued commitment to postmarket review of Essure and keeping women informed

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Statement from FDA Commissioner Scott Gottlieb, M.D., on manufacturer announcement to halt Essure sales in the U.S.; agency's continued commitment to postmarket review of Essure and keeping women informed

PR Newswire

SILVER SPRING, Md., July 20, 2018 /PRNewswire/ -- The U.S. Food and Drug Administration was notified by Bayer that the Essure permanent birth control device will no longer be sold or distributed after December 31, 2018. This decision follows the FDA's patient safety action in April, in which the agency issued an order restricting the sale and distribution of Essure; it was a unique type of restriction where the FDA used its authority to impose additional requirements to provide a reasonable assurance of the device's safety and effectiveness. The decision today to halt Essure sales also follows a series of earlier actions that the FDA took to address the reports of serious adverse events associated with its use.

U.S. Food and Drug Administration (FDA) logo (PRNewsfoto/FDA)

For women who have received an Essure implant, the postmarket safety of Essure will continue to be a top priority for the FDA. We expect Bayer to meet its postmarket obligations concerning this device.

Consumers rely on the FDA to oversee the regulation of vital medical products. In turn, the agency also relies on consumers for important feedback to help us learn more about the benefits and risks of medical products when they're used outside of clinical trials in the real world. Essure is estimated to have been used by more than 750,000 patients worldwide since it was first approved by global regulatory authorities. The device has been associated with serious risks including persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen. As the FDA learned more from patients about the serious adverse events associated with this device, we took a series of important actions to better understand the benefits and risks, and to address patient safety concerns.

Among other steps, we conducted a thorough review of our database and medical literature; we convened an expert panel to discuss new concerns; we ordered Bayer to conduct a new post-market surveillance study to better evaluate the safety profile of the device when used in the real world; and we required Bayer to add a boxed warning to the labeling and a Patient Decision Checklist to help women considering Essure to be fully informed about potential risks. In April, when the FDA became aware that many patients were not being adequately counseled, we required a restriction which limits the sale and distribution of the device to only health care providers and facilities that provide information to patients about the risks and benefits of this device and gives patients the opportunity to sign an acknowledgement that they fully understood these potential risks before having the device implanted. Since the FDA ordered Bayer to conduct the post-market study and then to add a boxed warning and a Patient Decision Checklist to the labeling, there has been an approximate 70 percent decline in sales of Essure in the U.S. The company stated its decision to halt sales and distribution of the device was due to commercial reasons.

In February, I personally had the opportunity to meet with women who have been adversely affected by Essure to listen and learn about their concerns. Some of the women I spoke with developed significant medical problems that they ascribe to their use of the product.

This method of permanent birth control, where coils are inserted into the fallopian tubes creating a blockage that prevents the passage of an egg from the ovary, has been associated with numerous adverse events that were reported to the FDA including a significant collection of recent reports that have mentioned issues involving surgery to remove the device. We're continuing our evaluation of these reports to better understand reasons for the device removal. The agency is committed to continuing to provide updates on our evaluation of this data as the information is collected and we develop new findings about the device.

Ensuring the safety and effectiveness of medical products is a core part of our consumer protection role, and I want to outline some of the steps we've taken in recent years with respect to Essure.

When we first became aware of an increase in adverse events submitted to our database concerning this device, we launched an ongoing effort to review these reports to better understand concerns.

September 2015: The FDA convened a panel of experts to get their input on how we should investigate patient complaints that included abdominal pain, abnormal uterine bleeding and device migration.

February 2016: The FDA ordered Bayer to conduct a postmarket (522) study to better evaluate the safety profile of the device when used in the real world. The agency announced that it intended to require labeling changes to help patients better understand the potential risks of the device.

October 2016: The FDA issued the final guidance, "Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization" and in November 2016, the FDA approved updated labeling for Essure consistent with the guidance that added a boxed warning and a Patient Decision Checklist.

February 2018: FDA officials met with women implanted with Essure and patient advocates to listen to their concerns and experiences with the device.

March 2018: The FDA reported on a rise in new medical device reports submitted to the agency's public database in 2017 with more than 90 percent of the reports involving potential device removal.

April 2018: In order to address concerns that not every patient was receiving adequate risk information, the FDA restricted the sale and distribution of the Essure device.

I want to stress that, even when Essure is no longer sold, the FDA will remain vigilant in protecting patients who've already had this device implanted. We'll continue to monitor adverse events reported to our database, as well as other data sources. And we'll communicate publicly on any new findings or concerns. The restriction on sale and distribution will remain in place. Regarding the postmarket 522 study, Bayer will continue to enroll new participants. Each study participant will be followed for a total of three years and the company will continue to submit reports to the FDA on the study's progress and results. Since Bayer will not be able to meet its expected enrollment numbers for this study that relied on enrolling patients who were newly implanted with Essure, we'll be working with the company to best determine how to move forward to answer the critical questions we posed concerning certain patient complications that may be experienced by patients who have Essure.

I also want to reassure women who've been using Essure successfully to prevent pregnancy that they can continue to do so. Those with Essure who suspect they may be having symptoms related to the device, such as persistent pain, should consult with their doctor on what steps may be appropriate for them to take. Device removal has its own risks. Patients should discuss the benefits and risks of any operation or procedure with their health care providers before deciding on the best option for them. 

The FDA continues to undertake important initiatives to prioritize and enhance our approach to medical device safety. Our Medical Device Safety Action Plan, issued in April, captures many of the efforts that we're undertaking. Some proposed actions include new policies to drive innovation to create safer medical devices and to better understand and address risks of devices that are already on the market.

We're committed to continuing to communicate publicly on issues related to the safety of Essure and other medical devices. We'll share what we learn to help doctors and patients 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, deborah.kotz@fda.hhs.gov 
Consumer Inquiries: 888-INFO-FDA

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SOURCE U.S. Food and Drug Administration

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