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FDA Update: Ongoing Essure Surveillance

FDA says enrollment in Bayer’s mandatory post-market surveillance study on the controversial Essure has ended.

Bayer announced in July 2018 that it would stop selling Essure in the United States at the end of that year, citing a decline in U.S. sales of the birth control device and the conclusion that the Essure business was no longer sustainable. Despite the thousands of adverse event reports and patient lawsuits related to the product, the company insisted that its decision to discontinue Essure was purely a business decision and not out of concern for the safety or efficacy of the device.

MD+DI/Amanda Pedersen

Just over a year after Bayer stopped selling its Essure birth control implant in the United States, the company's mandatory post-market surveillance study on the controversial device has ended.

FDA said the clinical data from the study will help patients, healthcare providers, and the agency better understand certain complications that women who have Essure permanent birth control may experience when compared to women who undergo tubal ligation. Follow-up of patients in the study is ongoing, and the agency said it will post the interim study results after the data has been analyzed and the next report is reviewed.

Jeff Shuren, MD, director of FDA’s Center for Devices and Radiological Health,  said the agency worked directly with Bayer to ensure that previously sold but unused devices were returned to the company by the end of 2019.

"As of today, Bayer has reported to the agency that over 99% of unused devices have been returned," Shuren said on Friday. "Bayer is aware of 10 unused devices that they are actively seeking to retrieve."

Women who have been using Essure successfully to prevent pregnancy can and should continue to do so, FDA noted.

The agency received about 6,000 medical device reports in 2018 related to Bayer's Essure birth control implant. This is in addition to the nearly 12,000 reports the agency received in 2017 related to Essure. As in 2017, most of the reports FDA received about Essure in 2018 were submitted by Bayer and are related to litigation against the company. Also, most of the reports mention potential surgical removal of the device, the agency previously noted.

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