FDA Update: Ongoing Essure Surveillance

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 ...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news