- FDA has presented more data on problems related to Bayer’s Essure birth control device, including an analysis of the medical device reports it received in 2021.
- The agency received 3,701 reports related to Essure last year. That figure is well down on the two prior years, when FDA received more than 30,000 reports in total. The percentage of reports citing litigation fell from over 90% to 63%. The decline comes as FDA data released last month showed more patients had the devices removed.
- FDA's webpage on problems reported with Essure now also features an overview of the reports Bayer submitted from June 2020 to March 2021, as it worked through adverse event information from social media.
Bayer stopped selling Essure, an implant designed to provide a permanent birth control option, late in 2018. The withdrawal followed tens of thousands of reports of complications, although Bayer stood by the safety of the device and framed its action as a business decision. While it is now years since Essure was sold in the U.S., the analysis of data on the safety of the device continues apace.
FDA updated its webpage on problems with Essure on Monday. The webpage now features details of the agency’s analysis of the medical device reports it received in relation to Essure last year. FDA analyzed the data in the context of reports on the safety of the device going back to when it came to market 20 years ago.
Having received 15,000 reports in 2019 and 16,000 reports in 2020, FDA received just 3,701 reports related to Essure last year. Bayer submitted 98% of the Essure reports received by the agency last year. The company has been the main source of Essure reports to FDA since 2016.
FDA said the "nature and severity of the reports in 2021 remain consistent with prior years." Across the entire 2002-2021 dataset, the most reported patient problems were pain/abdominal pain, heavier menses/hemorrhage/menstrual irregularities, foreign body/device fragment in patient and perforation.
There are now 95 reports coded by the submitter as death in the dataset through Dec. 31, up one from last year. The additional report is one of 29 that "reference information on deaths posted in social media or other media outlets." FDA said, "it is difficult ... to determine whether the device caused the death with only the information provided in the report."
Bayer has now completed the monthly reports of the adverse event information it received between November 2016 and November 2020 as part of litigation. FDA summarizes the 57,802 reportable events, the final set of which were published last year, on its webpage giving an overview of problems with Essure.