Yesterday, on August 11, 2020, the FDA posted the first spreadsheet of adverse event reports.
The Food and Drug Administration (FDA) continues its post-market evaluations of Essure devices and aims to keep information as updated as possible. Yesterday, on August 11, 2020, the FDA posted the first spreadsheet of adverse event reports.
The information was obtained via social media sources and, as such, may reference information already reported to the FDA. The information in the spreadsheet may not represent new adverse events.
In this spreadsheet, the FDA reviewed reportable events, with the nature and severity of the reports consistent with Medical Device Reports (MDRs) received for Essure since 2017.
The reports mentioned above were received from Bayer, manufacturer and seller of Essure until 2018. From now until April 2021, Bayer will continue to provide spreadsheets of reports and provide analysis reports detailing the information.
View the 522 post-market surveillance studies here.