On April 24, 2020, the FDA granted, in part, Bayer’s request for a variance from some medical device reporting requirements subject to the conditions outlined in a letter issued to Bayer. The variance is limited to MDR-reportable events for Essure that Bayer is, or becomes aware of, from information received November 2016 through November 2020 in connection with litigation regarding Essure and that originated from certain social media information.
Although Essure is no longer available for implantation in the U.S., the FDA remains committed to evaluating long-term safety information in women who have received the device, including data from an FDA-required postmarket surveillance study, sometimes referred to as the 522 study.
From 2017 to 2019, the majority of MDRs received from Essure were related to potential device removal, as were the majority of reports in the spreadsheet posted today. The FDA expects to have more real-world data from the 522 study about Essure removal, including better information on the reasons for removal and follow-up of patients after removal to assess outcomes. On July 8, 2020, the FDA provided interim results from the 522 study on the Essure 522 webpage.
The link to the data file for the first spreadsheet of reportable events is available on the FDA’s “Problems Reported with Essure” webpage. We will post future spreadsheets on this same webpage after the information is received from Bayer and reviewed by the FDA. Bayer submitted a summary of the information in the first spreadsheet through FDA’s Manufacturer and User Facility Device Experience (MAUDE) database.
Over the last several years, the FDA has taken a number of actions to monitor the safety of Essure. The agency regularly updates the public about these actions and remains committed to sharing new information as it becomes available.
“The FDA continues to take concerns about Essure very seriously. Consistent with our previous updates, we are committed to continuing our postmarket evaluation of this device and providing updated information periodically. In that spirit, today, the FDA posted the first spreadsheet of adverse event reports pertaining to information received from certain social media sources, in relation to ongoing litigation about this device,” Benjamin Fisher, Ph.D., director of the Reproductive, Gastro-Renal, Urological, General Hospital Device and Human Factors Office in the Center for Devices and Radiological Health said. “As this information is based on social media posts, these reports may reference information already reported to the FDA and do not necessarily represent new adverse events. The limited information provided in the reports prevents the ability to draw any conclusions as to whether the device, or its removal, caused or contributed to any of the events in the reports. The FDA reviewed the first spreadsheet of reportable events, and the nature and severity of the reports remain consistent with Medical Device Reports (MDRs) received for Essure since 2017. The FDA received these reports from Bayer, who manufactured and sold this device until 2018. Bayer will continue to provide monthly spreadsheets of reports through April 2021, as well as provide quarterly and final analysis reports evaluating the events reported and how the information compares to other MDRs for Essure. We will continue to ensure that all reportable adverse events identified from this information are submitted to the FDA and made publicly available.”
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