WASHINGTON —The FDA posted information and a link to a spreadsheet on its website providing details of the adverse event reports the agency received relating to the Essure implantable contraceptive device.
“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,” Benjamin Fisher, PhD, director of the Reproductive, Gastro-Renal, Urological, General Hospital Device and Human Factors Office in the Center for Devices and Radiological Health at the FDA, was quoted as saying in a statement. “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 agency received the information from Bayer, which manufactured Essure until its removal from the market in 2018 and which is still facing ongoing litigation related to these adverse events. The manufacturer will continue to update the spreadsheet until April 2021 and will “provide quarterly and final analysis reports evaluating the events reported and how the information compared to other [medical device reports] for Essure.”
While no longer available, the FDA is continuing to conduct its postmarketing evaluation on long-term safety for women who previously received the device.
“From January 2017 through December 2018, there were 11,854 medical device reports related to Essure in 2017 and 6,000 reports in 2018,” the FDA reported on its “Problems Reported with Essure” page also houses the downloadable spreadsheet, though this first spreadsheet only details 1,453 of these reports.
The FDA noted that 85% of reports received in 2017 and 2018 were in reference to device removal — of these, 80% cited litigation. Reasons for removing the device included pain, genital hemorrhage, device dislocation/migration/expulsion, perforation, suspected allergy to metals, and device breakage. They added that the agency received a further 15,083 reports in 2019, 91% of which were related to device removal and 95% of which cited litigation.
Candace Hoffmann, Managing Editor, BreakingMED™
Cat ID: 191
Topic ID: 83,191,184,730,191,192,725,925