UPDATE: Dec. 8, 2020: Bayer noted its analysis found many of the reports were already submitted to FDA “consistent with Essure’s known and labeled safety profile,” in a statement, reiterating its backing Essure's safety, based on data from more than 270,000 women over two decades. The company also echoed FDA’s acknowledgement of the challenges of drawing conclusions from social media posts, which come with potential for biased and inaccurate information.
- Bayer on Monday released the first quarterly analysis of adverse event information culled from social media reports for its discontinued Essure permanent birth control implant. The analysis included 73 death reports among the 7,509 events detailed for the June-August 2020 time period.
- FDA, in announcing the availability of the data, cautioned of the potential for duplication of cases in the numbers, given that the information is gleaned from comment threads on social media reports.
- The agency is requiring Bayer to process all adverse events that the company becomes aware of on social media as part of an agreement reached in April. Bayer has continued to stand by the safety of the device.
Bayer stopped selling Essure in the U.S. in late 2018, following tens of thousands of reports of complications in patients that ranged from pain to device migration and breakage and facing a mountain of litigation. At the time, 49 deaths had been linked to the implant.
Approved by FDA in 2002, the device consists of metal coils inserted into the fallopian tubes to block the passage of an egg. Scar tissue forms around the implant to prevent pregnancy.
In April 2018, FDA limited sales of the product to healthcare providers who agreed to share a patient-doctor discussion checklist provided by Bayer with women who chose to get the device. Three months later, faced with declining sales of the device as the number of adverse events climbed, Bayer announced it would discontinue Essure.
The company told MedTech Dive in August, when it released the first batch of adverse event reports based on social media posts, it stands behind the product's safety and efficacy. That initial spreadsheet contained 1,453 reportable events, including 53 deaths and 24 malfunction reports.
Bayer's quarterly analysis is based on data from the first three spreadsheets submitted by the manufacturer. The report includes a total of 7,509 reportable events, of which 7,332 are serious injuries, 104 malfunctions and 73 deaths. For the 73 death reports, the social media posting dates ranged from the years 2013 to 2019, though dates were not always provided.
Most common problems reported by patients were pain, perforation, fragmentation, pregnancy and heavier periods. In addition to the numbers reported in the quarterly analysis, there were 4,855 cases in the September spreadsheet and 3,386 cases in the October spreadsheet.
In addition to Bayer's quarterly analysis, FDA posted two new spreadsheets containing details of adverse events involving Essure in September and October.
FDA said the limited information in the event descriptions prevents conclusions from being drawn about whether the device or its removal caused or contributed to any of the reported deaths or other events. Bayer will continue to provide quarterly analyses as well as a final report on the adverse event information, the agency said.