Bayer' s second quarterly analysis of Essure adverse events culled from social media posts show reports of 11,830 serious injuries, 45 malfunctions and nine deaths. Most of the reports are linked to potential removal of the birth control implant, as has been the case for years.
FDA, as it has done previously, urged caution about data, stating “the limited information prevents the ability to draw any conclusions” about ties between Essure and adverse events. The agency published the analysis Monday.
Bayer pulled Essure from the U.S. market in 2018, calling it a business decision and standing behind the device's safety. The move came amid receiving thousands of reports of pain and other complications potentially linked to the device and as it faced tens of thousands of lawsuits. Bayer asked FDA to allow monthly submissions of the social media reports it learned about through the litigation process.
The analysis covers the reports for September, October and November. Those months saw Bayer report more serious injuries but fewer deaths than in the previous quarter, although events covered in the monthly spreadsheets come from old social media posts. There is little relation between when a report is processed and when the event occurred.
The reports may also be duplicates of events previously submitted to FDA. Given those issues and other shortcomings of the evidence, Bayer, like FDA, cautioned about the limitations of the data.
“This passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event and lack of information about frequency of device use,” Bayer wrote.
The litigation process that triggered the change in Essure reporting may now be drawing to a close. Bayer has reached agreements in principle to resolve around 99% of the almost 40,000 Essure claims it faces in the U.S. from women who allege device-related injuries. Resolving the claims will cost Bayer around $1.6 billion.
Throughout the process, Bayer has continued to stand behind the safety and efficacy of Essure, pointing to a body of research involving 270,000 women over 20 years to make its case. Even as it reached the planned settlements, Bayer said it continues to “support the safety and efficacy of the Essure device” and is “prepared to vigorously defend it in litigation where no amicable resolution can be achieved.”
The monthly submissions are continuing for now, though. FDA recently posted the spreadsheet for December, marking the start of the third quarter of monthly submissions from Bayer.
This story has been updated to clarify Bayer's position on why it pulled Essure from the market.