FDA has released the first batch of social media adverse event reports related to the Essure permanent birth control implant.
The spreadsheet includes details of 53 deaths and 1,376 reports of serious injuries. However, FDA is unsure if some of the reports describe the same event, or if it has previously received information about the events from other sources.
Bayer stopped marketing Essure in the U.S. at the end of 2018 following thousands of reports of complications linked to the contraceptive implant. However, the problems associated with the device continue to dog the company. As of February, Bayer had been served with lawsuits covering 33,100 users of Essure and expected additional legal actions.
The litigation led Bayer to request a change to the reporting requirements for Essure. FDA accepted the request in April, clearing the company to collate certain adverse events into spreadsheets that it will file with the agency every month. The spreadsheets are to contain social media posts that Bayer becomes aware of in connection with the litigation.
FDA released the first of the spreadsheets submitted by Bayer this week. The spreadsheet contains 1,453 reportable events, including 53 deaths and 24 malfunction reports. FDA said the reports do not necessarily describe unique events. Rather, the reports could be different social media posts on the same event. That is one of several factors that is complicating efforts to interpret the data.
“Based on the limited information in the event descriptions for the reports and the nature of the information, it is difficult to identify duplicate reports within the spreadsheet of events, as well as duplicate reports previously submitted to the FDA. The limited information prevents the ability to draw any conclusions as to whether the device, or its removal, caused or contributed to any of the reported deaths or other events in the reports,” FDA wrote.
Details of deaths were posted on social media between 2013 and 2019 but FDA is unsure when the events happened. It is possible deaths discussed on social media in 2019 happened years earlier. The broad takeaways from the spreadsheet are consistent with other sources of adverse event data, with 80% of the reports describing potential device removal.
Nonetheless, Bayer in a written statement said it "continues to stand behind the product’s safety and efficacy, which are demonstrated by an extensive body of research, undertaken by Bayer and independent medical researchers, involving more than 270,000 women over the past two decades."
The spreadsheet will be the first of many. The April agreement between Bayer and FDA changed the reporting requirements for Essure for at least 12 months. The agency plans to continue making spreadsheets it receives every month from Bayer available. Bayer will also share a quarterly analysis of the data, as required under the terms of its agreement with FDA.
Bayer said in its statement that the first quarterly analysis of the data will be submitted to FDA on October 1 and to draw conclusions from the raw data in monthly reports would be premature and potentially misleading.
This story has been updated with comments from Bayer.