Bayer has added another 33,097 adverse event reports related to the Essure birth control implant to the information resource it is compiling for FDA.
The company attributed the surge in the number reports, which was up 179% over the prior reporting period, to the presence of fewer source documents than in previous months. With fewer documents, processing times fell and Bayer completed more reports.
Most of the additional reports are based on social media posts made from 2014 to 2016. The number of reports since 2019 is relatively small, at 475, and largely unchanged from the last analysis.
Bayer pulled the birth control implant Essure from the U.S. market in 2018, calling it a business decision and standing behind the device's safety. The company took the action amid reports of pain and other complications potentially linked to the device that led to tens of thousands of lawsuits. As the litigation process exposed Bayer to social media posts related to the safety of Essure, it asked FDA to allow monthly submissions of the reports.
FDA published the ninth monthly report alongside Bayer's third quarterly analysis, which covers the information it shared with the agency in December, January and February. Over those months, Bayer submitted 32,667 serious injury reports, 411 malfunction reports and 19 death reports.
The reports relate to pain, perforation, foreign body or device fragments in patients, heavier periods, pregnancy and pregnancy loss. Most reports relate to potential device removal, which FDA said is consistent with the medical device reports for Essure in 2017.
As Bayer and FDA have said consistently throughout the process, the nature of social media makes it hard to draw conclusions from the reports. Multiple social media posts may describe a single event and, in the words of FDA, "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."
The report shows there was considerable discussion of Essure on social media from 2014 to 2016. For 2015, the current peak of activity, Bayer is aware of 11,484 variance medical device reports. Almost half of the 51 death reports in the dataset were posted on social media in 2015. None of the social media posts about death provided a date for the reported event.
In addition, due to the limited information in the event descriptions for the reports, FDA noted that "it is difficult to identify duplicate reports within the spreadsheet of events, as well as duplicate reports previously submitted" to the agency.