The FDA has received a glut of safety reports related to Bayer’s birth control device Essure. Attorneys involved in legal cases against Bayer provided the information to the agency, which is now evaluating the reports.
FDA Commissioner Scott Gottlieb, M.D. said the agency received 12,000 reports related to Essure last year. More than 90% of the reports covered issues related to potential device removal. But some of the reports lack information about whether the patient ultimately had the device removed. The FDA is working to better understand the drivers of device removal as part of its review of the reports.
That means the FDA has a sizable job on its hands. Gottlieb thinks the agency will need to follow up on the reports to gather extra information regarding removal.
In sifting through the material, the FDA will also assess whether it has already learnt of the cases reported by attorneys through other channels. Bayer thinks the surge in reports from attorneys gives a false impression of Essure’s safety signals.
“The number of Essure medical device reports that are not related to the litigation is declining, while litigation-related medical device reports are dramatically increasing,” Bayer spokesperson Courtney Mallon told Reuters.
Gottlieb reiterated that the FDA thinks the use of Essure remains appropriate for some women. But he also sought to present the agency as an organization that values the input of patients and will adapt its stance to evolving evidence. Some of the FDA’s peers, such as the British regulator, have been slammed by the public and politicians in the recent past over their responses to patient reports of adverse events.