Bayer Rebuts DeLauro Complaint on Essure Study

Bayer vice president Steven Immergut 12/7 disputed a complaint by Rep. Rosa DeLauro (D-CT) as reported by FDA Webview 12/4 that the company is under-performing on a commitment it made to FDA to study the post-marketing experience with its controversial permanent birth-control device, Essure. DeLauro complained that only one Essure patient had been enrolled so far in the study, but Immergut said in an email that 136 had been enrolled. “Bayer is working closely with the FDA to meet all study requirements and deadlines,” he wrote. “In fact, enrollment started three weeks early, on May 3, 2017, and is currently on schedule. According to FDA’s website, as of October 19, 2017, 136 patients were enrolled at 44 different sites. You can see this update here: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm?t_id=356&c_id=3854.  Bayer provides an interim study report to the FDA every six months, and it is up to the agency to determine when updates to the FDA Web site are made.”