Lawmakers Question FDA on Bayer’s Essure Device

Three members of Congress sent a letter to FDA Commissioner Scott Gottlieb to request a meeting to address the agency’s inaction on numerous reports of adverse events associated with Bayer’s contraceptive device Essure.

The device is “a prime example of systemic medical device oversight shortfalls and insufficient enforcement to ensure the safety and efficacy of medical devices,” wrote Reps. Rosa DeLauro (D-Conn.), Jan Schakowsky (D-Ill.), and Louise Slaughter (D-N.Y.).

They pointed to a 2015 analysis from the Government Accountability Office that showed medical device companies lack incentive to enroll participants in a post-market safety study requested by the FDA, and are slow to report findings.