The QMN Weekly Bulletin
Medical Devices / Postmarket Safety

Lawmakers Question FDA on Bayer’s Essure Device

Nov. 3, 2017
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Three members of Congress sent a letter to FDA Commissioner Scott Gottlieb to request a meeting to address the agency’s inaction on the 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. 

“The Bayer post-market study on Essure has held true to those GAO findings,” they said, adding that Bayer planned to enroll 78 patients per month but the FDA website indicates there is currently only one patient enrolled in the study.

The FDA’s database lists thousands of adverse events reports for Essure, some of which describe device migration and unplanned pregnancies.

The letter lists several questions the congress members hope to ask Gottlieb if their request for a meeting is granted, including: What is the FDA doing to ensure Bayer complies with the timeline for recruiting patients outline in the study plan?

The representatives also want a broad discussion about post-market surveillance on Class III devices in general.

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