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FDA Orders Bayer To Extend Essure Post-Market Study

With increased pressure on US FDA surrounding its approach to safety and growing concerns with Bayer's Essure birth control device, the agency is now requiring the manufacturer to extend a mandated post-market study of women who have been implanted with the product, among other requirements.

Bayer Pharma AG, Administration and laboratory buildings of Bayer HealthCare Pharmaceuticals in Berlin-Wedding on June 14, 2017, Germany - Image

US FDA is requiring Bayer AG to follow the medical condition of women implanted with its Essure permanent birth control device for five years instead of three years. The decision comes on the heels of a number of high-profile reports and a documentary spotlighting the safety concerns with the device and FDA's oversight role.

On Dec. 20, FDA Commissioner Scott Gottlieb said that on top of all the requirements the agency has put...

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