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.
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Clock’s Ticking: FDA Says It’s Almost Time For Health-Care Professionals To Return Essure Devices To Bayer
The US agency is reminding health-care professionals to return all Essure birth-control devices to its maker, Bayer AG, by 31 December. Although the company stopped selling Essure in the US in December 2018, professionals were allowed to continue implanting the problematic devices through the end of 2019. Meanwhile, the FDA updated its Sec. 522 postmarket surveillance study webpage for Essure.
The US FDA has released a new batch of information from its ongoing postmarket surveillance of Bayer’s Essure birth control device. Last year saw the number of Medical Device Reports filed about the device revert to historic norms, while more progress was made in shaping the ongoing Sec. 522 postmarket study.
A US House representative and two co-sponsors have reintroduced the Medical Device Safety Act, which would remove the defense against state product liability suits for premarket-approved devices from the Federal Food, Drug, and Cosmetic Act (FDCA).