FDA Advisory Panel Debates Science On Human Adverse Biological Reactions To Metal-Containing Devices
US FDA scientists and immunological experts discussed the latest science regarding patients’ biological reactions to metal implants and mercury in dental amalgam at a 13-14 November agency advisory committee meeting. The get-together was held to determine what additional actions the FDA can take to make sure certain patients are protected from immunological risks of the implants. The panel ultimately backed a transition away from mercury amalgam dental fillings and pushed for more research into risks associated with metal implants.
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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.
Manufacturers have until May 18 to either submit a premarket approval application (PMA) for their metal-on-metal (MoM) hip products or take them off the market, the US Food and Drug Administration announced in a Feb. 18 final order1.
An FDA advisory panel recommended a collection of activities to mitigate risk in the use of Bayer Healthcare’s Essure permanent contraceptive device, but dozens of patients describing hypersensitivity, extreme pain, insert migration, irregular bleeding, ectopic pregnancy and perforation events urged FDA to recall the device.