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FDA Advisory Panel Debates Science On Human Adverse Biological Reactions To Metal-Containing Devices

 
• By Sue Darcey and Elizabeth Orr

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.

Film X-ray radiograph show Avascular necrosis (AVN) or Osteonecrosis (ON) disease treated by total hip replacement (THR) surgery. Highlight on prosthesis with free space. Medical technology concept - Image
Metal-on-metal hips have injured patients

At a recent US Food and Drug Administration Immunological Devices Advisory Panel meeting, agency and outside scientists explored the risks of human sensitivities and immunological reactions to implanted metal devices in an effort to better protect patients from any harms caused by the devices.

“Recent issues with metal-on-metal hips and gynecological metal implants have heightened concerns about safety,” Stephen Weber, a medical officer in the FDA device center’s Office of Device Evaluation (ODE), told...

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