The FDA is slated to hold an advisory panel meeting to discuss immunology concerns about metal implants and dental alloys.
The Immunology Devices Panel meeting of the Medical Devices Advisory Committee is scheduled for Nov. 13-14 of this year to discuss the use of the materials and assess the adequacy of current approaches and standards for biocompatibility, the federal safety watchdog said.
Last March, the FDA said it was evaluating evidence that suggested patients receiving medical device implants may have biological responses to certain types of materials in the implants, including inflammatory reactions and tissue changes causing pain and fatigue.
The agency plans to continue evaluating patients who may be at risk of experiencing a hypersensitivity response with metal-containing implants and try to determine any potential issues before the implant is received.
The FDA posted two self-authored scientific reviews, with one summarizing the current scientific knowledge surrounding the metal implants in question and the other sharing the latest data on the risks associated with dental amalgam.
“The FDA continues to believe that the benefits of metal or metal alloys in medical device implants outweigh the risks for most patients,” the FDA said. “However, we recognize that it is critical to closely monitor and evaluate new data as science is always evolving. We continue to explore ways to modernize the FDA’s review of medical device materials in an effort to support safety and innovation in medical devices that can significantly improve patient health and quality of life while working to minimize the potential for patient risk. As we move forward, we’ll continue to gather input from patients, device manufacturers, researchers and physicians to learn more about their experiences, ideas, and feedback related to materials in medical devices. We’re committed to advancing new initiatives that are rooted in sound science with a focus on ensuring patient safety remains at the forefront.”