Metal Implants and Dental Amalgam: The FDA Announces Public Meeting and Papers

Today, the U.S. Food and Drug Administration (FDA) announced two papers on dental amalgam and metal-containing implants, and a panel meeting as part of ongoing efforts to evaluate materials in medical devices to address potential safety questions.   Metal-Containing Implants Paper Biological Responses to Metal Implants includes a summary of the science of the human body’s local and systemic responses to the most common metals present in implantable medical devices, as well as where gaps and opportunities for further research exist in the current scientific evidence. Dental Amalgam Paper  Epidemiological Evidence on the Adverse Health Effects Reports in Relation to Mercury from Dental Amalgam: Systematic Literature Review evaluates current medical literature related to neurological, cardiovascular, developmental, and other outcomes in populations exposed to dental amalgam. Public Meeting: Immunology Devices Panel of the Medical Devices Advisory Committee The panel meeting will discuss immunological responses to metal-containing products regulated as medical devices, specifically metal-containing implants, as well as dental amalgam.

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