FDA Investigates Implantable Devices That Contain Metals

The FDA is launching an investigation to better understand adverse events that may be associated with metal-containing implantable devices and dental amalgam.

To learn more about how patients respond to materials used in devices, the agency is engaging the public and industry stakeholders to determine the current state of the science, critical gaps in the existing science, and what approaches the FDA should consider.

“Based on our evaluation, we believe the current evidence, although limited, suggests some individuals may be predisposed to develop a local or systemic immune or inflammatory reaction when exposed to certain metals contained in select implantable devices,” the FDA said.