Statement From: Director- CDRH Offices: Office of the Center Director
Dr. Jeffrey E. Shuren, MD, JD                                          

Part of our role in protecting patients is to regularly evaluate, monitor and update scientific evidence on the risks from medical devices—including issues related to the materials used in devices, such as metals. In the case of implanted and inserted medical devices, where materials may be in contact with the body for extended periods of time, we evaluate safety issues involved with, among other things, the body’s long-term exposure to certain materials, taking into account that sometimes uncertainties remain and more research is needed.
Today, the FDA is issuing updated recommendations concerning dental amalgam and potential risks to certain high-risk individuals that may be associated with these mercury-containing fillings used to restore the missing structure and surfaces of a decayed tooth.
The FDA has found that certain groups may be at greater risk for potential harmful health effects of mercury vapor released from the device. As a result, the agency is recommending certain high-risk groups avoid getting dental amalgam whenever possible and appropriate.

Read FDA Statement Now