- For Immediate Release:
- 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.
These groups that may be at a greater risk for potential harmful health effects include:
- Pregnant women and their developing fetuses;
- Women who are planning to become pregnant;
- Nursing women and their newborns and infants;
- Children, especially those younger than six years of age;
- People with pre-existing neurological disease such as multiple sclerosis, Alzheimer’s disease or Parkinson’s disease
- People with impaired kidney function; and
- People with known heightened sensitivity (allergy) to mercury or other components of dental amalgam.
For over 20 years, the FDA has been reviewing scientific literature, monitoring reports and holding public discussions regarding the public health effects of dental amalgam and amalgam-related mercury vapor. Dental amalgam is a mixture of mercury and a powdered alloy made up of silver, tin and copper. The amalgam releases small amounts of mercury vapor over time. While low-levels of inhaled mercury vapor are generally not harmful to most people, these high-risk individuals may be at increased risk of adverse health outcomes. How much vapor is released can also depend on the age of the filling as well as a person’s habits such as teeth grinding.
These uncertainties in the most vulnerable patients are why today we are recommending people who may be at high risk for adverse health effects of mercury exposure use non-mercury alternatives to dental amalgam, such as composite resins and glass ionomer cement fillings […]