F.D.A. Deems Mercury Level in Fillings Safe
Silver dental fillings containing mercury are safe for use by adults and children ages 6 and above, the Food and Drug Administration said Tuesday. Only people who are allergic to mercury should avoid that type of filling, the agency said.
After reviewing more than 200 scientific studies, the agency concluded that mercury vapor released by the filling was not enough to cause brain damage. Still, the agency for the first time classified the fillings as a Class II, or “moderate risk,” medical device.
The move acknowledges the risk for patients and allows the agency to impose tighter safety controls.
The decision is somewhat of a change of heart for the F.D.A., which settled a lawsuit last year with groups opposed to mercury use by posting a warning on its Web site about the filling’s potential risks for fetuses, breast-feeding infants and children younger than 6. The agency said the findings showed that the fillings do not expose those groups to mercury levels considered unsafe by the Environmental Protection Agency, but added that there were few studies on the effects of mercury in fillings on children under 6.
The filling, known in the scientific community as dental amalgam, is a mixture of liquid mercury and a powdered alloy. The mercury and the alloy had previously been classified separately. The mercury component was considered a Class I “low risk.”
“While elemental mercury has been associated with adverse health effects at high exposures, the levels released by dental amalgam fillings are not high enough to cause harm in patients,” the agency said in a statement.
The regulator advised manufacturers to include labels recommending that dentists use adequate ventilation when handling the material for the fillings and discuss the scientific evidence on the benefits and risks of mercury fillings with patients.
Silver dental filling is the least expensive type of filling, used in roughly a third of procedures to replace tooth decay.