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Wednesday, July 29, 2009
FDA 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. Only people who are allergic to mercury should avoid that type of filling.
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 classified the fillings as a Class II or moderate risk medical device.
A Class II label allows the FDA to impose special controls to provide reasonable assurance of the safety and effectiveness of the device.
The special controls include: a warning against the use of dental amalgam in patients with mercury allergy; a warning that dental professionals use adequate ventilation when handling dental amalgam; and a statement discussing the scientific evidence on the benefits and risk of dental amalgam, including the risks of inhaled mercury vapor.
The FDA has previously warned on its web site about the filling’s potential risks for fetuses, breast-feeding infants and children younger than 6. 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, scientifically known as a 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 or low risk device.
Silver dental filling is the least expensive type of filling, used in roughly a third of procedures to replace tooth decay.
For more information please see: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm173992.htm
Labels: cavity, dental, dental amalgam, Dentist, FDA, filling, mercury
posted by
Jessica
at
12:57 PM
