The U.S. Food and Drug Administration (FDA) just issued a final regulation classifying dental amalgam, the silver colored dental fillings which contain mercury, and its component partsâ€”elemental <"http://www.yourlawyer.com/practice_areas/toxic_substances">mercury and a powder alloy.
The regulation classifies dental amalgam into Class IIâ€”a moderate risk. By classifying a device into Class II, the FDA can impose special controls, in addition to general controls such as good manufacturing practices that apply to all medical devices regardless of risk, to provide reasonable assurance of the safety and effectiveness of the device. The FDA explained that 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 regulation also reclassifies the mercury component of dental amalgam from Class I, or low risk, to Class II, which is a moderate risk.
The special controls that the FDA is imposing on dental amalgam include, among other controls, recommendations on performance testing, device composition, and labeling statements. More specifically, the FDA recommended that product labeling include:
A warning against dental amalgam use in patients with mercury allergy;
A warning that dental professionals use adequate ventilation when handling dental amalgam; and
A statementâ€”meant to assist dentists and patients in making informed decisions about dental amalgam useâ€”discussing the scientific evidence on the benefits and risk of dental amalgam, including the risks of inhaled mercury vapor.
The FDA explained that dental amalgam is a â€œpre-amendment device,â€ meaning that it was in use prior to May 28, 1976, when the FDA was given broad authority to regulate medical devices. That law required the FDA to issue regulations classifying pre-amendment devices according to their risk into class I, II, or III.
The FDA previously classified the two separate parts of amalgamâ€”elemental mercury and metal powder alloyâ€”but had not issued a separate regulation classifying the combination. In 2002, the agency issued a proposed rule to classify dental amalgam and identify any special controls needed for its safe and effective use.
In 2006, due to a high number of comments on the rule, the FDA held an advisory committee in which dental and neurology experts were invited to review existing scientific data on dental amalgam, especially its toxicity in pregnant women and children. The advisory committee asked the FDA to conduct an even deeper review.
Last year we wrote that the government warned that amalgam may pose a safety concern for pregnant women and young children. The FDA posted the precaution on its Website following the settlement of a lawsuit and was aimed at the two groups, which are urged to limit mercury from seafood over concerns that too much mercury can harm a developing brain. The FDA posting reads that dental amalgams, â€œcontain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses.â€