Highlights of the Report
Dental amalgam has been used as a dental restorative material for over 150 years. Amalgam remains popular because it is strong, durable, and relatively inexpensive. Roughly half of the 200 million restorative procedures performed in 1990 utilized amalgam. Nonetheless, amalgam use is declining because the incidence of caries is decreasing and because improved substitute materials are now available for certain applications.
Dental amalgam, an inter-metallic compound, contains elemental mercury that is emitted in minute amounts as vapor. Because vapor emitting from amalgam restorations can be absorbed by the patient through inhalation, ingestion, or other means, concerns have been raised about possible toxicity. At present, there is scant evidence that the health of the vast majority of people with amalgam is compromised, nor that removing amalgam fillings has a beneficial effect on health. It also is recognized that a total conversion from dental amalgam to alternative materials would cause a significant increase in U.S. health care costs. Nonetheless, the possibility that this material, as well as currently available alternatives, could pose health risks cannot be totally ruled out because of the paucity of definitive human studies.
Given the limitations of existing scientific data, a research program should be designed and implemented to fill as many gaps as possible in current knowledge about the potential long-term biological effects of dental amalgam and alternative restorative materials. The PHS should be a leader in this effort.
The PHS should also educate dental personnel and consumers about the risks and benefits of dental amalgam. An educational program should include information on all restorative materials to help dentists and their patients make informed dental treatment decisions, and encourage dental care providers to report adverse reactions. Such a program should promote the use of preventive measures such as fluoride and dental sealants to prevent caries and thus further reduce the need for dental restorations.
To exert greater control over dental amalgam use, the FDA should regulate elemental mercury and dental alloy as a single product. To help dentists identify patients who may exhibit allergic hypersensitivity to all restorative materials, including dental amalgam, FDA should require manufacturers to disclose the ingredients of these materials in product labeling.
Sweden, Denmark, and Germany have proposed restrictions on dental amalgam use. They have done so in an effort to diminish both human exposure to and environmental release of mercury and not because of any documented health effects associated with exposure to dental amalgam.
The U.S. Public Health Service believes it is inappropriate at this time to recommend any restrictions on the use of dental amalgam, for several reasons. First, current scientific evidence does not show that exposure to mercury from amalgam restorations poses a serious health risk in humans, except for an exceedingly small number of allergic reactions. Second, there is insufficient evidence to assure the public that components of alternative restorative materials have fewer potential health effects than dental amalgam, including allergic-type reactions. Third, there are significant efforts underway in the U.S. to reduce the amount of mercury in the environment. And finally, as stated previously, amalgam use is declining due to a lessening of the incidence of dental caries and the increasing use of alternative materials.
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