An Amalgam Of Opinions Federal Health Agencies Tout The Safety Of A Popular Dental Product

While the U.S. Food and Drug Administration (FDA) and other federal, public health organizations continue to investigate the safety of amalgams used in dental restorations, or fillings, no valid scientific evidence has shown that amalgams cause harm to patients with dental restorations, except in the rare case of allergy.

Dental amalgam (silver filling) is a durable material that has been used to restore the teeth of more than 100 million Americans. It contains a mixture of metals such as silver, copper, and tin, in addition to mercury, which chemically binds these components into a hard, stable substance. Dental amalgam has been studied and reviewed extensively, and has established a record of safety and effectiveness, according to the American Dental Association (ADA).

In 1997, the FDI World Dental Federation and the World Health Organization consensus statement on dental amalgam stated that “no controlled studies have been published demonstrating systemic adverse effects from amalgam restorations.” Aside from rare instances of local side effects of allergic reactions, the report noted, “the small amount of mercury released from amalgam restorations, especially during placement and removal, has not been shown to cause any adverse health effects.”

The ADA’s Council on Scientific Affairs’ 1998 report on its review of the recent scientific literature on amalgam states that, based on available scientific information, amalgam continues to be a safe and effective restorative material. “There currently appears to be no justification for discontinuing the use of dental amalgam.”
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Even earlier, the U.S. Public Health Service (USPHS) issued a report stating there is no health reason not to use amalgam, except in the very rare case of the patient who is allergic to a component of amalgam. This supports the findings of the FDA, the National Institutes of Health Technology Assessment Conference, and the National Institute of Dental and Craniofacial Research that amalgam is a safe and effective restorative material.

According to the FDA’s reaffirmation of the product’s safety last year, “USPHS scientists analyzed about 175 peer-reviewed studies submitted in support of three citizen petitions received by FDA after the 1993 report. They concluded that data in these studies did not support claims that individuals with dental amalgam restorations will experience problems, including neurologic, renal, or developmental effects, except for rare allergic or hypersensitivity reactions.”

In 1993, the USPHS found “no persuasive reason to believe that avoiding amalgams or having them removed will have a beneficial effect on health.” In fact, it is inadvisable to have amalgams removed unnecessarily because it can cause structural damage to healthy teeth.

Still, the agency will continue to gather data about possible risks of dental amalgams and other restorative products and to pursue new methods of dental treatment and oral health. As part of this plan, the USPHS will continue working with the dental profession to bring about changes in the delivery of oral health care based on valid scientific research.

For its part, the ADA publicly supports ongoing research in the development of new materials that it hopes will someday prove to be as safe and effective as dental amalgam. However, the ADA continues to believe that amalgam is a valuable, viable, and safe choice for dental patients and concurs with the findings of the USPHS that amalgam has “continuing value in maintaining oral health.”

Information for this story was provided by the American Dental Association and the U.S. Food and Drug Administration.