The FDA is investigating whether side effects of mercury dental fillings, commonly referred to as amalgams, could potentially pose a risk to human health.
A two-day meeting of the FDA Dental Products Panel (pdf) began on Tuesday in Maryland. The advisory panel was convened following increasing pressure from a number of organizations who say that the mercury in the commonly-used fillings may cause a number of health problems, including neurological damage and Alzheimer’s disease.
The hearing comes about 18 months after the FDA declared amalgams safe in March 2009. However, critics of their use are pointing to a number of recent studies that suggest the FDA may have erred in its decision. Several petitions have been filed for the FDA to reevaluate the safety of mercury dental fillings. While the advisory committee’s recommendations are not binding, the FDA usually follows their panels’ advice.
Amalgams have been in use for about 150 years in the dental industry. They contain about 50 percent liquid mercury, as well as powdered copper, tin and silver. The FDA estimates that more than 50 million amalgam restorations are implanted annually in U.S., but their use is on the decline.
Professional dental organizations, such as the American Dental Association (ADA), defend their use, saying that they have proven to be safe and effective. The ADA recently stated that there is no scientific reason for FDA to reconsider whether mercury in fillings is safe. However, amalgams have been banned in Denmark, Sweden and Norway, and their use is restricted in Canada, Germany, France and Italy.
Petitions calling amalgams dangerous have been filed by James Love, counsel for the International Academy of Oral Medicine and Toxicology; Citizens for Health Contraindications; the city of Costa Mesa, California, and others.
The petition from Citizens for Health Contraindications (pdf) says that the FDA’s 2009 ruling robs dental patients of informed consent by burying potential amalgam health risks deep in the agency’s website where no one is likely to look. The petition also blasts the agency for repeatedly calling on dentists to make the decision as to what type of filling to use instead of informing the patient and allowing the patient to decide.
An entire list of documents to be reviewed by the panel is available on the FDA’s website.
Some suggest that officials in the FDA are too closely connected to the dental industry. FDA Commissioner Margaret Hamburg is a former official with Henry Schein, Inc., a dental amalgam company, and did not divest her stock in the company until the day before FDA’s 2009 dental amalgam final rule was announced.