The U.S. Food and Drug Administration today issued a final regulation classifying dental amalgam and its component parts – elemental mercury and a powder alloy—used in dental fillings. 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 classifies dental amalgam into Class II (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 special controls that the FDA is imposing on dental amalgam are contained in a guidance document that contains, among other things, recommendations on performance testing, device composition, and labeling statements.
Specifically, the FDA recommended that the product labeling 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;
- A statement discussing the scientific evidence on the benefits and risk of dental amalgam, including the risks of inhaled mercury vapor. The statement will help dentists and patients make informed decisions about the use of dental amalgam.
The advocacy groups cite new studies pointing to neurological conditions and even Alzheimer's disease as consequences of some people's dental work. The organizations are asking the FDA's dental-products panel to, at the very least, reclassify the amalgam to bar its use in pregnant women and children. According to the news reports, "groups are also accusing the FDA and the American Dental Association of maintaining too cozy a relationship with the dental products industry."
Interesting reading from newsday, where you can find the article: http://www.newsday.com/long-island/fda-revisits-use-of-mercury-in-tooth-fillings-1.2540068