FDA Rules Mercury Amalgam Fillings Safe
The U.S. Food and Drug Administration's long-awaited final regulation on the use of mercury amalgam for dental fillings issued Tuesday deems the material safe, while at the same time moving the material from the Class I (low risk) medical-device category to Class II (moderate risk). This allows for tighter control over its manufacture and use. The agency had been working toward the regulation since 2002; many dental professionals were concerned that the final ruling would impose restrictions on amalgam's use.
Mercury amalgam, or "silver," fillings have been used for decades to repair cavities. It's the cheapest filling material available, and the American Dental Association (which supports the new regulation) has long warned that restricting its use would deprive dentists of an important tool and likely move needed dental work beyond the reach of low-income patients. But many people have raised concerns about the potential for mercury to "leak" from fillings into the body and cause neurological damage or diseases such as multiple sclerosis.
An FDA press release announcing the decision reports: "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."
Still, the agency suggests that amalgam package labels feature a warning to patients about the risk of mercury allergy, a reminder to dental professionals about the risk of working with mercury amalgam without proper ventilation, and "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," according to the press release.
Last year the FDA expressed caution about mercury amalgam's use in pregnant women and young children. But the new ruling reverses that stance, saying amalgam is safe for most patients, except those allergic to mercury. The agency reviewed some 200 scientific studies in reaching its decision.
Does this new regulation convince you that mercury amalgam fillings are safe?
Jennifer LaRue Huget
July 29, 2009; 1:00 PM ET
Categories: Environmental Toxins , Family Health , General Health
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