FDA Advisory Committee to Revisit the Safety of Dental Amalgam Fillings

LOVELAND, CO, December 14, 2010

This week, an advisory committee within the U.S. Food And Drug Administration will meet to "discuss and make recommendations on scientific issues raised in petitions received by [the] FDA concerning the final rule on the classification of dental amalgam," according to the FDA website. The final ruling referred to is a decision published in August of 2009 that classified dental amalgam fillings as a class 2 device. A class II designation indicates that the device poses moderate risk to the patient and that general controls in regulating the device are not alone sufficient to assure its safety and effectiveness. The FDA stated last year that, "The levels released by dental amalgam fillings are not high enough to cause harm in patients."

Still, the FDA continues to receive petitions and complaints that state otherwise. In his petition to the FDA in January of 2010, Dr. Richard Edlich states, "Amalgam restorative material generally contains 50% mercury (Hg) in a complex mixture of copper, tin, silver, and zinc. It has been well documented that this mixture continually emits mercury vapor, which is dramatically increased by chewing, eating, brushing, and drinking hot liquids. Mercury has been demonstrated to have damaging effects on the kidney, central nervous system, and cardiovascular system..." Dr. Edlich's petition goes on to cite the mercury in dental amalgam to be a "danger in dental practices" and to have negative environmental and economic impacts on American lives.

In an interview on the NBC Nightly News, Freya Koss told her story of the negative health effects that she suffered because of amalgam fillings. Her symptoms pointed to serious health problems such as lupus or multiple sclerosis. Her facial features gave her a drooped appearance, she suffered from double vision, poor balance, and was generally exhausted all the time. Finally a doctor said that he suspected mercury toxicity, and when her dentist removed all 12 of her amalgam fillings, her symptoms slowly disappeared.

Despite stories like Mrs. Koss', there is still much debate about the validity of claims that amalgam fillings are dangerous. According to the American Dental Association website, the ADA Council on Scientific Affairs said in July 2009 that, "the scientific evidence supports the position that amalgam is a valuable, viable and safe choice for dental patients."

Amidst the controversy, many dentists, particularly cosmetic dentists, have elected to remove amalgam fillings from their offerings. "I agree," said Spokane dentist, Dr. Ken Collins of Spokane Family Dentistry, when asked if he thought it was best to place mercury-free fillings, "It's just not worth the risk, and even when you set aside the mercury issue, the benefits of porcelain or even basic composite fillings over amalgam fillings makes it a no-brainer."

In fact, many cosmetic dentists boast on their websites that they are a "metal-free practice", and haven't placed an amalgam filling in a patient's mouth for years. "I haven't placed an amalgam filling in 8 years. Composite fillings are the best now if you utilize the proper technique. Personally, I don't believe the FDA would approve amalgam today if it were a new product just entering the market," says Denver dentist, Dr. Kevin Berry, who, like Koss' dentist and many other cosmetic dentists worldwide, regularly replaces silver amalgam fillings in his patients.

"It's better to be on the safe side and get rid of them. They are ugly and fracture teeth anyways. The important thing is that when replacing them they are done by a dentist who will take their time placing a well done composite filling or ceramic onlay," says Philadelphia cosmetic dentist, Dr. Kenneth Siegel.

Other dentists argue that dental amalgam is safe and that replacing silver fillings is unnecessary. According to an article by Aetna, Inc, which was reviewed by the faculty of the Columbia University College of Dental Medicine and published on Colgate's website, "You should replace amalgam fillings only when they are worn or broken. There's no evidence that they can cause a problem. Removing them can release more mercury," but then goes on to say, "If you are concerned about amalgam, choose a different material for new fillings."

The FDA advisory committee on dental products meets Tuesday and Thursday of this week (December 15-14, 2010).

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