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FDA Calls for Stricter Controls on Mercury Fillings


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Fleming emphasized that he was not speaking on behalf of the FDA.

The panel, which met in 2006 to review the issue, did not find that amalgam was unsafe. "We said you can't make a determination of safety based on the documents the FDA produced," Fleming said.

"The ADA has not come out and said it is unsafe in pregnant women and children, but that we need more information," Hewlett added.

Text Continues Below



Fleming said before the ruling that he expected the FDA to incorporate the committee's recommendations, which included making sure that patients be informed of the mercury content of the product and beefing up precautions for pregnant women and women of child-bearing age.

But Runner said the FDA found that "...concentrations of mercury in breast milk is an order of magnitude lower than EPA protective dose. FDA does not believe that maternal dental amalgam fillings put infants at risk."

Dental amalgam contains elemental mercury combined with other metals such as silver, copper, tin and zinc. The fillings, about 50 percent mercury, have been used for generations to stabilize decaying teeth. Dental experts contend that when mercury is bound to the other metals it's encapsulated and doesn't pose a health risk. Consumer groups, however, contend that mercury, a known neurotoxin, does leak out in the form of mercury vapor and then gets into the bloodstream.

However, Runner said Tuesday that "exposure to mercury vapor from dental amalgam do not put individuals age 6 and older at risk."

According to the ADA, the use of amalgam is declining. In 1990, dental amalgams made up 67.6 percent of all dental restorations, but by 1999 it was 45.3 percent and, in 2003, an estimated 30 percent. Cavities that previously would have been treated with dental amalgam are now mostly filled with a resin composite.

Several countries have already either banned or advised against the use of mercury fillings.

More information

The U.S. Centers for Disease Control and Prevention has more on amalgam fillings.

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Copyright © 2009 ScoutNews, LLC. All rights reserved.
Last updated 7/28/2009

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SOURCES: July 28, 2009, news conference with Susan Runner, acting director of the division of anesthesiology, General Hospital, Infection Control and Dental Devices, Center for Devices and Radiological Health,U.S. Food and Drug Administration; Charles Brown, national counsel, Consumers for Dental Choice; Michael Fleming, DDS, member, FDA Dental Products Panel, and dentist, Durham, N.C.; Edmond Hewlett, DDS, consumer advisor, American Dental Association, and associate professor, UCLA School of Dentistry; July 28, 2009, prepared statement, American Dental Association


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