From Our 2010 Archives
FDA Reconsidering Safety of Dental Amalgams
Opponents Say Mercury in the Fillings Harm Health; Dentists Disagree
By Matt McMillen
Reviewed by Louise Chang, MD
Dec. 14, 2010 -- An FDA panel met today to begin hearing testimony regarding the agency's position that dental fillings that contain mercury pose no danger to the public.
In 2009, the FDA declared the fillings, known as dental amalgams, safe. However, they have since received several petitions criticizing that decision.
Of particular concern to the petitioners, who represented both consumers and dentists, was the quality of the data that the FDA used in making its decision, as well as the levels below which mercury absorption could be considered safe. They were also critical of the lack of data regarding the risks that the amalgams may pose to pregnant women and their unborn children, breastfed infants, and children 6 years old and younger.
"We need to have an intense look at whether or not we can even establish safety," said James Turner, an attorney speaking on behalf of Citizens for Health, an advocacy group based in Washington, D.C.
Turner and his group would like to see dental amalgams reclassified as category III medical devices, which would effectively ban them from the market until approved by the FDA after being deemed both safe and effective.
Many of those who spoke during the public hearing portion of today's proceedings shared his view.
"Why is this poisonous element being drilled into the mouths of pregnant women and children?" asked Amanda Just of Waterford, Conn., who told the panel that the 13 dental amalgams she once had in her mouth had made her severely ill due to mercury toxicity. "It's a form of poison that nearly destroyed my life."
On the other side of the issue were several dentists who support the continued use of dental amalgams, telling the panel that they are safe, that they last longer and require less maintenance than alternative fillings, and that they would not hesitate to use them for themselves or for family members.
"I have silver fillings [dental amalgams containing mercury] in my mouth, and I am completely comfortable with that," said Carlisle, Pa., dentist William Spruill, DDS, who held that restrictions on dental amalgams would place an unnecessary burden on people seeking care.
Tomorrow morning, the panel will reconvene for another round of public hearings before deliberating what constitutes a safe level of mercury absorption, how best to measure it, and what can be concluded from existing studies about the potential risks posed by exposure to mercury contained in the fillings.
SOURCES: Dental Products Panel, Medical Devices Advisory Committee Meeting, December 14, 2010, Gaithersburg, Md.FDA: "What does it mean for FDA to "classify" a medical device?"