Critics to panel: ban amalgam dental fillings
Critics to panel: ban amalgam dental fillings
Critics of dental fillings that contain mercury said they should be banned or not implanted unless patients give consent and acknowledge the toxic metal.
During a two-day public meeting to discuss the cavity treatment, dental patients, advocacy groups and some dentists urged the Food and Drug Administration's panel of outside advisers to push the agency to reverse course and initiate stronger warnings, especially for children and pregnant women.
"The agency so far has taken no steps to protect this most vulnerable population," Sylvia Dove, a member of the group Consumers for Dental Choice, told the panel on Wednesday.
Mercury, a known toxin, has been linked to neurological damage at high exposure levels.
The FDA advisory panel is expected to offer its advice later Wednesday (Dec.15,2010) afternoon on how to regulate amalgam fillings after the agency last year declared them safe.
While no new specific new evidence has emerged about the fillings' safety or risks, FDA officials are seeking input on how the agency assessed the data and drew its conclusions after receiving four petitions questioning its 2009 ruling.
The FDA could decide to continue backing the metal fillings, urge more cautious use, or ban the products.
The agency's actions could affect dental filling makers such as Dentsply International Inc and Danaher Corp's Kerr unit, and distributors such as Henry Schein Inc and Patterson Cos Inc.
Metal fillings are used in millions of Americans' teeth to patch decay but are increasing being rejected in favor of bone-colored resin fillings that can cost more, are less durable but more eye-pleasing.
Some experts and advocacy groups told the advisors that there was a clear link between mercury fillings and side effects, especially in more vulnerable patients. But other dentists and trade groups said data shows they pose no harm once set in a patient's tooth.
"Dental amalgam is an appropriate option to offer patients," said Leslie Grant, past president of the National Dental Association, which represents black dentists. Grant added the cost-effective fillings help prevent further tooth decay or loss in poorer people.
Other dentists testified that mercury was too risky and that they no longer use such filings. Dozens of patients also detailed how their health deteriorated after getting amalgams.
Anthony Watson, head of the FDA's division that oversees dental devices, said "FDA and other agencies have tried to tackle the safety of dental amalgam for the better part of the last two decades."
Although FDA earlier said it was not necessarily going to take new regulatory action, Watson told panelists the agency would work with their recommendation: "Obviously everybody in this room wants something to happen quickly and so do we."
In early discussions, advisers raised questions about older scientific methods used to assess just how much mercury a patient is exposed to through their fillings. They also expressed concern that a number of the studies the FDA weighed in making its 2009 ruling were outdated.
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