FDA Panel Reviews Health Safety of Mercury Amalgam Fillings

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On Tuesday, the dental products panel of the FDA's Medical Devices Advisory Committee began reviewing the science upon which the agency made its most recent determination about mercury safety. Among the witnesses testifying at the meeting were three of the petitioners for restricting dental mercury, as well as three outside researchers asked by the FDA to review levels of mercury exposure from dental amalgams, evaluate the science used to establish daily exposure levels, and discuss the thresholds at which mercury exposure might be harmful.

Among dental mercury opponents was Dr. Richard F. Edlich, a distinguished professor emeritus of plastic surgery, biomedical engineering and emergency medicine at the University of Virginia. He urged the FDA to prohibit the use of mercury amalgam, citing legislative bans enacted in 2008 in Norway and Denmark, and last year in Sweden, as well as six U.S. states' decisions to require dental patients to read about mercury's benefits and risks before undergoing dental restorations.

The city of Costa Mesa, Calif., adopted a resolution in October opposing dental mercury and asked local dentists to voluntarily stop using it.

"In the very least, the Food and Drug Administration should developed informed consent brochures that are used in every dental office in the United States," Edlich said.

Another opponent of continued mercury use in dentistry accused the FDA of "covering up amalgam's mercury from the American people." James S. Turner, a Washington attorney and chairman of a group called Citizens for Health, said, "What keeps amalgam sales going is that most Americans are understandably deceived by the term 'silver fillings,' a grossly misleading marketing term approved by the FDA."

He proposed that by January 2011, the FDA's website should spell out the risks of mercury and mercury vapor; that by March 2011, the FDA should say mercury amalgam is risky for children, young women and people with kidney disease, or at least adopt strict warnings about it; and that by May 2011, the agency should contact every U.S. dentist about the dangers to pregnant women, children and those with kidney disease, and urge the dentists to use alternative materials for tooth restorations.

FDA Invites Outside Experts to Testify

In response to a request from the FDA's Olga Claudio, William Farland, vice president for research at Colorado State University and a former EPA official, recommended that the FDA re-evaluate how well its 2009 mercury rule protects those who might be most sensitive to mercury's effects, such as fetuses and young children.

Farland said the modest increases in mercury levels when fillings are inserted or removed would still fall within exposure levels the EPA considers acceptable, and that this level would still protect the kidneys and immune system. That view was echoed by another outside expert, Robert A. Yokel, a professor at the University of Kentucky's College of Pharmacy and specialist in the neurotoxic effects of metals.

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