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FDA Calls for Stricter Controls on Mercury Fillings
But notes dental devices pose no great risk to most people; consumer organization aghast at ruling
By Amanda Gardner
HealthDay Reporter
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TUESDAY, July 28 (HealthDay News) -- U.S. health authorities on Tuesday placed tighter safety controls on the use of mercury dental fillings.
The U.S. Food and Drug Administration will now categorize the fillings as Class II devices, which puts them into the middle range of risk. Class II devices usually carry some kind of precautions regarding their use.
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But U.S. health officials noted that the fillings pose no real harm to most people.
"Patients are not at risk for long-term, mercury-related adverse health events," Dr. Susan Runner, acting director of the Division of Anesthesiology, General Hospital, Infection Control and Dental Devices, part of the U.S. Food and Drug Administration's Center for Devices and Radiological Health, said during a news conference Tuesday afternoon. "There have only been 141 adverse event reports over 20 years. None resulted in death."
The agency did recommend the following labeling changes: a warning against the use of these fillings in patients with mercury allergy; a warning that dental professionals use adequate ventilation when handling the material for the fillings; and a statement discussing the scientific evidence on the benefits and risks of dental amalgam.
"We're not contraindicating dental amalgam in any patient group [other than those who have allergies]," Runner noted during the news conference.
The new ruling brought an angry reaction from the consumer organization Consumers for Dental Choice.
"I'm outraged. FDA broke its word," said Charles Brown, the group's national counsel. "They put a warning a year ago on the web site and promised to keep those warnings on the web site that warned of neurological damage to children and unborn children. Bowing to the dental products industry, FDA has, for the first time in memory, withdrawn a warning about neurological harm to children and the unborn. It's a contemptuous attitude toward lower income and minority children because they're the ones that get amalgam. The rich get resin."
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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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