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.
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 Bowing to the dental products industry, FDA has, for the first time in memory, withdrawn a warning about neurological harm to children and the unborn.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."
The agency's latest move follows a lengthy debate on the supposed dangers of these fillings, which was capped by a lawsuit filed in 2006 against the FDA by several consumer groups, including Moms Against Mercury and Consumers for Dental Choice.
As part of that settlement, the FDA agreed to classify mercury fillings, also known as dental amalgam, by July 28, 2009, and posted a notice on its Web site that said: "Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses."
The American Dental Association (ADA), one of the organizations that had expected a Class II classification, supported the FDA action.
"The FDA has left the decision about dental treatment right where it needs to be -- between the dentist and the patient," the ADA's president, Dr. John Findley, said in a prepared statement. "This decision underscores what the ADA has long supported -- a discussion between dentists and patients about the full range of treatment options to help patients make educated decisions regarding their dental care."