July 29, 2009
FDA Concludes Mercury Fillings Are Not Harmful
The amount of mercury found in the silver-colored dental amalgam fillings is not at a level high enough to harm patients, according to a statement by the FDA, which issued its final regulation on the controversial tooth filling material Tuesday.
"While elemental mercury has been associated with adverse health effects at high exposures, the levels released by dental amalgam fillings are not high enough to cause harm in patients," the FDA said, citing an agency review of about 200 scientific studies.
During the final regulations, the FDA is now classifying the encapsulated amalgams commonly sold to dentists as Class II devices, which is considered a moderate risk as opposed to the lower risk Class I devices.
Dental amalgams include liquid mercury and a powder containing silver, tin, copper, zinc, and other metals. According to the FDA, when the fillings are placed in the teeth or removed, or during chewing, mercury vapor is released. At high levels, mercury can cause damage to the brain and kidneys.
Such fillings can be found patching cavities in the mouths of millions of Americans and the FDA said it does not recommend patients have them removed.
The decision by the FDA was a bit of a turnaround considering just last year it settled a lawsuit with anti-mercury activists who sought to have mercury banned from the U.S. market. At that time, an FDA panel of outside experts said most people would not be harmed but that more information was needed about whether the small amount of mercury vapor the fillings can release is enough to harm the developing brains of fetuses or the very young.
Mercury has spurred an undeniably intense controversy between dental, vaccines, fish, or other products. Some consumer groups argue that the fillings can rouse a host of health problems such as multiple sclerosis and Alzheimer's disease.
The issue is in part due to the fact that so little is known about "what is happening at low-level exposure over a lifetime,", according to Urvashi Rangan, the director of technical policy for Consumer Reports, whose group was not part of the initial lawsuit.
"The best available scientific evidence supports the conclusion that patients with dental amalgam fillings are not at risk for mercury-associated adverse health effects," said Dr. Susan Runner, FDA's dental products director.
She added that in the past 20 years, there have only been 141 problems reported in patients with the fillings.
But that conclusion is at odds with one that the agency made last June, which said that the fillings very well may cause health problems for pregnant women, children and fetuses.
Tuesday's ruling supersedes the precaution from last year's lawsuit settlement, Runner said.
The American Dental Association (ADA) says that about 30 percent of fillings given to patients are mercury-filled now that more patients are opting for the more natural and ascetically appealing tooth-colored options such as resin composites.
However, there are some conditions that make amalgams a necessity, such as spots on back teeth that won't stay dry long enough for composite fillings to bond.
Other options include glass cement and porcelain as well as other metals such as gold, but at a higher price with less durability.
The ADA supported the FDA's decision not to ban mercury fillings, saying alternatives are also considered "moderate risk" by the FDA.
"The FDA has left the decision about dental treatment right where it needs to be -- between the dentist and the patient," ADA President Dr. John Findley said in a statement.
"Most consumers, and most dentists, have already switched to the main alternative, resin composite," said Brown, whose group was involved in the lawsuit settlement last June that called on the agency to issue more specific rules. He said his group is now considering its legal options.
Amy Carson, president of Moms Against Mercury, said she was disappointed in the FDA's reversal. Her group joined several others in filing a new petition with the FDA again to remove mercury fillings from the market.
On the Net: