People with multiple sclerosis (MS) are among the high-risk groups advised to avoid dental amalgams — silver-colored fillings that are 50% mercury — under new recommendations issued by the U.S. Food and Drug Administration (FDA).
Amalgams can be used by dentists to restore the structure and surfaces of teeth damaged by decay.
“The FDA has found that certain groups may be at greater risk for potential harmful health effects of mercury vapor released from the device. As a result, the agency is recommending certain high-risk groups avoid getting dental amalgam whenever possible and appropriate,” it stated in the guidance.
Half of the dental amalgam is made of pure mercury, along with a powdered alloy of silver, tin and copper. Over time, small amounts of mercury vapor are released from the fillings.
Although not seen as generally harmful, these vapors can present a health risk for select individuals, including those with neurological diseases such as MS, Alzheimer’s or Parkinson’s, the FDA stated in its release.
“While small inhaled amounts are generally not harmful to most people, this can pose an increased health risk to susceptible individuals. How much vapor is released may depend on the age of the filling and habits such as teeth grinding,” Jeffrey E. Shuren, MD, director of the agency’s Center for Devices and Radiological Health, said in a press release issued by the European Center for Environmental Medicine.
“Mercury vapor release from fillings can be highest during placement or removal,” Shuren added. The release noted that amalgams are “misleadingly” called silver fillings in the U.S.
Instead, the FDA recommends that dentists use mercury-free alternatives, such as composite or glass ionomer cement fillings, with these patients, and with children (especially those under age 6), women who are pregnant or planning a pregnancy, nursing mothers, people with poor kidney function, and those allergic to mercury or other components of dental amalgam.
The agency also advises against removing or replacing mercury-containing amalgam fillings if they are in good condition, unless if deemed clinically necessary.
“The FDA’s measures have the potential to protect millions upon millions of Americans from mercury in the mouth. But it is now important to ensure that the recommendations are implemented,” said Charlie Brown with the National Counsel of Consumers for Dental Choice and president of the World Alliance of Mercury-Free Dentistry.
Brown has campaigned for an FDA revision of its policy concerning dental amalgam. Guidelines issued by the agency in 2009 moved amalgam fillings into a higher risk category (a class II device), but did not take a position against their use.
The new recommendations follow FDA discussions with healthcare professionals, and evaluations of published research and public comments on dental amalgam and other metal-containing implants.
“While the available evidence suggests that dental amalgam use has generally declined over recent years, due to more alternative products being offered and used effectively for dental restorations, high-risk individuals, as noted in our recommendations, should discuss alternative products for restoring teeth with their dentist,” the FDA stated.
According to the European Center for Environmental Medicine, the use of such amalgam fillings has been banned in Europe for pregnant and breastfeeding women, as well as children under age 15, since July 1, 2018. The European Commission is considering legislation to largely stop amalgam use by 2030.
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