The US Food and Drug Administration (FDA) has issued a new guideline on the use of dental amalgam. The FDA recommends that mercury-containg fillings should no longer be used for patients with neurological diseases such as multiple sclerosis, Alzheimer’s and Parkinson’s, as well as patients with impaired kidney function and women who wish to have children.
Amalgam fillings consist of 50% pure mercury and a powdered alloy of silver, tin and copper and are often misleadingly called “silver fillings” in the USA. Over time, small amounts of mercury vapor are released from the fillings. “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,” said Dr. Jeffrey E. Shuren, FDA Office Director. “Mercury vapor release from fillings can be highest during placement or removal.” The FDA therefore recommends that existing amalgam fillings should not be replaced if they are in good condition, unless medically necessary.
As a precaution, the use of mercury-free alternatives such as composite or glass ionomer cement fillings is recommended in the USA for the following risk group: Children, especially under 6 years of age, pregnant and nursing women, women who wish to have children, patients with neurological diseases such as multiple sclerosis, Alzheimer’s or Parkinson’s disease, patients with impaired kidney function and persons with allergies to mercury or other components of amalgam.
“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, National Counsel of Consumers for Dental Choice and President of the World Alliance of Mercury-Free Dentistry, whose campaign has been crucial for the reconsideration of the FDA’s policy.
In Europe, the use of amalgam fillings has been banned for children up to 15 years of age, pregnant and breastfeeding women since July 1, 2018, and the European Commission recently examined whether amalgam can also be generally dispensed with by 2030. The investigations have shown that a phase-out is both technically and economically feasible, whereupon the Commission has announced a legislative proposal for 2022.
FDA press release:
Announcement from Consumers for Dental Choice
Report of the European Commission to the Council and the Parliament:
