FDA Warning on this Dental Procedure

The FDA seems to have changed its position on amalgam fillings. Until its statement on September 24 of this year, it had said dental amalgam (mercury) fillings were okay. But on September 24, 2020, it revised that opinion, issuing a statement that mercury/amalgam fillings may adversely affect:

Pregnant women and their developing fetuses,

Women who are planning to become pregnant,

Nursing women and their newborns and infants

People with pre-existing neurological disease such as multiple sclerosis, Alzheimer’s or Parkinson’s diseases

People with impaired kidney function,

People with known hypersensitivity (allergy) to mercury or other components in dental amalgam

The FDA said that “dental amalgam is a mixture of mercury and a powdered alloy made up of silver, tin and copper, that releases small amounts of mercury vapor over time.” The FDA added that there “is the potential for mercury in dental amalgam to convert to other mercury compounds in the body” and that mercury could potentially accumulate in body fluids and tissues resulting in “unintended outcomes”. The FDA added “These uncertainties in the most vulnerable patients are why today we are recommending people who may be at high risk for adverse health effects of mercury exposure use non-mercury alternatives to dental amalgam, such as composite resins and glass lonomer cement fillings.”

We wonder if there are very many people who would not be at “high risk for adverse health effects of mercury exposure”, since just a few years ago when someone at a local high school in the Fargo ND area broke an older fever thermometer that contained mercury, first responders in full hazmat suits were called to find and “contain” the mercury”, and the area was evacuated until it was “contained”.

The FDA also advised against the use of the misleading term “silver fillings” to describe amalgam or mercury fillings, urging all patients to discuss all dental filling options with their dentist. The FDA said that “silver filling” which is actually dental amalgam filling, “is a mixture of metals consisting of liquid (elemental) mercury and a powdered alloy composed of silver, tin, and copper. Approximately half (50%) of dental amalgam is elemental mercury by weight. The chemical properties of elemental mercury allow it to react with and bind together the silver/copper/tin alloy particles to form an amalgam”. It’s estimated that 75% of Americans don’t know that dental amalgam is 50% mercury and that in fact makes the amount of mercury double that of silver in the amalgam despite the ADA promoting amalgam fillings as silver fillings.

The FDA and the American Dental Association have said for years that dental amalgam was safe, but advocates have been calling for a filling material that doesn’t contain mercury since the 1970’s.

And though the FDA has modified its position, the American Dental Association (ADA) has not. Its comment after the FDA released its statement was that the ADA “reaffirms its position that dental amalgam is a durable, safe and effective, cavity-filling option”. It also claimed that “There was no new scientific evidence cited as part of the FDA recommendation”, which makes us wonder if the FDA simply reviewed evidence that’s been there for some time, but until now the FDA had just not seen it as a serious issue, or what? We haven’t been able to find the answer on that question.

But, in what advocates against amalgam fillings took as a good sign from the ADA, the ADA affirmed its support that treatment options should be made by the dentist and the patient. Since the ADA’s ethical rules in the past led state dental boards to bar dentists from even informing patients that mercury is a key ingredient in amalgam & promoted amalgam as “silver fillings” this small change by the ADA is welcomed by advocates as “better than nothing” and a step in the right direction. We agree & are grateful for the FDA’s new position.    

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