Health Blog

FDA Issues Warning Concerning Dental Amalgam

Nov 7 • 3 minute read

 An Important Announcement By the FDA

 

An important announcement was made by the FDA made on September 24, 2020:

 

“Today, the FDA is issuing updated recommendations concerning dental amalgam and potential risks to certain high-risk individuals that may be associated with these mercury-containing fillings …    The FDA has found that certain groups may be at greater risk for potential harmful health effects of mercury vapor released from the device [amalgam]. As a result, the agency is recommending certain high-risk groups avoid getting dental amalgam whenever possible and appropriate."

 

“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 ionomer cement fillings,”

 

The FDA specifically advises dentists against using the term “silver filling,” “as this may imply the filling is made solely from silver and does not accurately convey the mercury component of this restorative material.” The FDA also highlights this in its Dental Devices description page for amalgam, which received its last update September 29, 2020, noting that:

Dental amalgam 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.

Dental amalgam fillings are often referred to as ‘silver fillings’ because of their silver-like appearance, although the use of this term in not recommended because the term does not correctly explain the materials in amalgam.”

The FDA also recognized bioaccumulative effects of mercury. Since patients are exposed to many sources of mercury — including high-mercury fish in their diets, occupational exposures and environmental mercury from waste incinerators — the mercury from amalgam could be the proverbial straw that breaks the camel's back.

These high risk groups include:

  1. Pregnant women and their developing fetuses
  2. Women who are planning to become pregnant
  3. Nursing women and their newborns and infants
  4. Children, especially those younger than 6
  5. People with pre-existing neurological disease such as multiple sclerosis, Alzheimer’s disease or Parkinson’s disease
  6. People with impaired kidney function
  7. People with known heightened sensitivity (allergy) to mercury or other components of dental amalgam

While these are the only high risk groups mentioned, it makes sense that all people avoid all exposures to mercury all the time.

The first sign of progress came with the FDA's September 2019 scientific review of amalgam, “Epidemiological Evidence on the Adverse Health Effects Reported in Relation to Mercury from Dental Amalgam,” which recognized that the elemental mercury in dental amalgam can convert inside the body into toxic methylmercury — the same type of mercury that the FDA warns about in fish.

FDA was also made aware of the changes to amalgam rules in other parts of the world, such as amalgam phase-out dates set by the Philippines, Ireland, Slovakia, Finland, Nepal, Moldova, Czech Republic and New Caledonia, and the bans on amalgam use in children issued by the European Union, Vietnam and Tanzania.

A scientific advisory committee meeting — which included testimonies by 16 experts from the Children's Environmental Health Network, Tuskegee University, the International Indian Treaty Council, the Organic & Natural Health Association and the Connecticut Coalition for Environmental Justice, as well as city and county commissioners, a physician expert in environmental justice, a pharmacist specializing in toxicology and several attorneys — took place in November 2019.  Ultimately, the FDA advisory committee members recommended the agency provide information to patients about the risks of dental amalgam, especially for vulnerable populations. Many even agreed that the use of amalgam needs to end.

In response to the FDA’s updated recommendations, the ADA stated that there was “no new scientific evidence cited as part of the FDA recommendation," and that the ADA “reaffirms its position that dental amalgam is a durable, safe and effective cavity-filling option.” The ADA affirmed its support of patient decision-making, agreeing with the FDA’s statement that “all dental restorative decisions and treatment options should be made by the patient and the dentist.”

 


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