How the FDA’s New Recommendations for Dental Amalgam Affect Your Practice

Charles G. Brown, Esq.

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The US Food and Drug Administration (FDA) issued new safety reccomendations for dental amalgam on September 24, 2020. With cautions against amalgam use in several significant populations, an informational brochure for patients, and an admonition to stop marketing amalgam as “silver fillings,” these updates will have an impact on every dental practice still using amalgam in the United States today.

So let’s break down the FDA’s recommendations to see how they will affect your dental practice.

Vulnerable Populations

The FDA recommends that dentists use non-mercury filling materials in people who are at higher risk from the adverse effects of mercury exposure. It advises against amalgam use in these high-risk populations, including:

  • Pregnant women and their developing babies
  • Women who are planning to become pregnant
  • Nursing women and their newborns and infants
  • Children, especially those younger than six years of age
  • People with pre-existing neurological disease, such as multiple sclerosis, Alzheimer’s disease, and Parkinson’s disease
  • People with impaired kidney function
  • People with known heightened sensitivity (like an allergy) to mercury or other components of dental amalgam (such as silver, copper, or tin)

This list encompasses a significant part of the American population. For instance, 22% are children under 18 years of age, 15% are adults with chronic kidney disease.

People in these high-risk groups are often unaware of their conditions. According to the Centers for Disease Control and Prevention, 48% of people with severely reduced kidney function and who are not on dialysis are not aware that they have chronic kidney disease. Also, women on average are unaware that they are pregnant until five and a half weeks of gestation, although some do not find out until seven weeks or later.   

As such, dentists need to keep in mind that people in the high-risk populations listed by the FDA aren’t always identifiable with a patient questionnaire. But dentists nonetheless have a duty to protect these patients from unnecessary risks from amalgam.

Communicate Amalgam’s Risks

The FDA does more than recommend against the use of amalgam in vulnerable populations. It also urges dentists to tell patients about amalgam’s risks:

“Review the above Recommendations for Patients and Caregivers About the Use of Dental Amalgam and discuss the risks and benefits of using dental amalgam and other restorative materials with your patients to allow them to make informed choices regarding their treatment options. We encourage you to share the FDA’s informational brochure with your patients prior to any consent to treatment,” the FDA said.

In its informational brochure, the FDA explains important facts that all patients need to know before a dentist can claim to have obtained truly informed consent before placing amalgam.  For example:

  • “Dental amalgam is approximately half (50%) mercury, by weight… Dental amalgam fillings may release small amounts of mercury in the form of a vapor (gas), depending on the number and age of existing fillings, and actions such as tooth grinding and gum chewing.”
  • “inhaling (breathing in) mercury vapors may be harmful in certain patients… Certain people, including women who are pregnant or who are planning to become pregnant, nursing mothers, children (especially those under the age of six), people with a known allergy to mercury, and people with neurological impairment or kidney dysfunction, may be more susceptible to the effects of exposure to mercury from dental amalgam and may be at greater risk for adverse health effects.”
  • “As such, if you are a person who is in one of the high-risk populations identified and need a new filling, the FDA recommends you avoid dental amalgam if possible and appropriate. Talk to your dental provider about your health history and other available treatment options for fillings.”

Dentists have a duty to obtain informed consent before placing any amalgam filling, and that cannot be obtained without sharing the information in the FDA’s recommendations with patients.

Stop Saying “Silver Fillings”

The FDA’s recommendations also advise dentists not to use the term “silver fillings”:

“When discussing dental amalgam, avoid 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.”

Marketing a mercury-added product as a “silver filling” not only confuses patients, but it also can put other people at risk. Amalgam fillings and teeth with amalgam fillings can fall out or be lost outside of the dental office, leaving patients and others to dispose of them.

In one recent (albeit rare) instance, a man tried to melt down amalgam fillings he had obtained from his dentist grandfather to produce silver to sell. The emitted mercury landed him in the hospital and resulted in his apartment building being declared uninhabitable. The man had not realized that those “silver fillings” contained mercury.

Steps Dentists Should Take

Health professionals who ignore FDA safety sommunications that affect their profession do so at their legal peril. Here are four steps your dental practice should take to comply with FDA’s recommendations.

First, use mercury-free fillings. The FDA is now recommending against amalgam use in high-risk populations, so it is best to follow its recommendation as the standard of care and use mercury-free fillings for these patients.

And since these high-risk populations include such a significant number of patients—all children, most women of childbearing age, and the many people with both diagnosed and undiagnosed kidney impairments and neurological disease—the time has come to consider not using any amalgam in your dental practice.

After all, entire countries banning amalgam use or have announced an amalgam phase-out. Also, almost half of American dentists have already stopped using amalgam altogether in favor of the many mercury-free alternatives available today.1-3       

Second, if you persist in using amalgam, your patient health questionnaire must be substantially expanded. Young women need to be asked not only if they are pregnant or nursing but also if they plan to become pregnant. For dentists uncomfortable asking or patients uncomfortable answering, then the safe bet is no amalgam for young women.

Patients need to be asked if they have or suspect they have kidney disease. Patients need to be asked if they have a neurological disease or condition, perhaps specifying the more common ones on the questionnaire. For children, there is no need to ask the parent or guardian anything. Children should not receive amalgam.

Third, provide the FDA’s informational brochure to patients. Information for Patients About Dental Amalgam Fillings is available online, where you can print it to distribute to patients before amalgam placement to ensure that they are prepared to give truly informed consent. Some states such as California, Connecticut, Maine, and New Hampshire as well as the city of Philadelphia also legally require dentists to provide patients their own amalgam fact sheets.

Finally, update your marketing materials to eliminate the term “silver filling.” The FDA has explained how confusing the inaccurate term “silver fillings” can be to dental patients, so make sure to review your websites, your consent forms, and your own talking points with patients to eliminate this expression as well as similarly confusing variants like “silver amalgam,” “silver star,” and “silver-colored filling.”

The bottom line? Dentists ought to start planning an exit strategy away from the use of amalgam.

References

  1. US Environmental Protection Agency (EPA). Health Services Industry Detailed Study: Dental Amalgam. US EPA; August 2008:3-1.
  2. Haj-Ali R, Walker MP, Williams K. Survey of general dentists regarding posterior restorations, selection criteria, and associated clinical problems. Gen Dent. 2005;53:369-375.
  3. American Dental Association (ADA). 2007 Survey of Current Issues in Dentistry: Surgical Dental Implants, Amalgam Restoration, and Sedation. ADA; September 2008:9.

Mr. Brown is executive director of Consumers for Dental Choice. A twice-elected former state attorney general and author, he has represented dentists before dental boards in 14 states.

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