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ADA: Dental amalgam is safe and reliable

Association offers comments for Nov. 13-14 FDA hearing

November 18, 2019

By Jennifer Garvin

Spiro and Seymour
Expert testimony: Dr. Brittany Seymour and Spiro Megremis, Ph.D., following testimony at the FDA Medical Devices Advisory Committee’s Immunology Devices Panel.
Gaithersburg, Md. — “Dental amalgam is one of the safest and most affordable and durable materials available,” the ADA told the Food and Drug Administration in comments filed ahead of the agency’s Nov. 13-14 hearing on the immunological safety of metal implants, including amalgam.

The FDA Medical Devices Advisory Committee’s Immunology Devices Panel met to look at the available scientific and clinical data in light of reports on the adverse effects of some metal-on-metal orthopedic implants and gynecological metal-containing implants.

Dr. Brittany Seymour, an ADA member and assistant professor at the Harvard School of Dental Medicine in the oral health policy and epidemiology department, said, “dental amalgam has been a leading restorative material for more than 150 years.” Dr. Seymour also referenced several expert groups, including the ADA Council on Scientific Affairs, National Institutes of Health and World Health Organization, which all agreed that there is little or no evidence that amalgam poses a risk to health.  

Some 50 stakeholders, including providers, patients and industry, testified during the two-day open hearing. In addition to Dr. Seymour, Spiro Megremis, Ph.D., director of ADA research and standards in the ADA Science Institute, and Dr. Tom Hart, senior director of the ADA Foundation Research Center, also submitted testimony for the Association.

“One of the greatest risks to our health is misinformation and misinterpretation of scientific findings,” said Dr. Seymour, who told the committee that nonevidence-based content often negatively influences policy decisions and is harmful to the public when decisions are made based only on emotional testimony rather than sound scientific data.

In the ADA’s formal written comments, Association President Chad P. Gehani and Executive Director Kathleen T. O’Loughlin said that the scientific literature has repeatedly affirmed that dental amalgam is one of the safest and most affordable and durable materials available to restore damaged teeth.

“There are benefits and drawbacks to all dental materials, but dental amalgam is more affordable and offers longer lasting results than the alternatives,” they wrote.

Drs. Gehani and O’Loughlin stressed three key points:

• There is no evidence of amalgam being associated with systematic immunologic or other adverse effects beyond the approximately 1 percent of the population that may have local allergic responses.

• A series of comprehensive and systematic reviews of the literature have not found dental amalgam to pose serious health risks to the general public.

• Eliminating dental amalgam as a restorative treatment would exacerbate oral health disparities due to the limited selection of other restorative materials.

In his testimony, Dr. Megremis quoted from the ISO dentistry standard concerning corrosion test methods and noted that “from both this standard type of corrosion testing of amalgam coupled with nonstandard testing, the kinetics of ion release can be well characterized … to inform immunologists and toxicologists.”

Dr. Hart emphasized that since dental amalgam is not considered an implant, any amalgam recommendations should come from the FDA’s Dental Products Panel, since that panel contains members with expertise in dental amalgam. He pointed members of the immunology panel to FDA’s 2019 systematic review, which represents the most comprehensive review of dental amalgam from 2010 to the present. That review concluded that “there is not sufficient evidence of a relationship between clinically detectable adverse health outcomes and dental amalgam mercury exposure, which is consistent with previous analyses conducted by the Department of Health and Human Services and FDA.”

Drs. Gehani and O’Loughlin concluded by saying the ADA is confident that “sound science will guide [the panel’s] deliberations about one of the safest and most affordable and durable dental materials available: dental amalgam.”

For more information about the hearing, visit the FDA website.