THE MAJORITY of evidence suggests exposure to mercury vapor from dental amalgam fillings doesn’t lead to harmful health effects for most people.
This is the conclusion of the United States Food and Drug Administration (US FDA) as it issued on September 24 its recommendations for certain high-risk groups regarding dental amalgam containing mercury.
The US FDA recommendations came from Dr. Jeffrey E. Shuren MD, Director of the Center for Devices and Radiological Health at the Food and Drug Administration (CDRH).
The available evidence suggests that dental amalgam use has generally declined over recent years due to more alternative products being offered and used effectively for dental restorations, the CDRH said.
Still, it said high-risk individuals (see Part 1 of this column) should discuss alternative products for restoring teeth with their dentist.
The CDRH said there may be some effects in people with certain health issues such as those who are hypersensitive to mercury.
“Uncertainties remain about: the effects that long-term exposure to dental amalgam may have on the specific high-risk groups we’ve listed; the potential for mercury in dental amalgam to convert to other mercury compounds in the body; and whether the accumulation of mercury in some body fluids and tissues results in other unintended health outcomes.”
The US FDA made the recommendations after hearing from health care professionals, evaluating published literature and considering the public’s comments about dental amalgam and other metal-containing implants.
During the November 2019 meeting of the Immunology Devices Panel of the Medical Devices Advisory Committee, which discussed immunological responses to metal-containing implants and dental amalgam, the US FDA heard from several speakers, including those representing underserved communities, who expressed concern about the cumulative effect of mercury vapor exposure from dental amalgam, as well as from other (dietary and environmental) sources.
The US FDA said it continues to believe that the benefits of materials in FDA-approved or cleared implantable and insertable medical devices outweigh their risks for most patients.
“However, we recognize that it is critical to closely monitor and evaluate new benefit-risk related data as biomedical science is always evolving,” it said.
It continues to gather input from patients, device manufacturers, researchers and physicians to learn more about their experiences, ideas and feedback related to materials in medical devices, such as dental amalgam.
“We’re committed to advancing new initiatives that are rooted in sound science with a focus on patient safety remaining at the forefront,” it said.
The US FDA is an agency within the US Department of Health and Human Services.
It oversees the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.
It is also responsible for the safety and security of America’s food supply, cosmetics, dietary supplements, products that give off electronic radiation and for regulating tobacco products.
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Dr. Joseph D. Lim is the former Associate Dean of the UE College of Dentistry, former Dean of the College of Dentistry, National University, past president and honorary fellow of the Asian Oral Implant Academy, and honorary fellow of the Japan College of Oral Implantologists. Honorary Life Member of Thai Association of Dental Implantology. For questions on dental health, e-mail jdlim2008@gmail.com or text 0917-8591515./PN
