High-Risk Groups Should Avoid Amalgam Fillings: FDA
FDA has issued updated recommendations saying that individuals who are part of seven groups thought to be at greater risk for potential harmful health effects of mercury vapor released from amalgam dental fillings should avoid getting dental amalgam whenever possible and appropriate. An agency statement identifies the high-risk groups as pregnant women and their developing fetuses; women who are planning to become pregnant; nursing women and their newborns and infants; children, especially those under age six; people with preexisting neurological disease, such as muscular sclerosis, Alzheimer’s disease or Parkinson’s disease; people with impaired kidney function; and people with known heightened sensitivity to mercury or other dental amalgam components.
The statement says the agency has been studying the issue for more than 20 years. “The amalgam releases small amounts of mercury vapor over time,” it says. “While low levels of inhaled mercury vapor are generally not harmful to most people, these high-risk individuals may be at increased risk of adverse health outcomes…. 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 amalgams, such as composite resins and glass ionomer cement fillings.”
The FDA Immunology Devices Panel of the Medical Devices Advisory Committee at an 11/13/19-11/14/19 meeting recommended that FDA require dentists to move away from using mercury-containing amalgams. The committee action followed an agency literature review that did not find sufficient evidence of a relationship between clinically detectable adverse health outcomes and dental amalgam mercury exposure. The review did reveal “possible mercury increases in biofluids due to either occupational (dental professionals) or non-occupational exposure to dental amalgam; however, the corresponding evidence on clinically-manifested adverse outcomes is less consistent. The available reports on mercury-attributed manifestations such as tremor or other neurological conditions did not demonstrate convincingly that the outcomes under question have been caused by the mercury from dental amalgam. As a result, no increased risks of adverse systemic effects (e.g. neurologic, renal) have been clearly established in the general population or among dental professionals. The evidence linking dental amalgam exposure to local adverse outcomes (e.g., lichenoid and allergic lesions of oral mucosa) is stronger, and removal of amalgam fillings does not always result in complete healing.”
At the panel meeting, the advisors said the literature review provided more evidence on amalgam’s risks to the environment, and potentially to the dental professionals involved in the insertion and extraction of the materials. Panel members also said there is a lack of communication to the population at large, whether by dentists or FDA, as to potential risks of mercury-containing amalgams, particularly for vulnerable subgroups.
In 2018, a coalition of 50 environmental, public health, and children’s rights groups called on the agency to recommend a phase-down of the use of mercury amalgams, intending to phase mercury out completely over two years. FDA has been accused of dragging its feet on amalgam regulation for nearly 20 years.