Panel Recommends Against Mercury-containing Amalgam
FDA’s Immunology Devices Panel of the Medical Devices Advisory Committee last week recommended that FDA should require dentists to move away from using mercury-containing amalgams and towards non-mercury containing products like composite materials when conducting dental restoration procedures. The panel agreed that FDA’s latest literature review on dental amalgam (see earlier story) provided more evidence on amalgam’s risks to the environment, patients and potentially to the dental professionals involved in the insertion and extraction of these materials, panel chair and George Washington School of Medicine & Health Sciences professor Raj Rao summarized at the meeting.
The 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, particulary for vulnerable subgroups like children and pregnant women. The panel said there is a research gap on the risks of removal of amalgams, which is “not entirely known at this time and that it deserves more study and research by FDA or other federal bodies,” Rao said.
The panel was convened to discuss FDA’s findings from its literature review. The review highlighted “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.”
National Medical Association’s Commission on Environmental Health co-chair Mark Mitchell told the panel that while FDA estimates that the “use of amalgam is less than 40% based on an outdated American Dental Association estimate, the truth is that we really don’t know. No organization tracks who gets amalgam and who does not or what percentage of Americans get amalgam dental restorations. Based on my inquiries, however, I believe that the usage is much lower, and concentrated in low income people, the disabled, and people of color... Therefore, composites seem to be a safer alternative to amalgam dental restorations.”
Tuskegee University National Center for Bioethics in Research and Health Care director Rueben Warren called continued use of amalgam in children “unethical” when there are safer alternatives available. "The European Union virtually forbids amalgam use in children under 15 and in pregnant and breastfeeding women, and entire countries have phased out all amalgam use," said Charles Brown of the World Alliance for Mercury-Free Dentistry.
After the meeting, Chicago Declaration to End Mercury Use in the Dental Industry director Eric Uram said: “We applaud the scientific advisory committee for urging action by FDA's Center for Devices, and we thank director Jeff Shuren for adding immunological and neurological impacts of amalgam to the advisory committee's agenda. We look forward to working with FDA on implementing the committee's recommendations.”