Dentsply Exits Dental Amalgam Market
Anti-dental amalgam activists are rejoicing in a victory as Dentsply Sirona – the world’s largest manufacturer of dental products – has exited the amalgam market. In a 12/8 statement, Consumers for Dental Choice national counsel and World Alliance for Mercury-Free Dentistry president Charles Brown said the company had “quietly noted” in its annual report to the U.S. Securities and Exchange Commission: “[W]e have discontinued sales for all amalgam products as of December 2020.”
Brown said the “coup de grâce” for Dentsply appears to have been FDA’s 2020 recommendation against amalgam use in high-risk populations. The then-updated recommendation said 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 identified 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 noted that the agency has been studying the issue for more than 20 years. “The amalgam releases small amounts of mercury vapor over time,” it said. “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.”
In 2019, FDA’s Immunology Devices Panel of the Medical Devices Advisory Committee 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...”
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.
“The end of Dentsply amalgam sales culminates our eight-year campaign to convince Dentsply that its financial and reputational future was not in making a mercury product, ” Brown’s statement said. “We organized a grassroots campaign on Dentsply’s home turf of York, Pennsylvania, circulating petitions, writing letters, providing expertise to market analyses, and holding a well-publicized news conference less than a mile from company headquarters. Victories like these we savor, but not for long. Having brought down the giant, we have turned our attention to other manufacturers – here in the U.S. and abroad – who persist in selling this toxic product.”