In a bold move, the FDA issued a controversial, final regulation on Tuesday classifying dental amalgam a class II medical device with moderate risk. According to the official press release, the FDA can impose special controls (in addition to general controls such as good manufacturing practices that apply to all medical devices regardless of risk) to provide reasonable assurance of the safety and effectiveness of dental amalgam. What does this actually mean? Basically, this classification says that even though elemental mercury has been associated with adverse health effects at high exposures, the levels released by dental amalgam fillings are not high enough to cause harm in patients; therefore the use of amalgam fillings is safe.
Are you confused? Just over a year ago, this press release reveals that a court settlement filed by the Consumers for Dental Choice, required the FDA to withdraw claims of dental amalgams safety from its website and issue an advisory that clearly indicates that " Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses."
The American Dental Association released a statement on Tuesday as well, supporting the FDA's decision. President of the ADA, Dr. John Finderly firmly addresses the decision by stating "The FDA has left the decision about dental treatment right where it needs to be--between the dentist and the patient," adding, "This decision underscores what the ADA has long supported--a discussion between dentists and patients about the full range of treatment options to help patients make educated decisions regarding their dental care."
Believe me when I tell you that this issues is far from over. What has changed since the court decision in June 2008? The ADA says numerous scientific studies conducted over the past several decades, including two large clinical trials published in the April 2006 Journal of the American Medical Association, indicate dental amalgam is a safe, effective cavity-filling material for children and others. And, in its 2009 review of the scientific literature on amalgam safety, the ADA's Council on Scientific Affairs reaffirmed that the scientific evidence continues to support amalgam as a valuable, viable and safe choice for dental patients. On the other hand, the Consumers for Dental Choice have this to say: "FDA broke its contract and broke its word that it would put warnings for children and unborn children for neurological damage," adding "Bowing to the dental products industry, FDA for the first time in its history pulled a warning about neurological harm to children. This contemptuous attitude toward children and the unborn will not go unanswered. We will see FDA in court."