An advisory panel consisting of experts in the fields of toxicology, risk assessment, epidemiology, and pediatric medical and dental specialties began a two day meeting in Washington, D.C. on December 14, 2010, to determine whether the U.S. Food and Drug Administration should reclassify dental amalgam, based on risk assessment and clinical data that demonstrated dental amalgam as a dangerous filling material; carrying a class III medical device classification. A class III medical device is classified as such, because there is insufficient information available regarding the effectiveness and safety of the device solely through the general or special controls sufficient for Class I or Class II devices. Simply put, class III medical devices pose the greatest risk to patients.
Why the sudden change in the heart FDA? Back in July, 2009 the FDA issued their final ruling on amalgam safety; granting amalgam class II medical device status. But on the contrary, it seems the FDA could quite possibly be changing their mind about amalgam. The meeting to reevaluate dental amalgam safety was, in part, done so because the agency had received several petitions raising various issues relating to the final rule and special controls. According to a press release dated June 2009 announcing the meeting, the FDA notes "The concerns raised include the adequacy of the risk assessment method used by the FDA in classifying dental amalgam, the bioaccumulative effect of mercury, the exposure of pediatric populations to mercury vapor, and the adequacy of the clinical studies on dental amalgam. In addition, a recent report on risk assessments issued by the National Academy of Sciences, titled "Science and Decisions: Advancing Risk Assessment, NAP 2009," proposes new approaches to conducting risk assessments. These may be some of the issues the agency asks the advisory committee to review."
I've said it once, and now I will say it again: Will we ever know the truth about amalgam?