Monday, June 14, 2010

FDA Review Of Dental Amalgam - Advisory Panel To Consider Risks To Vulnerable Patients

FDA Review Of Dental Amalgam - Advisory Panel To Consider Risks To Vulnerable Patients

12 Jun 2010  

The US FDA (Food and Drug Administration) say it is to hold an advisory panel on December 14th-15th to discuss a number of scientific issues that may affect dental amalgam regulation, used for direct filling of carious lesions or structural faults in teeth. The meeting will focus mainly on the possible risk to vulnerable patients, such as pregnant women, young children and fetuses.

Amalgam is used for the treatment of tooth decay. It consists of a mixture of metals, composed of liquid mercury and powdered amalgam alloy, made up mainly of silver, tin and copper.

On July 28, 2009, the FDA issued a final rule that reclassified dental mercury from a class I device to class II, classified dental amalgam as a class II device, and designated special controls for dental amalgam, mercury and amalgam alloy. The special control for the devices is a guidance titled, "Class II Special Controls Guidance Document: Dental Amalgam, Mercury and Amalgam Alloy."

Since that final rule, the FDA has received numerous petitions raising various issues regarding the final rule and special controls.

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.
  • 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," recommends new approaches to carrying out risk assessments. These may be some of the issues the agency asks the advisory committee to review.

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