In July of 2009, the Food and Drug Administration (FDA) ruled that amalgam is a safe material for dental restorations. By the end of 2010, the FDA reopened the investigation due to pressures from various health organizations questioning the ruling. In December 2010, the American Dental Association (ADA) created an advisory panel to continue its own investigation on the safety of amalgam material for dental restoration. Last month the ADA panel intensively reviewed existing and new scientific information on amalgam dental safety and found that the FDA ruled appropriately in July of 2009.
Dr. Susan Runner, the 2009 FDA acting division director of anesthesiology, general hospital, infection control and dental devices, announced that the conclusions were based on multiple, evidence-based studies. Long-term studies show that the amount of mercury released by dental fillings is not high enough to cause harm to patients. In addition, studies have found that there is no adverse health effect of dental amalgam on developing fetuses, breast-fed infants and child under the age of 6. Thus, it is safe to perform amalgam restorations on pregnant woman and children. Runner noted that some patients may have an allergy or sensitivity to metals within the dental amalgam. Therefore, special controls will be in place to warn dental professionals and patients of possible allergies, and to encourage adequate ventilation when handling amalgam.
Nancy Stade, the FDA deputy director for policy in the FDA's medical device center, said that the current guideline for mercury fillings is not being modified during the reinvestigation of the 2009 ruling.
After the ADA panel announced its statement concluding amalgam as a safe dental material, ADA president Dr. Raymond Gist concluded that the use of amalgam restorations is a decision that should be made between the patient and the dentist. Patients are recommended to discuss the benefits and risks of amalgam restorations with their dentist prior to dental treatment.
Dr. Rashmi (Rush) Bhatnagar, DMD, MPH, can be contacted at (480) 598-5900 or visit www.BellaVistaDentalCare.com.