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Are These Medical Devices Too Dangerous? (Dental Amalgam)


Posted in Regulatory and Compliance by Jamie Hartford on April 9, 2014

Dental Amalgam

Dental amalgam, a filling for cavities, can release low levels of mercury vapor that can be inhaled and has been associated with allergic reactions or sensitivities in some people, according to FDA. The material has been used for more than 150 years in hundreds of millions of patients, according to the agency.

Activists Say:

We believe that there is ample evidence to show that the mercury vapor released from amalgam fillings can cause numerous debilitating and costly health problems. In addition, it can contribute to, or make worse any existing health condition. Mercury is especially poisonous to the fetus, nursing baby, and young children.”

—Moms Against Mercury Amalgams petition urging a ban on dental amalgams

Industry Says:

... in its 2009 review of the scientific literature on amalgam safety, the [American Dental Association] 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.”

ADA statement

FDA Actions:

2009: Reclassified mercury from a Class I to a Class II device. Classified dental amalgam as a Class II device and designated a special controls guidance document for dental amalgam.

2010: FDA advisory panel recommended the agency conduct further review of the safety of dental amalgam.

2011: Agency failed to meet informal deadline for decision on whether dental amalgam is safe for infants under 6 years of age and developing fetuses.

 

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