FDA updates its advice on amalgam

FDA updates its advice on amalgam

The US Food and Drug Administration (FDA) has updated its advice on dental amalgam outlining its benefits and potential risks. It concludes that dental amalgam fillings safe for adults and children ages 6 and above. It says: ‘The weight of credible scientific evidence reviewed by FDA does not establish an association between dental amalgam use and adverse health effects in the general population.’

The FDA lists the benefits of dental amalgam as:

  • Such fillings are strong and long-lasting, so they are less likely to break than some other types of fillings.
  • It is the least expensive type of filling material.

The FDA identifies potential risks as:

Dental amalgam contains elemental mercury. It releases low levels of mercury in the form of a vapor that can be inhaled and absorbed by the lungs. High levels of mercury vapor exposure are associated with adverse effects in the brain and the kidneys.

FDA has reviewed the best available scientific evidence to determine whether the low levels of mercury vapor associated with dental amalgam fillings are a cause for concern. Based on this evidence, FDA considers dental amalgam fillings safe for adults and children ages 6 and above.   The weight of credible scientific evidence reviewed by FDA does not establish an association between dental amalgam use and adverse health effects in the general population.  Clinical studies in adults and children ages 6 and above have found no link between dental amalgam fillings and health problems.

The developing neurological systems in fetuses and young children may be more sensitive to the neurotoxic effects of mercury vapor. Very limited to no clinical data is available regarding long-term health outcomes in pregnant women and their developing fetuses, and children under the age of six, including infants who are breastfed.  Pregnant women and parents with children under six who are concerned about the absence of clinical data as to long-term health outcomes should talk to their dentist.

However, the estimated amount of mercury in breast milk attributable to dental amalgam is low and falls well below general levels for oral intake that the Environmental Protection Agency (EPA) considers safe. Despite the limited clinical information, FDA concludes that the existing risk information supports a finding that infants are not at risk for adverse health effects from the mercury in breast milk of women exposed to mercury vapor from dental amalgam.

Some individuals have an allergy or sensitivity to mercury or the other components of dental amalgam (such as silver, copper, or tin). Dental amalgam might cause these individuals to develop oral lesions or other contact reactions. The FDA advises: “If you are allergic to any of the metals in dental amalgam, you should not get amalgam fillings. You can discuss other treatment options with your dentist.”

The full advice is at:

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DentalProducts/DentalAmalgam/ucm171094.htm



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