FDA says dental amalgam is safe, but recommends warning on product label

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The Food and Drug Administration has just released regulations on dental amalgam, a material is used to fill cavities in teeth and which, because it contains mercury, some fear may be dangerous to patients’ health.

‘While elemental mercury has been associated with adverse health effects at high exposures, the levels released by dental amalgam fillings are not high enough to cause harm in patients,’ the agency said in a statement.

The agency recommended that the product label contain a warning that dental professionals use adequate ventilation and that the amalgam not be used on people with mercury allergies. It also recommended the packaging carry ‘a statement discussing the scientific evidence on the benefits and risks of dental amalgam, including the risks of inhaled mercury vapor.’

And, it further says, a scientific review has found that ‘The amount of mercury measured in the bodies of people with dental amalgam fillings is well below levels associated with adverse health effects. Even in adults and children ages 6 and above who have fifteen or more amalgam surfaces, mercury exposure due to dental amalgam fillings has been found to be far below the lowest levels associated with harm. Clinical studies in adults and children ages 6 and above have also found no link between dental amalgam fillings and health problems.’

The agency said that there was less data to examine when it comes to risks to fetuses, breast-feeding infants and children under 6, but that the levels for kids under 6 are also likely to be safe and that the levels in breast milk are likely lower than those deemed risky by the Environmental Protection Agency. It added that pregnant and breast-feeding women should talk with their doctors about alternatives if they have concerns.

Dentists have been using dental amalgam for years. So why the rule now? Amalgam was already in use in 1976 when the agency acquired power to regulate medical devices. The agency was required by law to class pre-existing devices into classes I, II or III based on risk. They’d done mercury already, and they’d done powdered alloy (the other component of amalgam) but not the combined amalgam itself. The agency decided to do so in 2002, and this final ruling follows public comment and scientific reviews of several hundred studies.

Dental amalgam is rated Class II (moderate risk). Mercury, which used to be Class I (low risk), is now Class II.

Read more from the FDA on dental amalgam here.

-- Rosie Mestel