FDA Settles Personal Injury Lawsuit
By: Gerri L. Elder
The Food and Drug Administration has settled a personal injury lawsuit related to silver-colored dental fillings and has issued a warning that these types of dental filings may contain mercury that can be dangerous for pregnant women, children and unborn babies.
As part of the settlement with several consumer advocacy groups, the FDA agreed to warn consumers of the risks related to the silver-colored dental filings by posting an alert on its website. The FDA will also issue a more specific rule next year regarding dental fillings that contain mercury, according to a Reuters news report.
It is estimated that millions of people in the United States have had cavities in their teeth patched with the silver fillings, also called amalgams.
The FDA website now advises that:
- "Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses. Pregnant women and persons who may have a health condition that makes them more sensitive to mercury exposure, including individuals with existing high levels of mercury bioburden, should not avoid seeking dental care, but should discuss options with their health practitioner."
According to the terms of the settlement in the personal injury lawsuit, the FDA will be required to issue the new rules regarding dental fillings in July 2009. For now, the FDA has not recommended that people who already have these types of dental fillings make dental appointments to get them removed.
One of the consumer advocacy groups named as plaintiffs in the personal injury lawsuit was Moms Against Mercury. This group had sought to have the fillings that contain mercury completely removed from the market in the United States. The group was unsuccessful with their goal as the new FDA rules for the silver-colored dental fillings will only provide new controls and guidelines for the use of the product that they say will assure safety. The FDA is expected to require the fillings to be labeled to reflect the mercury content and restrict them from being used on pregnant or nursing women, children and people with compromised immune systems.
Studies conducted by the FDA had previously shown that the dental fillings that contain mercury were not dangerous. However, the consumer advocacy groups disagree and say that these dental fillings pose a significant risk and can trigger serious health problems such as multiple sclerosis and Alzheimer's disease. An FDA advisory panel composed of outside experts said in 2006 that most people would not be harmed by the mercury-tainted dental fillings but that more data was necessary.
Amalgams are composed of 50 percent mercury and the other 50 percent is a combination of other metals. Mercury has been shown to cause brain and kidney damage at some levels. The consumer groups who filed the personal injury lawsuit say that the FDA can no longer claim that there is no data available to prove that amalgams are a medical hazard.