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· · FDA admits that mercury fillings can be harmful

Silver-colored metal dental fillings contain mercury that may cause health problems in pregnant women, children and fetuses, the Food and Drug Administration said on Wednesday after settling a related lawsuit.

As part of the settlement with several consumer advocacy groups, the FDA agreed to alert consumers about the potential risks on its website and to issue a more specific rule next year for fillings that contain mercury, FDA spokeswoman Peper Long said.

"Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses," the FDA said in a notice on its Web site.

"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 dentists," the agency said.

The FDA said it did not recommend that people who currently have mercury fillings get them removed.

But, the FDA is scheduled to issue new guidelines in July 2009, Long said. Their ruling could impact the makers of metal fillings, which include Dentsply International Inc and Danaher Corp unit Kerr.

The lawsuit settlement was reached on Monday with several advocacy groups, including Moms Against Mercury, which had sought to have mercury fillings removed from the U.S. market.

While the FDA previously said various studies showed no harm from mercury fillings, some consumer groups contend the fillings can trigger a range of health problems such as multiple sclerosis and Alzheimer's disease. In 2006, an FDA advisory panel of outside experts said that the evidence shows that most people are not harmed by mercury fillings, but that more study is needed. Mercury has been linked to brain and kidney damage at certain levels. Amalgams contain half mercury and half a combination of other metals.

Charles Brown, a lawyer for one of the groups called Consumers for Dental Choice, said the agency's move represented an about-face. "Gone, gone, gone are all of FDA's claims that no science exists that amalgam is unsafe," he said in a statement.

J.P. Morgan Securities Inc. analyst Ipsita Smolinski said the FDA is not likely to outright ban the fillings next year but will probably call for restrictions. "We do believe that the agency will ask for the label to indicate that mercury is an ingredient in the filling, and that special populations should be exempt from such fillings, such as: nursing women, pregnant women, young children, and immunocompromised individuals," said Smolinski.

Fewer patients have been opting for mercury fillings in recent years, instead choosing lighter options such as tooth-colored resin composites. Only 30 percent of fillings given to patients were mercury-based ones as of 2003, according to the American Dental Association (ADA). Other options include glass cement and porcelain as well as other metals such as gold, but they cost more and are less durable, the group says.

Dr. Cinque's comments: I had all of my mercury fillings replaced with composites years ago. I did not do it all at once, rather over a period of 2 to 3 years, I had them replaced piecemeal. I was not having any problems that I related to mercury exposure. However, many of the fillings were very old, going all the way back to my childhood, and it was a good idea to replace them anyway. This is a very controversial issue, and over the years, I have spoken to many dentists about it. And for the record, I can think of two dentists- both of whom I respect very highly- who believe very strongly that the amalgam fillings are safe and have been falsely maligned. But regardless, since high quality composite filling materials are available today, which look better than the ugly silver fillings, and which last just as long or longer, there is really no good reason to resort to mercury fillings any longer. I have no regrets about spending the time and money to clear my mouth of them.

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