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amalgams (I know, no surprise) and the fda

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FDA Reluctantly Admits Mercury Fillings Have Neurotoxic Effects on

Children

“Dental amalgams contain mercury, which may have neurotoxic effects on

the nervous systems of developing children and fetuses,†reads a

statement that has been added to the agency’s 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 health practitioner.â€

The warning was one of the conditions that the FDA agreed to in

settling a lawsuit filed by several consumer health groups.

“Gone, gone, gone are all of FDA’s claims that no science exists that

amalgam is unsafe,†said Brown, a lawyer for Consumers for

Dental Choice, one of the plaintiffs.

“It’s a watershed moment,†said Bender of the Mercury Policy

Project, another plaintiff.

Mercury is a well-known neurotoxin that can cause cognitive and

developmental problems, especially in fetuses and children. It can also

cause brain and kidney damage in adults.

So-called dental amalgams, or fillings made with a mix of mercury and

other metals, have been used since the 1800s. Although it is known that

small amounts of mercury are vaporized (and can be inhaled) when the

fillings are used to chew food, and though Canada, France and Sweden

have all placed restrictions on the use of mercury fillings, the FDA

has always insisted that amalgams are safe.

Dental amalgams are considered medical devices, regulated by the FDA.

Even the FDA’s new warning stops short of admitting that dental

amalgams are dangerous for the general population. Instead, it focuses

on the same population that has already been warned to limit mercury

exposure by consuming less seafood: children and pregnant women. The

FDA says it does not recommend that those who already have mercury

fillings get them removed.

Millions of people have received amalgam fillings, although their

popularity has dropped off in recent years. Currently, only 30 percent

of dental fillings contain mercury - the rest are tooth-colored resin

composites made from glass, cement and porcelain. These alternative

fillings are more expensive and less durable than amalgam, however.

In 2002, the FDA began a regulatory review of amalgam that was expected

to be complete within a few years. In 2006, with the review still

incomplete, an independent FDA advisory panel of doctors and dentists

rejected the agency’s position that there is no reason for concern

about the use of amalgam. While the panel agreed that the majority of

people receiving such fillings would not be harmed, panel members

expressed concern for the health of certain sensitive populations,

including children under the age of six.

The panel recommended that the FDA conduct further studies on the risks

to children from dental amalgam, and that it consider a policy of

informed consent for children and pregnant: that is, warning those

groups of the risks associated with the fillings before installing

them.

Part of the lawsuit centered on the FDA’s failure to respond to these

recommendations in a timely fashion.

“This is your classic failure to act,†federal judge Ellen Segal

Huvelle told the agency.

As part of the lawsuit settlement, the FDA must reach a final decision

on the regulation of amalgam by July 28, 2009.

“This court settlement signals the death knell for mercury fillings,â€

Brown predicted.

But J.P. Securities analyst Ipsita Smolinski disagreed, saying

that the FDA is unlikely to ban amalgam entirely

“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,†Smolinski

said.=

epiousian = the expression of agape

quite a bit more than enough

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