FDA: Possible Risk From Dental Fillings
To Settle Lawsuit, FDA Now Says Mercury From Fillings Might
Pose Risk to Some
June 5, 2008 -- Mercury from amalgam dental fillings may be
toxic to children and developing fetuses, the FDA now admits.
Experts say there's no proof that dental fillings cause harm to
consumers. But they also say there's no proof that the fillings
-- which are half mercury by weight -- are entirely safe.
On its web site, the FDA has dropped much of its reassuring
language about dental amalgam. And it's added what amounts to a
warning: "Dental amalgams contain mercury, which may have
neurotoxic effects on the nervous systems of developing children
And there's more. "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," the FDA web site now says.
changes come in response to a lawsuit filed by consumer groups
and individuals concerned about mercury exposure. To settle the
suit, the FDA agreed to update its web site.
federal agency also agreed to rule -- within one year -- on
exactly how dental amalgam products should be regulated, and
exactly what warnings consumers should receive from their
dentists and doctors.
"It's been a long time coming," Nick
Brooks, a staffer for Consumers for Dental Choice, one of the
groups that brought the lawsuit, tells WebMD.
"This is a
good thing. It will be good to have a rule finalized in a year,"
FDA spokeswoman Peper Long tells WebMD. "In some cases, we know
mercury can have effects on the nervous system. It is something
we need information on so we can give the public the best
information on the risk from a product like this."
in 2002 proposed to classify the mercury-containing fillings as
a Class II device -- meaning a device that isn't absolutely safe
and should carry some kind of special controls (a Class I
device, like a Band-Aid, needs no warning; a Class III device,
like a cardiac defibrillator, requires specific FDA approval).
But the FDA never issued a final ruling. It's proposed "white
paper" on the topic was voted down in a 13-7 vote by a 2006
advisory panel made up of experts in dentistry and in neurology.
Neurologist Karl Kieburtz, MD, of the University of Rochester,
co-chaired the panel.
"The panel's concern was there are
populations that are particularly susceptible to the
neurological effects of mercury and might experience these
effects at the very low levels of exposure seen with dental
amalgam," Kieburtz tells WebMD. "That was the tenor of the
committee -- 'Let's consider vulnerable populations' -- so we
said fair enough, these vulnerable populations should at least
get a warning."
Behcet's is a autoimmune disease is a rare disease
characterised by painful mouth ulcers, genital ulcers, eye
problems and skin lesions. The disease is named after the
Turkish dermatologist Hulusi Behcet who first described the
syndrome in 1924.
Kieburtz notes that panel members also
agreed that there was no cause for alarm and said there was no
reason for pregnant women or others to have their dental
fillings removed."To the best of my knowledge, there is no
clinical evidence in humans that dental amalgams have led to
harm," Kieburtz says. "Is there a theoretical reason to suspect
harm? Yes. There is a rationale for concern, but no evidence
there is harm. So there is a theoretical concern and a lack of
evidence and that has led to a precautionary rule."Indeed,
clinical studies suggest that dental fillings cause harm.
But because millions and millions of children and pregnant women
received the fillings, the cost of cleaning toxic mercury
is a big task.
Amalgam fillings are made from liquid mercury
mixed with a powder containing silver, tin, copper, zinc, and
other metals. It was once thought that the mercury in fillings
was permanently trapped in the amalgam. Not any more.
When people chew, the fillings emit mercury vapor that is
absorbed by the body. Even for people with lots of fillings,
it's a small amount of mercury.
But since mercury is toxic
even at very low levels, there's growing concern that the
mercury in fillings could be the straw that breaks the camel's
back for people with other mercury exposures. And dental
professionals are routinely exposed to the vapors.
now, the FDA does not recommend that people have their fillings
removed. But the agency does say that people concerned about the
possible health effects of dental fillings should talk with
their "qualified health care practitioner."