Dental
amalgam is far from an essential dental product; it’s interchangeable
with many other filling materials that do not have the toxic profile
amalgam has. Modern materials like resin composites and glass ionomers
have rendered amalgam completely unnecessary for any clinical situation, and entire nations have already stopped using amalgam altogether
By Dr. Mercola
After enormous public pressure from scientists, dentists, health
professionals, and consumers, the U.S. Food and Drug Administration
(FDA) promised to make an announcement about dental amalgam by the end
of 2011.
Dental amalgam, of course, is composed 50% of the dreadful neurotoxin mercury.
Jeffrey Shuren, director of the Center for Devices and Radiological
Health (CDRH, the branch of the FDA responsible for the approval and
safety of all medical devises) said at a public hearing in September,
in San Francisco, that FDA will make an “announcement” on a new amalgam
policy by the end of 2011.
When questioned by a reporter at a major newspaper, FDA repeated that it would act in 2011.
As 2011 came to a close, the suspense grew as everyone speculated
whether FDA would act or whether it would continue its decades of
protecting the profits of pro-mercury dentists instead of protecting
the health of American children.
With just six minutes left in the work year, at 4:54 pm on Friday,
December 30, FDA conceded that no announcement was forthcoming – not in
2011, and maybe not at all.
In that midnight statement, one FDA press person, one Karen Jackler,
said that another FDA press person, Morgan Liscinsky, would answer
questions about amalgam.
So when the respected trade publication FDA Webview asked, Liscinsky said: No announcement.
And no target date for FDA to do anything on amalgam.
Instead, FDA said what it said ten years ago: it will “continue to study the safety of amalgam.”
FDA has broken yet another promise on amalgam.
Why Won't the FDA Act to Protect You Against Toxic Mercury?
The FDA's history of protecting dental amalgam is a long one.
For the past
32 years, the agency has refused to issue any public warning
about its neurotoxic risks, and in 2009, the FDA declared it safe under
Class 2 for adults and children over the age of 6 who are not allergic
to mercury—despite the overwhelming evidence showing mercury to be
highly toxic and easily released in the form of vapor each time you eat,
drink, brush your teeth or otherwise stimulate your teeth.
These mercury vapors readily pass through cell membranes, across your
blood-brain barrier, and into your central nervous system, where it can
cause psychological, neurological, and immunological problems.
Children and fetuses, whose brains are still developing,
are clearly most at risk, but anyone can be impacted, and the health
risks get greater the longer you have your fillings.
According to Boyd Haley, retired professor emeritus at the University
of Kentucky (where he headed the chemistry department), about 80
percent of the mercury vapor released from your fillings collect in your
body tissues and can take months or years to eliminate. Needless to
say, if your body keeps accumulating more mercury than it can eliminate,
after many years of chronic exposure you may end up with quite a bit of
accumulated mercury in your body. Studies on cadavers have confirmed
that the more amalgam fillings a person has, the more mercury collects
in their brain, for example.
World Health Organization Urges Phasing Out of Dental Amalgam
Many hoped that the FDA would reconsider this foolish stance after
the World Health Organization called for the phasing-out of amalgam in
their 2011 report: Future Use of Materials for Dental Restoration.
In May 2011, the Council of Europe also issued a proclamation calling
for restrictions and prohibitions of mercury fillings, which are already
banned in Norway, Sweden, and Denmark. Health Canada also stopped
endorsing amalgam for use in children, pregnant women, and people with
impaired kidney function, all the way back in 1996!
The World Health Organization noted the following three reasons for its new position:
- Amalgam releases a "significant amount of mercury" into the environment, including the atmosphere, surface water, groundwater, and soil. WHO reports:
"When released from dental amalgam use into the environment
through these pathways, mercury is transported globally and deposited.
Mercury releases may then enter the human food chain especially via fish
consumption."
- WHO determines that amalgam raises "general health concerns":
While the report acknowledges that a few dental trade groups still
believe amalgam is safe for all, the WHO report reaches a very different
conclusion: "Amalgam has been associated with general health concerns."
The report observes:
"According to the Norwegian Dental Biomaterials Adverse Reaction
Unit, the majority of cases of side-effects of dental filling materials
are linked with dental amalgam."
- WHO concludes "materials alternative to dental amalgam are available"
and cites studies indicating they are superior to amalgam. For example,
WHO says "recent data suggest that RBCs [resin-based composites]
perform equally well" as amalgam. And compomers have a higher survival
rate, says WHO, citing a study finding that 95% of compomers and 92% of
amalgams survive after 4 years.
In particular, WHO explains that "Alternative restorative materials
of sufficient quality are available for use in the deciduous [baby]
dentition of children" – the population whose developing neurological
systems are most susceptible to the neurotoxic effects of dental
mercury. Perhaps more important than the survival of the filling, WHO
asserts that:
"Adhesive resin materials allow for less tooth destruction and, as a result, a longer survival of the tooth itself."
The report also included mention of the known toxic effects of mercury exposure, stating that:
"Mercury is highly toxic and harmful to health. Approximately 80%
of inhaled mercury vapor is absorbed in the blood through the lungs,
causing damages to lungs, kidneys and the nervous, digestive,
respiratory and immune systems. Health effects from excessive mercury
exposure include tremors, impaired vision and hearing, paralysis,
insomnia, emotional instability, developmental deficits during fetal
development, and attention deficit and developmental delays during
childhood."
Why Does the FDA Ignore its Own Experts?
In December 2010, in response to the outrage over their 2009 ruling,
the FDA asked an advisory panel to examine the latest science on
amalgams. The panel recommended that the FDA promptly:
- Make sure that all consumers and all parents know that amalgam is mainly mercury
- Stop amalgam use for children and pregnant women
Still, the agency hesitated… Then, last year Shuren attended a series of town hall meetings
around the US, where he heard so much criticism against the agency's
amalgam policy that he eventually started saying the agency would act on
the petitions to reconsider its position. As recently as November 30,
the FDA confirmed to the Chicago Tribune that it did indeed intend to address amalgam in 2011, stating that:
" … in response to concerns about its [2009] ruling, the FDA
convened a panel last December to re-examine the issue and expects to
make a new announcement by the end of this year."
But, it didn't… According to Charlie Brown, national counsel for
Consumers for Dental Choice, and President of the World Alliance for
Mercury-Free Dentistry:
"At Jeff Shuren's Center for Devices, politics wins. Science
loses. Thirteen months ago, FDA's own advisory panel of handpicked
scientists told FDA to stop amalgam use for children and pregnant women.
But Shuren fails to heed the scientists — even though, since September,
he repeatedly announced that he intended to act on amalgam in 2011.
Every day that Shuren fails to act, more children are subjected to this
mercury product, which — FDA's own rule concedes — can have 'neurotoxic
effects' on the 'developing neurological systems' of children and
unborn babies."
No One NEEDS Amalgam to Remain Available...
Dental amalgam is far from an essential dental product; it's
interchangeable with many other filling materials that do not have the
toxic profile amalgam has. Just consider these disturbing facts:
- Amalgam is the MOST EXPENSIVE dental material when you count environmental costs and clean-up costs.
- Amalgam is the number one cause of mercury exposure for consumers, according to the Canadian government and other sources.
- Mercury from dental offices is the largest source of mercury in
wastewater. According to an article by Michael Bender (co-founder of the
Mercury Policy Project), at least 40 percent of mercury flowing into
municipal water treatment plants begins in dentist offices. And those
plants are not set up to remove it, so it ends up in your fish.
- Americans and Europeans have more mercury in their mouths than exists in all products combined—more than 1,000 tons.
- Amalgams of the dead pose a risk to the living. Emissions from
the combustion of mercury fillings during cremation are a significant
contaminator of air, waterways, soil, wildlife and food. Seven to nine
metric tons of mercury per year escapes into the atmosphere during
cremations, and it is estimated that, left unchecked, crematoria will be
the largest single cause of mercury pollution by 2020.
Modern materials like resin composites and glass ionomers have rendered amalgam completely unnecessary
for any clinical situation. In fact, the mercury-free alternatives are
so advanced that entire nations, such as the Scandinavian countries,
have stopped using amalgam altogether.
Already, about half of U.S. dentists are mercury-free and 77 percent of consumers
who are told that amalgam contains mercury choose mercury-free
alternatives. One of the most popular alternatives to amalgam is resin
composite. Resin composites are made of a type of plastic reinforced
with powdered glass. It is already common throughout the U.S. and the
rest of the developed world, offering notable improvements over amalgam,
as it:
- Is environmentally safe: Composite, which contains no mercury,
does not pollute the environment. This saves taxpayers from paying the
costs of cleaning up dental mercury pollution in our water, air, and
land – and the costs of health problems associated with mercury
pollution.
- Preserves healthy tooth structure, because, unlike amalgam, it
does not require the removal of significant amounts of healthy tooth
matter. Over the long term, composite preserves healthy tooth structure
and actually strengthens teeth, leading to better oral health and less
extensive dental work over the long-term.
- Is long-lasting: While some claim that amalgam fillings last
longer than composite fillings, the science reveals this claim to be
baseless. The latest studies show that composite not only lasts as long
as amalgam, but actually has a higher overall survival rate.
A lesser-known alternative is increasingly making mercury-free
dentistry possible even in the rural areas of developing countries.
Atraumatic restorative treatment (also called alternative restorative
treatment or ART) is a mercury-free restorative technique that has been
demonstrated a success in a diverse array of countries around the world,
including Tanzania, India, Brazil, Zimbabwe, Turkey, South Africa,
Thailand, Canada, and a dozen others. ART relies on adhesive materials
for the filling (instead of mercury) and uses only hand instruments to
place the filling, making it particularly well-suited for rural areas of
developing countries.
How You Can Help Protect Children Everywhere
It's high time for the FDA start acting on the science and get on the
bandwagon to protect the health of children and pregnant women across
the U.S.
Your voice is needed in order to bring about permanent change in the
fight for mercury-free dentistry. The FDA reneged on their stated intent
to address dental amalgam by the end of 2011. We now need you to urge
the FDA to heed the advice of its own scientists convened in December
2010 and the World Health Organization. To voice your opinion, please
contact Dr. Shuren. This time, we think it best if you telephone or fax, and make your message more direct, rather than emailing Dr. Shuren:
Dr. Jeffrey Shuren, Director
Center for Devices, U.S. Food & Drug Administration
10903 New Hampshire Ave.
WO66-5431, Room 5442
Silver Spring, MD 20993-0002
Phone: 301-796-5900 or 301.796-5000
Fax: 301-847-8149 or 301-847-8109
If you can't get through to Dr. Shuren via phone or fax, please write Anthony Watson, Director of the Division on Devices,
anthony.watson@fda.hhs.gov.
Phone calls and faxes are especially important because Dr. Shuren
cannot ignore them – keep calling and leaving messages until you get
answers! Here are some recommended talking points when you call or
write:
- Why is the FDA ignoring its own scientific advisory panel that
told the FDA to stop the use of amalgam immediately for children,
pregnant women, and hypersensitive adults (as a minimum) over a year ago? There is no excuse for endangering our children with dental mercury.
- Why is the FDA failing to warn every parent that amalgam is
mercury, not silver? Every consumer should be told the truth about
what's going into their mouths and their children's mouths.
- Why is the FDA so out-of-step with the World Health
Organization? In its 2011 report, the World Health Organization calls on
health authorities like FDA to take action against amalgam now: "Health
authorities can play an active role in advocacy for use of dental
materials alternative to amalgam."
It is time for the FDA to act now. An announcement that the FDA's
decision will be indefinitely postponed is unacceptable! We have
irrefutable scientific evidence about the dangers of mercury amalgams.
Your children are being subjected to harm now—they can't wait another
year.
It is time for the FDA to get out of the way of progress. Please join
Charlie and me in keeping the pressure on them — let's not allow them
to manipulate their way into placing dental industry profiteering before
of your children's health.
I also urge you to tell your family, friends, and neighbors the truth
about dental amalgams, and don't let your dentist talk you into one for
yourself or for your child. It's not your dentist's mouth—it's YOUR
mouth. And YOUR pocket book—which holds a great deal of buying power.
