The
FDA classifies mercury amalgam fillings as “moderate risk”
According to European and American NGOs this
represents an important step forward for the recognition of amalgam dangers,
but it is not enough
For Press Release - 1st August 2009 – The FDA (Food and Drug Administration),
the U.S. agency that regulates medicines and therapeutic devices, eventually
reclassified dental amalgam, the controversial material used for dental fillings
containing, by weight, about 50% of elemental mercury and 50% of other metals
in powder like silver, copper, tin, zinc (and sometimes traces of other non
declared metals such as nickel or cadmium).
The FDA was forced to conclude its evaluation process of
dental amalgam by a civil court ruling in June 2008[1], which gave reason to the request made by
a group of consumers and amalgam victims, such as Moms Against Mercury,[2] Connecticut Coalition for Environmental
Justice,[3] Oregonians for Life[4] and Consumers
for Dental Choice.[5] These NGOs had requested a
reclassification of amalgam since the early ‘90s and they wanted FDA to go
faster with the reclassification, especially in consideration of the growing
scientific evidence of potential harms posed by amalgam fillings to human
health.
Up to now there was a classification of the two
separate group of ingredients of amalgam (that is to say elemental mercury and
other metal powder) but FDA had not issued a separate regulation classifying
the combination of the two, namely dental amalgam.
The FDA concluded that amalgam is not toxic and that
the mercury vapor released from amalgam fillings do not pose any hazard to
health when, already in 1991[6]
and in 2003, the World Health Organization confirmed that mercury contained in
dental amalgam is the greatest source of mercury vapour in non-industrialized
settings,
exposing the concerned population to mercury levels significantly exceeding
those set for food and for air. In 2005 the WHO Policy Paper, Mercury
in Health Care, precised that the concerned population is exposed to an avarage of 3-17 mcg of mercury vapour from dental amalgams in
normal conditions.[7]
The U.S. agency passes this material from Class I,
which indicates a "low risk", to Class II, which indicates a
"moderate risk" and provides special controls more than the general
ones applying to all medical devices. “We are quite dismayed by this conclusion
–
Moreover, the FDA had published on its website more
cautious statements as a result of the agreement following the ruling of June
2008: "Dental amalgams contain mercury,
which may have neu
These
warnings are not present in the new labelling requirements of amalgam and there
is mainly the recognition of the risks for people with allergy and the
obligation for dentists to warn their patients about the presence of mercury in
this dental material.
The FDA recommends this information on the amalgam
labelling:
- WARNING: CONTAINS MERCURY
- Warning: May be harmful if vapours are
inhaled
- Precaution: Use with adequate ventilation
- Precaution: Store in a cool, well
ventilated place
- Contains
[… ]% mercury by weight
FDA warns dental professionals to use adequate
ventilation during processing of dental amalgam and wants the patients to
receive enough information about benefits and risks of dental amalgam,
including the risk of inhalation of mercury vapour.
According to the NGOs the new classification is
insufficient because it does not take into account various scientific aspects:
first of all, it doesn’t consider the inadequacy of studies based urine tests
used to determine the effects of exposure to mercury vapour or to other metal
of amalgam. Several experiments on sheep and monkeys, in fact, have shown that
a significant amount of the dental mercury is absorbed by kidneys, liver, brain
and the jaw bones, where, according to many scientists, it may interfere with
the neurological and immune system;
secondly, the mercury in urine test, often used in pro-amalgam studies,
may not be indicative because the minor presence of mercury in urine could be
caused by a poor ability to metabolize this toxic element[8]; thus, paradoxically, lower levels of
mercury in urine may indicate a state of toxicity and not a state of health.
"At
least one percent of those who have dental amalgam could be negatively affected
by mercury”, Servando Pérez Domínguez, university teacher of the Spanish
patients organization MERCURIADOS, said. “We try to tell people and politicians
that there are safer alternatives; in the end it will be a political
decision".[9] In May 2009 the Consejo General de los
Colegios Oficiales de Químicos de
“To pay
attention only to allergic or sensitive people is a paradox when you consider
that most of patients do not know their genetic susceptibility to mercury and
do not have any sensitization before they get exposed to this substance”, the
Vice-President of A.M.I.C.A. comments.
“In case of
chronic mercury intoxication the informed patient travels through whole Germany
to find a well trained physician, who is able to make a proper diagnosis, to
safely remove the amalgam fillings and to develop a therapy for the excretion
of the stored mercury. Uninformed patients are in danger to be treated as
psychosomatic or psychopathic cases.” – Reinhard Lauer of the German patients
association BBFU comments.
The FDA has a clear mandate, namely to research and
evaluate pending evidence of health risks, and the FDA document published on
July 28th 2009 about amalgam takes explicitly the distance from the
position of countries - such as Sweden,[10]
Norway[11]
(and soon Denmark) - that decided to ban mercury amalgam fillings in order to p
In Italy the law of 2001 prohibits the use of dental
amalgam in pregnant women and in people with allergy to mercury or with kidney
problems but A.M.I.C.A. has just launched the Petition
"Stop dental mercury!" (see www.infoamica.it)
to ask to the Minister of Health of Italian Government for a complete ban of
amalgam fillings in order to finally put an end to this terrible chapter of
modern medicine.
In Spain the National Health System has been taken to
court for placing dental amalgam in patients without, at least, Informed Consent.[12] Moreover, on July 10th 2009 the pulic Citizens
Defender (called El
Defensor del Pueblo) accepted
the MERCURIADOS claim against the National Health System about the dental
mercury issue.
On
an international congress in Luxembourg, 10th of November 2007, the European
Academy for Environmental Medicine (EUROPAEM) in cooperation with Aktionsgruppe für Umwelttoxikologie (AKUT asbl) Luxemburg proclaimed the “Luxembourg Appeal”. Scientists,
researcher, doctors specialized in environmental
medicine, physicians, and dentists as well as politicians, NGOs, and patien
In Germany, Max Daunderer, Director of the
“We
have a duty as parents to p
Moreover,
according to Anna Zucchero, MD, President of the italian organization for
Electro-Magnetic Hypersensitive patients, the amalgam fillings, like any metal,
amplify the effects of Electro Magnetic Fields (EMFs) at a cellular
level so there may be cross-exposure effects between EMFs and amalgam.
The NGOs believe that to consider dental mercury a
“moderate risk” clearly contradicts the basics of preventive medicine because
mercury from amalgam is absorbed into the
body at a rate of 3 to 17 mcg/day (WHO 1991 Health Criteria 118).[17]
Moreover, the use of mercury in dentistry has also serious
implications on the environment. Only in United Kingdom, annually 7.41 tonnes of mercury from
dental amalgam are discharged to the sewer, atmosphere or land, with another
11.5 tonnes sent for recycling or disposed with the clinical waste stream.
Together, mercury contained in dental amalgam and in laboratory and medical
devices, account for about 53% of the total mercury emissions. [18]
Full
report (in English) of the FDA Dental about amalgam:
Press release on the FDA classification of dental
amalgam, 28 July 2008:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm173992.htm
Signed by:
Vice President of
Associazione Malattie da Intossicazione Cronica e/o Ambientale
(Association for Environmental and Chronic Toxic Injury)
Rome - Italy
www.infoamica.it
amica@infoamica.it
Servando Pérez Domínguez
President of nation-wide association MERCURIADOS
(Spanish Association of Patients injured by
Dental Amalgam Mercury and from other Sources of Mercury)
Santiago de Compostela - Spain
Francisca Gutiérrez Clavero
President of ASQUIFYDE
Association
oordinator of GEDEA
Research Group
asquifyde44@gmail.com
Alicante –
Spain
Dr.
President of
Grünwald - Germany
Reinhard Lauer
BBFU (Federal Association of information
centres for environmental toxins, in particular amalgam, heavy metals and wood
preservatives)
www.bbfu.de
and amalgam.de.ki
Oberursel - Germany
Mercury
Madness
http://www.mercurymadness.org/
beckydutton@mercurymadness.org
United Kingdom
Alfredo
Herránz Sanz
Presidente de SUNAPTEIN
SUNAPTEIN,
Asociación para la Promoción de la Salud Mental
(Association for
the promotion of mental health)
Madrid - Spain
Clara Valverde
President of Liga SFC
(Chronic Fatigue Syndrome League)
www.ligasfc.org
Barcelona – Spain
Blanca
Mesistrano
President of
Asociación Civil FibroAmérica
(Personas con
Fibromialgia, Síndrome de Fatiga Crónica, Sensibilidad Química)
[People with Fibromyalgia, Chronic Fatigue Syndrome,
Multiple Chemical Sensitivity]
http://fibroamerica.blogspot.com
fibroamerica@gmail.com
Argentina
Ana Medina Torres
President of AVA (Asociación para Vencer el Autismo)
[Association to
Defeat Autism]
Barcelona –
Spain
Elena Navarro Chávez
Plataforma para la Fibromialgia, Síndrome de Fatiga Crónica y SSQM
[Association for
Fibromyalgia, Chronic Fatigue Syndrome and Multiple Chemical Sensitivity
Syndrome]
www.plataformafibromialgia.org
Madrid - Spain
Heidi Streminger
President of MCS-SOS - Selbsthilfeorganisation Schweiz
MCS self-help organization
Rainweg 11 - CH- 3250 Lyss, Switzerland
Arturo Samit Alvarado
President of DE-SA-MA
Asociación de
Ciudadanos para la Defensa de la Salud y el Medio Ambiente
(Association of
Citizens for the Defense of Health and Environment)
Viña del Mar –
Chile
Montserrat Porto
Deibe
President of AFFINOR
Asociación de Fibromialxia e Fatiga Crónica do Noroeste
(Association of Fibromyalgia and Chronic Fatigue Syndrome of the Northwest)
Ferrol - Spain
Marifé Antuña
Suárez
Coordinator of Foro de Fibromialgia y Fatiga Crónica
"FibroAmigosUnidos" & "FibroAdolescentes"
[Forum of Fibromyalgia and Chronic Fatigue Syndrome]
www.fibroamigosunidos.com and www.fibroadolescentes.foroes.net
Gijón – Spain
Dr.
Kurt E. Müller
President of EUROPAEM
(European Academy of Environmental Medicine)
www.europaem.org
europaem@europaem.de
Würzburg – Germany
Anna Zucchero
President of the
Associazione Italiana Elettrosensibili
(Italian organization of Electro-Magnetic
Hyper-Sensitivity)
www.elettrosensibili.it
presidente@elettrosensibili.it
Marian Barnes
Vázquez
President of ANDECO
Red Internacional de Promotores del
Ecoturismo en Andalucía,
Asociación para la P
(International
Network of Promoters of Ecotourism in Andalucía,
Asociation for Environmet P
andeco@ecoturismoenandalucia.org
Málaga - Spain
Ofelia Tabares Díaz
President of ALDIS
Asociación para
Prevenir y Sanar Enfermedades Infantiles
(Association to Prevent and to the Heal Infant
Illnesses)
www.antonioaaron.com/aldis.htm and www.comunidad-autista.org
Santa Cruz de Tenerife - Spain
María Dolores
Bermúdez Vázquez
President of AGAFI
Asociación Galega de Fibromialxia
(Fibromyalgia Galician Association)
Santiago de Compostela - Spain
María Eugenia Campoo Álvarez-Cruz
President of the ANPRODENT
Consejo General de
Colegios de P
(General Council of Colleges of Dental Prosthetists in
Spain)
www.consejo-protesicosdentales.org
info@consejo-protesicosdentales.org
Madrid - Spain
Dra. María del
Pilar Martín Santiago
Medical Director of Dentists PROB(V)OCA
Group
donquijote2122@gmail.com
Santa Cruz de Tenerife - Spain
Leticia Baselga
Responsable Campaña Mercurio Cero en
(Zero
Mercury Head Campaigner in Spain of Ecologistas en Accción)
mercurio@ecologistasenaccion.org
Madrid - Spain