letter to Australian dentists in 1998!!!!!!
On the stated warnings alone, the FDA should be taken to task. In 1998
Caulk warned against the exposure to children and pregnant women. The
timeline is rather troubling...
Click here: Letters BCD
http://www.bcd.com.au/LettersDocs/LegalLiability.htm
This is a letter sent by the ASOMAT to 10,500 dentists throughout
Australia
to try to inform them of some of the most dramatic changes
to effect the dental industry for the past 150 years.
_______________________________________________
ASOMAT 13th March 1998
Australasian Society of Oral Medicine and Toxicology
PO Box A860 Sydney South NSW 2000 Ph: 02-9867-1111 Fax: 61-2-9283-2230
Are you legally responsible for the Amalgam you are using?
Dear Colleague,
The Australasian Society of Oral Medicine and Toxicology is writing to all
dentists in Australia to inform them of one of the greatest changes to
affect dentistry in the past 150 years. Please be aware of the seriousness
of this situation and consider how it affects you.
Recently, Caulk Company, manufacturers of Dispersalloy, published the
latest
Materials Safety Data Sheet (MSDS) and their Direction For Use (DFU) which
includes contraindications to the use of dental amalgam.
(.http://www.caulk.com/MSDSDFU/DispersDFU.html
February 1998)
Contrary to the claims made by the Australian Dental Association that
amalgam is safe, the manufacturers are now acknowledging the intrinsic
dangers of this material. The legal implications of this latest
development
are far reaching. If you continue to use dental amalgam you may be playing
legal roulette with your assets
Caulk state that dental amalgam should not be used:
1. In proximal or occlusal contact to dissimilar metal restorations.
2. In patients with severe renal deficiency.
3. In patients with known allergies to amalgam.
4. For retrograde or endodontic filling.
5. As a filling material for cast crown.
6. In children 6 and under.
7. In expectant mothers.
The Caulk Co. home page also warns that mercury may be a skin sensitizer,
pulmonary sensitizer, nephrotoxin and neurotoxin and, further, cautions
that
the number of amalgam restorations for one patient should be kept to a
minimum.
Caulk has also published the Material Safety Data Sheet (MSDS) for
mercury.
Of particular im****tance, are some statements made in "Section VIII -
Control Measures, Inhalation, Chronic: Inhalation of mercury vapour over a
long period may cause mercurialism, which is characterized by fine tremors
and erethism. Tremors may affect the hands first, but may also become
evident in the face, arms, and legs. Erethism may be manifested by
abnormal
shyness, blu****ng, self consciousness, depression or despondency,
resentment
of criticism, irritability or excitability, headache, fatigue, and
insomnia.
In severe cases, hallucinations, loss of memory, and mental deterioration
may occur. Concentrations as low as 0.03 mg/m3 have induced psychiatric
symptoms in humans. Renal involvement may be indicated by proteinuria,
albuminuria, enzymuria, and anuria. Other effects may include salivation,
gingivitis, stomatitis, loosening of the teeth, blue lines on the gums,
diarrhea, chronic pneumonitis and mild anemia. Repeated exposure to
mercury
and its compounds may result in sensitisation. Intrauterine exposure may
result in tremors and involuntary movements in the infants. Mercury is
excreted in breast milk. Paternal reproductive effects and effects on
fertility have been re****ted in male rats following repeated inhalation
exposures."
Ivoclar/Vivadent go further in their contraindications. They state that
their amalgam is:
1. Not only contraindicated for expectant mothers but also for nursing
mothers.
2. Not only contraindicated for patients with severe renal deficiency but
for all
patients suffering from any reduced kidney function.
The Australian Dental Association is now in a difficult, if not untenable,
position. The prevailing ADA position is that patient exposure to mercury
from amalgam dental fillings is medically insignificant. At the same time
major amalgam manufacturers are exhibiting public warnings.
All dentists must now acknowledge the contradictions between ADA policy
and
amalgam manufacturers' public warnings.
Medico-legally, the dentist who ignores manufacturer's public warnings
places himself/herself in a precarious position. Dentists are obliged to
be
familiar with the information provided in MSDS's for the products they use
and if patients suffer ill effects from the product being used in a way
which is contrary to the manufacturer's directions, then the dentist may
be
liable for the consequences. In this situation it does not matter what the
Australian Dental Association says, as it is the dentist who will be held
responsible. You may be interested to know that the American Dental
Association has recognised such a possibility and in a recent case
petitioned the court to release it from a suit filed jointly against a
dentist and the AmDA,. The AmDA claimed that it owed no responsibility for
the advice being given. The court granted the petition, which left the
dentist, who had relied on AmDA advice, as the sole defendant. It is
little
comfort that you may be insured.
All dentists must be aware of the potential adverse effects of mercury
exposure and must also be attentive to the potential effects in pregnant
females and nursing mothers. Before placing another amalgam filling, a
dentist might be well advised to establish that the patient has normal
kidney function. It is not clear whether taking a medical history will
suffice or whether a kidney function test might need to be requested. The
galvanic effect created by placing different metals in a mouth with
amalgam
fillings has the potential to increase mercury release from all amalgam
fillings. This also has implications not generally considered when placing
stainless steel orthodontic appliances in a patient with amalgam fillings.
The use of metal pins with amalgam may need to be reconsidered. If amalgam
is contraindicated in a six year old, the next question must surely be -
at
what age is amalgam safe? The scientific research shows clearly that
mercury
is toxic to all people, at all levels. The Agency for Toxic Substances and
Disease Registry in the USA lists mercury as one of the twenty most
hazardous substances to human beings. The ATSDR's current allowable
Minimal
Risk Levels (MRL) for acute exposure are 0.02 mcgm/m3 and for chronic
exposure 0.014 mcgm/m3. Compare this with published research, indicating
amalgam mercury vapour concentrations in the mouth, as high as 87.5
mcgm/m3.
The absorption rate of inhaled mercury vapour is extremely high,
approximately 80% of the inhaled dose, reaching the brain tissue within
one
blood circulation cycle. The toxic threshold for mercury vapour has never
been found. Even the US Environmental Protection Agency has so stated. The
existing occupational standards are all specifically declared to be
estimates only on the appearance of clinically observable signs and
symptoms. The World Health Organisation, in 1991, made it clear that there
is NO safe level of mercury vapour and that amalgam represents the
greatest
source of mercury to the general population.
The spectre of potential liability for adverse effects from dental amalgam
is now a reality.
ASOMAT recently made a 4 page submission to the Federal Executive of the
Australian Dental Association offering confidential background briefings
about the latest research to all Executive members and any other officers
or
committees. ASOMAT's submission was conciliatory and asked for the lines
of
communication to be opened so that the ADA could stay informed about ALL
the
research. Our offer of cooperation was peremptorily rejected.
Any dentist faced with patients wanting the removal of amalgams from their
mouths should note that specific protocols exist for the safer removal of
amalgam. Unless you are familiar with these protocols, it is not
recommended
to proceed with the wholesale removal of dental amalgam. You may create
more
problems than you solve.
It would be appropriate for you to contact your insurer and ask the
specific
question..." If I use amalgam contrary to the specific warnings and
contraindications stated by the manufacturer and my patient suffers
effects
known to be associated with mercury exposure, will you cover me fully for
my
legal costs and any damages in the event that the patient sues me? "
Whatever the answer, get it in writing!
ASOMAT's concern has always been that dentists and patients be fully
informed. We are very worried that the profession is badly prepared to
deal
with these quickly changing cir***stances, especially in light of a recent
press conference in Sweden on the 19th February 1998. At that time the
Swedish Council for Planning and Coordinating Research, a body
commissioned
by the Swedish Government to review the literature on amalgams, stated the
following.. "Mercury from amalgam may damage the brain, kidneys and the
immune system of a great number of people. The effects in foetus and
children are of most concern." Those are the conclusions of a re****t soon
to
be handed to the Government. "There is no conflict any more", says Gunnar
Goude from the board of the Swedish Council for Planning and Coordinating
Research (FRN), after reviewing the comprehensive do***entation from the
four seminars. "There is total agreement among the Board members that it
is
time to move forward and leave amalgam behind". The Board will, in their
coming re****t to the Government, recommend discontinuing the use of
amalgam
as a dental material.
The Australasian Society of Oral Medicine and Toxicology was formed to
bring
the latest scientific research about bio-compatible dentistry to the
attention of the dental and medical community and the public. Again,
ASOMAT
is taking the lead in the distribution of critical information. ASOMAT
trusts that this notice has been of help to you and invites you to join us
in September for our 4th annual conference.
The following are available on request:
(Go to ASOMAT's Home Page to find the following information:
www.asomat.com)
- Copy of ASOMAT's submission and the Australian Dental Association's
response.
- A full page printout detailing the Swedish press conference.
- A copy of the Caulk Company DFU sheet listing the contraindications and
their MSDS
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