Ministry of Health
Senior Council of Health (SCH)
General secretariat
Ref. 100.CSS/ 05.01/ 57
Rome 15/ 07/ 1999
To the National Federation of the Orders
Of the Medical Surgeons and of the Dentists
Piazza Cola di Rienzo, 80/A
Rome 00192
(Fax 06-3222794)
Object: Request copy of advice
With reference to the request of 24th June ult., we
transmit to you the advice expressed from the General Assembly of the Senior Council of
Health on April 14 1999 regarding the "Dental Amalgam."
We bring to your attention - for each good purpose- that the Senior Council of Health is a
technical advisory organ of the Ministry of Health and, therefore, it expresses not final
says whenever it is asked for by the Ministry or by the Departments and Services of the
Ministry of Health: this is communicated because it must be known that advice don't
constitute health precautions (decrees, ordinances, circular, etc.) neither they are to
these necessarily preliminary. The precautions, in fact, are adopted from the
Administration which can also not take into consideration, in all or partly, what the
Council has deliberated.
The General Secretary
Ministry of Health
Senior Council of Health
XLIII Session
General assembly
Session of April 14 1999
The Senior Council of Health
General assembly
Read the report of the II Department having as object:
"Art.7, I and II paragraph L.175/92 - Advice of the Senior Council of Health -
(Dental Amalgam)"
Read the L. 5/ 2/ 92 n.175 "Rules about sanitary publicity and of repression of the
unauthorised exercise of the sanitary professions."
Considered that Art.7 of the above-mentioned law provides
that:
- the Minister of Health, on his own initiative or on request by the Orders and by
professional Boards, could arrange the rectification of information and news on
controversial matters of medical character, provided to people in an unilateral way by the
press or by means of television communications;
- the Minister of Health, heard, where necessary, the opinion of the SCH, requests the
responsible of the publication or of the transmission to provide for the diffusion of the
rectification.
Noted that the National Federation of the Orders of the
Medical Surgeons and of the Dentists has asked for the scheduled intervention according to
the above-mentioned Art.7, with reference to the telecast of the Third Channel RAI of the
day 8. 10. 98, in which information of medical character about the dangerousness of the
dental amalgam for the human health were given.
Viewed the tape relative to the program Report
Investigation "Not only the tooth is poisoned."
Heard the 'ad hoc' constituted preliminary group : Prof
Cuccurullo, Bucci, Curtoni, Apostles, Carere, Chiarotti, De Fazio, Flowers, Goracci,
Gramiccioni, Jandolo, Schiavino.
PREMISED
- that the dental amalgam is a medical device according
to the Law by Decree 24.2.97 n.46 Accomplishment of the Directive 93/ 42 EEC, and
therefore with obligation of CE marking;
- that the amalgam is constituted by an alloy of metals (silver, copper, zinc, etc.) and
from the mercury which must be in optimal ratio of 1: 1, in order that there are not
excesses of mercury and this doesn't disperse in the environment;
- that nowadays the use of premeasured and hermetic capsules, of vibrators for the mixture
and of separators in the dumping of the dental chairs has practically eliminated the
pollution from mercury in the dental office;
- that the amalgam, in use by now from beyond a century, still constitutes today the
material of choice for the restorations in the posterior sectors in conservative dentistry
in virtue of his physical quality of standing wear and tear and of marginal adjustment.
CONSIDERED
- that the incidence of the allergy to the
mercury is in increase, but there are not demonstrations that this observation is worth
also for the patient carrying fillings in amalgam in mercury;
- that it is possible to speak about allergy to the present metals and particularly to the
mercury of the dental amalgams if the following situations are present at the same time:
a) indicative symptoms (inflammatory lesions of oral mucosae, cutaneous systemic lesions
of urticaric-angioedematous or eczematous type);
b) positive patch for the mercury or compound containing mercury;
c) disappearance of the symptoms after the removal of the filling containing mercury
CONSIDERED ALSO
- that, from the studies performed on the toxicity and
biocompatibility of the amalgam, there is no reason to conclude that the mercury from the
fillings in amalgam could constitute a risk for the population;
- that the toxicological effects of the mercury has been described in professionally
exposed groups for significantly more elevated doses than those supposable for the
amalgams: besides, also concerning the toxicity after working exposure they have been
proved considerable differences located in the appearance and in the entity of the same
effects;
- that from the studies published about the correlation between the presence of dental
amalgams and the presence of mercury in fabrics, blood and urine, the latter appears
hardly considerable and however it never reaches a level that could be defined toxic.
- that we need more researches to evaluate the possible toxicity of the present materials
alternative to the amalgam.
BESIDES
The fact that the reports of onset of pathologies
correlated to the use of the amalgam concern essentially multifactorial illnesses should
invite to the maximum prudence in accepting these data, as a matter of fact:
- the hypothesis of a correlation between the multiple sclerosis (pathology of the nervous
system that recognises varied etiopathogenetic factors, among which the genetic
predisposition) and the amalgam is inconsistent, as shown in a recent case-control study,
of Bengasi et al., carried out in Canada (International Journal Epidemiology 27,667-671,
1998);
- real or likely elements don't result that may allow to identify a pathogenetically
causal element of secondary oculars diseases in the presence of amalgam in a dental
filling.
NOTED
- that to protect the right to health, if on the one hand
omitted information could not be tolerated, on the other hand any form of information not
supported from data fortified by scientifically validated experimentations must be
avoided;
- that to provide information without an accurate control of the sources means to deprive
the patient of the possibility to choose freely;
- that arouse an excessive alarmism on the hypothetical and however statistically very
slight consequence of a therapeutic device with proved effectiveness equals to catapult
the consumers of the NHS toward alternatives not carefully tested, abandoning remedies
that in the overwhelming majority of the cases has turned out curative and without
meaningful side effects;
but,
VALUED
that in the news of scientific-sanitary character, where
the right at stake is not only that of information but above all that of health, maximum
prudence become necessary
BELIEVES
that a possible amendment of the telecast could have a
counterproductive effect
on the population
VALUED ALSO
- that an appearance that must induce caution is that of
the existence, for the general population, of multiple sources of exposure to the mercury:
feeding, ecodispersion, use of medicines;
- that there is both the problem of subgroups of particularly susceptible population
(children, pregnant women, etc.) to protect most, and that of particular situations that
could expose to even important peaks of Hg.
CONSIDERS OPPORTUNE
- to define recommendations and limitations of use in
particular situations as:
- patient with allergies to the amalgam, women in state of pregnancy, children under the 6
years, patient with serious nephropathies;
- for the Ministry of Health to arrange an informative campaign on the dental amalgam.
POINTS OUT
that there is no indication to the removal of a dental
amalgam if not in case, surely verified, of allergy to this material.
Note of the Webmaster: to understand properly this
advice, I'll try to tell you shortly what's happened in the above-mentioned telecast.
First of all, it was the second one about this topic, the first having
been broadcast one year before; both of them were honestly terrifying about all the
consequences of amalgam, especially the first one. Actually in the second programme, tones
were softer, even though lots of people with multiple sclerosis were introduced. However
this program was very important to make start a great discussion among Italian dentists
whether it was worthwhile to keep on using amalgam or not.
Just to put a stop to discussions, we started to
collect signatures to appeal to the Ministry of Health for
clarity on this basic topic; we had about 200 dentists who helped us; in these days, after
8 months, we received a reply in which we were told that the Department is studying the
matter...