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The American Dental Association and Mercury "Silver" Amalgam


The legal position of the American Dental Association (ADA)  on the safety of mercury containing dental amalgam and the use of the material by dentists in the United States was recently stated as follows:

"The ADA owes no legal duty of care to protect the public from allegedly dangerous products used by dentists.  The ADA did not manufacture, design, supply or install the mercury-containing amalgams.  The ADA does not control those who do.  The ADA's only alleged involvement in the product was to provide information regarding its use.  Dissemination of information relating to the practice of dentistry does not create a duty of care to protect the public from potential injury".

Source: Legal brief filed in 1995 by attorneys for the ADA in W.H. Tolhurst vs. Johnson and Johnson Consumer Products, Inc.; Engelhard Corporation; ABE Dental, Inc.; the American Dental Association, et al., in the Superior Court of the State of California, in and for the County of Santa Clara, CA, Case No. 718228.

This legal position adopted by the ADA seems to contradict the organization's publicly stated mission.  According to their own web site (www.ada.org):

"The ADA is the professional association of dentists dedicated to serving both the public and the profession of dentistry. The ADA promotes the public's health through commitment of member dentists to provide quality oral health care, accessible to everyone. The ADA promotes the profession of dentistry by enhancing the integrity and ethics of the profession, strengthening the patient/dentist relationship and making membership the foundation of successful practice. The ADA fulfills its public and professional mission by providing services and through its initiatives in education, research, advocacy and the development of standards."

Somehow the ADA's stated mission of promoting public health does not require the organization to protect the public even when their own member dentists are following ADA guidelines and standards of care for the use of mercury containing dental amalgams.

For the uninformed public, most dental amalgam contains approximately 50% elemental mercury by weight (see amalgam composition)

To find out what the ADA "really meant" by its statements regarding the use and safety of dental amalgam in the Tolhust case see http://www.ada.org/prac/position/bioprobe.html

In contrast to what they say, the American Dental Association has endorsed Crest toothpaste and at least 1,300 other products. (NYT, 8/13/97) according to the Integrity in Science project of the Center for Science in the Public Interest, a non-profit group in Washington, D.C. CSPI is funded largely by its many members and somewhat by philanthropic foundations; CSPI receives no corporate or government funds. The project is directed by Ronald Collins (ronc@cspinet.org).. http://www.cspinet.org/integrity/corp_funding.html.   


In the class-action lawsuit recently brought by 500,000 smokers in Florida against the tobacco industry,  Robert Heim, the lead attorney for Philip Morris, stated the tobacco industry could not be held accountable for the health consequences caused by cigarettes because of the following:

"The basic common sense of the American people for the most part is: You knew the risk, you took the choice and you should be responsible".*

*Source: Associated Press article, dated 10/20/98, written by Tracy Fields.

Maybe someone should ask the American people these same three questions concerning the health consequences resulting from the mercury released from dental amalgam fillings.

Did you know there was a risk?

Were you given a choice?

Who should be held responsible?


What Does the ADA Seal of Acceptance Really Stand For?

For more than 125 years, the ADA has sought to ensure the safety and effectiveness of dental products. As early as 1866, an ADA committee prepared a statement on dentifrices (toothpaste).

The first Seal of Acceptance was awarded in 1931. Although it is strictly voluntary, about 350 companies participate in the Seal program. The ADA Seal generally is awarded for a three-year period.

More than 100 consultants, including members of the ADA's Council on Scientific Affairs and ADA staff scientists, review and declare oral care products safe, effective and worthy of the ADA Seal. 

The Seal on a product is an assurance for consumers and dentists against misleading or untrue statements concerning a product, its use, safety and effectiveness.

http://www.ada.org/public/topics/seal.html


Don't remove amalgam fillings, urges American Dental Association

Marilynn Larkin

The Lancet, Volume 360, Number 9330, 03 August 2002

http://www.thelancet.com/journal/vol360/iss9330/full/llan.360.9330.news.22012.5

The American Dental Association (ADA) has launched a media campaign aimed at discouraging patients from having amalgam [silver-coloured] fillings removed and physicians from recommending the intervention, says Frederick Eichmiller (Paffenbarger Research Center, Gaithersburg, MD, USA). "We're seeing more and more patients with multiple sclerosis, Alzheimer's disease, and autism thinking that the conditions can be corrected by removing amalgams. Their physicians don't know how to advise them, and so they say 'go ahead and try it' when the evidence isn't there. So patients are being given false hope, plus there are risks and often huge costs associated with removing and replacing the fillings", he warns.

Concerns about amalgam arose in large part because the material contains mercury, explains Eichmiller. But when mercury is mixed with such metals as silver, "it forms a stable alloy, similar to the way that sodium and chlorine--both hazardous in their pure state--combine to form ordinary table salt." Although a "minute" amount of mercury vapour may be released by amalgam fillings as a result of vigorous chewing and grinding, "a person would have to have almost 500 amalgam fillings in his mouth to see subtle symptoms, even if he were the most mercury-sensitive patient", asserts Eichmiller.

The ADA Code of Ethics prohibits member dentists from telling patients that removal of any type of dental filling will cure various diseases because such a statement cannot be substantiated scientifically, Eichmiller continues. Furthermore, "every time you remove fillings, you risk damaging the teeth. Each time you replace a filling it has to be a little bit larger. And the more often we surgically intervene on a tooth, the higher the risk of adverse reactions or the need for a root canal. Plus, it could cost tens of thousands of dollars to do this in some cases. So patients are making this large investment and not really seeing any relief", he emphasises.

The US National Institutes of Health are 2 years into a 7-year, multicentre clinical trial of children aged 6 to 10 years to see whether any adverse health effects result from amalgam fillings (http://www.clinicaltrials.gov; search on "amalgam"). "Of course, they can't release any findings yet, but they have told us that there are no indications right now that would cause them to discontinue the trial", says Eichmiller. "And we know from the recent oestrogen trial [see Lancet 2002; 360: 146] that if there were any adverse responses, they'd pull the plug in a hurry, especially in children."

Marilynn Larkin


Should amalgam fillings be removed?

*Gianpaolo Guzzi, Marco Grandi, Cristina Cattaneo

Airmeb-Unit of Metal Biology and Biocompatibility, Milan, Italy; and *Institute of Legal Medicine, University of Milan, 20133 Milan, Italy (e-mail:labanof@tin.it)

The Lancet Volume 360, Number 9350     21 December 2002

http://www.thelancet.com/journal/vol/iss/full/llan.360.9350.correspondence.23681.1

Sir--Marilyn Larkin's news item (Aug 3, p 393)1 on the American Dental Association's campaign to discourage people from having amalgam fillings removed deserves some comment. In her report, she cites Frederick Eichmiller's concerns about the number of patients with multiple sclerosis, Alzheimer's disease, and autism requesting removal of these fillings.

Dental amalgam is a mercury-based filling that contains elemental mercury at about 50% by weight. Amalgam is classified as an intermetallic compound, because it is mixed with silver, tin, copper, and zinc. To the chemist, this intermetallic compound is unstable by definition--and not a "stable alloy", as reported by Eichmiller--and mercury vapour leaks from dental amalgam over time.

Mercury adsorbed daily from dental amalgam ranges from 2 to 17 µg (not "minute" amounts as Eichmiller claims), and people that use chewing gum or are affected by bruxism may have higher intake of mercury from dental amalgams. Moreover, individuals with dental amalgams are exposed to continuous long-term amounts of mercury (in vapour form and in organic form from biotransformation by oral bacteria). Mercury vapour and organic mercury are the two most important forms of mercury in terms of toxic effects, their major target organ being the central nervous system. Furthermore, T Clarkson2 describes individuals with immunological susceptibility to mercury compounds who present with clinical adverse effects.2

F L Lorscheider and co-workers3 found a correlation between the total number of amalgam surfaces and total mercury content in whole blood, plasma, urine, faeces, breastmilk, and placenta. Postmortem examinations by M Nylander and colleagues4 show significant correlations between mercury tissue concentrations and the number of amalgam fillings. Similarly, our necropsy findings show a correlation between number of amalgam fillings and mercury content of tissue in brain, pituitary, thyroid, and kidney (unpublished data). Leistevuo and colleagues5 also report higher concentrations of organic mercury in saliva samples from patients with dental amalgams compared with controls.

We believe that Eichmiller's comments are not supported by the findings of experimental studies. The health effects of amalgam fillings warrants further investigation and should be commented on with caution, from whichever view you approach the issue.

*Gianpaolo Guzzi, Marco Grandi, Cristina Cattaneo

Airmeb-Unit of Metal Biology and Biocompatibility, Milan, Italy; and *Institute of Legal Medicine, University of Milan, 20133 Milan, Italy (e-mail:labanof@tin.it)

1 Larkin M. Don't remove amalgam fillings, urges American Dental Association. Lancet 2002; 360: 393.

2 Clarkson TW. The three modern faces of mercury.  Environ Health Perspect 2002; 110: (suppl) 1 11-23. [PubMed]

3 Lorscheider FL, Vimy MJ, Summers AO. Mercury exposure from "silver" tooth fillings: emerging evidence questions a traditional dental paradigm.  FASEB J  1995; 9: 504-05. [PubMed]

4 Nylander M, Friberg L, Lind B. Mercury concentrations in the human brain and kidneys in relation to exposure from dental amalgam fillings.  Swed Dent J 1987; 11: 179-87. [PubMed]

5 Leistevuo J, Leistevuo T, Helenius H, et al. Dental amalgam fillings and the amount of organic mercury in human saliva.  Caries Res 2001; 35: 163-65. [PubMed]

 


Should amalgam fillings be removed?

*Matthias Folwaczny, Reinhard Hickel

Department of Operative Dentistry and Periodontology, Ludwig-Maximilians University, 80336 Munich, Germany (e-mail:mfolwa@dent.med.uni-muenchen.de)

The Lancet Volume 360, Number 9350     21 December 2002

http://www.thelancet.com/journal/vol/iss/full/llan.360.9350.correspondence.23681.1

Sir--The American Dental Association's recommendation not to remove amalgam restorations solely for the treatment of different systemic diseases,1 is primarily based on the lack of evidence that amalgam fillings have any effect on the clinical course of disorders such as multiple sclerosis, autism, and Alzheimer's disease.

In many cases of removal, the amalgam filling is replaced by composite or gold restorations. Although the composite materials do not contain mercury, F Reichl and colleagues' in-vitro studies2 show significant cytotoxic and even genotoxic activity for some of their components. These restorative materials are partially composed of organic polymerisable monomers. Experimental in-vitro models point to a possible association between certain composite monomers and mutagenic damage within eukaryontic cells.3,4 However, the clinical significance of the mutagenic effects of some of the composite monomers in human beings remains to be investigated. Gold restorations might also have systemic effects. G Drasch and co-workers5 found that in patients with dental gold restorations systemic gold did reach concentrations that may induce side-effects comparable to those seen during disease-modifying antirheumatic therapy with gold.5

Most patients who want amalgam fillings removed are worried about the toxic effects of mercury, even though there is little evidence to substantiate this concern. On the contrary, there is evidence that the restorative materials that are commonly used as an alternative to amalgam might have genotoxic and cytotoxic effects.

*Matthias Folwaczny, Reinhard Hickel

Department of Operative Dentistry and Periodontology, Ludwig-Maximilians University, 80336 Munich, Germany (e-mail:mfolwa@dent.med.uni-muenchen.de)

1 Larkin M. Don't remove amalgam fillings, urges American Dental Association. Lancet 2002; 360: 393.

2 Reichl FX, Walther U, Durner J, et al. Cytotoxicity of dental materials in lung cells.  Dent Mat 2001; 17: 95-101. [PubMed]

3 Heil JG, Reifferscheid P, Waldmann G, et al. Genotoxicity of dental materials.  Mutat Res 1996; 368: 181-94. [PubMed]

4 Schweikl H, Schmalz G. Triethylene glycol dimethacrylate induces large deletions in the hprt gene of V79 cells. Mutat Res 1999, 438: 71-78.

5 Drasch G, Muss C, Roider G. Gold and palladium burden from dental restoration materials.  J Trace Elem Med Biol 2000; 14: 71-75. [PubMed]

 


ADA Statement on Dental Amalgam

Revised Oct 14, 2002

http://www.ada.org/prof/prac/issues/statements/amalgam.html

Dental amalgam (silver filling) is considered a safe, affordable and durable material that has been used to restore the teeth of more than 100 million Americans. It contains a mixture of metals such as silver, copper and tin, in addition to mercury, which chemically binds these components into a hard, stable and safe substance. Dental amalgam has been studied and reviewed extensively, and has established a record of safety and effectiveness.

Issued in late 1997, the FDI World Dental Federation and the World Health Organization consensus statement on dental amalgam stated, "No controlled studies have been published demonstrating systemic adverse effects from amalgam restorations." The document also states that, aside from rare instances of local side effects of allergic reactions, "the small amount of mercury released from amalgam restorations, especially during placement and removal, has not been shown to cause any … adverse health effects."

The ADA’s Council on Scientific Affairs’ 1998 report on its review of the recent scientific literature on amalgam states: "The Council concludes that, based on available scientific information, amalgam continues to be a safe and effective restorative material." The Council’s report also states, "There currently appears to be no justification for discontinuing the use of dental amalgam."

In an article published in the February 1999 issue of the Journal of the American Dental Association, researchers report finding "no significant association of Alzheimer’s Disease with the number, surface area or history of having dental amalgam restorations" and "no statistically significant differences in brain mercury levels between subjects with Alzheimer’s Disease and control subjects."

The U.S. Public Health Service issued a report in 1993 stating there is no health reason not to use amalgam, except in the extremely rare case of the patient who is allergic to a component of amalgam. This supports the findings of the Food and Drug Administration (FDA), the National Institutes of Health Technology Assessment Conference and the National Institute of Dental and Craniofacial Research, that dental amalgam is a safe and effective restorative material. In addition, in 1991, Consumer Reports noted, "Given their solid track record . . . amalgam fillings are still your best bet."

In 1991, the FDA’s Dental Products Panel found no valid data to demonstrate clinical harm to patients from amalgams or that having them removed would prevent adverse health effects or reverse the course of existing diseases. The FDA's most recent reaffirmation of amalgam's safety was published in March 2002

The reaffirmation reads, “FDA and other organizations of the U.S. Public Health Service (USPHS) continue to investigate the safety of amalgams used in dental restorations (fillings). However, no valid scientific evidence has ever shown that amalgams cause harm to patients.”

It continues, “Also, USPHS scientists analyzed about 175 peer-reviewed studies submitted in support of three citizen petitions received by FDA after the 1993 report. They concluded that data in these studies did not support claims that individuals with dental amalgam restorations will experience problems, including neurologic, renal or developmental effects, except for rare allergic or hypersensitivity reactions.”

The U.S. Public Health Service found in 1993 "no persuasive reason to believe that avoiding amalgams or having them removed will have a beneficial effect on health." In fact, it is inadvisable to have amalgams removed unnecessarily because it can cause structural damage to healthy teeth.

The ADA supports ongoing research in the development of new materials that it hopes will someday prove to be as safe and effective as dental amalgam. However, the ADA continues to believe that amalgam is a valuable, viable and safe choice for dental patients and concurs with the findings of the U.S. Public Health Service that amalgam has "continuing value in maintaining oral health."

Page Updated: March 03, 2003


More on Amalgam from the ADA

http://www.ada.org/prof/prac/issues/topics/amalgam.html

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