Government Agencies: The influence of the ADA with government agencies is a matter of record; the ADA has been represented on amalgam "committees" established by government agencies and, arguably, is instrumental in the composition and conclusions of these committees. An example is the current proposal of the Agency for Toxic Substances and Disease Registry (ATSDR) to raise their Minimal Risk Level (MRL) standard for general population chronic exposure to mercury vapor by almost fifteen fold, and declare patient exposure to dental amalgam mercury to be harmless, based primarily on the position of the ADA!

The position of the Food and Drug Administration (FDA) is of particular interest, as FDA regulations specifically direct the Agency to rely on safety information on products that is provided by the manufacturer. So, if the information from the manufacturer is contrary to that from the ADA, the FDA must follow the manufacturer. The FDA currently has accepted and classified only "dental mercury (Class I)" and "amalgam alloy (Class II)", but not mixed amalgam. The FDA is now responsible for the information provided by Dentsply/Caulk, which contradicts a classification of Class I for dental mercury, and complicates their current consideration for classification of "dental amalgam."

Dental Boards: The Dentsply/Caulk public statement should have a profound effect on the attacks by dental boards on mercury-free dentists, many of whom have been brought before boards simply for providing information on potential adverse effects of amalgam mercury. The Boards have claimed that the information challenging the safety of amalgam constitutes fraud and misrepresentation. This position by the Boards is obviously now determined to be improper. The question now becomes: "Can dental boards legally discipline dentists for providing information that is publicly displayed by a major amalgam manufacturer?"

Perhaps as importantly, can dental boards allow dentists to provide information on amalgam safety that is contrary to information publicly provided by the manufacturer? Such conduct might legally be interpreted as "negligent misrepresentation." It may very well be that the dental boards may now be obliged to ensure that all practicing dentists issue the amalgam contraindications and warnings to all patients! These are points that should be investigated by legal minds.

Dental Schools: In order to practice dentistry in most states, the dentist must have graduated from an "accredited" School of Dentistry. The "Accreditation" is a function of a committee of the ADA! So, the curriculum and policies of dental schools are dictated by the ADA. This is rather like the tail wagging the dog; it should be the other way around. This is, nonetheless, the case currently.

Now, dental schools are facing a serious dilemma. They are teaching the use of a product, and promoting the ADA position of safety of that product, in direct contradiction to public warnings by the manufacturer. It would seem that dental schools now have the obligation to instruct dental students on the amalgam warnings and contraindications. This would place them in direct opposition to the professional trade organization that accredits them!

It is now arguable that the ADA position on the safety of dental amalgam presents a conflict of interest to dental schools, in view of the requirement for accreditation by the ADA. The time has clearly come to establish dental school accreditation independent of the ADA.

The Media: Many, if not most, segments of the media provide information to the public on amalgam safety based on input from the ADA. Now, public information from the manufacturer contradicts the information they have been providing.. The concept of responsible journalism dictates that the media now correct the misinformation that they are providing to the public. On the other hand, media entities such as "60 Minutes" and others are now vindicated. Their credibility would be reinforced by addressing the issue once again, with inclusion of the new information. The Public: The public has open access to the Internet, so the Dentsply/Caulk information can be considered to be in the public realm, and an increase in public awareness might be anticipated. Denial of potential adverse effects from amalgam mercury could now be a serious problem for all members of the dental industry who claim that the product is harmless.

Dentists: All dentists must now acknowledge contraindications and potential adverse effects to amalgam fillings! It does not matter what the American Dental Association (ADA) says, the manufacturer has publicly issued warnings and contraindications for the product being used. Medico-legally, the dentist will be bound to the information being publicly provided by the manufacturer.

It is also established that dentists are obliged to be familiar with and to be responsible for the information provided in MSDSs for products. Therefore, all dentists must be aware of the potential adverse effects of mercury vapor inhalation. They are especially responsible for the adverse effects occurring in the oral cavity; salivation, gingivitis, stomatitis, loosening of the teeth, and blue lines on the gums. Dentists must also be attentive to the potential effects on unborn and nursing babies, as their product use includes pregnant females and nursing mothers.

The specter of potential liability for adverse effects from dental amalgam must also be considered. Since the ADA has bailed out on potential amalgam liability, the FDA refuses to accept and classify the mixed dental amalgam actually implanted into patients, and the manufacturers now are issuing warnings (for their own legal protection), the full responsibility now rests with the practicing dentists! ADA members may now be well advised to consider their prevailing confidence in their trade organization.

Mercury-Free Dentists: The new development should provide valuable ammunition for dentists who feel a moral obligation to inform their patients of potential adverse effects from a product present in their mouths. The most important aspects of this are medico-legal, relating to obligations to the patient and experiences that may arise with dental boards.

Please note the changes to the above information that was published in the May, 1998 Bio-Probe Newsletter

In the last issue [BPNL, 14(2), March 1998], we reported that Densply/Caulk (D/C) had placed side effects, warnings, precautions and contraindications for its Dispersalloy and other amalgam products in the "Directions For Use (DFU)" on their Internet site. Subsequently, we learned that Ivoclar had issued even more stringent warnings and contraindications in the DFUs for their amalgam products, although these were not placed on the Internet.

As might be expected, the hue and cry resulting from this was monumental! Densply/Caulk quickly removed the DFUs from its Internet site and has announced that the DFUs would be "modified" to conform with the "current" position that amalgam products are harmless to patients. The explanation for the original posting was that it was in response to Proposition 65 in California and European Union (EU) requirements for the CE labeling, for marketing specifically in Germany. A letter from Dentsply, United Kingdom stated: "Regulations in the State of California, USA and Germany only, stipulate that these regulations must be adhered to. This however, does not apply to the UK where BDA [Ed note: British Dental Association] assurances are currently fully supported by DENTSPLY." Bio-Probe has learned that Dispersalloy sold in California does contain the DFU insert containing the warnings and contraindications, whereas that sold in some other states do not. The message, apparently, is that if Dispersalloy is placed in California, it could have adverse effects and requires warning the patient. If, however, it is placed in other states there could not be any adverse effects and therefore warning patients is not required. The same, apparently, would apply to the other European Union countries other than Germany.

While the logic of this dichotomy defies explanation, the legal question should provide fertile grounds for investigation by attorneys. As an example, if a manufacturer issues warnings, precautions and contraindications for its product in one locale, does the potential for liability extend to any locale where the product is sold? If so, does the duty to inform require that the patients be warned in all locales, or only where the warning is required? In the event of liability, who bears the responsibility in the locale requiring warning, and in other locales [More on this issue in the next article.]?

Of further interest is the posting of MSDSs [Material Safety Data Sheets] on the amalgam products. These clearly depict adverse effects from exposure to mercury, including chronic exposure. Dentists are responsible for the information found in MSDSs; they must make the information available to patients and staff members. There is no defense for not doing so. This presents dentists using amalgam with another medico-legal dilemma. It also provides a strong defense to mercury-free dentists for informing patients of potential adverse effects from exposure to amalgam mercury. State dental boards should take note of this when addressing the amalgam controversy.

Source: BioProbe Newsletter

Also make sure to read these books: Poison in Your Teeth: Mercury Amalgam (Silver) Fillings...Hazardous to Your Health! and Mercury Detoxification by Tom McGuire