On September 6-7, 2006, in Gaithersburg, MD, a very important event took place affecting every practicing dentist. Two FDA panels of distinguished scientists convened for the sole purpose of addressing the neuro-toxicity of mercury amalgam. There was a joint meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (CDER) and the Dental Products Panel (CDRH). One panel was primarily physicians, the other primarily dentists with numerous scientist-consultants. All of the panel members were credentialed in their fields, and all had met FDA ethics requirements before being appointed. After hearing pro-mercury comments from the FDA staff, they then heard from a group of witnesses whose testimony precisely demonstrated the health risks of mercury fillings. The witnesses included numerous injured patients, scientists, physicians, mercury-free dentists, and lawyers.

The first day the joint committee heard from a dental materials expert, from officials of Health Canada and the Medical Products Agency (Sweden), from the FDA, and from the public, all concluding with a talk by the honorable Congresswoman Diane Watson of California.

Fifty-two speakers testified on the second day. The panel then deliberated on a series of questions the FDA staff had posed on its draft "white paper" review of the amalgam literature.

These are the two major questions posed for a vote regarding the FDA staff’s white paper:

1. Did the white paper objectively and clearly present the current state of knowledge about the exposure and health effects related to dental amalgam?"

   Response: The panel voted "no" by a 13-7 margin.

2. Were the conclusions of the white paper reasonable?

When the voting was over, each panelist made a statement. Virtually all expressed the same or similar concerns covering one or more of the following areas:

1. The need for real informed consent after telling patients about mercury and its effects.
2. The need to stop placing mercury amalgam fillings in pregnant women and children (as Canada, Sweden, the U.K.., etc. have already decided).
3. The reality that a substantial number of persons are severely hypersensitive.
4. The reality that the majority of consumers are unaware "silver" fillings contain mercury, so dentists should be obliged to correctly identify the restoration as a mercury filling.

It is highly unusual for such a panel to disagree with the FDA staff, signifying internal division over the safety of amalgam fillings. This means, under our regulatory system, mercury fillings have not been proven safe. Please note that "safe" and "unsafe" are the only options. In short, our government can no longer assure current and future American parents that mercury fillings are safe for their children and babies.

The complete transcript of the above FDA panel hearing will be available at:

http:/www.fda.gov/ohrms/dockets/ac/cdrh05.html#Dental Products

or may be purchased from:

Neal R. Gross, Court Reporters and Transcribers: 1323Rhode Island Ave. N.W. Washington DC 202-234-4433 or 800-473-1433. Or FDA, Freedom of Information Staff (HFI-35) 5600 Fishers Lane, Rockville MD 20857, Telephone: 301-443-1726.

Before we answer that question, let us look at recent mercury amalgam litigation that has taken place over the last number of years. The general scenario usually goes this way:

1. A dentist restores a patient's teeth with mercury amalgam fillings (without telling the patient what the fillings were made out of and/or without testing the patient for sensitivity to dental materials). The patient becomes ill. Follow-up medical tests determine that the illness was caused by mercury leaking (continuously) from the amalgam fillings. All of this took place without the patient's knowledge or informed consent.
2. The patient walks in with a team of lawyers, who sues the dentist, the mercury amalgam manufacturer, and the ADA.
3. The manufacturer wiggles out of the suit by explaining that each alloy box contains warning labels (used routinely in Europe) listing side effects of amalgam filling components and dangers associated with its use. (see…http://www.altcorp.com/DentalInformation/amalgamcomp.htm)
4. The ADA avoids the lawsuit by claiming that they have no legal responsibility for whatever dangerous dental materials dentists may be placing into their patients' teeth. And rightfully so, since the ADA does not know the patient's sensitivities to dental materials nor what material the dentist has in hand and is planning to use for each individual patient.
5. The dentist has no excuse. He or she is now left alone to face the music, now solely responsible and liable for making this patient sick.

Prior to this hearing, such litigation has not gone very far. However, one can see the tremendous liability problem for all dentists using mercury amalgam fillings if determined unsafe to use in dentistry.

Dentists now have a very good reason to stop using amalgam fillings. They can say to their patients that two panels of distinguished scientists, physicians, and dentists voted 13-7 to reject the position that mercury fillings are safe.

The solution is obvious. We need to adopt the Health Canada model and immediately stop using this pre-Civil War dental filling material, particularly for pregnant women and children under seven years of age.

We dentists made an oath to do what is best for our patients. We need to err on the side of caution. This is the right thing to do.