FDA says dental amalgam is safe, but recommends warning on product label

The Food and Drug Administration has just released regulations on dental amalgam, a material is used to fill cavities in teeth and which, because it contains mercury, some fear may be dangerous to patients' health.

"While elemental mercury has been associated with adverse health effects at high exposures, the levels released by dental amalgam fillings are not high enough to cause harm in patients," the agency said in a statement.

The agency recommended that the product label contain a warning that dental professionals use adequate ventilation and that the amalgam not be used on people with mercury allergies. It also recommended the packaging carry "a statement discussing the scientific evidence on the benefits and risks of dental amalgam, including the risks of inhaled mercury vapor."

And, it further says, a scientific review has found that "The amount of mercury measured in the bodies of people with dental amalgam fillings is well below levels associated with adverse health effects. Even in adults and children ages 6 and above who have fifteen or more amalgam surfaces, mercury exposure due to dental amalgam fillings has been found to be far below the lowest levels associated with harm. Clinical studies in adults and children ages 6 and above have also found no link between dental amalgam fillings and health problems."

The agency said that there was less data to examine when it comes to risks to fetuses, breast-feeding infants and children under 6, but that the levels for kids under 6 are also likely to be safe and that the levels in breast milk are likely lower than those deemed risky by the Environmental Protection Agency. It added that pregnant and breast-feeding women should talk with their doctors about alternatives if they have concerns.

Dentists have been using dental amalgam for years. So why the rule now? Amalgam was already in use in 1976 when the agency acquired power to regulate medical devices. The agency was required by law to class pre-existing devices into classes I, II or III based on risk. They'd done mercury already, and they'd done powdered alloy (the other component of amalgam) but not the combined amalgam itself. The agency decided to do so in 2002, and this final ruling follows public comment and scientific reviews of several hundred studies.

Dental amalgam is rated Class II (moderate risk). Mercury, which used to be Class I (low risk), is now Class II.

Read more from the FDA on dental amalgam here.

-- Rosie Mestel

Photo: Al Seib / Los Angeles Times

Comments

[Joe S]

The FDA is lying again. Do not get mercury amalgam fillings. They are extremely poisonous and will affect your nervous system. FDA...shame shame on you.

[Birgit Calhoun]

I am reading with dismay that the FDA is once more shirking its responsibility by downplaying the risks of mercury from amalgam. I can only deduce form their ruling that the rule-making individuals are either unable or unwilling to understand the problem with dental amalgam. How is a mother to judge whether a child has a mercury allergy? Also why is it called allergy?

Since it is known that mercury is poisonous, why is the word allergy being used? My step-father thought he had a mercury allergy. He was a veterinary surgeon in the 1930s. Because in those days mercury ointments were used to treat joint inflammations in horses he knew how mercury affected him. He had lost all his teeth by the time he was 50. He had connective tissue inflammation as long as I can remember. What's more he died demented at around age 72. Does that sound like an allergy?

This ruling is like saying getting a little bit poisoned is not so bad. It is clearly known that mercury from amalgam is released and inhaled constantly. I am outraged at the casual nature with which the FDA is treating this problem. My son, now 43 received 30 amalgams before he was 3 years old. He has suffered from chronic depression and is unable to work because of it.

I have another child who had all the symptoms of mercury poisoning. But the doctor did not recognize it. To that pediatrician every skin disease was called eczema. I now know that it was mercury poisoning (allergy?).

[DrSmile]

Yes Joe S, you know something that hundreds of scientific studies could not divulge. Science prevails over hysteria, a rare occurrence!

[Student]

Posterior resin = higher risk of needing a root canal. They leak easier and dont last as long so everytime you replace them you take more and more tooth structure away. Resins have an estrogen-like compound that people could be just as hysteric about that (unfounded but could happen), but it hasn't reached the mainstream in the same manner. So in short - if you want to avoid it all brush you're teeth and avoid neeeding restorations all together.

[ed d]

joe s is probably a big "global warming" advocate and believes those studies. pick and choose your science.

[Johnny]

Concerning the allergy/poisoning controversy, these are 2 different body reactions. Allergic reactions can then be subcategorized into 5 different types, but the two most recognized are when a person has a reaction causing hives or problems breathing. The other reaction is more localized to the body surface that touched the substance causing allergy.

Poisoning is of a very different nature. Mercury poisoning may cause such symptoms as problems speaking, walking, numbness, and vision problems. This is not a comprehensive list, but what is more commonly known. It should also be noted that all of the described symptoms could relate to a number of other diseases.

I hope explaining the difference allows for a more intellectual discussion of the topic. Mercury in fillings is released at such low levels that I have never heard of a documented case of mercury poisoning from fillings. The higher risk exposure to mercury used in dental amalgam is to the professionals who handle the materials. A responsible dentist takes the necessary precautions to properly handle mercury and works with a very low level of risk. I know several dentists who have practiced dentistry for about 50 years free of mercury poisoning. Keep in mind that for much of theses dentists' careers, gloves were not commonly used in practice.

Dental amalgam restorations are very predictable and when indicated and placed properly may last longer than other filling materials. In a country looking for ways to manage the rising cost of health care, I hope that dental amalgam is maintained as a routine restorative material in dentistry.

[Birgit Calhoun]

I can only talk about what I experienced. My experience included all the known symptoms of mercury poisoning after having my amalgams removed. Don't get me wrong, I am glad I did. But these symptoms were mostly related to mind and mood. The "allergy?" portion is a very characteristic sloughing off of pink skin between the feet and hands. It's what they called pink disease in the late '40s early '50s. But what do I know? I only had a stepfather who died demented and toothless. He was certain that he had a "mercury allergy" that he acquired when he was a veterinary surgeon in the '30s when they still used gray (mercury) ointment on horses’ joints.

In passing I would also like to add that there are studies from abroad (Baasch, Switzerland, 1966) suggesting that there is a dental amalgam-MS (Multiple Sclerosis) connection.

[Kim k]

to calhoun- 30 filling by the age of 3- really?!?
sounds to me that your family just has BAD oral hygeine habits.
I'm so tired of people in general not being responsible for themselves-
it's always easier to blame someone else.

[Taajah]

My 15 y.o. son has spent the majority of the year in the hospital due to mercury poisoning from amalgams. Amalgams are dangerous. Read his story and learn about amalgams at www.kjsstory.com