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Questions and Answers on Dental Amalgam
1. What is dental amalgam?
Dental amalgam is the silver-colored material used to fill (restore) teeth that have cavities. Dental amalgam is made of two nearly equal parts: a powder containing silver, tin, copper, zinc and other metals, and liquid mercury.
Dental amalgam has been used to fill cavities for over 100 years. It is easy to use, strong, durable, and relatively inexpensive.
2. What is FDA’s role in dental amalgam?
Dental amalgams are medical devices and are regulated by FDA’s Center for Devices and Radiological Health (CDRH). CDRH is responsible for ensuring that medical devices are reasonably safe and effective and that the labeling has adequate directions for use and any appropriate warnings.
3. What are the safety concerns about dental amalgam?
When amalgam fillings are placed in teeth or removed from teeth, they release mercury vapor. Mercury vapor is also released during chewing. Some people believe that this mercury vapor can cause health problems, including neurological disorders, in certain sensitive individuals.
4. Is there evidence that dental amalgam is unsafe?
Since the 1990s, FDA and other government agencies (CDC, NIH) have reviewed the scientific literature looking for links between dental amalgams and health problems. To date, the agencies have found no scientific studies that demonstrate dental amalgams harm children or adults. But we continue to review the literature and ask experts their opinions on the safety of dental amalgam.
In September 2006, an advisory panel to the FDA reviewed FDA’s research and heard presentations from the public about the benefits and risks of mercury and amalgam. This was a combined panel of the Dental Products Panel from FDA’s Center for Devices and Radiological Health (CDRH), and the Peripheral and Central Nervous System Drugs Advisory Committee from FDA’s Center for Drug Evaluation and Research (CDER).
The panel generally agreed that there is no evidence that dental amalgams cause health problems in the majority of the population. However, the panel did raise concerns about the lack of knowledge concerning the effects of dental amalgam on specific groups, including pregnant women, small children, and people who are especially sensitive to mercury.
During the meeting, FDA presented a draft white paper that reviewed the scientific literature from 1997 to the present on the safety of dental amalgam. FDA asked the panel for its opinion on this paper. The panel recommended that the FDA reevaluate the literature. Specifically, they wanted to know if there was additional information available regarding the effects of dental amalgam on pregnant women, small children, and sensitive individuals, and on exposure levels during initial placement or removal of amalgam fillings.
You can read the summary of the panel meeting at: http://www.fda.gov/cdrh/meetings/090606-summary.html
In addition, a complete transcript is available at: http://www.fda.gov/ohrms/dockets/ac/cdrh06.html#dentalproductspanel
5. Are there other dental filling materials that can be used instead of amalgam?
Yes, there are several other types of dental fillings.
Resin composites are tooth-colored materials made from powdered glass and resin compounds. When composites were initially introduced, they were not very strong and were used primarily in the front teeth. Newer composites are stronger, although they still tend to wear more than metal-based materials and generally need earlier replacement.
Glass ionomer cement is also a tooth-colored material. It is not usually used for long-term fillings because it breaks easily.
Porcelain, gold, and other metals are also used as filling materials. Gold and porcelain are used for inlays, veneers, crowns, and bridges. These fillings are made outside the mouth and cemented into place after they are formed.
6. Should I have my amalgam fillings removed and replaced with these other materials?
There are no scientific studies that show that having dental amalgams is harmful, or that removing your amalgam fillings will improve your health.
If you are concerned about the possible health effects of amalgam fillings, you should talk with your dentist or doctor.
7. If I have a cavity, should I choose to get amalgam fillings?
If you are concerned about whether or not dental amalgam is appropriate for you, you should talk with your dentist or doctor.
Dental amalgam fillings are very strong and durable, they last longer than most other types of fillings, and they are relatively inexpensive. You may want to weigh these advantages against the possibility that dental amalgam could pose health risks that are not yet scientifically known.
8. Should pregnant women and young children use or avoid amalgam fillings?
The recent advisory panel believed that there was not enough information to answer this question.
Some other countries follow a “precautionary principle” and avoid the use of dental amalgam in pregnant women. Canada and Sweden have environmental policies that favor a reduction of mercury in all products, and in Sweden amalgam has been almost entirely replaced by alternative materials. Both countries, however, state that there is no scientific evidence of a connection between the use of dental amalgam and medical problems.
Pregnant women should not avoid seeking dental care, but should discuss options with their health practitioner.
9. What is the next step for FDA?
FDA has opened a public docket to collect additional comments about dental amalgams. The docket will be open until November 9, 2006. You may submit a comment on dental amalgams to docket number 2006N-0352. You will find the docket at: http://www.fda.gov/dockets/ecomments.
After the docket closes, FDA will review all of the comments submitted. It will also study peer-reviewed literature and the findings and recommendations from the 2006 panel meeting.
Once FDA has completed its review, the next steps will depend on FDA’s scientific evaluation. For example, if the research shows that amalgams are more risky for certain groups of people, FDA may propose that the labeling for amalgams be changed to address these issues.
(See also: 2002 Consumer Update: Dental Amalgams)
Updated October 31, 2006
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