Dental Amalgam Fillings

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Dental Amalgam Fillings are fillings made form "a mixture of metals, consisting of liquid mercury and a powdered alloy composed of silver, tin, and copper. Approximately 50% of dental amalgam is elemental mercury by weight."[1] They are a controversial subject, as the U.S. Food and Drug Administration and the American Dental Association maintain that they are safe, whereas others believe the scientific data available shows they are not safe.[2]

Safety

FDA Position

As of 2014, the FDA maintains that amalgam fillings are safe. They say:[3]

"FDA has reviewed the best available scientific evidence to determine whether the low levels of mercury vapor associated with dental amalgam fillings are a cause for concern. Based on this evidence, FDA considers dental amalgam fillings safe for adults and children ages 6 and above. 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 FDA cites several scientific studies to back its case for safety.[4][5][6][7][8][9][10]

ADA Position

The American Dental Association (ADA) states that "Dental amalgam is considered a safe, affordable and durable material that has been used to restore the teeth of more than 100 million Americans."[11] To support its position, the ADA refers to studies and findings published between 1997 and 2009, and it offers a "comprehensive literature review" summarizing evidence of amalgam safety from 2004 to 2009.[12]

Amalgam Opponents

Opponents of amalgam fillings include the International Academy of Oral Medicine and Toxicology (IAOMT) and Moms Against Mercury. In 2103, IAOMT issued a position paper summarizing their views.[13]

Children's Amalgam Trials

In backing its case for amalgam safety, the FDA cites two randomized, controlled, clinical trials on dental amalgam. These two studies are known as the "Children’s Amalgam Trials."[9][10] However, between 2011 and 2013, four studies were published that re-examined the data from one of the Children's Amalgam Trials and found evidence that amalgam fillings are not safe for some, if not all, of the children.

In 2011, scientists re-evaluated the data from one of the studies[14] and found evidence that amalgam fillings are "a significant chronic contributor to mercury body burden."[2] This was followed by a 2012 study that considered genetic differences between the children in the study.[15] It found that children with one genetic variant had neurobehavioral deficits linked with mercury exposure. In 2013, two more studies were published. One examined the same group of children with the susceptible gene, finding biomarkers of kidney damage linked to mercury exposure.[16] The second found a link s mercury exposure and neurobehavioral deficits in groups with two other genes.[17]

History of Regulation and Lawsuit

In September 2006, the FDA convened a meeting of its Dental Products Panel (CDRH) and the Peripheral and Central Nervous System Drugs Advisory Committee (CDER) to vote on a white paper "regarding the potential adverse health risks associated with exposure to mercury in dental amalgam."[18] The 24 experts on the panel voted down the white paper by a vote of 13 to 7.

In December 2007, the group Moms Against Mercury and other plaintiffs filed a lawsuit against the FDA commissioner (Moms Against Mercury v. Eschenbach), asking the FDA to take dental amalgam off the market. The case was based on the fact that the FDA was required by a 1976 law (the Medical Device Amendments) to classify medical devices in "one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device" and it still had not done so for amalgam fillings after 31 years.[19] The case settled in 2008, and the FDA promised to classify dental amalgam by July 28, 2009.

Several days before the deadline, on July 25, 2009, Moms Against Mercury and other plaintiffs submitted a Citizens Petition, asking the FDA to formally ban amalgam fillings or, alternatively, classify them as a Class III medical device and to subsequently "seek strict proof of safety and effectiveness" of the fillings. (Class III devices require approval from the FDA before they can be sold.) The last option sought by the petition - of a ban or a reclassification to Class III did not take place - was for the FDA to place restrictions on the use of amalgam fillings for groups such as pregnant women, children, and others with increased sensitivity to mercury. Last, the petition asked the FDA to prepare an Environmental Impact Statement (EIS) or at least an Environmental Assessment (EA) for amalgam fillings.

Ignoring the petition, "On July 28, 2009, FDA issued a final rule that: (1) reclassified mercury from a class I (least risk) device to class II (more risk) device; (2) classified dental amalgam as a class II device; and (3) designated a special controls guidance document for dental amalgam."[20]

A few months later, in September, Moms Against Mercury and other plaintiffs responded by submitting another petition, asking the FDA to reconsider its decision. This petition cited 29 alleged flaws in the FDA's final rule. That same month, two other petitions were independently submitted to the FDA, also calling for the banning of amalgam fillings.

The FDA convened a Dental Products Panel meeting to discuss amalgam fillings on December 14-15, 2010.[21] The meeting was to focus particularly on "potential risk to vulnerable populations, such as pregnant women, fetuses, and young children."[22][23]

In 2013, the petitioners submitted a document to the FDA containing scientific evidence published since their initial petition was filed. As of March 2014, the FDA has not responded to any of the petitions. The petitioners, including IAOMT and Moms Against Mercury, filed a lawsuit against the FDA in March 2014 to compel them to respond to the petitions.

Articles and Resources

Related SourceWatch Articles

References

  1. About Dental Amalgam Fillings, FDA, Accessed March 25, 2014.
  2. 2.0 2.1 Kristin G. Homme, Janet K. Kern, Boyd E. Haley, David A. Geier, Paul G. King, Lisa K. Sykes, Mark R. Geier, "New science challenges old notion that mercury dental amalgam is safe," Biometals, December 29, 2013, Accessed March 25, 2014.
  3. About Dental Amalgam Fillings, FDA, Accessed March 25, 2014.
  4. Dental Amalgam: A Scientific Review and Recommended Public Health Service Strategy for Research, Education and Regulation; Public Health Service, U.S. Department of Health and Human Services, January 1993.
  5. Barregard, L. et al., “Renal Effects of Dental Amalgam in Children: The New England Children’s Amalgam Trial,” Environmental Health Perspectives, Volume 116, 394-399,,No. 3, March 2008.
  6. Woods, J.S. et al., “Biomarkers of Kidney Integrity in Children and Adolescents with Dental Amalgam Mercury Exposure: Findings from the Casa Pia Children’s Amalgam Trial,” Environmental Research, Vol. 108, pp. 393-399, 2008.
  7. Lauterbach, M. et al., “Neurological Outcomes in Children with and Without Amalgam-Related Mercury Exposure: Seven Years of Longitudinal Observations in a Randomized Trial,” Journal of the American Dental Association, Vol. 139, 138-145, February 2008.
  8. Agency for Toxic Substances and Disease Registry (ATSDR) and Research Triangle Institute, Toxicological profile for mercury, U.S. Dept. of Health and Human Services, Public Health Service, Atlanta, Georgia, 1999. United States Environmental Protection Agency (EPA), “Integrated Risk Information System (IRIS) Screening-Level literature Review” – Mercury, elemental, 2002.
  9. 9.0 9.1 Bellinger, D.C. et al., “Neuropsychological and Renal Effects of Dental Amalgam in Children: A Randomized Clinical Trial,” Journal of the American Medical Association, Vol. 295, No. 15, April 19, 2006, 1775-1783, 2006.
  10. 10.0 10.1 De Rouen, T. et al., “Neurobehavioral Effects of Dental Amalgam in Children, A Randomized Clinical Trial,” Journal of the American Medical Association, Vol. 295, 1784-1792,No. 15, April, 19, 2006.
  11. Statement on Dental Amalgam, Accessed March 25, 2014.
  12. Comprehensive Literature Review, ADA Council on Scientific Affairs.
  13. IAOMT (International Academy of Oral Medicine and Toxicology), IAOMT position paper against dentalmercury amalgam, 2013, Accessed March 25, 2014.
  14. Geier DA, Carmody T, Kern JK, King PG, Geier MR (2011) A significant relationship between mercury exposure from dental amalgams and urinary porphyrins: a further assessment of the Casa Pia Children’s Dental Amalgam Trial. Biometals 24(2):215–224
  15. Woods JS, Heyer NJ, Echeverria D, Russo JE, Martin MD, Bernardo MF, Luis HS et al (2012) Modification of neurobehavioral effects of mercury by a genetic polymorphism of coproporphyrinogen oxidase in children. Neurotoxicol Teratol 34(5):513–521
  16. Geier DA, Carmody T, Kern JK, King PG, Geier MR (2013) A significant dose-dependent relationship between mercury exposure from dental amalgams and kidney integrity biomarkers: a further assessment of the Casa Pia Children’s Dental Amalgam Trial. Hum Exp Toxicol 32(4):434–440
  17. Woods JS, Heyer NJ, Russo JE, Martin MD, Pillai PB, Farin FM (2013) Modification of neurobehavioral effects of mercury by genetic polymorphisms of metallothionein in children. Neurotoxicol Teratol 39C:36–44
  18. Joint Meeting of the Dental Products Panel (CDRH) and the Peripheral and Central Nervous System Drugs Advisory Committee (CDER) - September 6-7, 2006, FDA.
  19. Classify Your Device, Accessed March 25, 2014.
  20. Appendix I : Summary of Changes to the Classification of Dental Amalgam and Mercury, Accessed March 25, 2014.
  21. 2010 Meeting Materials of the Dental Products Panel," Accessed March 25, 2014.
  22. Press Release: FDA Advisory Panel to Review Dental Amalgam, Accessed March 25, 2014.
  23. 24 hours summary December 14-15, 2010 Dental Products Panel Meeting, Accessed March 25, 2014.

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