Assessment of the FDA backgrounder on platinum in silicone breast implants: Implications for public health policy

International Journal of Health Services

Volumn 38, Issue 1, 2008, Pages 95-102

  Maharaj, S V M ^a  

^a Center for Research on Environmental Medicine   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PLATINUM; SILICON;

ASSESSMENT METHOD; HEALTH POLICY; PUBLIC HEALTH; SILICON;

ARTICLE; BREAST ENDOPROSTHESIS; CATALYST; FOOD AND DRUG ADMINISTRATION; HEALTH CARE POLICY; HUMAN; MEDICAL ASSESSMENT; MEDICAL PRACTICE; OXIDATION; PUBLIC HEALTH SERVICE; WOMEN'S HEALTH;

BREAST IMPLANTS; CONFLICT OF INTEREST; FEMALE; HEALTH POLICY; HUMANS; INSTITUTE OF MEDICINE (U.S.); PLATINUM; SILICONE GELS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

NORTH AMERICA; UNITED STATES;

EID: 38749118182     PISSN: 00207314     EISSN: 15414469     Source Type: Journal    
DOI: 10.2190/HS.38.1.e     Document Type: Article

References (40)

1. Freedom of Information Act. Food and Drug Administration, Department of Health and Human Services, Rockville, MD (author's request, 2005).
2. Bondurant, S., et al. Safety of Silicone Breast Implants. Institute of Medicine, Washington, DC, 2000.
3. Merget, R., et al. Absence of relationship between degree of nonspecific and specific bronchial responsiveness in occupational asthma due to platinum salts. Eur. Respir. J. 9:211-216, 1996.
4. Biagini, R. E., et al. The diversity of reaginic immune responses to platinum and palladium metallic salts. J. Allergy Clin. Immunol. 76:794-802, 1985.
5. Cleare, M. J., et al. Immediate (type I) allergic responses to platinum compounds. Clin. Allergy 6:183-195, 1976.
6. Freedman, S. O., and Krupey, J. Respiratory allergy caused by platinum salts. J. Allergy 42:233-237, 1968.
7. Kedar, A., et al. Peripheral neuropathy as a complication of cis-dichlorodiammineplatinum(II) treatment: A case report. Cancer Treat. Rep. 62:819-821, 1978.
8. Rosenfeld, C. S., and Broder, L. E. Cisplatin-induced autonomic neuropathy. Cancer Treat. Rep. 68:659-660, 1984.
9. Saunders, M. P., et al. Hypersensitivity reactions to cisplatin and carboplatin - A report on six cases. Annal. Oncol. 3:574-576, 1992.
10. U.S. Food and Drug Administration. FDA Backgrounder on Platinum in Silicone Breast Implants. June 16, 2006. www.fda.gov/cdrh/breastimplants/ platinum.html (March 23, 2007).
11. Curfman, G. D., et al. Blueprint for a stronger Food and Drug Administration. N. Engl. J. Med. 355:1821, 2006.
12. Horton, R. Politics trumps science at the FDA. Lancet 366:1827, 2005.
13. Horton, R. What is going on at the FDA? Lancet 366:1137, 2005.
14. Stein, J., et al. In situ determination of the active catalyst in hydrosilylation reactions using highly reactive Pt(0) catalyst precursors. J. Am. Chem. Soc. 121:3693-3703, 1999.
15. Chandra, G., et al. A convenient and novel route to bis(alkyne) platinum(0) and other platinum(0) complexes from Speier's hydrosilylation catalyst. Organometallics 6:191-192, 1987.
16. Lappert, M. F., and Scott, F. P. A. The reaction pathway from Speier's to Karstedt's hydrosilylation catalyst. J. Organomet. Chem. 492:C11-C13, 1995.
17. Lewis, L. N., et al. Mechanism of formation of platinum(0) complexes containing silicon-vinyl ligands. Organometallics 14:2202-2213, 1995.
18. Lykissa, E. D., and Maharaj, S. V. M. Total platinum concentration and platinum oxidation states in body fluids, tissue, and explants from women exposed to silicone and saline breast implants by IC-ICPMS. Anal. Chem. 78:2925-2933, 2006.
19. Brook, M. A. Platinum in silicone breast implants. Biomaterials 27:3274-3286, 2006.
20. Maharaj, S. V. M. Platinum concentration in silicone breast implant material and capsular tissue by ICP-MS. Anal. Bioanal. Chem. 380:84-89, 2004.
21. Yaphe, J., et al. The association between funding by commercial interests and study outcome in randomized controlled drug trials. Fam. Prac. 18:565-568, 2001.
22. Als-Nielsen, B., et al. Association of funding and conclusions in randomized drug trials. JAMA 290:921-928, 2003.
23. Lexchin, J., et al. Pharmaceutical industry sponsorship and research outcome and quality: Systematic review. BMJ 326:1167-1170, 2003.
24. Bhandari, M., et al. Association between industry funding and statistically significant pro-industry findings in medical and surgical randomized trials. CMAJ 170:477-480, 2004.
25. Perlis, R. H., et al. Industry sponsorship and financial conflict of interest in the reporting of clinical trials in psychiatry. Am. J. Psychiatry 162:1957-1960, 2005.
26. Perlis, C. S., et al. Extent and impact of industry sponsorship conflicts of interest in dermatology research. J. Am. Acad. Dermatol. 52:967-971, 2005.
27. Jorgensen, A. W., et al. Cochrane reviews compared with industry supported meta-analyses and other meta-analyses of the same drugs: Systematic review. BMJ, doi:10.1136/bmj.38973.444699.0B, 2006.
28. Arepalli, S. R., et al. Allergic reaction to platinum in silicone breast implants. J. Long-Term Eff. Med. Implants 12:299-306, 2002.
29. Harbut, M. R., and Churchill, B. C. Asthma in patients with silicone breast implants: Report of a case series and identification of hexachloroplatinate contaminant as a possible etiologic agent. Isr. J. Occup. Health 3:73-82, 1999.
30. Schierl, R., et al. Long-term platinum excretion in patients treated with cisplatin. Cancer Chemother. Pharmacol. 36:75-78, 1995.
31. Herr, C. E. W., et al. Influences on human internal exposure to environmental platinum. J. Exp. Anal. Envir. Epidemiol. 13:24-30, 2003.
32. Centers for Disease Control and Prevention. Third National Report on Human Exposure to Environmental Chemicals. Atlanta, 2005.
33. Naidoo, R. N., et al. Respirable coal dust exposure and respiratory symptoms in South-African coal miners: A comparison of current and ex-miners. J. Occup. Environ. Med. 48:581-590, 2006.
34. Girardot, S. P., et al. Ozone and PM2.5 exposure and acute pulmonary health effects: A study of hikers in the Great Smoky Mountains National Park. Environ. Health Perspect. 114:1044-1052, 2006.
35. Inoue, K., et al. Levels and concentration ratios of polychlorinated biphenyls and polybrominated diphenyl ethers in serum and breast milk in Japanese mothers. Environ. Health Perspect. 114:1179-1185, 2006.
36. Smith, A. H., et al. Increased mortality from lung cancer and bronchiectasis in young adults after exposure to arsenic in utero and in early childhood. Environ. Health Perspect. 114:1293-1296, 2006.
37. Farmer, J. G., et al. Human teeth as historical biomonitors of environmental and dietary lead: Some lessons from isotopic studies of 19th and 20th century archival material. Environ. Geochem. Health 28:421-430, 2006.
38. El-Jammal, A., and Templeton, D. M. Measurement of platinum in biomedical silicones by ICP-MS. Anal. Proc. Incl. Anal. Comm. 32:293-295, 1995.
39. Clapp, R., et al. Erosion of the integrity of public health science in the USA. Occup. Environ. Med. 63:367-368, 2006.
40. Michaels, D., and Monforton, C. Manufacturing uncertainty: Contested science and the protection of the public's health and environment. Am. J. Public Health 95:S39-S48, 2005.