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Safety and the Precautionary Principle Public Health vs. Profit Lessons from the Past - Ongoing Risks
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Registering the Impact of Breast Implants Ann Pederson, British Columbia Centre of Excellence for Women’s Health, and Aleina Tweed, British Columbia Centre of Disease Control
Breast implants are used for breast augmentation, breast reconstruction (for example, following mastectomy), and/or revision (replacement) of an existing implant. In Canada an estimated 100,000 to 200,000 women have breast implants.[1] Approximately 80% of these surgeries are for breast augmentation, while the remaining 20% are for reconstruction after cancer or prophylactic mastectomy or to correct underdeveloped or non-developed breasts.[2] While most women are typically pleased with the results of their breast implant surgery, others feel that implants have compromised their short- and long-term health.[3] Recent reports indicate that the rates of localized complications and repeat surgeries following breast implantation are high and the long-term effects remain unknown.[4] Although many studies have found no association between breast implants and systemic complications such as autoimmune or connective tissue diseases,[5] the fact that implant removal frequently produces a reversal of symptoms in women who suffer from them continues to raise questions about a causal link.[6] To ensure that breast implants are not causing harm, systematic documentation and the development of a credible evidence base on the effects of breast implants are scientifically and ethically necessary. The key to such credible information is the establishment of a registry for women with breast implants. While there are some American data on the number of procedures performed, Canadian plastic surgery and/or medical organizations do not track even crude numbers. In both countries, the absence of mechanisms to track patients over time and across jurisdictions further hampers efforts to document the impact of cosmetic surgery. And while many health care procedures can be investigated in Canada through an examination of public administrative records, most cosmetic surgery is financed privately and isn’t recorded in public databases. This means that analysts face significant challenges when conducting assessments, and consumers and policy makers have a very limited evidence base for decision making. The United States, Australia, Denmark, and the United Kingdom have established national breast implant registries for the purposes of identification, health protection, and research. In Canada, researchers, policy advisors, and women with breast implants have called for authorities to take similar action.[7] Canada is in a position to benefit from the experiences of these countries; the registry in United Kingdom provides an important case in point. In response to a recommendation by the Department of Health’s Independent Expert Advisory Group, in July 1993, the United Kingdom was the first country in the world to establish a national registry. Consisting of a prospective and retrospective registry covering both private and National Health Service activities, the aim of the National Breast Implant Registry (NBIR) in Odstock Hospital in Salisbury is to establish a cohort for studies of breast implantation and its associated effects. (Information in the registry is subject to the national Data Protection Act.) A pilot study using NBIR data is now underway.[8] Key features of the NBIR are:
The British government’s recall of the Trilucent™ breast implant in 2000 illustrates the usefulness of the NBIR. Through the registry, thousands of women were notified of the manufacturer’s concerns about leakage of the implant filler, based on soybean oil, that could potentially produce toxic components. The government advised women to have their implants removed or replaced. If the registry did not exist, the only mechanisms that would have been available to advise women of the medical directive would have been the mass media and individual practitioners. A registry alone will not answer all of the questions surrounding the safety of breast implants. As the case of the British registry demonstrates, it is a strategy that has been proven to work quickly and efficiently to protect women’s health. For a copy of the full report, Registering the Impact of Breast Implants, contact: British Columbia Centre of Excellence for Women’s Health NOTES [1] In the USA more than 200,000 breast augmentations were performed in 2000 alone. See the American Society of Aesthetic Plastic Surgeons at http://www.surgery.org. Comparable Canadian data are not available, although the Canadian Society of Plastic Surgeons (http://www.plasticsurgery.ca) suggests that Canadian numbers would be one tenth of those in the United States. [2] Segal M. 1992. Silicone breast implants: Available under tight controls. FDA Consumer (June). Internet. Web reference: http://openseason.com/annex/library/cic/X0078_silicone.txt.html (Accessed 13 March 2000); Baines CJ, Arseneau J, Davis P, Smith DC. Report on Silicone Gel-Filled Implants. Ottawa: Department of National Health and Welfare, 1992. [3] Bondurant S, Ernster V, Herdman R. (Eds.) Safety of silicone breast implants. Washington: Committee on the Safety of Silicone Breast Implants, Division of Health Promotion and Disease Prevention, Institute of Medicine, 2000. E-book On-line. Web reference: http://books.nap.edu/books/0309065321/html/index.html (Accessed 26 June 2001). [4] Bondurant et al., 2000; Gabriel SE, Woods JE, O’Fallon WM, et al. Complications leading to surgery after breast implantation. New England Journal of Medicine 1997;336(10):677-82; Wall W, Martin L, Fritzler MJ, et al. Non-fasting chylomicronaemia in breast implant patients.Lancet 1995;345(8961):1380; Logothetis ML. Women’s reports of breast implant problems and silicone-related illness. Journal of Obstetric, Gynecologic, & Neonatal Nursing 1995;24(7):609-16; Silverman BG, Brown SL, Bright RA, et al. Reported complications of silicone gel breast implants: An epidemiologic review. Annals of Internal Medicine 1996;124(8):744-756; Hoffman DA, Stockdale S, Hicks LL, et al. Neurocognitive symptoms and quantitative EEG results in women presenting with silicone-induced autoimmune disorder. International Journal of Occupational Medicine and Toxicology 1995;4:91-98; Edworthy S., Martin L, Barr SG, et al. A clinical study of the relationship between silicone breast implants and connective tissue disease. Journal of Rheumatology 1998;25(2):254-60. [5] United Kingdom Independent Review Group. 1998. Silicone gel breast implants: The report of the Independent Review Group. Internet. Web reference: http://www.silicone-review.gov.uk/ (Accessed 13 March 2000). [6] Sarwer DB, Nordmann JE, Herbert JD. Cosmetic breast augmentation surgery: A critical overview. Journal of Women’s Health & Gender- Based Medicine 2000;9(8):843-856. [7] Private Members’ Business. Wednesday, 21 June 1995. Internet. Available from http://collection.nlc-bnc.ca/100/201/301/handard-e/35-1/223_95-06-21/223PB1E.html (Accessed 27 Feb 2001). [8] Medical Devices Agency, Department of Health, United Kingdom. Breast Implants. 2002, July 27. Available from: http://www.medical-devices.gov.uk/mda/mdawebsitev2.nsf/webvwPrint/19e38f96ea6e776c00 |
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