Silicone BI's and Scleroderma.......evidence of ........

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Breast silicone implants and risk of systemic lupus erythematosus

Journal of Clinical Epidemiology, Volume 47, Issue 10, October 1994, Pages 1211-1214

L. Strom, Marcus M. Reidenberg, Bruce Freundlich, Rita Schinnar

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Abstract

The uncertain safety of breast implants has been a major controversy of late, both in the lay press and in the scientific literature. A case-control study had been performed in the Philadelphia metropolitan area during 1985–1987 to investigate potential risk factors for systemic lupus erythematosus (SLE). A total of 219 eligible cases who met the American Rheumatism Association criteria for SLE were identified from the medical practices of cooperating rheumatologists in the area; 195 (89%) of these were enrolled in the study. Friends of the cases, matched to the cases on sex and age (±5 years) served as controls. For the current investigation, conducted during June 1992 through September 1992, we attempted to re-contact each of these individuals. Using a short telephone interview, we asked each subject to provide information on any surgery that they may have had prior to the index date, i.e. the year of diagnosis of SLE in the cases and the same year for the age-matched friend controls. Specific questions were asked about plastic surgery in general and breast implants in particular. 148 (75.9%) of the 195 SLE cases being sought and 111 (77.6%) of the 143 controls being sought agreed to be re-interviewed for this study. Only 1 (0.8%) out of 133 female SLE cases reported having had a breast implant, 8 years prior to the diagnosis of SLE. This compared to 0 out of the 100 female friend controls (Fisher exact one-tailed p-value = 0.57). If we use the results from the population-based controls of the Cancer and Steroid Hormone study, to reflect the frequency of surgical implants or injections to increase breast size (specifically, 8 out of 4754 controls), then the experience from our cases would provide an odds ratio (90% exact confidence interval) of 4.5 (0.2–27.3) (Fisher exact one-tailed p-value = 0.22). In conclusion, based on this very large case-control study of SLE, no association was seen between silicone breast implants and the subsequent development of SLE. While the power of the study was limited, it was sufficient to provide evidence against a very large association. Given this, and the other data available in the literature, it would seem that future studies of the association between silicone breast implants and connective tissue diseases should focus primarily on scleroderma.

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