BREAST SILICONE IMPLANTS AND RISK OF SYSTEMIC LUPUS-ERYTHEMATOSUS

The uncertain safety of breast implants has been a major controversy o f late, both in the lay press and in the scientific literature. A case -control study had been performed in the Philadelphia metropolitan are a during 1985-1987 to investigate potential risk factors for systemic lupus erythematosus (SLE). A total of 219 eligible cases who met the A merican Rheumatism Association criteria for SLE were identified from t he medical practices of cooperating rheumatoiogists in the area; 195 ( 89%) of these were enrolled in the study. Friends of the cases, matche d to the cases on sex and age (+/- 5 years) served as controls. For th e current investigation, conducted during June 1992 through September 1992, we attempted to re-contact each of these individuals. Using a sh ort telephone interview, we asked each subject to provide information on any surgery that they may have had prior to the index date, i.e. th e year of diagnosis of SLE in the cases and the same year for the age- matched friend controls. Specific questions were asked about plastic s urgery in general and breast implants in particular. 148 (75.9%) of th e 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 femal e friend controls (Fisher exact one-tailed p-value = 0,57). If we use the results from the population-based controls of the Cancer and Stero id Hormone study, to reflect the frequency of surgical implants or inj ections 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 st udy of SLE, no association was seen between silicone breast implants a nd the subsequent development of SLE. While the power of the study was limited, it was sufficient to provide evidence against a very large a ssociation. Given this, and the other data available in the literature , it would seem that future studies of the association between silicon e breast implants and connective tissue diseases should focus primaril y on scleroderma.