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Previous Volume 342:781-790 March 16, 2000 Number 11 Next

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ABSTRACT

Background The postulated relation between silicone breast implants and the risk of connective-tissue and autoimmune diseases has generated intense medical and legal interest during the past decade. The salience of the issue persists, despite the fact that a great deal of research has been conducted on this subject. To provide a stronger quantitative basis for addressing the postulated relation, we applied several techniques of meta-analysis that combine, compare, and summarize the results of existing relevant studies.

Methods We searched data bases and reviewed citations in relevant articles to identify studies that met prestated inclusion criteria. Nine cohort studies, nine case–control studies, and two cross-sectional studies were included in our meta-analyses. We conducted meta-analyses of the results of these studies, both with and without adjustment for confounding factors, and a separate analysis restricted to studies of silicone-gel–filled breast implants. Finally, we estimated the annual number of new cases of connective-tissue disease that could be attributed to breast implants.

Results There was no evidence that breast implants were associated with a significant increase in the summary adjusted relative risk of individual connective-tissue diseases (rheumatoid arthritis, 1.04 [95 percent confidence interval, 0.72 to 1.51]; systemic lupus erythematosus, 0.65 [95 percent confidence interval, 0.35 to 1.23]; scleroderma or systemic sclerosis, 1.01 [95 percent confidence interval, 0.59 to 1.73]; and Sjögren's syndrome, 1.42 [95 percent confidence interval, 0.65 to 3.11]); all definite connective-tissue diseases combined (0.80; 95 percent confidence interval, 0.62 to 1.04); or other autoimmune or rheumatic conditions (0.96; 95 percent confidence interval, 0.74 to 1.25). Nor was there evidence of significantly increased risk in the unadjusted analyses or in the analysis restricted to silicone-gel–filled implants.

Conclusions On the basis of our meta-analyses, there was no evidence of an association between breast implants in general, or silicone-gel–filled breast implants specifically, and any of the individual connective-tissue diseases, all definite connective-tissue diseases combined, or other autoimmune or rheumatic conditions. From a public health perspective, breast implants appear to have a minimal effect on the number of women in whom connective-tissue diseases develop, and the elimination of implants would not be likely to reduce the incidence of connective-tissue diseases.

Source Information

From the Department of Epidemiology (E.C.J., B.S.H.), and the Department of Biostatistics (L.L.K.), School of Public Health, University of North Carolina at Chapel Hill, Chapel Hill, N.C.

Address reprint requests to Dr. Janowsky at the Department of Epidemiology, CB 7400, School of Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, or at esther_ janowsky{at}unc.edu.

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