Scleroderma, a systemic connective tissue disease, is relatively rare. Case reports of women with silicone breast implants who have developed scleroderma began appearing in the US medical literature in the 1980s. By mid-1993, of the 72 case reports of women with breast implants and connective tissue disease, 38 were reported to have scleroderma. As a result of the publication of these case reports, a number of epidemiologic studies were conducted to find out if silicone breast implants are associated with the development of scleroderma. Five case-control studies of scleroderma were done, plus four prospective studies of connective tissue diseases (including scleroderma) and breast implants. In eight other epidemiologic studies, no cases of scleroderma were identified among women with breast implants. This article includes a qualitative review of the epidemiologic studies and a quantitative summary (meta-analysis) of the case-control studies. Neither the case-control studies nor the other epidemiologic data support the hypothesis that scleroderma is associated with or causally related to breast implants.