Silicone breast implantation-induced scleroderma: description of four patients and a critical review of the literature.

Since the early 1980s, case reports and case series describe an association between silicon breast implants and the appearance of autoimmune diseases, particularly scleroderma. The publication of those cases led to a large number of studies to investigate this association. The conclusion of those studies is that most probably there has not been an increased incidence of autoimmune diseases in women with silicon breast implants. Nevertheless, the US Food and Drug Administration determined that silicone gel breast implants are not completely safe, only that they are 'reasonably safe.' The debate continues regarding this association. In this article we present new cases of silicon breast implant-induced scleroderma and review the literature on this subject.