Connective-tissue disease following breast augmentation: a preliminary test of the human adjuvant disease hypothesis.

It has been proposed that scleroderma in particular or connective-tissue diseases in general may be caused by exposure to silicone-containing materials used for breast augmentation. We performed a historical cohort study to estimate the point prevalence of this potential complication sometimes referred to as "human adjuvant disease." Three-hundred and seventy-eight patients who underwent augmentation mammaplasty with silicone-containing envelope-type prostheses from 1970 through 1981 were surveyed. Regional musculoskeletal syndromes, fibrositis, or osteoarthritis occurred in a third (38 of 125) of our responders. No patient developed an inflammatory systemic rheumatic disease during the period of observation (mean 6.8 years for the 125 subjects). Using calculations based on risk for development of rheumatic disease, it does not appear likely that augmentation mammaplasty is a significant or major inducer of inflammatory connective-tissue diseases in general. However, the number of patients surveyed was small, and our results must be considered preliminary. We could not exclude a specific risk for the development of scleroderma.