Silicone mammary implants and connective tissue disease.

The American Food and Drug Administration recently restricted the use of silicone gel-filled mammary implants for breast augmentations and reconstructions because a number of case reports had suggested that there was an association between silicone and connective tissue disease. We have found 36 such case reports published since 1982. Systemic sclerosis is the most common reported diagnosis (n = 15). Implants were removed from 15 patients, in nine of whom symptoms improved. The mechanism behind the postulated relationship is obscure, and most authors focused on an auto-immune-like response to silicone, which acts directly as a hapten or as an adjuvant. We found no conclusive evidence to implicate silicone mammary implants in connective tissue diseases. We do, however, recommend removal of implants from patients with severe connective tissue diseases. Patients with symptoms or active connective tissue disease should not be considered for silicone implants.