Silicone breast implants and systemic rheumatic disease. Some smoke but little fire to date.

For over 20 years silicone breast implants have been used for cosmetic and breast reconstruction purposes. They have been recently banned by the American Food and Drug Administration other than for reconstruction or in the setting of a study. Complications of rupture, leaking, bleeding, capsular thickening and contracture are acknowledged but the potential of silicone implants in causing classic rheumatic diseases or a new syndrome has caused much controversy; there are millions of dollars at stake in legal suits. The biological plausibility of silicone breast implants causing disease is not without merit. The epidemiological evidence linking the two are reviewed. There is considerable concern as to whether there will ever be a definitive study of the question.