A review of the possible health implications of silicone breast implants.

BACKGROUND: The silicone gel breast implant has long been an important method of reconstruction for the mastectomy patient. Because of concerns about possible health implications of the implant, the Food and Drug Administration banned its use for augmentation mammaplasty and limited its use in the mastectomy patient to a research protocol study. This article reviews the recent literature about the possible health hazards of the silicone implant.
METHODS: In this review of the literature, specific attention was directed toward structural failure of the device as well as the diagnosis of rupture, tissue response to silicone, systemic immunologic response to silicone, the relationship of silicone to connective tissue diseases, and the association of the silicone implant with breast carcinoma in both the augmentation mammaplasty patient and the patient undergoing postmastectomy reconstruction. A total of 88 works were reviewed.
RESULTS: The literature fails to support an association between silicone gel breast implants and systemic diseases. Although implants may cause local symptoms, rupture over time, or be associated with an immunologic reaction, comprehensive epidemiologic studies have concluded that there is no connection between breast implants and the known connective tissue diseases or between the implants and breast carcinoma. There is no increase in the risk of recurrence in mastectomy patients reconstructed with implants and no delay in the detection of recurrences. Recent laboratory studies in animals suggest that silicone may have anticarcinogenic effects.
CONCLUSIONS: Silicone gel breast implants may rupture and cause local symptoms, but they have not been demonstrated to be a systemic health hazard for patients who have undergone augmentation mammaplasty or postmastectomy reconstruction.