SILICONE BREAST IMPLANTS - IMMUNOTOXIC AND EPIDEMIOLOGIC ISSUES

Silicone gel implants for breast augmentation and reconstruction have been in use since 1962. Significant local complications include capsul ar contracture, rupture, gel ''bleed'', and spread of the implant mate rial to regional lymph nodes (1-7) as well as histologic findings of f oreign body granulomas in the capsular tissue and in lymph nodes (7-9) . Through magnetic resonance spectroscopy and atomic emission spectros copy, silicon compounds were found in the blood of some women with sil icone breast implants; silicone and silica have also been found in liv er (10). Well-publicized case reports have raised significant concerns regarding an association between implants and systemic disease. Howev er, despite the availability of silicone implants for over 30 years, c ontrolled epidemiological studies were not carried out until 1992. Cur rently available epidemiologic data are extremely limited. In part, be cause the majority of implants were used after 1981, the incidence of long-term problems is not yet known. In 1992, due to the unavailabilit y of studies demonstrating the safety of implants, the U.S. Food and D rug Administration advised that silicone breast implants should be use d only in reconstructive surgery and as part of clinical trials (11). This decision spurred a wave of research on the bioreactivity of silic one and clinical observations of patients with implants. Herein, we re view the adverse immune effects following contact with silicone as wel l as the epidemiologic data available.