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.