Silicone gel breast implants.

Abstract

ABSTRACT To the Editor. —In their Commentary,1 Dr Kessler and colleagues lament "the uncertainty and unease that patients are experiencing" without acknowledging the Food and Drug Administration's (FDA's) significant contribution to this incertitude. The FDA's risk-benefit deliberations have consistently dwelt on safety issues while undervaluing the benefits of implants. For example, their Commentary selectively cited two anecdotal clinical studies without adequate controls and a study in rats that used a physically altered gel form not seen in vivo. Recent, much more meaningful epidemiologic studies showing no increase in autoimmune disease2,3 were ignored. Despite the efforts of many investigators, no good evidence yet exists supporting a causal relationship between implants and any known medical disease.The FDA publications have consistently accentuated the negative while refusing to add reassurance for apprehensive patients where appropriate. This is exemplified in their literature on breast cancer and breast-feeding, which raises concern that the language