Injectable liquid silicone (ILS), used worldwide since the 1940s to elevate scars and wrinkles, is the Jekyll and Hyde of dermal implants. Although capable of producing highly desirable and permanent results in capable hands, it is extremely technique-sensitive and easily abused. It has produced highly publicized disfiguring complications, particularly when adulterated and used in large volumes by untrained, nonmedical personnel. The occasional report by credible authors detailing extremely favorable results is overwhelmed by a torrent of lurid accountings of silicone-induced disasters. This disparity has produced rancorous disagreement (largely supported by anecdotal evidence). Advocates of ILS earnestly believe that almost all the horror stories, including death and disfigurement, are due to criminal misuse or media-fanned hysteria often involving agents that are unrelated to silicone. Critics just as earnestly believe that the advocates are lying about the true incidence of complications following proper use.

HOW DOES SILICONE FIT IN TODAY?

If ILS can overcome a reputation tainted by misuse, abuse, adulteration, and substitution of unrelated substances, it may take its place among a variety of agents used in the exponentially growing field of soft tissue augmentation. This process may be facilitated by multiple scientific, regulatory, and product developments, including (1) an exhaustive federal study that could not support an association between silicone and immune-related health conditions; (2) the availability of two types of liquid silicone now approved by the Food and Drug Administration (FDA) for human use as ophthalmologic implant devices; (3) the FDA Modernization Act of 1997, which permits physicians to use drugs and devices for off-label purposes; and (4) proof of concept.