Silicone gel implants in breast augmentation and reconstruction.

Silicone gel implants have been widely used for breast augmentation and reconstruction since the 1960s. Several alterations to both elastomer shell and filler gel have been made over the years to improve their ability to replicate the natural breast and to decrease the incidence of capsular contracture. The latter is a pathologic process involving the periprosthetic tissues formed in response to the presence of the implant. When severe, capsular contracture may cause firmness, distortion, and pain. In response to many claims of implant-related connective tissue disease, the US Food and Drug Administration placed a moratorium in 1992 on silicone gel breast implants for cosmetic purposes. Despite a preponderance of scientific data to their safety, silicone gel implants are presently available in the United States only as part of limited clinical trials. They continue to be used in Europe and other parts of the world.