Breast implants: facts, controversy, and speculations for future research.

The breast implant crisis has been widely publicized. Beyond its immediate problems for the patients, the crisis has also discredited the use of silicone rubber as one of the most widely used biomaterials. Silicone elastomer or gel, the primary material in mammary prostheses, may be exposed to the body's tissues via envelope rupture, gel bleed, or elastomer fragmentation. Local responses to silicone include granulomatous inflammation, capsular contraction, and infection, all in varying degrees depending on ill-defined factors, which may include patient condition, peri- and postoperative complications, and hereditary predisposition, as well as material properties such as surface texture. The theory that silicone breast implants cause immunological disorders has not been proven. However, further study is necessary because some patients report autoimmune-like disorders (human adjuvant disease) following implant placement. Like autoimmune disease, human adjuvant disease is characterized by abnormalities of the immune response, autoantibody formation, and chronic inflammation. Silicone has been shown to play the role of an adjuvant, providing constant nonspecific stimulation of the immune system. Some researchers have hypothesized the role of silicone in specific immune reactions, including immunoglobulin formation and T-cell activation. This report examines the role of silicone as an agent of disease, focusing on material surface-tissue interactions.