Future directions in breast implant surgery.

Numerous perceived and suspected problems were associated with silicone gel breast implantation during the 30 years of use before the 1992 FDA moratorium. The lack of adequate safety data, the Food and Drug Agencies, requirement for such data to grant pre market approval, and widespread product liability litigation has, since that time, resulted in a proliferation of research on implant performance, silicone materials, properties, and retrospective and prospective breast implant studies. To satisfy the desire by patients for augmentation, there has also been a dramatic interest in saline breast implantation in recent years concurrent with the widespread removal of gel implants from the market place. The problems will remain the same for saline breast implants, which are FDA approved. It is the objective of this report to provide an overview of inherent silicone gel and saline implant problems, especially to provide a perspective for future new and improved implant opportunities. The objective that has been identified and the center of the controversy is the manufacturing process for the silicone shell, its mechanical integrity, and longevity because it has not changed much.