The objective of the proposed program is the development of two types of breast prosthesis for cosmetic correction of the effects of minimal breast surgery and/or radiation therapy. The prostheses employ a textured surface to promote tissue attachment and minimize the formation of a tissue capsule, and their internal volume is percutaneously adjustable to permit subsequent optimization of the volume occupied by the prosthesis or the degree of firmness desired. A readily metabolized, non-toxic fluid is used as the charging medium, and the devices themselves are fabricated from silicone rubber with an integrally textured surface being separately developed. A series of 18 animal experiments are to be used to examine healing around the devices under a wide range volume and firmness and to evaluate the suitability of the percutaneous filling system that has been designed and to evaluate the volume stability of the implanted devices. Because the tissue capsule thickness around the devices is controlled, the tactile and volume of the implanted devices should be readily adjustable to compensate for late tissue changes or continued therapy.
