Prospective study on Trilucent soybean oil-filled breast prosthesis

BACKGROUND: The use of Trilucent breast implants dates back to 1995. These implants were produced in an attempt to overcome the perceived shortcomings of other implants filled with saline and silicone gel. The filler material, which was derived from soybean oil, was said to be biodegradable and biocompatible. When this prosthesis was subsequently found to be prone to rapid aging and rupture of the silicone shell, the company that manufactured this implant decided to withdraw it from the market and offered to remove or replace all Trilucent prostheses. METHODS: The authors present a clinical study of the Trilucent implant in which 36 patients received a total of 63 implants and 33 patients had 58 implants removed. The authors also examined the implant shell of the removed prostheses to investigate the possible cause of silicone implant aging and rupture. RESULTS: Each of the implants removed was carefully inspected visually, and samples of the implant shell were analyzed by scanning electron microscopy. All the implants removed had a very bizarre appearance; they were variegated in color, with shades of yellow and brown, and were studded with whitish yellow nodules whose number grew in proportion to the time the prosthesis was implanted. Scanning electron microscopic analysis of the implant shell revealed a heterogeneous inner surface of the implant together with fissures and globoid deposits on the cut surface. CONCLUSIONS: The authors' findings on Trilucent implants are similar to those reported in previously published studies for other types of breast implants for the first 2 years after implantation, after which a progressive, rapid deterioration was observed.