Complications and outcomes were monitored following the implantation of 1655
breast implants over a 15-year period. Smooth,
polyurethane, and textured implants were used in a variety of clinical settings. The time course of capsular
contracture was analyzed by the Kaplan-Meier method. Regardless of implant type or indication for surgery, the probability of
contracture increased with time.
Polyurethane-covered implants were associated with a significant reduction in the risk of
contracture for at least 7 years following implantation. Smooth and textured
silicone implants had
contracture rates similar to each other, and the particular type of surface texturing (Biocel versus Siltex) was of no consequence.
Contracture was more common following
breast reconstruction and implant replacement than after augmentation
mammaplasty and was not affected by filler material or implant size. Implant position did not alter the risk of
contracture after augmentation;
tissue expansion did not affect the risk of
contracture after
breast reconstruction.
Infections were unusual but most common after reconstruction and unrelated to surface texture or filler material. Skin wrinkling was more frequent with saline implants and in the presence of surface texturing. Implant
rupture was rare, with an incidence of 1 per 760 implant-years. Implant-associated
connective-tissue disease was noted in only one individual, an incidence of 1 per 3801 implant-years.