A long-term study of outcomes, complications, and patient satisfaction with breast implants.

BACKGROUND Breast implants have been used worldwide for more than 40 years. Despite extensive clinical experience, there is continued concern about the safety of these devices. The purpose of this study was to compare the efficacy, complication rates, frequency of reoperation, and degree of patient satisfaction with different types of implants. METHODS This is a consecutive, population-based study consisting of all patients receiving implants at a multidisciplinary breast center between 1979 and 2004 (25 years). A prospective implant database was constructed and maintained in Excel, and statistical analysis was performed using SAS 8.2. Various outcomes, including infections, hematomas, undesirable waviness, capsular contracture, deflation, rupture, reoperation, and patient satisfaction, were monitored. RESULTS Data were collected on 3495 implants in 1529 women. The longer implants were in place, the greater the cumulative risk of developing contracture; hematoma significantly increased the risk of contracture; smooth and textured implants had similar contracture rates; polyurethane foam-covered implants had a reduced risk of contracture persisting for at least 10 years after implantation. There was a relatively high rate of reoperation and a relatively short interval between primary surgery and reoperation; the most common indication for reoperation was capsular contracture. Implant recipients expressed a high overall level of satisfaction. CONCLUSIONS Breast implants are associated with a significant rate of local complications and reoperation. There are marked differences in outcomes as a function of implant surface type and surgical indication. Despite relatively frequent complications and reoperations, implant recipients are largely satisfied.