Abstract
BACKGROUND: Mentor MemoryGel Xtra breast implants (Mentor Worldwide LLC, Irvine, CA) were designed to maintain the soft, natural feel of MemoryGel implants while increasing fullness and projection and minimizing wrinkling, rippling, and related complications through optimization of shell gel-fill. OBJECTIVES: To measure 3-year safety and effectiveness of MemoryGel Xtra breast implants in the Mentor MemoryGel and MemoryShape Combined Cohort Clinical Study. METHODS: Participants were implanted with MemoryGel Xtra breast implants in a prospective, multicenter clinical trial. Rates of complications and reoperations were analyzed to assess device safety and BREAST-Q was employed to assess device effectiveness. RESULTS: Two hundred eighty-seven females receiving MemoryGel Xtra breast implants were enrolled. Complication rates in the primary augmentation cohort included rates of 1.5% for implant-related reoperation, 2.3% for explantation, and 1.5% for Baker grade III or IV capsular contracture. For the revisional augmentation cohort, these rates were 2.8% for implant-related reoperation, 4.3% for explantation, and 3.0% for capsular contracture. For the primary reconstruction cohort, these rates were 12.0% for implant-related reoperation, 12.3% for explantation, and 7.3% for capsular contracture. For the revisional reconstruction cohort, these rates were 7.1% for capsular contracture, with zero implant-related reoperations or explantations. There were no reports of infection or implant malposition or displacement in any of these cohorts. Each cohort showed significantly improved satisfaction with breasts and psychosocial and sexual well-being at 1 year following the primary procedure. CONCLUSIONS: These data are consistent with legacy clinical data for MemoryGel and provide the first published safety and effectiveness data regarding the use of MemoryGel Xtra breast implants for breast augmentation and reconstruction.