Five-Year Clinical Performance and Patient-Reported Outcomes of Mentor MemoryGel and MemoryShape Breast Implants (GLOW Study)

Background Long-term clinical safety and patient-reported outcomes are critical for guiding breast implant selection. Current implant options include MemoryGel (round) and MemoryShape (anatomical) implants, which are designed to meet diverse anatomical and aesthetic needs. Objectives To measure interim 5-year safety and effectiveness outcomes of MemoryGel (including MemoryGel Xtra) and MemoryShape breast implants in the 10-year Mentor MemoryGel and MemoryShape Combined Cohort Clinical Study. Methods Participants received breast augmentation or reconstruction with MemoryGel round (referred to as “MemoryGel non-Xtra”), MemoryGel Xtra round, or MemoryShape implants in this prospective, multicenter clinical trial. To assess device safety, incidence of complications and reoperations was estimated using Kaplan-Meier analyses; effectiveness was evaluated using a validated patient-reported questionnaire (BREAST-Q). Results Overall, 2,043 patients received MemoryGel non-Xtra implants, 289 received MemoryGel Xtra, and 397 received MemoryShape in augmentation or reconstruction procedures. The study was not designed for direct comparisons between devices. For the primary augmentation cohort, estimated 5-year incidences of Baker grade III/IV capsular contracture were 1.42% (MemoryGel Xtra), 5.16% (MemoryGel non-Xtra), and 0.31% (MemoryShape); implant-related reoperation rates were 2.9%, 5.49%, and 3.37%; and explantation rates were 5.90%, 6.39%, and 4.01%, respectively. BREAST-Q satisfaction with breasts, psychosocial well-being, and sexual well-being improved significantly from baseline to Year 5 (p < 0.001) across all primary augmentation cohorts, and physical well-being returned to baseline levels. Conclusions These 5-year interim results support a finding of long-term safety, high patient satisfaction, and sustained quality-of-life benefits of MemoryGel and MemoryShape breast implants.