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.