Background: The availability of different styles of silicone gel implants-including traditional round devices and shaped, form-stable implants-offers a variety of choices for women undergoing breast augmentation and reconstruction. The purpose of this analysis was to characterize clinical outcomes associated with the Mentor MemoryGel (round) MemoryShape/Contour Profile Gel (shaped) devices through 9 years of use in women undergoing breast augmentation or reconstruction.
Methods: The Mentor Core studies are nonrandomized, open-label clinical trials designed to assess the long-term safety and efficacy of silicone gel breast implants. The cumulative incidence of selected complications and reoperations was estimated using the Kaplan-Meier method. Patient satisfaction was assessed by asking the patient if she would decide to have breast implant surgery again.
Results: Shaped implants were associated with lower cumulative incidence rates of Baker Grade III/IV capsular contracture compared with round implants (3.4% vs 11.3%, respectively, in primary augmentation, P < 0.0001; 15.6% vs 24.4% in revision-augmentation, P < 0.05). Reoperation, explantation, and infection rates were comparable between devices across cohorts, except for lower incidence of infection with shaped than round implants in primary reconstruction (1.6% vs 6.2%, P < 0.05). Rupture rates were lower with shaped implants, with significance reached in primary augmentation patients at 8 years (3.1% vs 10.3%, P < 0.05). High levels of patient satisfaction (exceeding 94%) with both devices were reported at 9 years across cohorts.
Conclusion: Prospective data through 9 years support comparable safety of round and shaped breast implants, and high levels of patient satisfaction, in patients undergoing primary and revision breast augmentation and reconstruction.
Trial registration: ClinicalTrials.gov NCT00753922 NCT00812097.