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.
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.
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.
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.
St. Louis, Mo.
From Parkcrest Plastic Surgery.
Received for publication March 19, 2014; accepted April 8, 2014.
Disclosure: Dr. Caplin has participated in breast implant studies and is a consultant for Mentor Worldwide LLC.
David A. Caplin, MD, 845 North New Ballas Court, St. Louis, MO 63141, Info@Parkcrestplasticsurgery.com