Long-term Clinical Performance Of Memoryshape® Breast Implants In Breast Augmentation And Reconstruction: Prospective Data Through 10 Years
Dennis Hammond, MD1, Janet Vargo, PhD2, Roger Wixtrom, PhD3, John Canady, MS, MD4.
1Partners in Plastic Surgery, Grand Rapids, MI, USA, 2Mentor Wordwide LLC, Santa Barbara, CA, USA, 3LSCI, Springfield, VA, USA, 4Mentor Worldwide LLC, Santa Barbara, CA, USA.
Shaped, form-stable silicone breast implants provide an additional option to round gel implants for aesthetic and reconstructive breast surgery. This analysis reports key safety and efficacy outcomes associated with the Mentor MemoryShape® (formerly CPG™) through 10 years in breast augmentation and reconstruction.
The Kaplan-Meier cumulative incidence of complications through 10 years was estimated for 572 primary augmentation and 190 primary reconstruction patients enrolled in the MemoryShape®/CPG™ (NCT00812097) Core Study. Rupture rates were analyzed for patients with MRI scans at 1, 2, 4, 6, 8, and 10 years postoperatively. Global patient satisfaction was assessed by asking patients if they would decide to have breast implant surgery again.
The cumulative 10-year incidence of capsular contracture III/IV was 3.8% in primary augmentation (Table, Figure). The most common reasons for the 148 reoperations in primary augmentation through 10 years were breast mass/cyst (n=29) and patient-requested size change (n=16); asymmetry (n=17) and seroma (n=12) were the most common reasons in primary reconstruction (n=137 reoperations). Global satisfaction at 10 years was 96.5% in primary augmentation and 98.6% in primary reconstruction.
These prospective, multicenter clinical data demonstrate the long-term clinical performance, safety and efficacy of the MemoryShape® breast implant for augmentation and reconstruction.
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