Long-Term Clinical Performance of Memoryshape Silicone Breast Implants in Breast Augmentation: Prospective Data through 9 Years

Purpose:

The recent FDA approval of shaped, form-stable breast implants adds an important alternative to round gel implants for patients undergoing aesthetic breast surgery. The purpose of this analysis was to report key safety and efficacy outcomes associated with the Mentor MemoryShapeª (formerly Contour Profile Gelª, CPGª) through 9 years of use in women undergoing breast augmentation and revision surgery.

Methods:                                                            

The MemoryShapeª/CPGª (NCT00812097) Core study is a non-randomized, open-label clinical trial designed to assess the long-term safety and efficacy of this device in women undergoing breast augmentation or reconstruction surgery. The cumulative incidence of complications and reoperations was estimated using the Kaplan-Meier (KM) method. Rupture rates were analyzed for patients with MRI scans at 1, 2, 4, 6, and 8 years postoperatively. Global patient satisfaction was assessed by asking the patient if she would decide to have breast implant surgery again.

Results:

Overall, 56% of primary augmentation (N=572) and 61% of revision-augmentation patients (N=124) provided follow-up data at 9 years post-implantation. The cumulative 9-year estimated incidence rates for key complications by patient are summarized in the table. The incidence of capsular contracture III/IV remained below 5% in women who underwent primary augmentation through 9 years (Figure). Implant rotation rates were 1.1 (95% CI: 0.5, 2.4) in primary augmentation and 1.7 (95% CI: 0.4, 6.6) in revision-augmentation cohorts, respectively. The most common reasons for the 139 reoperations performed through 9 years in primary augmentation patients included breast mass/cyst (n=29), patient request for size change (n=16), and calcification (n=11), with breast mass and calcification generally associated with biopsies to assess potential breast cancer. Patient request for size change was the most common reason for reoperation among revision-augmentation patients (accounting for 7 of 45 reoperations). At the 9-year follow-up, 292 of 301 (97.0%) primary augmentation and 59 of 63 (93.7%) revision-augmentation patients indicated satisfaction.

Conclusion:

Prospective data through 9 years affirm excellent long-term clinical performance and high levels of patient satisfaction with shaped implants in women undergoing breast augmentation. In addition to lower rates of capsular contracture and rupture than their round counterparts, shaped gel implants are an important option for breast augmentation, particularly for patients with limited or no ptosis, constricted breasts, and those who prefer a natural slope to the upper pole of the breast.