Mentor Contour Profile Gel implants: clinical outcomes at 6 years.

BACKGROUND MemoryShape (Contour Profile Gel) is a textured contoured implant filled with a cohesive silicone gel intended for use in aesthetic and reconstructive breast surgery. The 6-year summary of the clinical outcomes and satisfaction rates for this device from a 10-year, prospective, open-label, multicenter clinical trial is presented. METHODS According to 2006 guidelines set forth by the U.S. Food and Drug Administration, 955 women were enrolled: 572 undergoing primary augmentation, 124 undergoing revision-augmentation, 191 undergoing primary reconstruction, and 68 undergoing revision-reconstruction. The cumulative incidence of selected complications was estimated using the Kaplan-Meier method. RESULTS For the primary augmentation cohort, Kaplan-Meier estimated 6-year cumulative incidence rates for key complications by patient were as follows: 2.4 percent Baker grade III/IV capsular contracture, 0.9 percent infection, 7.0 percent explantation, and 18.1 percent any reoperation. Corresponding rates were 9.7, 2.1, 13.6, and 24.1 percent for revision-augmentation; 10.1, 1.6, 21.8, and 44.5 percent for primary reconstruction; and 16.4, 3.0, 34.2, and 45.4 percent for revision-reconstruction. The Kaplan-Meier estimated rupture rate at 6 years was 2.1 percent for primary augmentation, 2.9 percent for revision-augmentation, 1.5 percent for primary reconstruction, and 0 percent for revision-reconstruction. Implantation of Contour Profile Gel breast implants resulted in a significant increase in circumferential chest size in the overall population (mean change, 1.5 inches; p < 0.0001), and 96.6 percent of patients would make the same decision to have Contour Profile Gel breast implant surgery. CONCLUSIONS At 6 years postoperatively, Contour Profile Gel breast implants were found to be effective and have an acceptable safety profile in women undergoing breast augmentation, reconstruction, and revision surgery. CLINICAL QUESTION/LEVEL OF EVIDENCE Therapeutic, II.