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.
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.
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.
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.
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Grand Rapids, Mich.; Edina, Minn.; St. Louis, Mo.; and Santa Barbara, Calif.
From Partners in Plastic Surgery, MMK Plastic Surgery, Parkcrest Plastic Surgery, and Mentor Worldwide LLC.
Received for publication September 21, 2011; accepted December 29, 2011.
Disclosure:Dr. Hammond serves as the medical monitor for the Contour Profile Gel Core Study and is a consultant for Mentor Worldwide LLC. He has participated in breast implant studies with Mentor Worldwide LLC and Allergan, Inc. Drs. Migliori and Caplin are Contour Profile Gel Clinical Study investigators and consultants for Mentor. Dr. Garcia is a medical writer for Mentor Worldwide LLC. Ms. Phillips is the director of the Contour Profile Gel Clinical Study for Mentor Worldwide LLC.
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Dennis C. Hammond, M.D.; Partners in Plastic Surgery, 4070 Lake Drive SE, Suite 202, Grand Rapids, Mich. 49546, email@example.com