BACKGROUND: Contour Profile Gel/MemoryShape breast implants consist of a textured silicone elastomer shell filled with silicone gel. The objective of this clinical study was to assess the safety and effectiveness of Contour Profile Gel/MemoryShape breast implants in women who were undergoing primary breast augmentation, primary breast reconstruction, or revision surgery (revision-augmentation or revision-reconstruction). METHODS: This was a prospective, open-label, multicenter clinical study involving Contour Profile Gel/MemoryShape breast implants in 955 female subjects, including 572 primary augmentation, 124 revision-augmentation, 190 primary reconstruction, and 69 revision-reconstruction subjects. Safety was assessed based on the incidence, severity, and method of resolution of all complications. Endpoints were examined on both a per-subject and a per-implant basis. RESULTS: For the primary augmentation, revision-augmentation, primary reconstruction, and revision-reconstruction cohorts, the Kaplan-Meier estimated 10-year cumulative incidence rates for the key complications at the subject level were as follows: Baker grade III/IV capsular contracture, 3.6 (primary augmentation), 15.5 (revision-augmentation), 14.3 (primary reconstruction), and 16.4 (revision-reconstruction) percent; infection, 0.7 (primary augmentation), 1.9 (revision-augmentation), 1.6 (primary reconstruction), and 2.9 (revision-reconstruction) percent; explantation with or without replacement, 9.2 (primary augmentation), 25.9 (revision-augmentation), 34.1 (primary reconstruction), and 49.0 (revision-reconstruction) percent; explantation with replacement with study device, 4.0 (primary augmentation), 10.8 (revision-augmentation), 16.7 (primary reconstruction), and 27.9 (revision-reconstruction) percent; and any reoperation, 22.3 (primary augmentation), 35.0 (revision-augmentation), 52.7 (primary reconstruction), and 59.7 (revision-reconstruction) percent. CONCLUSION: The results of this study demonstrate that Contour Profile Gel/MemoryShape breast implants are safe and effective for primary and revision breast augmentation and reconstruction for women at least 22 years old.