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).
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.
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.
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.
Grand Rapids, Mich.; Irvine, Calif.; Oklahoma City, Okla.; Springfield, Va.; and St. Louis, Mo.
From Partners in Plastic Surgery of West Michigan; Mentor Worldwide LLC; private practice; LSCI; and Parkcrest Plastic Surgery.
Received for publication January 13, 2017; accepted June 29, 2017.
This trial is registered under the name “Mentor Siltex® Contour Profile Gel Mammary Prosthesis Clinical Trial (CPG),” ClinicalTrials.gov identification number NCT00812097 (https://clinicaltrials.gov/ct2/show/NCT00812097).
Disclosure:This study was sponsored by Mentor Worldwide, LLC. Neither honoraria nor payments were made for authorship. Dr. Hammond serves as a paid consultant for the Mentor Corporation and Establishment Labs. Dr. Canady is an employee of Mentor Worldwide, LLC and a stockholder of Johnson & Johnson. Dr. Wixtrom is a consultant for Mentor Worldwide, LLC. Dr. Caplin is a consultant to, and speaker for, the Mentor Corporation. Drs. Hammond, Love, and Caplin all served as principal investigators in the Mentor Worldwide, LLC MemoryShape (CPG) breast implant clinical trial (NCT identifier NCT00812097).
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Dennis C. Hammond, M.D., 4070 Lake Drive SE, Suite 202, Grand Rapids, Mich. 49546, firstname.lastname@example.org