Round Gel Breast Implants: Interactive Effects of Texturing and Device Placement in 8-Year Prospective Clinical Results

Saturday, April 26, 2014: 10:46 AM
Roger Wixtrom, PhD, LSCI, Springfield, VA, John Canady, MS, MD, DSc (hon), FACS, FAAP, Mentor WW, LLC, Santa Barbara, CA, Dennis C. Hammond, MD, Partners in Plastic Surgery, Grand Rapids, MI and Neal Handel, MD FACS, Associate Clinical Professor, Division of Plastic Surgery, David Geffen School of Medicine at UCLA, Los Angeles, CA, Santa Barbara, CA

Goals/Purpose: Cox regression analyses of prospective clinical data from multicenter Core clinical trials of silicone gel breast implants have at certain time points, but not consistently, indicated a potentially lower cumulative incidence of capsular contracture for primary augmentation patients associated separately with: 1) submuscular/subpectoral placement versus subglandular placement, and 2) textured- versus smooth-surface implants.  The purpose of this study was to evaluate whether there is evidence for an interactive effect of device placement and implant texturing on capsular contracture incidence through 8 years among a very large population of patients receiving these devices for primary augmentation.

Methods/Technique: The incidence of capsular contracture was estimated at the implant level using the Kaplan-Meier (KM) method for MemoryGel¨ Smooth and Siltex¨ textured silicone gel-filled breast implants within the MemoryGel¨ Core Study, a prospective, non-randomized, open-label clinical trial [www.ClinicalTrials.gov NCT00753922].  In this study, there were a total of 786 smooth devices and 344 Siltex¨ textured devices used for primary augmentation.

Results/Complications: The estimated cumulative incidence of Baker III/IV contracture over time for smooth-subglandular, textured-subglandular, smooth-submuscular/subpectoral and textured-submuscular/subpectoral are depicted in the figure. Siltex¨-textured implants placed in the subglandular plane were associated with a statistically significant 5.0-fold lower estimated incidence of Baker III/IV contracture through 8 years as compared with smooth devices placed in the same plane (p<0.0001).  No significant differences were observed between Siltex¨-textured implants placed in the subglandular versus submuscular/subpectoral plane, or between smooth and textured implants placed in the submuscular/subpectoral plane.

Conclusion: For round gel devices used for primary augmentation, prospective, multicenter clinical trial data have demonstrated an interactive effect of device placement and surface texturing on the incidence of capsular contracture.  As compared with smooth devices placed subglandularly, significantly lower incidence rates for contracture through 8 years were observed for textured devices placed subglandularly and for either smooth or textured devices placed in the submuscular/subpectoral plane.

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