LAUSR

BACKGROUND The relative risks and benefits of various textured breast implants is a focus of considerable discussion. Studies have suggested different risk benefit profiles for different textured implants with different surface topography. OBJECTIVE The study aim was to provide device-specific, quantitative information on Mentor imprinted-style Siltex Textured (Siltex) breast implants with respect to: textured surface characteristics and classification by ISO 14607, risk of BIA-ALCL, and risk reduction benefits relative to smooth implants. METHODS Surface metrology was performed. Data for smooth and Siltex implants from the prospective MemoryGel Core study were evaluated by Kaplan-Meier analysis for the most frequently occurring postoperative complications leading to subsequent reoperation in augmentation and reconstruction. RESULTS The overall average surface area roughness for Siltex implants, MemoryGel and MemoryShape, was 29.5 µm and 36.1 µm, respectively. A statistically significantly lower rate of reoperation in patients with Siltex vs. smooth devices through 10 years was observed for both capsular contracture in subglandular primary augmentation patients (2.02% versus 19.84%) and for asymmetry in primary reconstruction patients (3.88% versus 11.1%). CONCLUSION Surface analysis demonstrated Siltex implants fall within the ISO 14607 category of "microtexture" breast implants. These devices exhibited a rare risk of BIA-ALCL (0.0012%) based on the most extensive data available. Relative to smooth implants, these Siltex devices provided risk reduction benefits for the most common reason of reoperation in patients who underwent primary augmentation (capsular contracture) or primary reconstruction (asymmetry) in the Core clinical study. These findings provide valuable risk benefit information for surgeons and their patients.