Device-Specific Findings of Imprinted-Texture Breast Implants: Characteristics, Risks, and Benefits.

[BACKGROUND] The relative risks and benefits of various textured breast implants are the focus of considerable discussion. Studies have suggested different risk-benefit profiles for different implant surface topographies.

[OBJECTIVES] The study aim was to provide device-specific, quantitative information on Mentor's imprinted Siltex Textured breast implants with respect to textured surface characteristics and ISO 14607 classification, risk of breast implant-associated anaplastic large cell lymphoma (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 in augmentation and reconstruction leading to subsequent reoperation.

[RESULTS] The overall average surface roughness for Siltex MemoryGel and MemoryShape implants was 29.5 and 36.1 µm, respectively. A statistically significantly lower rate of reoperation in patients with Siltex compared with smooth devices over 10 years was observed for both capsular contracture in subglandular primary augmentation patients (4.21% vs 19.84%) and for asymmetry in primary reconstruction patients (3.88% vs 11.1%).

[CONCLUSIONS] Surface analysis demonstrated that 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 Study. These findings provide valuable risk-benefit information for surgeons and their patients.