One-Stage Implant-Based Breast Reconstruction With Polyurethane-Coated Device: Standardized Assessment of Outcomes

Background: Nipple-sparing mastectomies (NSM) and implant-based breast reconstructions (IBR) have evolved from two-stage reconstructions with tissue expansion (TE) and implant exchange, to direct-to-implant (DTI). In this study, we tested safety and efficacy of Polyurethane based implants according to standard assessment tools. Objectives: This study aims to test safety and feasibility of polyurethane coated implants using standardized assessment with internationally acknowledge evaluation criteria. Methods: Cases of nipple sparing mastectomies followed by breast reconstruction in one stage with immediate pre-pectoral polyurethane coated implants placement were retrospectively reviewed. Pre-operative characteristics of the population Adherence to quality assurance criteria or ABS-BAPRAS was verified. Complications were assessed using the Clavied-Dindo classifications modified for breast. Rippling, implant rotation and malposition were also evaluated. Results: Sixty-three consecutive patients underwent 74 nipple-sparing mastectomies (NSM) and immediate breast reconstruction with micro-polyurethane foam-coated anatomic implants. In five cases we had an unplanned re-admission with return to theatre under general anaesthesia (6.7%) and implant loss within 3 months from breast reconstruction (5 implants 6.7%). Post-operative complications according to Clavien Dindo were grade 1 in 6 cases (8.1%), grade 2 in 3 (4%) and 3b in 5 cases (6.7%). Conclusions: Polyurethane coated implants may prevent rotation and malposition and capsular contracture in the short term. Unplanned re-admission rates and implant loss rates in the short term may be slightly higher.