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

Abstract

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.