Post-Mastectomy Direct-to-Implant Pre-Pectoral Breast Reconstruction With Polyurethane-Coated Implants: A Systematic Review of Efficacy and Safety

Background Pre-pectoral (PP) direct-to-implant (DTI) breast reconstruction has gained popularity as a muscle-sparing alternative to subpectoral techniques. Polyurethane-coated implants, with their unique mechanical and biological properties, may further optimize outcomes by reducing capsular contracture and improving implant stability. Objectives This systematic review aimed to evaluate the safety, efficacy, and patient-reported outcomes of post-mastectomy PP DTI breast reconstruction using polyurethane-coated implants. Methods A systematic search of PubMed, Embase, Scopus, and Cochrane Library databases was conducted in accordance with PRISMA guidelines. Data on study design, patient and surgical characteristics, complications, aesthetic outcomes, and patient satisfaction were extracted. Risk of bias was assessed using the ROBINS-I tool. Results Thirteen studies met inclusion criteria, comprising 1,717 patients and 2,502 breasts reconstructed with polyurethane-coated implants. Mean follow-up across included studies was 12.3 months (range 1–60 months). Mean implant size was 327 cc (range 160–680cc). Across all studies, implant loss occurred in 1.0% of cases and infection in 0.9%. Capsular contracture with reported Baker grade III–IV cases occurred in 1.0% of cases within ≤12 months of follow-up, increasing to 12.3% in studies with ≥36 months’ follow-up. The most frequent aesthetic drawback was rippling or contour deformity, affecting 183 breasts (7.3%). Patient-reported satisfaction was consistently favorable: five studies using the BREAST-Q reported mean scores ranging from 72.6–78.3 for Satisfaction with Breasts and 79.9–84.6 for Psychosocial Well-Being. Conclusions Pre-pectoral DTI reconstruction with polyurethane-coated implants is a safe and effective technique, associated with low complication rates and high patient satisfaction. Careful flap selection and adjunctive fat grafting optimize results. Prospective multicenter studies with long-term follow-up are warranted to confirm durability and refine patient selection criteria.