Prepectoral direct-to-implant breast reconstruction using a novel acellular dermal matrix: framework for a cohort study

Background: Capsular contracture remains a significant complication in implant-based breast reconstruction, particularly in the context of prepectoral direct-to-implant (DTI) techniques. The advent of acellular dermal matrices (ADMs) has enabled broader adoption of prepectoral reconstruction by enhancing implant support and tissue integration. FlexHD Pliable PRE is a novel ADM designed specifically for prepectoral breast reconstruction, featuring fenestrations and conformable architecture to optimize pocket support and aesthetic outcomes. However, clinical data evaluating capsular contracture rates and associated risk factors with this product remain limited. Objective: To determine the incidence of capsular contracture and identify associated risk factors in patients undergoing prepectoral DTI breast reconstruction using FlexHD Pliable PRE. Methods: This retrospective cohort study includes all consecutive patients who underwent prepectoral DTI breast reconstruction with FlexHD Pliable PRE between February 2017 and June 2024. Exclusion criteria include subpectoral placement, autologous reconstruction, and follow-up under 12 months. Patient demographics, procedural details, and postoperative outcomes (including capsular contracture, implant malposition, infection, implant loss, and other potential complications) will be collected. Capsular contracture will be defined as Baker grade III/IV. Univariate analysis and multivariable logistic regression will identify independent predictors of contracture.