Litigation Meets Evidence: A Novel Approach to Understanding Preventable Complications in Breast Reconstruction

Breast reconstruction surgery can result in various complications, some of which lead to medical litigation or formal mediation. However, systematic comparison of these medicolegal cases with evidence-based preventive strategies from randomized controlled trials remains unexplored. This study employed a novel methodology comparing complications resulting in litigation/mediation with contemporary randomized controlled trial (RCT) evidence. A mixed-methods approach was utilized, combining systematic review of RCTs (PubMed, 2020-2024) following modified PRISMA guidelines with comprehensive analysis of medical litigation and mediation databases. Narrative synthesis compared complication patterns between medicolegal cases and preventive interventions validated in RCTs. Nineteen RCTs and seven medicolegal cases (5 litigations, 2 mediations) were analyzed. All cases involved complications with proven preventive strategies. In implant-based reconstruction, tissue necrosis leading to implant loss (3/5 cases, 60%) occurred despite RCT evidence showing 50% reduction with indocyanine green assessment and 37% reduction with prostaglandin E1 (34.3% to 21.6%, p < 0.001). Both autologous reconstruction cases developed abdominal hernias, contrasting with 1-3% rates using synthetic mesh versus 38% with biological materials (p < 0.001). No cases utilized these evidence-based interventions. Informed consent violations were identified in 86% of cases. Total awards (compensation plus consolation money) ranged from $0-34,509, granted in 86% (6/7) of cases. A critical evidence-practice gap exists where validated preventive strategies remain unutilized in complications severe enough to prompt litigation or formal mediation. The comprehensive safety protocol developed from this analysis provides an actionable framework for implementing evidence-based interventions, offering a pathway to prevent catastrophic complications and reduce medicolegal risk in breast reconstruction.