Long-Term Outcomes After Slowly Resorbable P4HB Mesh Implantation: A Multicenter Analysis From European Registry.

Abstract

<h4>Background</h4>Fully resorbable biosynthetic mesh composed of poly-4-hydroxybutyrate (P4HB), have been designed for incisional hernia (IH) repair, including in contaminated surgical fields. While existing studies have demonstrated its safety and efficacy in the short term, comprehensive long-term data, particularly after complete mesh resorption, remain scarce.<h4>Methods</h4>This multicenter European registry analysis investigates the incidence of short- and long-term complications following IH repair with Phasix (P4HB) or Phasix ST (P4HB with hydrogel barrier; BD, Warwick, RI, USA) mesh. Adult patients from registries in France, Greece, Germany, and Spain were included and stratified using the Ventral Hernia Working Group (VHWG) classification. The primary endpoint was the incidence of long-term mesh-related complications one to five years post-implantation, after mesh resorption. Secondary endpoints included short-term complications and hernia recurrence.<h4>Results</h4>A total of 790 patients underwent incisional hernia repair with P4HB mesh, with a median follow-up of 38 months (IQR 36-48). Long-term follow-up beyond 24 months was available in 57% of patients. The majority of complications occur during the first 6 months. Long-term mesh-related morbidity remained low, with mesh infection occurring in 2% of patients and chronic pain in 3%-5%, even after complete mesh resorption. Rates of enterocutaneous fistula and mesh explantation were rare. Long-term complication profiles varied by hernia complexity, comorbidity burden, and mesh position, with higher ASA class associated with increased risk of mesh infection and chronic pain. The overall hernia recurrence rate was 22%, with recurrence increasing after the expected resorption period and stabilizing thereafter. Higher recurrence risk was independently associated with VHWG grade III-IV (HR of 2.55 and 2.49), obesity (HR 1.41), and intraperitoneal mesh placement (HR 2.72).<h4>Conclusion</h4>P4HB mesh demonstrated a favorable long-term safety profile after complete resorption, with low rates of mesh-related complications, even in high-risk patients. Hernia recurrence remains an important secondary outcome and is strongly influenced by patient risk factors and surgical technique. These findings support a tailored, risk-stratified approach to the use of biosynthetic meshes in IH repair.