Evaluation of the safety and effectiveness of crural reinforcement with bio-a® or phasix-st® mesh: results from a multicenter study

Hernia. 2025 Nov 10;30(1):9. doi: 10.1007/s10029-025-03516-3.

Abstract

Background: Absorbable synthetic meshes have gained increasing acceptance for crural reinforcement during hiatus hernia (HH) repair because their safety profile and the potential of reducing recurrence rates. Bio-A® (Gore Medical, Newark, DE, USA) and Phasix-ST® (C.R. Bard, Inc./Davol, Inc., Warwick, RI, USA) are the most commonly used meshes. While previous single-arm studies have been published, there are no articles reporting the comparison between Phasix-ST® vs. Bio-A®.

Aim: Compare safety, efficacy, recurrence rates, and quality of life after laparoscopic HH repair and cruroplasty reinforced with either Bio-A® or Phasix-ST® mesh.

Methods: Retrospective multicenter study (September 2011- December 2024). All patients that underwent minimally invasive HH repair with Phasix-ST® or Bio-A® reinforced cruroplasty and Toupet fundoplication were included.

Results: Overall, 271 patients were included. Bio-A® reinforcement was utilized in 46.8% of patients. The median follow-up time was 94 (IQR 21) months for Bio-A® and 51 (IQR 17) months for Phasix-ST® mesh. Hernia recurrence was diagnosed in 10.1% of patients with similar rates for Phasix-ST® vs. Bio-A® (7.8% vs. 12.6%; p = 0.28). The regression analysis showed that Phasix-ST® (HR 0.66), 'keyhole' configuration (HR 0.81), hernia type III-IV (HR 1.38), and recurrent HH (HR 1.27) were not independent predictor or protective factors for recurrence. The 55-month recurrence free probability for Bio-A® vs. Phasix-ST® was comparable (86.2% vs. 91.8%; p = 0.132).

Conclusions: This study shows that Bio-A® and Phasix-ST® are equally safe for crural reinforcement during HH repair. Due to the longer absorption rate, Phasix ST® might presumably confer enhanced hiatal protection early in the course of the follow-up.

Keywords: Composite hiatoplasty; Crural reinforcement; Hernia recurrence; Hiatus hernia repair; Posterior hiatoplasty.

Publication types

  • Multicenter Study
  • Comparative Study

MeSH terms

  • Aged
  • Female
  • Fundoplication / methods
  • Hernia, Hiatal* / surgery
  • Herniorrhaphy* / adverse effects
  • Herniorrhaphy* / instrumentation
  • Herniorrhaphy* / methods
  • Humans
  • Laparoscopy / methods
  • Male
  • Middle Aged
  • Quality of Life
  • Recurrence
  • Retrospective Studies
  • Surgical Mesh* / adverse effects
  • Treatment Outcome