Outcomes of Poly-4-hydroxybutyrate Mesh in Ventral Hernia Repair: A Systematic Review and Pooled Analysis

Abstract

Background: Within the past decade, poly-4-hydroxybutyrate (P4HB) biosynthetic mesh has been introduced as a potential alternative to traditional biologic and synthetic mesh in ventral hernia repair (VHR). The aim of this study was to systematically assess clinical outcomes with the P4HB in VHR. Methods: A literature search identified all articles published in 2000 involving the use of P4HB in VHR. Descriptive statistics were used to synthesize collective data points, including postoperative outcomes. A pooled analysis of postoperative outcomes was performed using chi-square test and Fisher exact test. Results: Across 7 studies, the P4HB was used in 453 patients. The mean rate of surgical site infection (SSI) was 6.8% (31/453), reoperation 10.7% (30/281), and recurrence 9.1% (41/453). At an average follow-up of 26.8 months, the incidence of recurrence was 10.4% (28/270). Onlay was significantly associated with increased recurrence (14.2% versus 4.4%, P = 0.001). Among sublay placements, there was no difference in recurrence in clean (Center for Disease Control [CDC] 1) or contaminated (CDC >1) wounds (2.7% versus 6.1%, P = 0.585), but contaminated wounds were associated with increased SSI (2.7% versus 15.2%, P = 0.028). Ventral Hernia Working Group grade 2 and 3 did not have different incidences of recurrence (8.0% versus 5.1%, P = 0.526) nor SSI (5.1% versus 14.6%, P = 0.265). Conclusions: Overall, clinical outcomes of the P4HB mesh in VHR are acceptable. The P4HB mesh serves as a reliable alternative to traditional synthetic and biologic mesh across a range of defect characteristics and patient health conditions. Further research is needed to better understand the conditions in which it may provide a clinical benefit over traditional mesh types.

Risks and Prevention of Surgical Site Infection After Hernia Mesh Repair and the Predictive Utility of ACS-NSQIP

“…14,[39][40][41] Poly-4-hydroxybutyrate monofilament biosynthetic mesh in clean or contaminated VHR appears a reliable and cost-effective long-term alternative to biological or non-absorbable synthetic mesh, but its use is still being evaluated. 42 A synchronous hernia mesh repair should not be contraindicated during other intra-abdominal operations (appendicectomy, cholecystectomy, small bowel resection). 8,9,11 An extraperitoneal mesh repair (retrorectus or onlay) rather than intraperitoneal mesh repair is preferable in contaminated VHR, emergency VHR, emergency laparotomy or with concurrent colorectal surgery.…”

Absorbable Electrospun Poly-4-hydroxybutyrate Scaffolds as a Potential Solution for Pelvic Organ Prolapse Surgery

“…For the current study, we produced our own absorbable electrospun P4HB scaffolds. P4HB was chosen as knitted P4HB implants have shown promise in reconstructive surgery for ventral hernia repair and in our preclinical studies for pelvic floor repair. ,,, In addition, electrospun P4HB for other applications such as a dural or dermal , substitution are encouraging, but the available studies are limited, and no studies on electrospun P4HB for pelvic floor repair have been conducted. Because fibroblasts are the main cell type of the connective tissue of the vaginal wall and are responsible for maintaining the ECM, , their function is critical in assessing implant performance in the pelvic floor and to predict how the implant will interact with the host.…”

Long-Term, Prospective, Multicenter Study of Poly-4-Hydroxybutyrate Mesh (Phasix Mesh) for Hernia Repair in Cohort at Risk for Complication: 60-Month Follow-Up

“…Several clinical studies have reported outcomes associated with P4HB mesh with a variety of hernia repair techniques and patient populations. 5 - 14 The majority of these studies have reported medium-term outcomes in the range of 18 to 36 months. 5 - 13 The current study is uniquely designed to evaluate clinical outcomes of P4HB mesh along a continuum of early, intermediate, and long-term timeframes.…”