RESUMEN
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.
RESUMEN
The prevalence of complex abdominal wall defects continues to rise, which necessitates increasingly sophisticated medical and surgical management. Insurance coverage for reconstructive surgery varies due to differing interpretations of medical necessity. The authors sought to characterize the current insurance landscape for a subset of key adjunctive procedures in abdominal wall reconstruction, including component separation and simultaneous ventral hernia repair with panniculectomy (SVHR-P) or abdominoplasty (SVHR-A), and synthesize a set of reporting recommendations based on insurer criteria. METHODS: Insurance companies were selected based on their national and state market share. Preauthorization criteria, preauthorization lists, and medical/clinical policies by each company for component separation, SVRH-P, and SVRH-A were examined. Coverage criteria were abstracted and analyzed. RESULTS: Fifty insurance companies were included in the study. Only 1 company had clear approval criteria for component separation, while 38 cover it on a case-by-case basis. Four companies had clear approval policies for SVHR-P, 4 cover them on an individual case basis, and 28 flatly do not cover SVHR-P. Similarly, 3 companies had clear approval policies for SVHR-A, 6 cover them case by case, and 33 do not cover SVHR-A. CONCLUSIONS: Component separation and soft tissue contouring are important adjunctive AWR procedures with efficacy supported by peer-reviewed literature. The variability in SVHR-P and SVHR-A coverage likely decreases access to these procedures even when there are established medical indications. The authors recommend standardization of coverage criteria for component separation, given that differing interpretations of medical necessity increase the likelihood of insurance denials.