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.
Background: Although guidelines have been published on treatment of breast implant–associated anaplastic large-cell lymphoma (BIA-ALCL), there has been no comprehensive analysis of BIA-ALCL treatment variation based on the available literature. The authors sought to assess current treatment strategies of BIA-ALCL relative to current guidelines. Methods: Database searches were conducted in June of 2020. Included articles were case reports and case series with patient-level data. Collected variables included clinicopathologic features, implant characteristics, diagnostic tests, ALCL characteristics, treatment, and details of follow-up and outcome. Treatment data from before and after 2017 were compared with National Cancer Center Network guidelines. Results: A total of 89 publications were included and 178 cases of BIA-ALCL were identified. Most patients presented with seroma (n = 114, 70.4 percent), followed by a mass (n = 14, 8.6 percent), or both (n = 23, 14.2 percent). Treatment included en bloc capsulectomy of the affected implant in 122 out of 126 cases with treatment details provided (96.8 percent). Radiation therapy was given in 38 cases (30.2 percent) and chemotherapy was given in 71 cases (56.3 percent). Practitioners used less chemotherapy for local disease after treatment guideline publication in 2017 (p < 0.001), whereas treatment for advanced disease remained unchanged (p = 0.3). There were 10 recurrences and eight fatalities attributable to BIA-ALCL, which were associated with advanced presentation (29 versus 2.1 percent; OR, 19.4; 95 percent CI, 3.9 to 96.3; p < 0.001). Conclusions: BIA-ALCL remains a morbid but treatable condition. Current guidelines focus treatment for local disease and reduce nonsurgical interventions with radiation or chemotherapy. Patients presenting with advanced BIA-ALCL experience higher rates of recurrence and mortality.
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