Department of Surgery
Pathological Conditions, Signs and Symptoms | Surgery | Surgical Procedures, Operative
Background: This study represents a prospective, multicenter, open-label study to assess the safety, performance, and outcomes of poly-4-hydroxybutyrate (P4HB, Phasix) mesh for primary ventral, primary incisional, or multiply-recurrent hernia in subjects at risk for complications. This study reports 3-year clinical outcomes.
Materials and methods: P4HB mesh was implanted in 121 patients via retrorectus or onlay technique. Physical exam and/or quality of life surveys were completed at 1, 3, 6,12, 18, 24, and 36 months, with 5-year (60-month) follow-up ongoing.
Results: A total of n = 121 patients were implanted with P4HB mesh (n = 75 (62%) female) with a mean age of 54.7 +/- 12.0 years and mean BMI of 32.2 +/- 4.5 kg/m(2) (+/-standard deviation). Comorbidities included: obesity (78.5%), active smokers (23.1%), COPD (28.1%), diabetes mellitus (33.1%), immunosuppression (8.3%), coronary artery disease (21.5%), chronic corticosteroid use (5.0%), hypo-albuminemia (2.5%), advanced age (5.0%), and renal insufficiency (0.8%). Hernias were repaired via retrorectus (n = 45, 37.2% with myofascial release (MR) or n = 43, 35.5% without MR), onlay (n = 8, 6.6% with MR or n = 24, 19.8% without MR), or not reported (n = 1, 0.8%). 82 patients (67.8%) completed 36-month follow-up. 17 patients (17.9% +/- 0.4%) experienced hernia recurrence at 3 years, with n = 9 in the retrorectus group and n = 8 in the onlay group. SSI (n = 11) occurred in 9.3% +/- 0.03% of patients.
Conclusions: Long-term outcomes following ventral hernia repair with P4HB mesh demonstrate low recurrence rates at 3-year (36-month) postoperative time frame with no patients developing late mesh complications or requiring mesh removal. 5-year (60-month) follow-up is ongoing.
Hernia repair, Infection, Mesh, Poly-4-hydroxybutyrate, Recurrence, Seroma
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© 2020 The Authors. Published by Elsevier Ltd on behalf of IJS Publishing Group Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
DOI of Published Version
Roth JS, Anthone GJ, Selzer DJ, Poulose BK, Pierce RA, Bittner JG, Hope WW, Dunn RM, Martindale RG, Goldblatt MI, Earle DB, Romanelli JR, Mancini GJ, Greenberg JA, Linn JG, Parra-Davila E, Sandler BJ, Deeken CR, Verbarg J, Salluzzo JL, Voeller GR. Prospective, multicenter study of P4HB (Phasix™) mesh for hernia repair in cohort at risk for complications: 3-Year follow-up. Ann Med Surg (Lond). 2020 Dec 15;61:1-7. doi: 10.1016/j.amsu.2020.12.002. PMID: 33363718; PMCID: PMC7750179. Link to article on publisher's site
Annals of medicine and surgery (2012)
Roth JS, Romanelli JR, Dunn RM. (2020). Prospective, multicenter study of P4HB (Phasix) mesh for hernia repair in cohort at risk for complications: 3-Year follow-up. Open Access Publications by UMMS Authors. https://doi.org/10.1016/j.amsu.2020.12.002. Retrieved from https://escholarship.umassmed.edu/oapubs/4487
Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.