Prospective, multicenter study of P4HB (Phasix™) mesh for hernia repair in cohort at risk for complications: 3-Year follow-up

dc.contributor.authorRoth, John Scott
dc.contributor.authorAnthone, Gary J.
dc.contributor.authorSelzer, Don J.
dc.contributor.authorPoulose, Benjamin K.
dc.contributor.authorPierce, Richard A.
dc.contributor.authorBittner, James G.
dc.contributor.authorHope, William W.
dc.contributor.authorDunn, Raymond M.
dc.contributor.authorMartindale, Robert G.
dc.contributor.authorGoldblatt, Matthew I.
dc.contributor.authorEarle, David B.
dc.contributor.authorRomanelli, John R.
dc.contributor.authorMancini, Gregory J.
dc.contributor.authorGreenberg, Jacob A.
dc.contributor.authorLinn, John G.
dc.contributor.authorParra-Davila, Eduardo
dc.contributor.authorSandler, Bryan J.
dc.contributor.authorDeeken, Corey R.
dc.contributor.authorVerbarg, Jasenka
dc.contributor.authorSalluzzo, Jennifer L.
dc.contributor.authorVoeller, Guy R.
dc.contributor.departmentSurgery, School of Medicineen_US
dc.date.accessioned2022-04-22T15:49:54Z
dc.date.available2022-04-22T15:49:54Z
dc.date.issued2021-01
dc.description.abstractBackground: 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/m2 (±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.en_US
dc.eprint.versionFinal published versionen_US
dc.identifier.citationRoth, J. S., Anthone, G. J., Selzer, D. J., Poulose, B. K., Pierce, R. A., Bittner, J. G., ... & Voeller, G. R. (2021). Prospective, multicenter study of P4HB (Phasix™) mesh for hernia repair in cohort at risk for complications: 3-Year follow-up. Annals of Medicine and Surgery, 61, 1-7. https://doi.org/10.1016/j.amsu.2020.12.002en_US
dc.identifier.urihttps://hdl.handle.net/1805/28709
dc.language.isoen_USen_US
dc.publisherElsevieren_US
dc.relation.isversionof10.1016/j.amsu.2020.12.002en_US
dc.relation.journalAnnals of Medicine & Surgeryen_US
dc.rightsAttribution 4.0 International
dc.rights.urihttps://creativecommons.org/licenses/by/4.0
dc.sourcePMCen_US
dc.subjectHernia repairen_US
dc.subjectRecurrenceen_US
dc.subjectInfectionen_US
dc.subjectPoly-4-hydroxybutyrateen_US
dc.subjectMeshen_US
dc.subjectSeromaen_US
dc.titleProspective, multicenter study of P4HB (Phasix™) mesh for hernia repair in cohort at risk for complications: 3-Year follow-upen_US
dc.typeArticleen_US
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