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, and Voeller GR
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., Competing Interests: Dr. Roth reports a grant and consulting fees from C.R. Bard, Inc./Davol/Becton Dickinson (BD) during the conduct of this study. Dr. Roth also reports consulting fees (Johnson & Johnson) and stock (Miromatrix) outside of the current work. Dr. Anthone has no conflicts of interest to disclose related to this study. Dr. Anthone reports consulting fees and speaker honoraria (Becton Dickinson (BD)) outside of the current work. Dr. Selzer reports a grant from C.R. Bard, Inc./Davol/Becton Dickinson (BD) during the conduct of the study. Dr. Selzer also reports consulting fees (Cook Biotech, Inc.) outside of the current work. Dr. Poulose has no conflicts of interest to disclose related to the current study. Dr. Poulose reports salary support (Americas Hernia Society Quality Collaborative) and research support (Becton Dickinson (BD) and Advanced Medical Solutions) outside of the current work. Dr. Pierce has no conflicts of interest to disclose related to the current study. Dr. Pierce reports research support (Intuitive Surgical Solutions) outside of the current work and his spouse is a salaried employee of a medical device company (CareFusion) that falls under the overall umbrella of the parent company, Becton Dickinson (BD). Drs. Dunn, Bittner, Linn, Romanelli, and Sandler report a grant from C.R. Bard, Inc./Davol/Becton Dickinson (BD) during the conduct of the study but have nothing to disclose outside of the current work. Dr. Hope reports consulting fees and research support from C.R. Bard, Inc./Davol/Becton Dickinson (BD) during the conduct of the study. Dr. Hope also reports consulting fees, honoraria, and research support (Intuitive, W.L. Gore, and Medtronic) outside of the current work. Dr. Martindale has no conflicts of interest to disclose related to the current study. Dr. Martindale reports consulting fees (Allergan, C.R. Bard, Inc./Davol/Becton Dickinson (BD), and Nestle) and employment (OHSU) outside of the current work. Dr. Goldblatt reports a grant from C.R. Bard, Inc./Davol/Becton Dickinson (BD) during the conduct of the study. Dr. Goldblatt also reports consulting fees (W.L. Gore, Medtronic, and Allergan) and a grant (Medtronic) outside of the current work. Dr. Earle has no conflicts of interest to disclose related to the current study. Dr. Earle reports consulting fees (Becton Dickinson (BD) and Medtronic) and ownership stake/advisory board (Via Surgical) outside of the current work. Dr. Mancini has no conflicts of interest to disclose related to the current study. Dr. Mancini reports consulting fees (Stryker Endoscopy) and speakers’ fees (Gore Medical and Medtronic) outside of the current work. Dr. Greenberg reports a grant from C.R. Bard, Inc./Davol/Becton Dickinson (BD) during the conduct of the study. Dr. Greenberg also reports grants (Becton Dickinson (BD) and Medtronic), as well as course registration, travel, and lodging (Intuitive) outside of the current work. Dr. Parra-Davila has no conflicts of interest to disclose related to the current study. Dr. Parra-Davila reports consulting fees (C.R. Bard, Inc./Davol/Becton Dickinson (BD), Intuitive, Auris, Johnson & Johnson, and Titan), board membership (C.R. Bard, Inc./Davol/Becton Dickinson (BD)), and proctoring (Intuitive) outside of the current work. Dr. Deeken reports consulting fees from C.R. Bard, Inc./Davol/Becton Dickinson (BD) during the conduct of the study. Dr. Deeken also reports consulting fees from C.R. Bard, Inc./Davol/Becton Dickinson (BD), Surgical Innovation Associates, Americas Hernia Society Quality Collaborative, Colorado Therapeutics, TelaBio, and Aran Biomedical outside the submitted work, as well as grants from Ethicon, Inc. and TelaBio to support a book chapter outside the submitted work. In addition, Dr. Deeken is the owner of Covalent Bio, LLC and holds the following issued patents: 2009293001, 2334257, 2,334,257UK, 602009046407.8, 2,334,257FR, 16/043,849 and 2,737,542. Dr. Verbarg reports consulting fees from C.R. Bard, Inc./Davol/Becton Dickinson (BD) during the conduct of the study. Dr. Verbarg has no other conflict of interest to disclose outside of the current work. Drs. Salluzzo and Voeller have no conflicts of interest to disclose relative to the current study or any other work., (© 2020 The Authors. Published by Elsevier Ltd on behalf of IJS Publishing Group Ltd.)