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

John Scott Roth; Gary J. Anthone; Don J. Selzer; Benjamin K. Poulose; Richard A. Pierce; James G. Bittner; William W. Hope; Raymond M. Dunn; Robert G. Martindale; Matthew I. Goldblatt; David B. Earle; John R. Romanelli; Gregory J. Mancini; Jacob A. Greenberg; John G. Linn; Eduardo Parra-Davila; Bryan J. Sandler; Corey R. Deeken; Jasenka Verbarg; Jennifer L. Salluzzo; Guy R. Voeller

doi:10.1016/j.amsu.2020.12.002

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

John Scott Roth, Gary J. Anthone, Don J. Selzer, Benjamin K. Poulose, Richard A. Pierce, James G. Bittner, William W. Hope, Raymond M. Dunn, Robert G. Martindale, Matthew I. Goldblatt, David B. Earle, John R. Romanelli, Gregory J. Mancini, Jacob A. Greenberg, John G. Linn, Eduardo Parra-Davila, Bryan J. Sandler, Corey R. Deeken, Jasenka Verbarg, Jennifer L. SalluzzoGuy R. Voeller

Research output: Contribution to journal › Article › peer-review

20 Scopus citations

Abstract

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/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.

Original language	English
Pages (from-to)	1-7
Number of pages	7
Journal	Annals of Medicine and Surgery
Volume	61
DOIs	https://doi.org/10.1016/j.amsu.2020.12.002
State	Published - Jan 2021

Bibliographical note

Funding Information:
This study was funded by CR Bard/Becton Dickinsone. Authors were reimbursed for expenses related to the conduct of the study.

Funding Information:
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.

Publisher Copyright:
© 2020

Keywords

Hernia repair
Infection
Mesh
Poly-4-hydroxybutyrate
Recurrence
Seroma

ASJC Scopus subject areas

Surgery

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1016/j.amsu.2020.12.002

Cite this

Roth, J. S., Anthone, G. J., Selzer, D. J., Poulose, B. K., Pierce, R. A., Bittner, J. G., Hope, W. W., Dunn, R. M., Martindale, R. G., Goldblatt, M. I., Earle, D. B., Romanelli, J. R., Mancini, G. J., Greenberg, J. A., Linn, J. G., Parra-Davila, E., Sandler, B. J., Deeken, C. R., Verbarg, J., ... 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.2020.12.002

@article{d5ee0a395d8040d8b8c181657f9290c2,

title = "Prospective, multicenter study of P4HB (Phasix{\texttrademark}) mesh for hernia repair in cohort at risk for complications: 3-Year follow-up",

abstract = "Background: This study represents a prospective, multicenter, open-label study to assess the safety, performance, and outcomes of poly-4-hydroxybutyrate (P4HB, Phasix{\texttrademark}) 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.",

keywords = "Hernia repair, Infection, Mesh, Poly-4-hydroxybutyrate, Recurrence, Seroma",

author = "Roth, {John Scott} and Anthone, {Gary J.} and Selzer, {Don J.} and Poulose, {Benjamin K.} and Pierce, {Richard A.} and Bittner, {James G.} and Hope, {William W.} and Dunn, {Raymond M.} and Martindale, {Robert G.} and Goldblatt, {Matthew I.} and Earle, {David B.} and Romanelli, {John R.} and Mancini, {Gregory J.} and Greenberg, {Jacob A.} and Linn, {John G.} and Eduardo Parra-Davila and Sandler, {Bryan J.} and Deeken, {Corey R.} and Jasenka Verbarg and Salluzzo, {Jennifer L.} and Voeller, {Guy R.}",

note = "Funding Information: This study was funded by CR Bard/Becton Dickinsone. Authors were reimbursed for expenses related to the conduct of the study. Funding Information: 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. Publisher Copyright: {\textcopyright} 2020",

year = "2021",

month = jan,

doi = "10.1016/j.amsu.2020.12.002",

language = "English",

volume = "61",

pages = "1--7",

}

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 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, vol. 61, pp. 1-7. https://doi.org/10.1016/j.amsu.2020.12.002

TY - JOUR

T1 - Prospective, multicenter study of P4HB (Phasix™) mesh for hernia repair in cohort at risk for complications

T2 - 3-Year follow-up

AU - Roth, John Scott

AU - Anthone, Gary J.

AU - Selzer, Don J.

AU - Poulose, Benjamin K.

AU - Pierce, Richard A.

AU - Bittner, James G.

AU - Hope, William W.

AU - Dunn, Raymond M.

AU - Martindale, Robert G.

AU - Goldblatt, Matthew I.

AU - Earle, David B.

AU - Romanelli, John R.

AU - Mancini, Gregory J.

AU - Greenberg, Jacob A.

AU - Linn, John G.

AU - Parra-Davila, Eduardo

AU - Sandler, Bryan J.

AU - Deeken, Corey R.

AU - Verbarg, Jasenka

AU - Salluzzo, Jennifer L.

AU - Voeller, Guy R.

N1 - Funding Information: This study was funded by CR Bard/Becton Dickinsone. Authors were reimbursed for expenses related to the conduct of the study. Funding Information: 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. Publisher Copyright: © 2020

PY - 2021/1

Y1 - 2021/1

N2 - 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/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.

AB - 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/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.

KW - Hernia repair

KW - Infection

KW - Mesh

KW - Poly-4-hydroxybutyrate

KW - Recurrence

KW - Seroma

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DO - 10.1016/j.amsu.2020.12.002

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VL - 61

SP - 1

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ER -

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

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

UN SDGs

Access to Document

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