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Prospective Evaluation of Poly-4-hydroxybutyrate Mesh in CDC Class I, High-Risk Ventral and Incisional Hernia Repair: 3-Year Follow-up

John S Roth, Professor of Surgery1, G J Anthone2, D J Selzer3, Ben K Poulose4, J G Bittner5, William W Hope6, R M Dunn7, Robert J Martindale8, Matthew J Goldblatt9, David Earle10, John Romanell11, Greg Mancini12, J A Greenbert13, J G Linn14, E Parra-Davilla15, Brian J Sandler16, G R Voeller12. 1University of Kentucky, 2Nebraska Methodist Hospital, 3Indiana University, 4Ohio State University, 5Virginia Commonwealth University, 6New Hanover Regional Medical Center, 7University of Massachusetts, 8Oregon Health Sciences University, 9Medical College of Wisconsin, 10Lowell General Hospital, 11Baystate Medical Center, 12University of Tennessee, 13University of Wisconsin, 14Evanston, IL, 15Celebration, 16University of California, San Diego

Introduction: Long-term resorbable mesh represents a promising technology for complex ventral and incisional hernia repair (VIHR). Preclinical studies indicate that Poly-4-hydroxybutyrate (P4HB) bioresorbable mesh supports strength restoration of the abdominal wall. The objective of this study is to evaluate outcomes of CDC Class I/High-Risk patients undergoing VIHR with P4HB mesh.

Methods: This is a prospective multi-institutional study of patients undergoing retrorectus or onlay VIHR. Inclusion criteria are: CDC Class I, defect size 10-350cm2, ≤3 prior repairs, and ≥1 high-risk criteria (i.e. obesity, active smoker, COPD, diabetes, immunosuppression, coronary disease, steroid use, hypoalbuminemia, advanced age and renal insufficiency). Physical exam and/or quality of life surveys are performed at regular intervals through 5 years (60 months).

Results: 121 patients (46M, 75F) with a mean age of 54.7+/-12.0 years and BMI of 32.2 +/-4.5 kg/m2 underwent VIHR.  Comorbid conditions include: obesity (78.5%), hypertension (59.5%), COPD (28.1%), cardiovascular disease (34.7%), diabetes (33.1%), active smoker (23.1%), malignancy (24.8%), immunosuppression (8.3%), chronic corticosteroid use (5.0%), hypoalbuminemia (2.5%), advanced age (5.0%), and renal insufficiency (0.8%). Hernia types include: primary ventral hernia (14.0%), primary incisional hernia (44.6%), recurrent ventral hernia (12.4%), and recurrent incisional hernia (28.9%). Mean defect and mesh size are: 115.7+/-80.6 cm2 and 459.38 +/-172.3 cm2, respectively. Repair types include: retrorectus (43, 35.5%), retrorectus with component separation (45, 37.2%), onlay (24, 19.8%) and onlay with component separation (8, 6.6%), and other (1, 0.8%). 82 patients (67.8%) have completed at least 36 months follow-up to date. Postoperative wound infection, seroma requiring intervention, and hernia recurrence occurred in 11 (9.1%), 8 (6.6%) and 19 (15.7%) Among the recurrences, nine occurred in the onlay group and 10 in the retrorectus group. 

Conclusion: Intermediate term outcomes following VIHR with P4HB mesh are favorable and demonstrate low recurrence rates at the 3-year (36-month) postoperative time frame.  5-year (60-month) follow-up is ongoing. 


Presented at the SAGES 2017 Annual Meeting in Houston, TX.

Abstract ID: 93623

Program Number: P553

Presentation Session: Poster Session (Non CME)

Presentation Type: Poster

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