Mid-term safety profile evaluation of Bio-A absorbable synthetic mesh as cruroplasty reinforcement

  • Angelo IossaEmail author
  • Gianfranco Silecchia



The aim of the present paper is to report the results of a single institution series of hiatal hernia repair (HHR) with augmented mesh hiatoplasty focusing on safety and efficacy profile of Bio-A absorbable synthetic mesh.

Materials and methods

A retrospective evaluation of prospectively maintained database showed 120 consecutive patients submitted to HHR reinforced with bio-absorbable synthetic mesh. The study populations included two groups: (A) 92 obese patients—reinforced hiatoplasty concurrent with bariatric procedure; (B) 28 non-obese patients—reinforced hiatoplasty concurrent with antireflux surgery. Symptoms assessment was made with GERD-HRQL and Rome III. The X-ray with barium swallow, the CT scan, in selected cases, and the endoscopy were used as recurrence evaluation and as endoscopic complications assessment. Only patients with a mean follow-up of 12 months were included in this study. A Cox hazard was made to evaluate factors affecting the recurrence.


No case of intra-peri and post-operative (mean follow-up of 41 months) complications mesh related were registered. The dysphagia-rate was 8.7% for Group A and 11% for Group B. 74% of Group A and 61% of Group B patients are actually PPIs free with median GERD-HRQL score of 4 (from 16) and 6 (from 23), respectively (difference pre-post-operative < 0.05). Recurrence rate was 5.4% in Group A and 7.1% in Group B. The Cox hazard analysis showed that the use of more than four stitches for cruroplasty represents a negative factor on recurrence (HR = 8; p < 0.05).


This is, in our knowledge, the largest report (120 consecutive patients) with mid-term follow-up (41 months of mean FU) on bio-absorbable mesh on the hiatus in obese and non-obese patients. These results supports the use of absorbable mesh for HHR (safe profile—0% of complications rate), showing excellent recurrence rate results and good GERD symptoms control.


Mesh on the hiatus Hiatal hernia repair with mesh Synthetic bio-absorbable mesh Obesity Risk factors hernia recurrence 


Compliance with ethical standards


Dr Angelo Iossa and Prof. Gianfranco Silecchia have no conflicts of interest or financial ties to disclose.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

For this type of study formal consent is not required.


  1. 1.
    Kohn GP, Price RR, DeMeester SR, Zehetner J, Muensterer OJ, Awad Z, Mittal SK, Richardson WS, Stefanidis D, Fanelli RD; SAGES Guidelines Committee (2013) Guidelines for the management of hiatal hernia. Surg Endosc 27(12):4409–4428. CrossRefGoogle Scholar
  2. 2.
    Corley DA, Kubo A (2006) Body mass index and gastroesophageal reflux disease: a systematic review and meta-analysis. Am J Gastroenterol 101(11):2619–2628CrossRefGoogle Scholar
  3. 3.
    Anand G, Katz PO (2008) Gastroesophageal reflux disease and obesity. Rev Gastroenterol Disorder 8(4):233–239Google Scholar
  4. 4.
    Perez AR, Moncure AC, Rattner DW (1999) Obesity is a major cause of failure for both abdominal and transthoracic antireflux operations. Gastroenterology 116:A1343Google Scholar
  5. 5.
    Mechanick JI, Youdim A, Jones DB et al (2013) Clinical practice guidelines for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient—2013 update: cosponsored by American Association of Clinical Endocrinologists, the Obesity Society, and American Society for Metabolic & Bariatric Surgery. Surg Obes Relat Dis 9(2):159–191. CrossRefGoogle Scholar
  6. 6.
    Tatum RP, Shalhub S, Oelschlager BK et al (2008) Complications of PTFE mesh erosion at the diaphragmatic hiatus. J Gastrointest Surg 12:953–957CrossRefGoogle Scholar
  7. 7.
    Dutta S (2007) Prosthetic esophageal erosion after mesh hiatoplasty in a child, removed by transabdominal endogastric surgery. J Pediatr Surg 42:252–256CrossRefGoogle Scholar
  8. 8.
    Köckerling F, Schug-Pass C, Bittner R (2018) A word of caution: never use tacks for mesh fixation to the diaphragm! Surg Endosc 32(7):3295–3302. CrossRefGoogle Scholar
  9. 9.
    Rengo M, Bellini D, Iorio O et al (2013) Role of preoperative imaging with multidetector computed tomography in the management of patients with gastroesophageal reflux disease symptoms after laparoscopic sleeve gastrectomy. Obes Surg 23(12):1981–1986. CrossRefGoogle Scholar
  10. 10.
    Silecchia G, Iossa A, Cavallaro G et al (2014) Reinforcement of hiatal defect repair with absorbable mesh fixed with non-permanent devices. Minim Invasive Ther Allied Technol 23(8):302–308CrossRefGoogle Scholar
  11. 11.
    Ruscio S, Abdelgawad M, Badiali D et al (2016) Simple versus reinforced cruroplasty in patients submitted to concomitant laparoscopic sleeve gastrectomy: prospective evaluation in a bariatric center of excellence. Surg Endosc 30(6):2374–2381. CrossRefGoogle Scholar
  12. 12.
    Drossman DA, Dumitrascu DL (2006) Rome III: new standard for functional gastrointestinal disorders. J Gastrointestin Liver Dis 15(3):237–241Google Scholar
  13. 13.
    Velanovich V (1998) Comparison of generic (SF-36) vs disease-specific quality of life (GERD-HRQL) scales for gastroesophageal reflux disease. J Gastrointest Surg 2(2):141–145CrossRefGoogle Scholar
  14. 14.
    Schindler A, Mozzanica F, Monzani A et al (2013) Reliability and validity of the Italian Eating Assessment Tool. Ann Otol Rhinol Laryngol 122(11):717–724CrossRefGoogle Scholar
  15. 15.
    Antoniou SA, Antoniou GA, Koch OO et al (2012) Lower recurrence rates after mesh-reinforced versus simple hiatal hernia repair: a meta-analysis of randomized trials. Surg Laparosc Endosc Percutan Tech 22(6):498–502. (Review)CrossRefGoogle Scholar
  16. 16.
    Memon MA, Memon B, Yunus RM et al (2016) Suture cruroplasty versus prosthetic hiatal herniorrhaphy for large hiatal hernia: a meta-analysis and systematic review of randomized controlled trials. Ann Surg 263(2):258–266. CrossRefGoogle Scholar
  17. 17.
    Tam V, Winger DG, Nason KS (2016) A systematic review and meta-analysis of mesh vs suture cruroplasty in laparoscopic large hiatal hernia repair. Am J Surg 211(1):226–238 CrossRefGoogle Scholar
  18. 18.
    Zhang C, Liu D, Li F, Watson DI et al (2017) Systematic review and meta-analysis of laparoscopic mesh versus suture repair of hiatus hernia: objective and subjective outcomes. Surg Endosc 31(12):4913–4922. CrossRefGoogle Scholar
  19. 19.
    Mahawar KK, Carr WR, Jennings N et al (2015) Simultaneous sleeve gastrectomy and hiatus hernia repair: a systematic review. Obes Surg 25(1):159–166. (Review)CrossRefGoogle Scholar
  20. 20.
    Soricelli E, Iossa A, Casella G et al (2013) Sleeve gastrectomy and crural repair in obese patients with gastroesophageal reflux disease and/or hiatal hernia. Surg Obes Relat Dis 9(3):356–361CrossRefGoogle Scholar
  21. 21.
    Santonicola A, Angrisani L, Cutolo P et al (2013) The effect of laparoscopic sleeve gastrectomy with or without hiatal hernia repair on gastro-esophageal reflux disease in obese patients. Surg Obes Relat Dis 10(2):250–255. CrossRefGoogle Scholar
  22. 22.
    Macedo FIB, Mowzoon M, Mittal VK et al (2017) Outcomes of laparoscopic hiatal hernia repair in nine bariatric patients with prior sleeve gastrectomy. Obes Surg 27(10):2768–2772. CrossRefGoogle Scholar
  23. 23.
    Asti E, Sironi A, Bonitta G et al (2017) Crura augmentation with Bio-A® mesh for laparoscopic repair of hiatal hernia: single-institution experience with 100 consecutive patients. Hernia 21(4):623–628. CrossRefGoogle Scholar
  24. 24.
    Massullo JM, Singh TP, Dunnican WJ et al (2012) Preliminary study of hiatal hernia repair using polyglycolic acid: trimethylene carbonate mesh. JSLS 16:55–59CrossRefGoogle Scholar
  25. 25.
    Powell BS, Wandrey D, Voeller GR (2013) A technique for placement of a bioabsorbable prosthesis with fibrin glue fixation for reinforcement of the crural closure during hiatal hernia repair. Hernia 17:81–84CrossRefGoogle Scholar
  26. 26.
    Priego Jiménez P, Salvador Sanchís JL, Angel V et al (2014) Short-term results for laparoscopic repair of large paraesophageal hiatal hernias with Gore Bio A® mesh. Int J Surg 12(8):794–797. CrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Division of General Surgery and Bariatric Centre of Excellence, Department of Medical-Surgical Sciences and BiotechnologiesUniversity of Rome “La Sapienza”RomeItaly

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