Pre-Clinical and Clinical Data

Outcomes: Hernia Recurrence Rates

889 patients in clinical literature, including a multicenter prospective clinical study, provide data to show GORE® BIO-A® Tissue Reinforcement is an excellent choice in soft tissue repair.* GORE® BIO-A® Tissue Reinforcement has low recurrence rates when used in hiatal hernia repair.1,2,3

Pre-Clinical Data

GORE® BIO-A® Tissue Reinforcement exhibited higher degree of cellular and vascular in-growth and collagen deposition than three commonly used biologic meshes in a sterile field. The use of a polyglycolic acid/trimethylene carbonate absorbable mesh results in a favorable tissue response.4

GORE BIO-A Tissue Reinforcement cellular ingrowth chart

Paraesophageal/Hiatal Hernia Repair

Title: "Reinforcement of hiatal defect repair with absorbable mesh fixed with non-permanent devices"

Study Type: Prospective Clinical Study
Authors & Journal Facts Highlighted Data

Silecchia G, Iossa A, Cavallaro G, Rizzello M, Longo F.

Minimally Invasive Therapy & Allied Technologies 2014;23(5):302-308.
  • Upper GI series at 1 & 12 months
  • Remission of GERD symptoms in 91% of patients
  • 2.3% recurrence rate, one asymptomatic patient
  • No mesh related complications
 43 patients

17.4 months follow up

Title: "Resorbable biosynthetic mesh for crural reinforcement during hiatal hernia repair"

Study Type: Retrospective Clinical Study
Authors & Journal Facts Highlighted Data

Alicuben ET, Worrell SG, DeMeester SR.

American Surgeon 2014;80(10):1030-1033.
  • Objective follow up by videoesophagram and/or esphagogastroduodenoscopy
  • 0.9% recurrence rate, one hernia identified 3 years after repair
  • No mesh related complications
 114 patients

12 months follow up

Title: "Initial outcomes of laparoscopic paraesophageal hiatal hernia repair with mesh"

Study Type: Retrospective Clinical Study
Authors & Journal Facts Highlighted Data

Gebhart A, Vu S, Armstrong C, Smith BR, Nguyen NT.

American Surgeon 2013;79(10):1017-1021.
  • 45% patients had objective follow up at 1 year
  • Favorable 18.5% long term recurrence rate, with respect to reported 59% long term recurrence rate of primary closure alone
  • No early hiatal hernia recurrence or late mesh erosion
 92 patients

30 months follow up

 

Complex Ventral Hernia

Title: "One-year outcomes in a prospective, multicenter study of contaminated ventral hernia repairs using a biosynthetic material"

Study Type: Prospective, Multicenter Clinical Study
Authors & Journal Facts Highlighted Data

Rosen M, Bauer J, Carbonell A, Cobb W, Matthews B, Selzer D,
Goldblatt M, Harmaty M, Poulose B, Rosman C, Hansson B, Jacobsen G, Chao J

Hernia
2014;18(Supplement 1):S24. FP-182.
  • 77% contaminated and 23% clean-contaminated ventral hernia repairs
  • 18% infection rate with no removals of infected biosynthetic mesh
  • 14% recurrence rate
 104 patients

15 months follow up

Title: "Utilization of a bioabsorbable matrix as an adjunct to abdominal wall reconstruction"

Study Type: Retrospective Clinical Study
Authors & Journal Facts Highlighted Data

Jacobsen G, Chao J, Sandler B, Barajas-Gamboa J, Macias C, Talamini M.

Hernia
2013;17(Supplement 1):S30. FP-28927.
  • 4 year experience
  • 25% of wounds were CDC class 2 or higher
  • 16.1% wound complication rate
  • 1.1% recurrence rate (1 recurrence identified)
 93 patients

9 months follow up

 

Ostomy Reversal

Title: "Two year follow up with no hernia formation after ostomy closure with biosynthetic material reinforcement"

Study Type: Retrospective Clinical Study
Authors & Journal Facts Highlighted Data

Pandey SR, Najafian H, Ramanujam K, Ramanujam P.

Hernia
2014;18(Supplement 2):S38. Abstract O58.
  • 70% ileostomy and 30% colostomy closures
  • 8% infection rate without removal of biosynthetic mesh
  • 0% wound hernia rate
 50 patients

24 months follow up

 

References

  1. Birk D, von Heesen M. Tissue reinforcement with Gore BioA in large hiatal hernias. A prospective clinical study. Abstract presented at the 15th Annual Hernia Repair Meeting; March 13-16, 2013; Orlando, FL. Hernia 2013;17(Supplement 1):S85.
  2. Massullo JM, Singh TP, Dunnican WJ, Binetti BR. Preliminary study of hiatal hernia repair using polyglycolic acid : trimethylene carbonate mesh. Journal of the Society of Laparoendoscopic Surgeons 2012;16(1):55-59.
  3. Jethwa P, Sriskandarajah K, James A. Laparoscopic hiatus hernia repair with Gore Bio-A mesh: a pilot study. Abstract presented at the 33rd International Congress of the European Hernia Society; May 10-13, 2011; Ghent, Belgium. Hernia 2011;15(Supplement 2):S60. Abstract P-076.
  4. Zemlyak AY, Colavita PD, Tsirline VB, et al. Absorbable glycolic acid/trimethylene carbonate synthetic mesh demonstrates superior in-growth and collagen deposition. Presented at: 2012 Abdominal Wall Reconstruction Conference; June 13-16, 2012; Washington, D.C.

*Data on File

STRATTICE® is a trademark of LifeCell. MAXON®, PERMACOL are trademarks of Covidien AG or its affiliates. FLEXHD® is a trademark of Ethicon, Inc. ALLOMAX, XENMATRIX®, COLLAMEND®, are trademarks of C. R. Bard, Inc. SURGIMEND® is a trademark of TEI Biosciences, Inc. SURGISIS® is a trademark of Cook Medical, Inc. VERITAS® is a trademark of Synovis Surgical Innovations, Inc.

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