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

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.

Residents of some states have the right to opt-out of the “sharing” or “selling” of their personal information. Gore does not "sell" the personal information of website users. Gore may "share" the personal information of website users, as standard advertising practice meant to offer you a more personalized service.

If you want to opt-out from Gore “sharing” your personal information, click on Opt-Out of Sharing to turn off the targeting cookies that we share with our advertising partners in order to provide you with personalized information. Disabling sharing will stop the use of cookies to targeted advertising but you may still see generic Gore ads.

Please note that your exercising of the rights outlined will have no adverse effect on the price and quality of our goods or services.

Opt-Out of Sharing

You Have Successfully Opted Out of the Sharing of Your Personal Information

Please note that if you clear your cookies and then use another device or browser, etc. your opt-out status is not transferred to the new device or browser.