Outcomes: Hernia Recurrence Rates 

Over 150 publications (over 30 peer-reviewed publications) 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 

Chart of bio a cellular ingrowth

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 
  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.

ALLERGAN and STRATTICE® are trademarks of Allergan, Inc. 

ETHICON and FLEXHD® are trademarks of Ethicon, Inc. 

MEDTRONIC and PERMACOL are trademarks of Medtronic, Inc. 

 

IFU Consult instructions

Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available. RXOnly

INDICATIONS FOR USE: The GORE® BIO-A® Tissue Reinforcement is intended for use in the reinforcement of soft tissue. An example of an application where the GORE® BIO-A® Tissue Reinforcement may be used is hernia repair as suture line reinforcement.

CONTRAINDICATIONS: The GORE® BIO-A® Tissue Reinforcement is contraindicated for use in reconstruction of cardiovascular defects. Because GORE® BIO-A® Tissue Reinforcement is absorbable, it is contraindicated for use in patients requiring permanent support from the device. 

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