The shape of strong hiatal hernia repair

  • For 13+ years*, in more than 115 clinical studies
  • Proven low recurrence and complication rates in hiatal hernia repair† 
  • More than 4x lower long-term recurrence rate than repair with sutures alone.†

12 Key Clinical Studies

1700+ Patients

6 months - 5 years Follow-up

  • Average recurrence rate: 6.2%†
  • Only ONE mesh-related complication†
  • GERD significantly improved: Control rate > 80%†
  • ZERO reported incidence of device erosion†
  • ZERO reported incidence of mesh infections†
  • ZERO reported complete mesh removals due to infection†

Clinical experience and data 

    Paraesophageal hernia repair using GORE® BIO-A® Tissue Reinforcement - William S. Cobb, IV, M.D., FACS 

    Patient quality of life with innovative materials: Clinical review

     

    Dr. Scott Symposium Quality Outcomes Long Term Data

     

    Learn More

    Outcomes: Hernia Recurrence Rates

    See study data

    * GORE® BIO-A® Tissue Reinforcement first commercial marketing authorization, U.S. FDA in 2008.

    † Data on file 2024; W. L. Gore & Associates, Inc; Flagstaff, AZ.

    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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