Clinical experience across multiple hernia repair procedures
MORE than 400 publicationsa
OVER 4,800 patients in the clinical literature1
NO long-term mesh-related complications1
Complex ventral hernia repair with GORE® BIO-A® Tissue Reinforcement:
- Supported by an extensive body of positive clinical results over 15 years1
- Proven low recurrence rates in high-risk AWR patients1
- Proven low complication rates in high-risk AWR patients1
- Zero reported complete mesh removals due to infection
Hiatal/paraesophageal hernia repair with GORE® BIO-A® Tissue Reinforcement:
- More than 224,900 hiatal-configured devices have been sold.a
- Clinical literature cites more than 1,980 repairs.1
- Mean follow-up of 5 years has been reported, which is 53-54 months beyond the 6-7 month resorption time period of the mesh.1
- There have been no reports of erosion or infection in the clinical literature.1
Complex ventral hernia repair
Published results: Rosen 20172
Study type:
Prospective, multicenter
Number of patients:
104
| BMI | Recurrent hernia | Active smokers | Diabetes | Mean defect size | CDC class II | CDC class III |
|---|---|---|---|---|---|---|
28 kg/m2 | 45% | 19% | 18% | 137 cm2 | 23% | 77% |
Complication rates
Months follow-up vs. recurrence rate
Published results: Yu 20223
Study type:
Retrospective review of prospectively maintained data
Number of patients:
49
| BMI | Recurrent hernia | Active smokers | Diabetes mellitus | Mean defect size |
|---|---|---|---|---|
34.4 kg/m2 | 44% | 12% | 6% | 136 cm2 |
Complication rates
Months follow-up vs. recurrence rate
Published results: Finch 20214
Study type:
Retrospective single center review
Number of patients:
56
| BMI | Recurrent hernia | Active smokers | Diabetes | Mean defect size | CDC class I | CDC class II | CDC class III |
|---|---|---|---|---|---|---|---|
29 kg/m2 | 25% | 23% | 25% | 83 cm2 | 14.3% | 21.4% | 1.8% |
Complication rates
Months follow-up vs. recurrence rate
Published results: Keogh 20195
Study type:
Retrospective review of prospectively maintained data
Number of patients:
GORE® BIO-A® Tissue Reinforcement: 55
| BMI | Recurrent hernia | Active smokers | Diabetes mellitus | Mean defect size | CDC class clean | CDC class contaminated: |
|---|---|---|---|---|---|---|
33.8 kg/m2 | 56% | 12% | 6% | NR | 69% | 31% |
Study type:
Retrospective review of prospectively maintained data
Number of patients:
COVIDIEN® PARIETEX® PROGRIP® Self Fixating Mesh: 60
| BMI | Recurrent hernia | Active smokers | Diabetes mellitus | Mean defect size | CDC class clean | CDC class contaminated: |
|---|---|---|---|---|---|---|
33.8 kg/m2 | 56% | 12% | 6% | NR | 95% | 5% |
Complication rates by wound class
Months follow-up vs. recurrence rate
Hernia prophylaxis
Published results: Pizza 20226
Study type:
Double-blind randomized control trial – Parastomal hernia prevention
Number of patients:
GORE® BIO-A® Tissue Reinforcement: 55
| BMI | ASA I-II | ASA III-IV | Diabetes mellitus | Oncologic disease |
|---|---|---|---|---|
28.6 kg/m2 | 70.9% | 29.1% | 23.1% | 45.4% |
Study type:
Double-blind randomized control trial – Parastomal hernia prevention
Number of patients:
Suture only: 55
| BMI | ASA I-II | ASA III-IV | Diabetes mellitus | Oncologic disease |
|---|---|---|---|---|
28.1 kg/m2 | 65.4% | 34.6% | 27.3% | 41.8% |
Follow-up time vs. hernia occurrence rate
Published results: Pizza 20207
Study type:
Case control – prospective consecutive patients – Loop ileostomy reversal – Incisional hernia prevention
Number of patients:
GORE® BIO-A® Tissue Reinforcement: 26
| BMI | ASA I-II | ASA III-IV | Diabetes mellitus | Oncologic disease |
|---|---|---|---|---|
24 kg/m2 | 85% | 15% | 19% | 15% |
Study type:
Case control – prospective consecutive patients – Loop ileostomy reversal – Incisional hernia prevention
Number of patients:
Suture only: 58
| BMI | ASA I-II | ASA III-IV | Diabetes mellitus | Oncologic disease |
|---|---|---|---|---|
23 kg/m2 | 85% | 15% | 20% | 15% |
Hernia occurrence rate vs. follow-up time
NO statistically significant difference in complication rates
NO mesh removals
Hiatal hernia repair
Published results:
Diab et al, performed a systematic literature review of GORE® BIO-A® Tissue Reinforcement use in hiatal hernia repair.
Results were presented at 2022 American Foregut Society Meeting.8
Overall data summary
Outcomes from 17 studies and 1,576 patients:
- Postoperative dysphagia: 15%
- Persistent dysphagia: 4%
- Mesh related complications: 0%
- Symptomatic objective hernia recurrence: 3%
- Revisional repair: 2%
Subgroup data summary
Outcomes from 11 studies that included mean follow-up duration of 33.4 months:
- Postoperative dysphagia: 14%
- Persistent dysphagia: 3%
- Mesh related complications: 0%
- Symptomatic objective hernia recurrence: 4%
- Revisional repair: 2%
a. Data on file 2026; W.L. Gore & Associates, Inc; Flagstaff, AZ.
- W. L. Gore & Associates, Inc. Clinical Evaluation Report for GORE® BIO-A® Tissue Reinforcement. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2026. [Clinical Evaluation Report – CER]. MD114935. Rev 16.
- Rosen M, Bauer JJ, Harmaty M, et al. Multicenter, prospective, longitudinal study of the recurrence, surgical site infection, and quality of life after contaminated ventral hernia repair using biosynthetic absorbable mesh: the COBRA Study. Annals of Surgery 2017;265(1):205-211.
- Yu JF, Goldblatt HE, Alter-Troilo K, Hetzel E, Goldblatt MI. Long-term outcome of absorbable synthetic mesh in clean ventral hernia repairs. Surgical Endoscopy 2022;36(7):5144-5148.
- Finch D, Mehmood S, Varghese J. Abdominal wall reconstruction using biosynthetic absorbable mesh in high-risk complex ventral hernia. Swiss Medical Weekly 2021;151:w20449.
- Keogh K, Slater K. Comparison of biosynthetic versus synthetic mesh in clean and contaminated ventral hernia repairs. ANZ Journal of Surgery 2020;90(4):542-546.
- Pizza F, D’Antonio D, Lucido FS, et al. Is absorbable mesh useful in preventing parastomal hernia after emergency surgery? The PARTHENOPE study. Hernia 2022;26(2):507-516.
- Pizza F, D’Antonio D, Arcopinto M, Dell’Isola C, Marvaso A. Safety and efficacy of prophylactic resorbable biosynthetic mesh in loop-ileostomy reversal: a case-control study. Updates in Surgery 2020;72(1):103-108.
- Diab ARF, Sujika JA, Saad AR, DuCoin CG, Docimo S. Bio-A mesh use in hiatal hernia repair. A systematic literature review. Presented at the 2022 American Foregut Society Annual Meeting; September 15-18, 2022; Orlando, FL. Foregut 2022;2(3):331. Abstract ID: 47.
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 IN EUROPE: The GORE® BIO-A® Tissue Reinforcement is intended for use in the reinforcement of soft tissue, including hiatal and ventral hernia repair and hernia prophylaxis as suture-line reinforcement.
CONTRAINDICATIONS: The GORE® BIO-A® Tissue Reinforcement is contraindicated for use in reconstruction of cardiovascular defects. The GORE® BIO-A® Tissue Reinforcement is absorbable and contraindicated for use in patients requiring permanent support from the device.