GORE® SYNECOR Biomaterial is not authorized for use in Canada.
Data Summary
Long-term follow up:
- 32 months mean (14-53 months range)
- Patients: 459
- Intraperitoneal placement: 76%
- Bridging repair: 57%
- Laparoscopic and robotic approaches: 95%
Quality outcomes
- Hernia recurrence:
- 0.9% clinically confirmed hernia recurrence (4/459 patients, mean 32 months)
(data on file 2022; W. L. Gore & Associates, Inc; Flagstaff, AZ.)
- 0.9% clinically confirmed hernia recurrence (4/459 patients, mean 32 months)
- Seroma: 0% (12 months)
- Surgical site infection (SSI): 2% (12 months)
- Surgical site occurrence requiring procedural intervention (SSOPI): <3% (24 months)
- Adhesion formation: 0% (12 months)
Patient characteristics
- Mean body mass index (BMI): > 33 kg/m2
- Obese: 63%
- Diabetes mellitus: 20%
- Tobacco users: 9%
- Current users: 19%
- Former users: 32%
- Ventral hernia working group (VHWG) classification
- Grade 1: 23%
- Grade 2: 77%
- Doerhoff C, Grantham D, Mallico E, Washington R, Linn J. Long-term outcomes following hybrid biomaterial repair of ventral hernias: a multicenter, retrospective study. Presented at the EHS-AHS Joint Congress 2021; October 13-16, 2021; Copenhagen, Denmark. British Journal of Surgery 2021;108(8)Supplement:viii42. PO90.
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® SYNECOR Intraperitoneal Biomaterial device is intended for use in the repair of hernias and abdominal wall or thoracic wall soft tissue deficiencies that may require the addition of a nonabsorbable reinforcing or bridging material.
CONTRAINDICATIONS: The GORE® SYNECOR Intraperitoneal Biomaterial is contraindicated for use in reconstruction of cardiovascular defects.
INDICATIONS FOR USE: The GORE® SYNECOR Preperitoneal Biomaterial device is intended for use in the repair of hernias and abdominal wall soft tissue deficiencies that may require the addition of a non-absorbable reinforcing or bridging material.
CONTRAINDICATIONS: The GORE® SYNECOR Preperitoneal Biomaterial is contraindicated for use in reconstruction of cardiovascular defects.