Open Complex Ventral Incisional Hernia Repair Using Biosynthetic Material for Midline Fascial Closure Reinforcement

The study will evaluate the performance of the biosynthetic mesh when used to reinforce the
midline fascial closure in single-staged open complex ventral incisional hernia repair. It
is designed to test the null hypothesis that the two year recurrence rate associated with
the device is greater than or equal to 50% vs the alternative hypothesis that the two year
recurrence rate is less than 50%.

Inclusion Criteria:

- Subjects will be informed about the study, and will have read; understood and signed
the informed consent and authorization to use their PHI, as applicable

- Subjects willing and able to submit to postoperative follow-up evaluations including
quality of life assessments up to 24 months after surgery

- Subjects of either gender that are at least the age of 18 years

- Subjects will have a Body-Mass Index (BMI) of < 40

- Subjects will be undergoing single-staged open complex ventral incisional hernia
repair with the retrorectus or intraperitoneal placement technique of the GORE®
BIO-A® Tissue Reinforcement

- Subjects in which intraoperatively their surgical field/wound is characterized either
a Type 2 or Type 3 in Table 1 in Section 12.0

- Subjects with a hernia defect > 9 cm2 large when measured intraoperatively

- Subjects in which the required mobility for midline fascial closure without excessive
tension to reapproximate the rectus abdominis muscle intraoperatively can be achieved

- Subjects in which one unit of GORE® BIO-A® Tissue Reinforcement will adequately
reinforce the midline fascial closure with at least 4 cm of overlap laterally

Exclusion Criteria:

- Subjects who, in the surgeon's opinion, would have a difficult time comprehending or
complying with the requirements of the study

- Subjects with a BMI > 40

- Subjects with evidence of pre-existing systemic infections

- Subjects with cirrhosis or are currently being treated with dialysis

- Subjects with a wound-healing disorder

- Subjects with autoimmune disorder requiring > 10mg of a corticosteroid per day

- Subjects who are immunocompromised such as, with HIV or transplant, or receiving
chemo or radiation therapy

- Subjects with a hernia defect < 9 cm2 large when measured intraoperatively

- Subjects with a hernia defect requiring more than one unit of GORE® BIO-A® Tissue
Reinforcement

- Subjects in which intraoperatively there is an inability to achieve retrorectus or
intraperitoneal placement of the device

- Subjects in which a midline fascial closure without excessive tension cannot be
achieved

- Subjects in which intraoperatively their surgical field/wound is characterized either
a Type 1 or Type 4 in the Table 1 in Section 12

- Subjects in need of concomitant surgical procedures other than indicated in the
protocol as acceptable

- Subject in which their complex ventral incisional hernia repair requires more than
one operation to reduce hernia and close fascia, including serial excision procedures
- requiring subsequent surgery to complete their hernia repair

- Subjects with a hernia repair requiring an emergent procedure, such as strangulated
bowel

- Subjects in which intraoperatively untreated cancer was found