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

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 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