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 \< 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