ProGripTM Self-Gripping Polyester Mesh in Incisional Hernia Prevention

Exclusion Criteria

• •1. Subject is undergoing emergency surgery, i.e. lifesaving procedures performed where subject is in imminent danger of death.
• •2. Subject for which the device is used outside the product IFU, including;
• •1. Pregnant women: Women who are known or suspected to be pregnant, or who are planning to become pregnant during the study follow-up period
• •2. Subject who has an infection within 30 days of enrollment or, at the time of the surgery, has any active, acute or chronic infection(s) that are uncontrolled and/or requiring treatment such as antibiotics
• •3. Subject whose surgical site is contaminated or dirty/infected intraoperatively, as assessed by the Investigator (Exclude Altemeier classification III-IV).
• •3. Subject who had received a mesh in a previous ventral hernia repair or has a ventral hernia.
• •4. Investigator determined that a planned future surgery would interfere with application of mesh reinforcement.
• •5. Subject has participated in an investigational drug or device research study within 30 days of enrollment.
• •6. Subject has a life expectancy of \<2 years.
• •7. Subject has an ASA Physical Status Classification System score \>3.
• •8. Subject has \>5 total risk factors or \>2 high-risk factors