Transorb™ Self-Gripping Resorbable Mesh in High-risk Subjects Undergoing Open Repair of Ventral Hernia

Exclusion Criteria

• •1. Subject is involved in another interventional drug or device study
• •2. Subject is unable or unwilling to comply with the study requirements or follow-up schedule
• •3. Subject has a history of:
• •1. Previous hernia repair involving retrorectus/retromuscular mesh placement or a component separation technique (CST)
• •2. Allergic reactions to products with PLLA/TMC (Poly-L-lactide, poly-trimethylene carbonate copolymer)
• •3. Solid organ transplantation
• •4. Subject has current diagnosis/usage of:
• •1. BMI greater than or equal to 40.0 kg/m2
• •2. Human Immunodeficiency Virus (HIV)
• •3. Collagen formation disorder (such as Ehlers-Danlos syndrome and Marfan's syndrome)
• •4. Liver cirrhosis and/or current ascites
• •5. Renal disease requiring dialysis
• •6. Bleeding disorder and/or cannot be removed from anticoagulants prior to surgery based on surgeon discretion and standard-of-care (excluding aspirin)
• •7. Chronic immunosuppression therapy (10 mg or greater of prednisone or equivalence/ day)
• •8. Current or anticipated chemotherapy/radiotherapy during study period
• •9. Stoma
• •10. Any systemic or local ongoing infection that is uncontrolled and/or requiring treatment such as antimicrobial medication (Note: other uses of antimicrobial medications not excluded)
• •5. Subject has life expectancy of less than 5 years based on the judgement of investigator
• •6. Subject is pregnant or is planning pregnancy within the 60-month follow-up period (females of childbearing potential will be required to provide either a urine or serum pregnancy test, except for subjects who are surgically sterile, or are at least 2 years post-menopausal)
• •7. Subject is breastfeeding or is planning to breastfeed during the study duration period
• •8. Subject has any other medical condition that precludes the subject from participation, in the opinion of the investigator
• •9. Subject is undergoing:
• •1. Minimally invasive hernia repair (i.e., laparoscopic or robotic surgery)
• •2. An emergency surgery (i.e., lifesaving procedures performed where subject is in imminent danger of death)
• •3. Multi-stage hernia repair
• •4. Parastomal hernia repair
• •5. Concomitant ostomy (creation or closure)
• •6. Any other additional anticipated surgery, if subsequent surgery that would jeopardize previous application of study device, in the opinion of the investigator
• •10. Subject is American Society of Anesthesiology Class 4, 5, or 6
• •11. Subject has a BMI greater than or equal 40.0 kg/m2
• •12. Subject is pregnant or is planning pregnancy within the 60-month follow-up period (females of childbearing potential will be required to provide either a urine or serum pregnancy test, except for subjects who are surgically sterile, or are at least 2 years post-menopausal)
• •1. Subject has existing mesh from previous ventral hernia surgery that investigator was unable to completely remove
• •2. Subject has concomitant diastasis (\>2 cm) that was not repaired
• •3. Hernia defect that will require a multi-stage repair