GORE® ENFORM Biomaterial Product Study

Exclusion Criteria

• •The subject is / has:
• •1. Treated in another drug or medical device study within 1 year of study enrollment.
• •2. Implanted with GORE® ENFORM Biomaterial in the reconstruction of cardiovascular defects.
• •3. Hernia repair expected to be performed as part of a bridged procedure (i.e., expected inability to perform primary closure of fascia or crura, patients requiring permanent support from the device).
• •4. A BMI \>40.
• •5. Evidence of a systemic infection.
• •6. Cirrhosis or undergoing dialysis.
• •7. A wound-healing disorder.
• •8. Immunocompromised such as, with HIV or transplant, or receiving chemo or radiation therapy.
• •9. Expected to undergo mesh implantation in conjunction with any bariatric procedure and / or panniculectomy procedure.
• •10. A stoma.
• •11. Co-morbid conditions that may limit their ability to comply with study and follow-up requirements.
• •12. Positive pregnancy or lactation status as confirmed by site standard of care.
• •13. Hernias requiring treatment within multiple body regions or expected use of multiple hernia mesh devices.
• •At the time of index procedure, the subject is / has:
• •1. Treated in another drug or medical device study within 1 year of study enrollment.
• •2. Implanted with GORE® ENFORM Biomaterial in the reconstruction of cardiovascular defects.
• •3. Hernia repair that was performed as part of a bridged procedure (i.e., inability to perform primary closure of fascia or crura, patients requiring permanent support from the device).
• •4. A BMI \>40.
• •5. Evidence of a systemic infection.
• •6. Cirrhosis or undergoing dialysis.
• •7. A wound-healing disorder.
• •8. Immunocompromised such as, with HIV or transplant, or receiving chemo or radiation therapy.
• •9. Underwent mesh implantation in conjunction with any bariatric procedure and / or panniculectomy procedure.
• •10. A stoma.
• •11. Co-morbid conditions that may limit their ability to comply with study and follow-up requirements.
• •12. Positive pregnancy or lactation status as confirmed by site standard of care.
• •13. Hernias requiring treatment within multiple body regions or expected use of multiple hernia mesh devices.