GORE® ENFORM Biomaterial Product Study

Eligibility Criteria

• 1. At least 18 years old at the time of informed consent. Minimum age required by state regulations (as applicable).
• 2. An expected scored Class I (Clean) surgical wound using CDC Surgical Wound Classification system.
• 3. A planned implant with GORE® ENFORM Biomaterial for a single site ventral or hiatal hernia repair as suture line reinforcement.
• 4. An expected scored Grade 1 or Grade 2 using the Ventral Hernia Working Group Grading system.
• 5. Willing to provide informed consent and comply with follow-up requirements.
• 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.
• 1. At least 18 years old. Minimum age required by state regulations (as applicable).
• 2. Implanted with GORE® ENFORM Biomaterial for a single site ventral or hiatal hernia repair as suture-line reinforcement on or before 365 days prior to site protocol amendment 3 approval date.
• 3. Unless there is an Informed Consent waiver issued by the Institutional Review Board (IRB), an Informed Consent Form (ICF) signed by subject.
• 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.