GORE® ENFORM Biomaterial Product Study

Pre-procedure Inclusion Criteria:

The subject is / has:

1. At least 18 years old at the time of informed consent. Minimum age required by stateregulations (as applicable).

2. An expected scored Class I (Clean) surgical wound using CDC Surgical WoundClassification system.

3. A planned implant with GORE® ENFORM Biomaterial for a single site ventral or hiatalhernia repair as suture line reinforcement.

4. An expected scored Grade 1 or Grade 2 using the Ventral Hernia Working Group Gradingsystem.

5. Willing to provide informed consent and comply with follow-up requirements.

Pre-procedure 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 cardiovasculardefects.

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 requiringpermanent 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 radiationtherapy.

9. Expected to undergo mesh implantation in conjunction with any bariatric procedureand / or panniculectomy procedure.

10. A stoma.

11. Co-morbid conditions that may limit their ability to comply with study and follow-uprequirements.

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 multiplehernia mesh devices.

Post-procedure Inclusion Criteria

At the time of index procedure, the subject is / has:

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 herniarepair as suture-line reinforcement on or before 365 days prior to site protocolamendment 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.

Post-procedure Exclusion Criteria

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 cardiovasculardefects.

3. Hernia repair that was performed as part of a bridged procedure (i.e., inability toperform primary closure of fascia or crura, patients requiring permanent supportfrom 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 radiationtherapy.

9. Underwent mesh implantation in conjunction with any bariatric procedure and / orpanniculectomy procedure.

10. A stoma.

11. Co-morbid conditions that may limit their ability to comply with study and follow-uprequirements.

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 multiplehernia mesh devices.