A Prospective, Multicenter All Comers Study of Phasix Mesh for Ventral or Incisional Hernia Repair

Pilot Study of patients across all wound classes for recurrence

Inclusion Criteria:

- Subject or subject's legally authorized representative must be willing to give written
informed consent

- Subject must be diagnosed with ventral or incisional hernia

- Subject must be willing to undergo open ventral hernia repair and be able to undergo
all other study procedures as outlined in this protocol.

Exclusion Criteria:

- Subject is an active smoker (if attempts to quit smoking within two weeks of surgery
have failed and the patient is still an active smoker at the time of surgery).

- Subject's hernia has recurred four or more times.

- Subject's body mass index (BMI) >40 kg/m2.

- Subject has peritonitis.

- Subject is on or suspected to be placed on chemotherapy medications during any part of
the study.

- Chronic steroid use or immunosuppression drugs (> 6 months).

- Subject has cirrhosis, and/or ascites.

- Subject is American Society of Anesthesiology Class 4 or 5.

- Subject is pregnant or planning to become pregnant during the course of the study.

- Subject is known to be infected with human immunodeficiency virus (HIV).

- Subject has a life expectancy of less than 2 years at the time of enrollment.

- Subject has been treated with an investigational product in the past 30 days.

- Subject is part of the site personnel directly involved with this study

- Subject has a known allergy to tetracycline hydrochloride or kanamycin sulfate, the
test device or its component materials.

- Subject has any condition that in the opinion of the Investigator would preclude the
use of the study device, or preclude the subject from completing the follow-up
requirements