Hernia Repair With or Without Sutures

This is a randomized study in which subjects will undergo one or two currently accepted
techniques of mesh fixation during laparoscopic ventral hernia repair. Subject will undergo
mesh fixation with either trans-abdominal sutures and metallic tacks or metallic tacks only.

Pain will be assessed through week 12, and hernia recurrence will be assessed for 2 years
after surgery. Subjects will complete pain questionnaires at baseline, each day during
hospital stay, and at follow-up visits at 2, 6, and 12 weeks after discharge. Quality of life
questionnaires will be completed at baseline, at discharge from hospital, and during
follow-up visits at 2, 6, and 12 weeks after discharge.

Inclusion Criteria:

Demographics:

- Age ≥ 18 years old

- If female, negative pregnancy test

Pre-Operative Findings:

- Presence of an abdominal hernia associated with previous surgical incision

- Midline ventral\incisional hernia demonstrated either on physical examination by
investigators or radiologic imaging tests.

- CT scan, MRI, Ultrasound

- No evidence of incarceration, strangulation

- Size of hernia ≥ 4 centimeters or ≤ 20 centimeters (cross-sectional diameter)

- Multiple hernias cumulative size ≤ 20 centimeters in cross-sectional diameter

Exclusion Criteria:

Pre-Operative History:

- Severe medical co-morbidities that prevent safe performance of laparoscopic surgery
including coronary artery disease, obstructive pulmonary disease, etc.

- History of the following:

- Connective tissue or wound healing disorder (e.g. Ehlers-Danlos syndrome)

- Chronic use (defined as greater than 3 months) of narcotic analgesic for pain
other than from the hernia that is intended to be repaired

- Allergy to products used in hernia repair including surgical mesh

- Any abdominal ventral incisional hernia previously repaired with permanent synthetic
mesh placed inside the peritoneal cavity

- Loss of abdominal domain (i.e. majority of abdominal organs lie outside confines of
the abdominal musculature and fascia)

- Presence of simultaneous intra-abdominal infection

- Simultaneous presence of a bowel obstruction

- History of suspected or known addiction to or abuse of illicit drug(s), prescription
medicine(s), or alcohol within the past 2 years.

- Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the
opinion of the Investigator, may interfere with study assessments or compliance.

Intra-operative Findings:

- Simultaneous performance of another surgical procedure during hernia repair other than
acts necessary to complete hernia repair (e.g. cutting of abdominal adhesions)

- Intra-operative identification of full thickness injury to intestine (i.e.
enterotomy), liver, bladder, etc.