A SERI® Surgical Scaffold Postmarket Study of Soft Tissue Support in Ventral Hernia Repair

Inclusion Criteria:

The following are requirements for entry into the study. The subject MUST:

1. Be ≥ 18 years of age

2. Be diagnosed with a ventral hernia as defined as:

1. Midline Ventral Hernia AND

2. Defect(s) MUST meet the following criteria:

- contained within an anatomical area of ≤ 150 cm2

- not be longer than 8cm in any direction

- size must have a total sum ≤ 64 cm2

3. Be eligible for retro-rectus placement of SERI

4. Have a BMI < 40

Exclusion Criteria:

The following are criteria for exclusion from participating in the study. The subject must

NOT:

1. Be > 70 years of age

2. Have prior occurrence of ventral hernia or parastomal hernia

3. Have a presence of a stoma or have a perforated bowel

4. Have any documented disease which is clinically known to impact wound healing,
including Chronic Obstructive Pulmonary Disease (COPD), and Congestive Heart Failure
(CHF), with the exception of controlled diabetes

5. Have documented history of diabetes with an A1C of ≥ 8 at time of pre-operative visit

6. Have documented autoimmune disease, an immune deficiency, or be on immunosuppressive
drugs with the exception of steroids for:

1. prophylactic one-time-use administered peri-operatively

2. inhaled general use

3. topical administration

7. Have documented collagen-vascular, connective tissue, bleeding disorders and/or on
anticoagulation therapy, with the exception of baby aspirin for one week prior to SERI
placement

8. Have documented cancer < 6 months prior to surgery or chemotherapy treatment < 6 months
prior to surgery

9. Have documented history of abdominal radiation therapy or is expected to have abdominal
radiation therapy during the conduct of this study

10. Have documented history of liver disease and/or renal failure requiring dialysis

11. Have documented history of a previous wound infection at the surgical site or have an
active infection at the time of surgery

12. Have had prior surgery with synthetic and/or biologic mesh in the abdominal, chest or
pelvic area

13. Have documented allergy to silk

14. Have documented UTI at the time of surgery

15. Have smoked within 6 weeks of surgery and have a positive nicotine test at time of
preoperative visit

16. Have a concurrent procedure intra-operatively (with the exception of lysis of abdominal
adhesions)

17. Require intra-peritoneal or bridging placement of the soft tissue support device or
require component separation at time of surgery

18. Have surgical circumstances that are contraindicated for use of SERI™ Surgical Scaffold
per the supplied package insert

19. Have a concomitant unrelated condition of abdominal/chest wall/skin that would require
a surgical intervention during the follow-up period

20. Have documented alcohol and/or substance abuse problem at time of pre-operative visit

21. Be pregnant, lactating, or if of childbearing potential, be unwilling to use
contraceptive methods and avoid pregnancy throughout the study