Safety Study of MotifMESH (cPTFE) in Abdominal Surgery

cPTFEi s a mesh-like product designed to reduce associated post surgical complications.

Inclusion Criteria:

Has a non-sterile abdominal wall defect (incisional hernia or fascial defect) and needs to
be repaired

Exclusion Criteria:

Non-pregnant, breast feeding or plans to become pregnant during the study; Using adequate
birth control methods and agrees to continue using those methods for the duration of the
study

Confirmation of incisional hernia or fascial defect by CT scan within 6 months Incisional
hernia or facial defect has no necrotic tissue. Such as fascial dehiscence, evisceration,
small or large bowel repair, stoma manipulation, small chronic abdominal skin wounds, bowel
obstruction

Acceptable state of health and nutrition with pre-albumin levels of ≥ 15 mg/dL (0.15 g/L),
serum albumin ≥ 2.0 g/dL (20 g/L). No abnormal pre-surgery laboratory values that, in the
opinion of the Principal Investigator, place the subject at risk for the study.

For subjects with Diabetes Mellitus, HbA1C <12%

BMI ≤ 40 kg/m²