Observational Biologic or Prosthetic Mesh

Incisional hernias are very common, leading to over 380,000 operative repairs done annually.
Despite the commonality of this problem, there has been no single operative repair that has
become the standard. This is due to the high recurrence rates with all types of repairs,
especially primary suture repair. Because of this, most repairs are done with some type of
mesh, either made out of a prosthetic material or biologic material. Mesh repairs, however,
have their own problems, namely surgical site infections and potential bowel erosion.
Potential complications associated with prosthetic mesh for hernia repairs include: adverse
reactions to the mesh, mesh erosion, stricture formation, adhesions resulting in bowel
obstruction, enterocutaneous fistulas, injuries to nearby organs, nerves or blood vessels,
infection, chronic pain and hernia recurrence. Potential complications associated with
biological mesh include: adverse inflammatory response, laxity, eventration, and recurrent
herniation. To address these mesh related complications, the separation of components
technique was developed to reduce tension on the midline repair and the underlay technique
was developed to place the mesh in the retrorectus space. Nevertheless, this technique still
has a significant recurrence rate.

Therefore, the purpose of this study is to evaluate the effectiveness of biological or
prosthetic mesh in incisional hernia repair, by assessing the associated rates of hernia
recurrence and complications.

Inclusion Criteria:

- Male and female patients > 21 years old.

- Able to provide informed consent in English or Spanish.

- Stated willingness to comply with all study procedures and availability for the
duration of the study.

Exclusion Criteria:

- Pregnant, breastfeeding, or unwilling to practice birth control during participation
in the study, if applicable.

- Allergy or hypersensitivity to materials in porcine-based study products, prosthetic
or biological meshes, or personal preference.

- Male and female patients ≤ 21 years old

- History of drug addiction (recreational drugs, prescription drugs or alcohol) that in
the Investigator's opinion may interfere with protocol assessments and/or the
subject's ability to complete the required follow up.

- Serious or active medical or psychiatric condition which, in the opinion of the
Investigator, may interfere with treatment, assessment, or compliance with the
protocol.