Comparison of the Efficacy of a Biological Implant to Reinforce Overlapping Sphincter Repair Versus Overlapping Sphincter Repair Alone

Inclusion Criteria:

- Female

- Age 18 years or older

- fecal incontinence due to an anterior defect in the external anal sphincter or both
external and internal anal sphincter muscles

- Fecal incontinence severity score of 10 or more

- Fecal incontinence episodes of 4 or more over a 2 week period

Exclusion Criteria:

- History of diabetes

- History of allergy to porcine derivatives

- History of infection in the anal area (abscess, fistula)

- History of inflammatory bowel disease

- History of hidradenitis suppurativa

- History of immunosuppression

- History of HIV positivity

- History of radiation to the study site within the last 12 months

- Patients who cannot travel to keep follow up appointments

- Patients who are prisoners

- Patients who are mentally handicapped

- Patients who are pregnant or plan to become pregnant during the study period, or who
are currently breastfeeding

- Patients with significant posterior pelvic organ prolapse and who would be candidates
for concomitant treatment.

- Patients with a FIQL baseline score of ≤ 4

- Patients participating in another clinical trial for the same indication

- Patients unwilling to give informed consent