Evaluation of Outcomes of Restoring Pelvic Floor Support With TOPAS in Women With Moderate Fecal Incontinence Symptoms

This is a multi-center study under a common protocol. Approximately 20-30 patients will be
enrolled across 5 sites in the U.S. The study population is females at least 21 years of age
who have attempted but have not been satisfied with conservative therapy for their fecal
incontinence symptoms. The study follow-up is two years.

Inclusion Criteria:

- Females at least 21 years of age who have evidence of pelvic floor weakness

- Females who attempted but not been satisfied with conservative therapies such as
dietary changes, dietary bulking agents, biofeedback, etc.

- Subjects, who have an external anal injury, must have some voluntary sphincter
control

Exclusion Criteria:

- Subjects who are unwilling or unable to sign an Informed Consent form

- Subjects who are currently pregnant or considering future child-bearing

- Subjects who are contraindicated for surgery

- Subjects who are allergic to polypropylene mesh

- Subjects who are enrolled in a concurrent clinical trial

- Subjects with previous implantation of mesh or trauma to the pelvic area

- Subjects who engage in anal receptive intercourse

- Subjects with a significant evacuation disorder such as chronic constipation

- Subjects with Crohn's Disease, ulcerative colitis or chronic diarrhea as the primary
cause for fecal incontinence

- Subjects who had a hysterectomy within 6 months prior to enrollment

- Subjects with vaginal prolapse that passes the hymen

- Subjects with complete rectal prolapse

- Subjects with a history of pelvic radiation that compromises the anal canal

- Subjects who have psychiatric disturbance or debilitation as a possible cause for
fecal incontinence

- Subjects with a neurological disorder such as amyotrophic lateral sclerosis, multiple
sclerosis, or brain tumor as a possible cause for fecal incontinence symptoms

- Subjects with an active pelvic infection or a recto-vaginal fistula

- Subjects who have not had a negative screening exam for colon cancer within 10 years
of enrollment

- Subjects who have other inappropriate conditions as determined by the physician