Safety and Performance of a Silicone Implant for Fecal Incontinence Treatment (SimplyFI)

Inclusion Criteria:

• Both male and female subjects

• Age ≥ 18 years, <85 years

• Subject has failed standard conservative therapy for fecal incontinence (at least 6months)

• Subject is a surgical candidate

• Subject is willing and able to cooperate with follow-up examinations

• Subject has been informed of the study procedures and the treatment and has signedan informed consent form and provided authorization to use and disclose informationfor research purposes.

Exclusion Criteria:

• Treatment with another investigational drug or investigational device

• Unable to understand study requirements or is unable to comply with follow-upschedule

• Contraindicated according to the instruction for use of the device

• Pregnancy or nursing, or plans to become pregnant

• History of significant obstructed defecation or other significant chronic defecatorymotility disorders

• Current, external full thickness rectal prolapse or vaginal prolapse

• Inflammatory Bowel Disease

• Irritable Bowel Syndrome

• Systemic disease as source of FI (scleroderma, neurologic disorders, Crohn's)

• Active pelvic infection

• Chronic diarrhea

• Medical history of anal, rectal, or colon cancer

• Prior anterior resection of the rectum

• Medical history of pelvic radiation therapy

• Significant scarring of the recto-vaginal septum, a permanent implant in therectovaginal septum, or a history of recto-vaginal fistula

• Previous anorectal posterior compartment surgery

• History of complex anal fistula