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

The purpose of the clinical investigation is to verify that the device under investigation (SimplyFI) is appropriate to significantly improve fecal incontinence in patients in whom its use is indicated.

Inclusion Criteria:Both male and female subjectsAge ≥ 18 years, <85 yearsSubject has failed standard conservative therapy for fecal incontinence (at least 6 months)Subject is a surgical candidateSubject is willing and able to cooperate with follow-up examinationsSubject has been informed of the study procedures and the treatment and has signed an informed consent form and provided authorization to use and disclose information for research purposes.Exclusion Criteria:Treatment with another investigational drug or investigational deviceUnable to understand study requirements or is unable to comply with follow-up scheduleContraindicated according to the instruction for use of the devicePregnancy or nursing, or plans to become pregnantHistory of significant obstructed defecation or other significant chronic defecatory motility disordersCurrent, external full thickness rectal prolapse or vaginal prolapseInflammatory Bowel DiseaseIrritable Bowel SyndromeSystemic disease as source of FI (scleroderma, neurologic disorders, Crohn's)Active pelvic infectionChronic diarrheaMedical history of anal, rectal, or colon cancerPrior anterior resection of the rectumMedical history of pelvic radiation therapySignificant scarring of the recto-vaginal septum, a permanent implant in the rectovaginal septum, or a history of recto-vaginal fistulaPrevious anorectal posterior compartment surgeryHistory of complex anal fistula