A Prospective, Multi-center, Randomized, Blinded Study to Evaluate Durasphere FI for the Treatment of Fecal Incontinence

Inclusion Criteria: * History of fecal incontinence; * Incontinence episodes over a 14-day period; * Eighteen years of age or older; Exclusion Criteria: * Abnormalities of the external sphincter greater than 10 mm; * Fibrosis of the tissue at the likely injection sites; * Has a condition that could lead to significant postoperative complications * Rectal varices; * Cancer of the rectum or colon, undergoing active treatment; * Crohn's disease or ulcerative colitis; * Chronic diarrhea unmanageable by drugs and/or diet; * Rectal bleeding; * Pregnant or within one year postpartum.