Mayo Clinic First to Implant Device to Solve Fecal Incontinence

A clinical team on Mayo Clinic’s Florida campus is the first to offer four patients with long-term fecal incontinence a new and potentially long-lasting treatment — a small band of interlinked magnetic titanium beads on a titanium string that successfully mimics the function of the anal sphincter.

At this point, Mayo Clinic is the only medical center that has surgically implanted this device, known as the Fenix Continence Restoration System. In December 2015, the system received U.S. Food and Drug Administration approval under a humanitarian device exemption, which requires approval for patient use by a hospital’s Institutional Review Board (IRB). The IRB at Mayo Clinic is the first and, as yet, the only center to approve use of the device.

The issue of fecal incontinence, or accidental bowel leakage, is not unusual. It can affect more than 20 percent of women over 45, says Paul Pettit, M.D., a female pelvic medicine and reconstructive surgery specialist at Mayo Clinic. “The condition can be debilitating due to social isolation, depression, loss of self-esteem and self-confidence.