• By Kevin Punsky

Mayo Clinic First to Implant Device to Solve Fecal Incontinence

June 7, 2016

FENIX Device implanted around the anal canal in a closed position

JACKSONVILLE, Fla. — 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.

“If a patient does not improve through use of less invasive techniques, our only option has been a colostomy,” says Dr. Pettit, who performed the four surgeries. “This device now offers a new option that restores function, and we are happy to be able to offer it.”

MEDIA CONTACT: Kevin Punsky, Mayo Clinic Public Affairs, 904-953-0746, punsky.kevin@mayo.edu

FENIX Device: a small, flexible band of interlinked titanium beads with magnetic cores in a circle

The magnetic attraction between the beads then brings the device back to the closed position to prevent unexpected opening of the anal canal that may lead to accidental bowel leakage.

The operation itself lasts about 45 minutes and requires an overnight hospital stay.

Most patients with fecal incontinence — a syndrome that involves unintentional loss of solid or liquid stool — are women, and often the cause is childbirth, when the muscles and nerves near the anus are damaged, Dr. Pettit says.

When the system is implanted, the string of magnetic titanium beads is placed around the anal canal in the closed position. Increased intra-abdominal pressure opens the beads to allow for passage of stool. The magnets then spontaneously close.

The device works immediately after surgery and does not require any activation by the patient or adjustments by a physician, according to the manufacturer, Torax Medical Inc., in St. Paul, Minnesota.

Mayo researchers and clinicians who worked with Dr. Pettit on clinical use of the system are Heidi Chua, M.D., Anita Chen, M.D., and Chris DeStephano, M.D., M.P.H.

Sound bites with Dr. Pettit are available in the download section. 

###
About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to clinical practice, education and research, providing expert, whole-person care to everyone who needs healing. For more information, visit http://www.mayoclinic.org/about-mayo-clinic or https://newsnetwork.mayoclinic.org/.

Comment

Please login or register to post a comment.