Anal Sphincter Augmentation Helps Treat Fecal Incontinence

A new magnetic system helps treat fecal incontinence in patients who are not candidates for, or have previously failed, medical or other surgical options.

The main component of the Fenix Fecal Incontinence system is an implant that is constructed of a series of titanium beads with magnetic cores, which are connected by titanium wires to form a ring shape. The attractive force of the magnetic beads augments the function of the anal sphincter, thus minimizing involuntary opening of the anal canal and reducing the likelihood of severe fecal incontinence. The magnetic titanium bead system implant is placed around the anal sphincter during a surgical procedure that requires a single incision.

A proprietary sizing tool is used to associate the anal sphincter size to an appropriate implant, and a special introducer tool is used to guide both the sizing tool and the implant into position. Once the correct position has been confirmed using fluoroscopy, the Fenix system is implanted and secured by suturing. The correct size is reconfirmed once again using fluoroscopy before closure, and no post implant adjustments are required. Once in position it is immediately effective.

The system should not be implanted in patients with suspected or known allergies to titanium, and is considered unsafe for magnetic resonance imaging (MRI), as the magnetic forces could interfere with the strength and the function of the device. The Fenix Fecal Incontinence system is a product of Torax Medical (St. Paul, MN, USA), and is offered in multiple sizes to accommodate variation in sphincter size. The device is similar to another Torax Medical device, the Reflux Management System.

“Noninvasive treatment options for fecal incontinence, such as drugs, dietary changes and other medical measures, sometimes don't adequately address a patient's symptoms,” said William Maisel, MD, acting director of the office of device evaluation at the US Food and Drug Administration (FDA). “The Fenix System affords a viable surgical option to address this condition when other methods have failed to improve a patient's quality of life. The device was approved using the humanitarian device exemption pathway for devices that treat rare diseases or conditions.”

Fecal Incontinence is the inability to control bowel movements, causing stool to leak unexpectedly from the rectum. The leakage can range from an occasional small quantity of stool to a complete loss of bowel control. Fecal incontinence can have several causes, including constipation, damage to anal sphincter muscles and nerves, damage to the muscles or the rectum, loss of storage capacity in the rectum, diarrhea, and pelvic floor dysfunction.

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