New Fecal Continence Restoration System on The Market

The US Food and Drug Administration recently approved the Fenix Continence Restoration System for the treatment of fecal incontinence for patients who have tried and failed other medical and surgical options.

A frequently underreported medical issue, especially among older adults, the most common cause of fecal incontinence is muscle damage around the anus from vaginal childbirth or functional disorders like diabetes.

The Fenix System comprises an implant, an anal sphincter sizing tool, and an introducer tool, which all work together to expand the anal sphincter to minimize involuntary opening of the anal canal thereby reducing the risk of severe fecal incontinence.

Researchers studied the system in 35 adults who all failed traditional medical therapies. These patients were monitored before and after the procedure and at six weeks, three months, and 12 months post-implant.

The experts used a bowel diary to track fecal incontinence events and quantify any changes in quality of life before and after implantation.

Results indicated after 12 months, 62.9% of patients experienced a decrease in fecal incontinence by more than half and 37.1% saw a reduction in urgent episodes by half or more. Additionally, all patients reported significant improvements in depression, self-perception, and feelings of embarrassment.

The research team noted the Fenix System should not be implanted in patients with titanium allergies and once implanted, patients should not be exposed to MRIs to avoid any interference in magnetic strength.

William Maisel, MD, MPH, acting director, Office of Device Evaluation, FDA’s Center for Devices and Radiological Health, remarked, “Non-invasive treatment options for fecal incontinence, such as drugs, dietary changes, and other medical measures, sometimes don’t adequately address a patient’s symptoms. The Fenix System affords a viable surgical option o address this condition when other methods have failed to improve a patient’s quality of life.”