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FDA Approves Device to Treat Fecal Incontinence
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The FDA has approved the Fenix Continence Restoration System for the treatment of fecal incontinence in patients for whom medical or other surgical treatments are not an option, according to an FDA press release.
The Fenix System (Torax Medical) includes a ring-shaped implant composed of titanium beads with magnetic cores connected by titanium wires, which is available in multiple sizes. “The attractive force of the magnetic beads augments the anal sphincter to minimize involuntary opening of the anal canal, reducing the likelihood of severe fecal incontinence,” according to the press release. The system also includes an anal sphincter sizing tool, and an introducer tool for positioning the sizing tool and implant.
“Noninvasive treatment options for fecal incontinence, such as drugs, dietary changes and other medical measures, sometimes don’t adequately address a patient’s symptoms,” William Maisel, MD, MPH, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in the press release. “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.”
Through the humanitarian device exemption process, the FDA reviewed study data involving 35 adults with fecal incontinence who failed conventional medical treatment and underwent treatment with the Fenix System. Participants were evaluated before and after the procedure and at 6 weeks, 3 months, 6 months and 1 year, and 15 participants being studied in the U.S. will continue annual evaluations up to 5 years after the procedure. They completed bowel diaries and the validated Fecal Incontinence Quality of Life Scale questionnaire.
One year after the procedure, 62.9% had at least a 50% reduction in fecal incontinence episodes, 54.3% had at least a 50% reduction in fecal incontinence days, and 37.1% had at least a 50% reduction in urgent episodes. Quality of life measures, including depression, self-perception and feeling embarrassed, also improved. Adverse events included pain, infection, impaction or defecatory disorder, device erosion, device removal or re-operation, and bleeding.
“These results suggest that patients with fecal incontinence could benefit from the device when they have failed other fecal incontinence therapies,” according to the press release.
The implant should not be used in patients who are or may be allergic to titanium, nor should the sizing and introducer tools be used in patients who are or may be allergic to titanium, stainless steel, nickel or ferrous materials. The implant is also considered magnetic resonance unsafe, but can be safely removed if an MRI is required. Accordingly, patients should be advised to register their implant with the MedicAlert Foundation or an equivalent organization, according to the press release.