The FDA approves New Treatment for Fecal Incontinence

What is the Fenix System?

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Fecal incontinence (aka bowel incontinence) is the partial or complete loss of bowel control. The accidental passing of solid and liquid stool or mucous results in involuntary leakage. This condition can be emotionally, socially, and physically crippling. Sufferers have a hard time talking about or acknowledging their issues. Too many suffer in silence. According to the US National Library of Medicine National Institutes of Health, more than 18 million Americans suffer from fecal incontinence. Because this number is so high, researchers are consistently trying to find treatment. Many types of treatments are available (medication, physical therapy, adult briefs, etc.), but those options don’t always work. Surgery is another treatment option for those with fecal incontinence, but again, this option may prove fruitless. That’s why the new FDA approved treatment for fecal incontinence is so exciting.

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Researchers from Torax Medical have developed a device called, the Fenix Continence Restoration System for the treatment of fecal incontinence in patients for whom medical or other surgical treatments are not an option. The Fenix Continence Restoration System (aka The Fenix System) consists of inserting a ring-shaped implant into the anal sphincter to minimize involuntary leakage from the dysfunctional anal canal. This ring gives the anal sphincter the functional ability to prevent and or lessen bowel accidents.

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How does the Fenix System work?

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Now that we’ve learned what it does, let’s discuss how it does it! According to the Torax Medical and FDA press release, the Fenix System works with “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.”

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The Fenix System measures the anal sphincter, and has a tool to position the implant, for the best results.

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What were the results of the Fenix System?

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The FDA reviewed the study data of participants with fecal incontinence who failed other treatment options, and underwent the Fenix System. The study consisted of 35 adults with fecal incontinence, who were evaluated before and after the procedure. Each participant was evaluated  at 6 weeks, 3 months, 6 months and 1 year. And of the 35 participants, 15 participants will be annually evaluated for up to 5 years, post-procedure.

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The participants were to record the physical and emotional results after the procedure in a daily bowel diary. Because fecal incontinence notably causes depression, anxiety and insecurity, they also completed a Fecal Incontinence Quality of Life Scale questionnaire.

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The results were staggeringly positive!

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After one year post-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,” according to reporters from Helio Gastroenology, who attended the press release. The emotional quality of life also significantly improved compared to pre-procedure.

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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.”

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If you are suffering from fecal incontinence, do not give up on treatment options! Don’t let incontinence control your life. If you treat your condition, you can take back control and live a happy and healthy lifestyle. You will continue to experience fecal incontinence anyway, so why not treat it. I can’t stress treatment enough!

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Talk to your physician about your options, and bring up the Fenix System. This may be just the thing you need.

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