How a Ring of Titanium Beads Can Help Fecal Incontinence

Novel device mimics anal sphincter’s function

How a Ring of Titanium Beads Can Help Fecal Incontinence

A new device made up of magnetic titanium beads may help certain patients who have problems controlling their bowels, a condition called fecal incontinence.

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The Fenix® Continence Restoration System mimics the function of the anal sphincter. It is the newest treatment option available to certain patients who have fecal incontinence caused by childbirth complications, trauma, prior surgeries, anal sex or another cause of muscle and nerve damage.

How does it work?

“What we like about this device is that it’s fairly simple,” says colorectal surgeon Massarat Zutshi, MD. “It’s a small ring of magnets surgically placed around the anal muscles that expand when you have a bowel movement. It’s dynamic, but it doesn’t require anything from the patient but the ability to push.”

The Fenix received approval from the Food and Drug Administration (FDA) under a humanitarian device exemption, which means it’s only available to patients who have tried and failed more traditional treatments for bowel leakage such as fiber, bowel stoppers and neuromodulation. Cleveland Clinic is one of a handful of medical centers offering the device.

Fecal incontinence means uncertainty

Fecal incontinence occurs in both sexes and a wide range of ages. Research indicates between 4 percent and 18 percent of the population suffers from fecal incontinence, but Dr. Zutshi believes the number could be higher because some patients don’t seek help for a variety of reasons.

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“For people with fecal incontinence, the situation is unbelievably embarrassing,” says colorectal surgeon Brooke Gurland, MD, who along with Dr. Zutshi performed Cleveland Clinic’s first Fenix implant surgery in December 2016. The procedure takes about 45 minutes and only requires an overnight hospital stay.

“They don’t want to leave the house,” Dr. Gurland says. “They want to be close to a bathroom. When they travel, they don’t want to get on a plane. There’s just a lot of uncertainty.”

Early results are promising

The Fenix is among the latest fecal incontinence treatments that range from noninvasive to minimally invasive to invasive. They include:

  • Noninvasive: Incontinence plugs
  • Minimally invasive: Sacral neuromodulation, radiofrequency energy (used to create collagen deposits that may increase the rectum’s ability to retain stools)
  • Invasive: Fenix, pelvic floor slings, other surgeries

Drs. Zutshi and Gurland say that while the Fenix is considered invasive, it is easier for patients to use on their own than previously available devices.

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Still, not all patients are eligible for the Fenix. Patients must also have adequate healthy tissue between the rectum and the vagina or the rectum and the prostate for the device to be placed.

A handful of studies, mostly in Europe, have looked at patients who have received the device. So far, Dr. Gurland says, the Fenix has had a good success rate. The risk, as with any similar device located around the rectum, is of infection. It will take time to determine if Fenix users struggle with that.

“We just have to wait and see,” she says. “But, so far, it looks like a promising option for patients with bowel incontinence.”

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