New Device for Fecal Incontinence Approved by the FDA
(HealthDay News) — The Fenix Continence Restoration System has been approved by the US Food and Drug Administration to treat an inability to control bowel movements for patients who can't tolerate or use other approved methods.
The Fenix system was evaluated in 35 adults, 15 of them from the United States. U.S. trial participants will be examined for 5 additional years to evaluate the device's performance, the FDA said.
The system should not be implanted in patients with known or suspected allergies to titanium, stainless steel, nickel, or iron. And patients who have had the device implanted should not undergo magnetic resonance imaging, the agency warned. Side effects of the system have included pain, infection, device erosion, additional surgery to remove the device, and bleeding.
"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," William Maisel, MD, MPH, acting director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health, said in a statement. "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 Fenix system is produced by Torax Medical, based in Shoreview, Minnesota.