Fenix Continence Restoration system approved by FDA

The Fenix Continence Restoration System was approved by the U.S. Food and Drug Administration Dec. 18.

Fecal incontinence is the inability to control bowel movements. It occurs when there is damage to the muscles of the anal sphincter usually from vaginal childbirth or a disorder such as diabetes. The restoration system is designed for patients struggling with fecal incontinence who are not candidates for other medical options or whose previous options have failed.

“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, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said. “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 consists of an implant, an anal sphincter sizing tool and an introducer tool. Titanium beads with magnetic cores are inserted in a ring shape. The attractive force of the magnetic beads augment the anal sphincter to minimize involuntary opening of the anal canal, reducing the likelihood of severe fecal incontinence.

 In a study of 35 adults, 62.9 percent of the patients experienced a reduction of fecal incontinence episodes by half or more. In addition, quality of life measures also improved. Adverse effects included pain, infection, impaction or defecatory disorder, device erosion, device removal/re-operation and bleeding.