JACKSONVILLE, Fla., June 7 (UPI) -- Four patients who received an implantable device that mimics the anal sphincter are the first patients to be treated for fecal incontinence with it since the U.S. Food and Drug Administration approved its use last year.
The Mayo Clinic announced the surgeries on June 7, becoming the first medical facility in the country to offer relief from a condition that previously had limited methods of treatment -- and in a relatively non-invasive way.
Fecal incontinence is the inability control bowel movements, often caused by damage to the muscles around the anus from vaginal childbirth or conditions such as diabetes, is difficult to treat, and affects 20 percent of women over age 45. Non-invasive techniques such as drugs and dietary changes don't always work to return bowel control to patients.
"The condition can be debilitating due to social isolation, depression, loss of self-esteem and self-confidence," Dr. Paul Pettit, a female pelvic medicine and reconstructive surgery specialist at the Mayo Clinic, said in a press release. "If a patient does not improve through use of less invasive techniques, our only option has been a colostomy."
The Fenix Continence Restoration System is an anal sphincter sizing tool made up of a titanium beads with magnetic cores connected by a titanium wires, forming a ring. The magnetic beads minimize involuntary opening of the anal sphincter, offering patients greater control of their bowels.
"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," Dr. William Maisel, acting director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health, said in a press release.
The FDA approval was for a humanitarian device exemption, and required specific approval for each patient from the Mayo Clinic's institutional review board -- the first to approve any patient receiving the implant.
Pettit said the four surgeries, all of which he performed, took about 45 minutes, requiring an overnight hospital stay, but the device works immediately after the procedure and does not have to be activated or adjusted once implanted.
"This device now offers a new option that restores function, and we are happy to be able to offer it," Petit said.