Fecal incontinence is the involuntary loss of bowel control that may be caused by nerve damage, weakened anal sphincter associated with aging, or rectum muscle damage. As per the National Institutes of Health statistics, more than 5.5 million Americans suffer from fecal incontinence. The U.S. Food and Drug Administration have approved a sterile, injectable gel to treat this condition among patients for whom other therapies such as diet change, fiber therapy or anti-motility medications failed.
The Solesta gel has to be injected into a layer of tissue beneath the anus lining and seemingly aids in building tissue in that area. As the surrounding tissue grows, the opening of the anus possibly narrows and the patient can better control those muscles. The gel received FD approval after being tested on 206 patients. During the primary study, most patients were subjected to two treatments, consisting of four injections each, for a total of eight injections. On completion of six months, more than half of the patients injected with Solesta registered a 50 percent reduction in the number of fecal incontinence episodes. But one-third of patients who did not receive Solesta also reported a similar decline.
“Fecal incontinence is difficult to treat. This approval provides a minimally invasive treatment option for patients with fecal incontinence that does not respond to conservative therapies,” said Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health.
Scientists mention that overall a greater proportion of patients treated with Solesta had improvements. The gel has been approved for patients aged 18 and above. It does not appear favorable for patients with active inflammatory bowel disease, immunodeficiency disorders and previous radiation treatment to the pelvic area. Also those with a significant rectal prolapse, active infections, bleeding, tumors or malformations in the anorectal area, rectal distended veins, an existing implant in the anorectal region, or allergy to hyaluronic acid based products should not employ Solesta. The most common side effects of the gel probably were injection area pain and bleeding.
The injectable gel Solesta is made by Oceana Therapeutics Inc. of Edison, N.J.