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Injectable Gel Approved by FDA to Treat Fecal Incontinence


Solesta gel was approved Friday, May 27, by the U. S. Food and Drug Administration (FDA) for treatment of fecal incontinence.

Solesta gel is a sterile, injectable gel approved to treat fecal incontinence in patients for whom other therapies such as diet change, fiber therapy or anti-motility medications failed.

Fecal incontinence (FI) is the involuntary loss of bowel control which may involve the inability to hold a bowel movement until reaching a bathroom and/or the accidental leakage of solid or liquid stool (for example when passing gas).

An often embarrassing problem, FI affects nearly 18 million U.S. adults according to the National Institutes of Health. Though not always a part of aging, FI is more common in older adults.

Fecal incontinence can have different causes including nerve damage, weakened anal sphincter associated with aging, or rectum muscle damage.

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The Solesta gel is injected into a layer of tissue beneath the anus lining and may help build tissue in that area. This helps build up the surrounding tissue and narrows the opening of the anus which may allow the patient better control those muscles.

“Fecal incontinence is difficult to treat,” said Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “This approval provides a minimally invasive treatment option for patients with fecal incontinence that does not respond to conservative therapies.”

The FDA based its approval on results from a clinical study of 206 patients. In the primary study, most patients received two treatments, consisting of four injections each, for a total of eight injections. After six months, more than half of the patients injected with Solesta experienced a 50 percent reduction in the number of fecal incontinence episodes. However, one-third of patients who received no Solesta in the study also experienced a similar reduction. Overall, a greater proportion of patients treated with Solesta experienced improvements, indicating the gel provides benefit.

Solesta is approved for use in patients ages 18 and up. It should not be used in patients who have active inflammatory bowel disease, immunodeficiency disorders, previous radiation treatment to the pelvic area, 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.

The most common side effects associated with Solesta include injection area pain and bleeding. Infection and inflammation of anal tissue are more serious risks, but are less common.

Solesta is manufactured by Oceana Therapeutics Inc. of Edison, N.J.

Food and Drug Administration
National Institutes of Health: Fecal Incontinence