-- Scott Roberts
TUESDAY, May 31 (HealthDay News) -- Solesta gel has been
approved by the U.S. Food and Drug Administration to treat fecal
incontinence in adults after other therapies have failed.
The sterile substance is injected into the layer of tissue
beneath the anal lining. Approval was sanctioned for people in whom
therapies such as modified diet, fiber therapy, or medication
haven't worked, the agency said in a news release.
Loss of bowel control can result from nerve damage, muscle
damage, or certain effects of aging. More than 5.5 million
Americans have fecal incontinence, U.S. Government statistics
Solesta was evaluated in clinical studies involving 206 people.
The most common side effects included injection-site pain and
bleeding, and less frequently, infection and inflammation of anal
tissue. The gel should not be used in people with active
inflammatory bowel disease, immune disorders, or active infection,
bleeding or tumors, the FDA said.
Solesta is produced by Oceana Therapeutics, based in Edison,
The National Digestive Diseases Information Clearinghouse has
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