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Solesta Gel Approved for Fecal Incontinence

Solesta Gel Approved for Fecal Incontinence

05/31/11

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 show.

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, N.J.

More information

The National Digestive Diseases Information Clearinghouse has more about fecal incontinence.

Copyright © 2011 HealthDay. All rights reserved.

Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.

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