Solesta Gel Approved for Fecal Incontinence

powered by healthline

Average Ratings

A condition affecting 5.5 million Americans

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.


-- Scott Roberts
Copyright © 2011 HealthDay. All rights reserved.
Article from
Top of page
General Drug Tools
General Drug Tools view all tools
Tools for
Healthy Living
Tools for Healthy Living view all tools
Search Tools
Search Tools view all tools
Insurance Plan Tools
Insurance Plan Tools view all tools

What is a reference number?

When you register on this site, you are assigned a reference number. This number contains your profile information and helps UnitedHealthcare identify you when you come back to the site.

If you searched for a plan on this site in a previous session, you might already have a reference number. This number will contain any information you saved about plans and prescription drugs. To use that reference number, click on the "Change or view saved information" link below.

You can retrieve information from previous visits to this site, such as saved drug lists and Plan Selector information.