Navigation Links
FDA Approves Injectable Gel to Treat Fecal Incontinence

SILVER SPRING, Md., May 27, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved a sterile, injectable gel to treat fecal incontinence in patients for whom other therapies such as diet change, fiber therapy or anti-motility medications failed.


Fecal incontinence is the involuntary loss of bowel control. It can have different causes including nerve damage, weakened anal sphincter associated with aging, or rectum muscle damage. According to the National Institutes of Health, there are more than 5.5 million Americans with fecal incontinence.

The Solesta gel is injected into a layer of tissue beneath the anus lining and may help build tissue in that area. By growing the surrounding tissue, the opening of the anus narrows and the patient may be able to 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.

For more information:

Gastroenterology-Urology Devices Panel Advisory Committee Meeting Transcript from Dec. 2nd and Dec. 3rd, 2010. ( (

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Amanda Sena, 301-796-0393,
Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA approves Incivek for hepatitis C
2. FDA Approves Sutent for Rare Type of Pancreatic Cancer
3. FDA Approves New HIV Treatment
4. FDA Approves Victrelis for Hepatitis C
5. FDA Approves New Treatment for Rare Type of Pancreatic Cancer
6. FDA Approves Novartis Drug Afinitor to Treat Pancreatic Neuroendocrine Tumors
7. FDA Approves Tradjenta™ (linagliptin) Tablets for the Treatment of Type 2 Diabetes
8. FDA Approves New Treatment for Type 2 Diabetes
9. FDA Approves Zytiga for Late-Stage Prostate Cancer
10. FDA Approves Updated, Clarified Indication for Use for iFuse Implant System®
11. FDA Approves Lamictal®XR™ (Lamotrigine) for Conversion to Monotherapy for Treatment of Partial Seizures in Appropriate Patients
Post Your Comments:
(Date:6/26/2016)... 2016 One of Australia,s successful ... of a new biotechnology company, Noxopharm Limited [ABN 50 608 966 ... and to list on the ASX. Noxopharm is a ... enter a Phase 1 clinical study later this year. ... of the biggest problems facing cancer patients - the ability of ...
(Date:6/26/2016)... 27, 2016 Jazz Pharmaceuticals plc (Nasdaq: ... the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended ... Pharmaceuticals, Inc. ("Celator"; Nasdaq: CPXX ) expired ... Time). As previously announced on May 31, ... merger agreement under which Jazz Pharmaceuticals has commenced a ...
(Date:6/26/2016)... , June 27, 2016  VMS Rehab Systems, ... Board will take whatever measures required to build a ... stock which is currently listed on the OTC Markets-pink ... Company Chairman and CEO, "We are seeing an anomaly ... to understand, not only by the Company, but shareholders ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... 2016 , ... The OSHA Training Center at Chabot-Las ... headquartered in Northern California, has issued an important reminder to employers to prevent ... Employers with workers exposed to high temperatures should establish a complete heat illness ...
(Date:6/27/2016)... ... June 27, 2016 , ... "FCPX editors can now reveal ... Final Cut Pro X," said Christina Austin - CEO of Pixel Film Studios. ... Cut Pro X users can now reveal the media of their split screens ...
(Date:6/27/2016)... ... ... TherapySites, the leading website and online marketing ... Association. This new relationship allows TherapySites to continue to extend their online ... and promotional offers. , "TCA is extremely excited about this new partnership, as ...
(Date:6/27/2016)... ... June 27, 2016 , ... ... its strategic partnership with Connance, a healthcare industry leader providing predictive analytics ... proprietary technology combine to provide health systems, hospitals and ambulatory surgical centers ...
(Date:6/27/2016)... ... June 27, 2016 , ... A revolution is ... emergency ambulance transport experience for the millions of people who require these medical ... the taxi industry through the use of technology. Now, SmartEMS has put forth ...
Breaking Medicine News(10 mins):