Navigation Links
FDA Approves Injectable Gel to Treat Fecal Incontinence
Date:5/27/2011

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.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

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. (http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM242373.pdf) (http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM242376.pdf)

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, amanda.sena@fda.hhs.gov
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:
*Name:
*Comment:
*Email:
(Date:2/8/2016)... , Feb. 8, 2016  Echo Therapeutics, ... device company focused on non-invasive continuous glucose ... today announced that it will host a ... 17, 2015 at 9:00 a.m. Eastern Time ... its corporate strategy, advancements in its CGM ...
(Date:2/8/2016)... , Feb. 8, 2016 ... the "Global Skin Protective Equipment Market 2016-2020" ... --> http://www.researchandmarkets.com/research/fqx6nz/global_skin ) has announced the addition ... 2016-2020" report to their offering. ... ) has announced the addition of the ...
(Date:2/8/2016)... , Feb. 8, 2016   HighPoint ... November Research Group (NRG),s pharmacovigilance technology services division.  ... consulting services and an Oracle Argus Specialized partner, ... to Life Sciences companies. --> ... expands HighPoint,s life sciences capabilities and provides a ...
Breaking Medicine Technology:
(Date:2/8/2016)... (PRWEB) , ... February 08, 2016 , ... ... offices in Houma, LA, celebrates the beginning of a new charity campaign. As ... assist Court Appointed Special Advocates (CASA). In the belief that children deserve a ...
(Date:2/8/2016)... ... February 08, 2016 , ... If you are feeling that your clothes are ... alone. According to the Center for Disease Control and Prevention (CDC), 34.9% of U.S. ... certain types of cancer, some of the leading causes of preventable death. February ...
(Date:2/8/2016)... ... February 08, 2016 , ... Local insurance agency ... Venice, FL area, has initiated a fundraiser for a two year old little ... days after Christmas. To support this beautiful child who is facing life’s journey ...
(Date:2/8/2016)... ... February 08, 2016 , ... Eating disorders and post-traumatic ... of women and men with eating disorders report a history of trauma, research ... development of an eating disorder. , At the 2016 iaedp Symposium, the ...
(Date:2/8/2016)... ... February 08, 2016 , ... The Association of ... AHCC and the Home Health and Hospice ICD-10 Transition Workgroup are working closely ... coding guidance and clarifications, to address concerns over the use of 'A' as ...
Breaking Medicine News(10 mins):