FDA Permits Marketing of Device for Female Fecal Incontinence

Share this content:
FDA Permits Marketing of Device for Female Fecal Incontinence
FDA Permits Marketing of Device for Female Fecal Incontinence

(HealthDay News) -- The U.S. Food and Drug Administration has allowed marketing of the Eclipse System for the treatment of fecal incontinence in adult women aged 18 to 75, the agency said in a news release.

The new system -- an inflatable balloon placed inside the vagina -- exerts pressure onto the rectal area, reducing the number of incontinence episodes, the agency said. The user is able to inflate and deflate the product as needed for periodic cleaning.

After one month of clinical testing, 80 percent of women using the device had a 50 percent drop in the number of episodes, the FDA said. Common side effects included pelvic cramping, vaginal abrasion, redness, discharge, and urinary incontinence. All effects were described as mild to moderate, the agency said.

"Current treatment options for fecal incontinence include drugs, dietary changes, exercise, and surgery," William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA's Center for Devices and Radiological Health, said in a statement. "The Eclipse System provides an additional treatment option for women who suffer from this condition."

The Eclipse system is manufactured by Pelvalon Inc., based in Sunnyvale, Calif.

More Information

Share this content:

is free, fast, and customized just for you!




Already a member?

Sign In Now »

Drug Lookup

Browse drugs by: BrandGenericDisease



Sign up for myCME e-newsletters




More in Home

Some California Mosquitoes Can Carry Zika Virus

Some California Mosquitoes Can Carry Zika Virus

Aedes aegypti mosquitoes found to transmit Zika virus

Periodontal Inflammation a Risk With Tongue Piercing

Periodontal Inflammation a Risk With Tongue Piercing

And, two young females with tongue piercings have deep lingual infrabony lesions, periodontitis

Risk of OD Highest for First Days of Opioid  Benzodiazepine Use

Risk of OD Highest for First Days of ...

Five-fold increased risk of opioid-related overdose during first 90 days of concurrent use

is free, fast, and customized just for you!




Already a member?

Sign In Now »