FDA Permits Marketing of Device for Female Fecal Incontinence

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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.

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