Device approved for female fecal incontinence
(HealthDay)—The Eclipse System has been approved by the U.S. Food and Drug Administration to treat fecal incontinence in adult women aged 18 to 75, the agency said in a news release.
Fecal incontinence is especially common among older adults. Vaginal childbirth can strain the anal muscles, which can lead to this condition, the FDA said.
The new system, inflated inside the vaginal area, 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.
The Eclipse system is manufactured by Pelvalon Inc., based in Sunnyvale, Calif.
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