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Fecal Incontinence Device

Fecal incontinence is the inability to control bowel movements, causing stool (feces) to leak unexpectedly from the rectum. It is the inability to control bowel movements and is a common problem, especially among older adults. The most common cause of FI is damage to the muscles around the anus (anal sphincters). Vaginal childbirth can damage the anal sphincters or their nerves, which is why FI impacts women about twice as often as men.

Also called bowel incontinence, fecal incontinence ranges from an occasional leakage of stool while passing gas to a complete loss of bowel control.

Common causes of fecal incontinence include diarrhea, constipation, and muscle or nerve damage. The muscle or nerve damage may be associated with aging or with giving birth.

Whatever the cause, fecal incontinence can be embarrassing.

Fecal incontinence is even a bigger issue than urinary incontinence. Close to 50 percent of people in long-term care suffer from it. That’s an amazing number. U.S. sales of fecal incontinence products is predicted to hit $1.9 billion by 2018.

The U.S. Food and Drug Administration has recently allowed marketing of a System for the treatment of fecal incontinence (FI) in adult women.

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

The System is intended to treat FI in women 18 to 75 years old who have had four or more FI episodes in a two-week period. The device includes an inflatable balloon, which is placed in the vagina. Upon inflation, the balloon exerts pressure through the vaginal wall onto the rectal area, thereby reducing the number of FI episodes. The device is initially fitted and inflated by a clinician (with the use of a pump) and after proper fitting, the patient can inflate and deflate the device at home as needed. The device should be removed periodically for cleaning.

Adverse events associated with the device included pelvic cramping and discomfort; pelvic pain; vaginal abrasion, redness, or discharge; and urinary incontinence. All device-related adverse events were mild or moderate, and none required any significant intervention (i.e., no surgeries were needed).







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