Female Fecal Incontinence Balloon Device Cleared for U.S. Market

A few weeks ago we covered the story of Pelvalon’s Female Fecal Incontinence (FI) device, specifically a study which found that 98 percent of patients would recommend it. So, it seems would the U.S. FDA, which has now cleared the Eclipse System for use in adult women.

Background

Fecal incontinence 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.

The Eclipse 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.

The FDA has cleared the system under its de novo classification rules, based on non-clinical testing as well as a clinical trial of 61 women with FI treated with the device. The trial showed that after one month almost 80 percent of women in the study experienced a 50 percent decrease in the number of FI episodes while using the device, as compared to baseline.

In case you were wondering, there were some adverse events reported, including pelvic cramping and discomfort, pelvic pain, vaginal abrasion, redness, or discharge, and urinary incontinence. None of these were considered serious enough to warrant further treatment.

Physician comments

“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.”

Source: U.S. Food and Drug Administration

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