FDA Permits Marketing of Fecal Incontinence Device for Women

The US Food and Drug Administration (FDA) has officially allowed marketing of the Eclipse System for treating adult women afflicted with fecal incontinence (FI), the inability to control bowel movements.

As vaginal childbirth can damage the anal sphincters or their nerves, FI has been reported to impact women about twice as often as men.

The Eclipse System, manufactured by Pelvalon, Inc., in Sunnyvale, CA, was designed to treat FI in women 18 to 75 years old who have had 4 or more FI episodes over a period of 2 weeks. The device includes an inflatable balloon inserted in the vagina, which exerts pressure through the vaginal wall onto the rectal area upon inflation — ultimately reducing the number of FI episodes.

The device is initially fitted and inflated by a clinician and after proper fitting, the patient can inflate and deflate the device at home as needed. Clinicians said that the device should be removed periodically for cleaning.

The FDA’s approval of the manufacturer’s de novo request to market the device was 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% of women in the study experienced a 50% decrease in the number of FI episodes while using the device, as compared to baseline.

The primary adverse events reported were mild or moderate and included pelvic cramping and discomfort; pelvic pain; vaginal abrasion, redness, or discharge; and urinary incontinence.

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