FDA Approves Device for Fecal Incontinence in Women



A new device to aid females with fecal incontinence (FI) has been approved for marketing by the FDA. The device, known as the Eclipse System, is intended for adult women (18-75) who severely suffer from FI – experiencing four or more episodes a week. Fecal incontinence is caused by weakening of the pelvic muscle walls and/or nerve damage, and makes it hard for a person to control bowel movements.

FI affects more women than men because of the nerve and muscle damage that commonly occurs during childbirth. But similar to urinary incontinence, many have suffered in silence and don’t discus symptoms due to the concern for embarrassment. People have instead altered their social schedules or physical activity. But now treatment is available.

Manufactured by Pelvalon in California, the device resembles a ring pessary, with an inflatable chamber attached to it. It is vaginally inserted and when inflated, the chamber pushes thought the muscle wall to act as a blockade on the rectum. After properly being fitted by a clinician, the patient can inflate and deflate the device themselves whenever it’s time to have a bowel movement.

To approve the device, the FDA evaluated data from both a clinical and non-clinical trials. The clinical trial consisted of 61 women. After just one month, 80 percent of women showed a 50 percent decrease in FI episodes.  Until now, the only treatments for FI were diet and exercise, drugs, or surgery. Unlike urinary incontinence, no approved treatment devices were available.

Factors that cause a weakening of pelvic muscles put a person at risk for developing fecal incontinence. Age is the most frequent factor, since muscles in the body naturally weaken over time. Others include poor overall health, IBS, urinary incontinence, and bowel surgery. Aside from damage that may occur during childbirth or surgery, FI onset can be triggered by medications, radiation and chemotherapy, as well as conditions that affect the nervous system, such as a spinal injury or stroke. FI can even be triggered by something as simple as an improper diet.

Side effects seen with the Eclipse device included pelvic pain or irritation, discharge and urinary incontinence. But the FDA noted that all of the displayed side effects were mild to moderate, and didn’t need any special medical treatment.