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FDA Approves Marketing of Fecal Incontinence Device for Women

February 17, 2015 2 min read

The U.S. Food and Drug Administration announced last week that they have approved the marketing of the Eclipse System, a tool used to treat fecal incontinence (FI) in adult women aged 18 to 75 years old.

Manufactured by Pelvalon, Inc., the Eclipse System is designed to treat women who have had four or more FI episodes, or accidents, in two weeks. The device is a balloon that is inflated within the vagina (same area where a tampon is inserted) and exerts pressure on the rectum to keep stool from involuntarily escaping. The vaginal insert is first inserted by a trained clinician and can then be controlled and removed by the user.

Approval for the Eclipse System was based on a clinical trial of 61 women with FI. Results showed that after one month of using the device, approximately 80 percent of the women experienced a 50 percent decrease in FI accidents. Side effects for the vaginal device included pelvic cramping, redness, and urinary incontinence.

“It is so exciting that a new low risk approach for treatment has proven to be so effective for women suffering from loss of bowel control, and the Eclipse System is clinically demonstrated to be exactly that,” said Holly E. Richter, director of Division of the Urogynecology and Pelvic Reconstructive Surgery at the University of Alabama at Birmingham, said in a press release. “…Eclipse offers a new alternative to these women, for immediate bowel control as well as greatly restored confidence and freedom.”

Over 20 million women in the U.S. suffer from fecal incontinence. Most people don’t report the problem to their doctor for fear of embarrassment. Current non-surgical treatment options for bowel incontinence include laxatives, eating high-fiber foods, bowel training (similar to bladder training), and biofeedback.


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