FDA Approves Marketing of Fecal Incontinence Device for Women

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.

Continue reading