The U.S. Food and Drug Administration (FDA) has allowed
marketing of the Eclipse System for the treatment of fecal incontinence (FI) in
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. Vaginal childbirth can damage the anal sphincters or their nerves,
which is why fecal incontinence impacts women about twice as often as men.
William Maisel, M.D., M.P.H., deputy director for science
and chief scientist in the FDA's Center for Devices and Radiological Health
said that, "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."
The Eclipse System is intended to treat FI in women 18 to 75
years old. 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
The Eclipse System is manufactured by Pelvalon, Inc., in Sunnyvale, California.