First Vaginal Insert for Fecal Incontinence Clears FDA

Megan Brooks


February 18, 2015

The US Food and Drug Administration (FDA) has cleared for marketing the Eclipse System (Pelvalon, Inc) for treatment of fecal incontinence (FI) in adult women who have had four or more FI episodes in a two-week period.

The device includes an inflatable balloon, which is placed in the vagina. When inflated, the balloon puts 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. After proper fitting, the patient can inflate and deflate the device at home as needed. The device should be removed periodically for cleaning.

FI is a common problem, particularly among older women. Risk factors include pregnancy, childbirth, or nerve or muscle damage in the pelvic region.

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

The FDA reviewed data for the Eclipse System through the de novo classification process, a regulatory pathway for some low-to-moderate-risk medical devices that are not substantially equivalent to a legally marketed device.

The data included nonclinical testing and a clinical trial involving 61 women with FI treated with the device. 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 with baseline, the FDA said.

Adverse events associated with the device included pelvic cramping and discomfort, pelvic pain, vaginal abrasion, redness, or discharge, as well as urinary incontinence. All device-related adverse events were mild or moderate, and none required any significant intervention.

The women in the study found the insert to be "comfortable, and uniformly said they would recommend it to a friend," the company said in a news release.

"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," Holly E. Richter, PhD, MD, director, Division of Urogynecology and Pelvic Reconstructive Surgery, University of Alabama at Birmingham, and immediate Past President of the Society for Gynecological Surgeons, said in the company release. Dr Richter led the pivotal study of the Eclipse System.

"Fecal incontinence is a truly devastating condition, and many women in my practice have tried every existing treatment without success. Eclipse offers hope to these women, of immediate bowel control as well as greatly restored confidence and freedom," she added.

The company said the Eclipse System will be available later this year.


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