FDA Panel Gives the Nod to Bowel Control Device

Aug. 17, 2001 (Washington) -- An advisory panel to the FDA has recommended for approval a new device that may be able to help thousands of people who have bowel control problems.

Nancy Loitz, a sufferer of the condition known as fecal incontinence, says the device has changed her life. That device, called an artificial sphincter, was implanted in her rectum as part of a study, and it has given her control over her bowel movements.

Prior to the surgery, just leaving the house was a burden for Loitz because she had to carry a change of undergarments and always make sure she knew the location of the nearest bathroom. But the artificial sphincter, implanted when she was 36 years old, dramatically improved her quality of life and allowed her to carry on her daily activities without worrying about having an accident, she says.

Fecal incontinence, which can be caused by a variety of factors including damage to nerves or the muscles that control bowel function, affects 5 million to 18 million people in this country, including half of all nursing home patients. For the 170,000 with a severe form of the disease, it can be debilitating because they are unable to carry out daily activities for fear that they will have an accident.

The new artificial sphincter device, manufactured by American Medical Systems under the brand name Neosphincter, may help many of these people.

In a clinical trial, 115 people who had failed to improve on other treatments for the condition, such as biofeedback, antidiarrheal medicines, and surgery, had the Neosphincter device implanted.

Bowel control and quality of life improved in more than half the patients, said Ron Yustein, MD, an FDA medical reviewer.

However, half of the patients had to undergo repeat surgery at least once due to side effects of the treatment, such as pain and infection. And about one-third had to have the device removed.

The panel felt that these complications were acceptable, given that most were manageable and there was the potential for a high level of improvement in incontinence.

"I'm not particularly concerned about the high incidence of complications," but patients should be made aware of these risks, said panel member Arthur Smith, MD, a urologist at the Albert Einstein College of Medicine in New York. He suggested that patients be given an information kit explaining the device and the procedure and that they be required to sign a form indicating that they understand the risks prior to surgery.

Panel member Karen Woods, MD, a gastroenterologist at Baylor College of Medicine in Houston, added that it's important that patients understand that there's at least a 50% chance of having to undergo another surgery to replace or remove the device. She also wanted patients to be made fully aware that another option for this condition is a stoma, which involves surgery on the intestine so that fecal matter drains into a colostomy bag that can either be placed outside or underneath.

The panel was concerned that some of the complications may be due to a surgeon's inexperience with the procedure to implant the Neosphincter. To ensure that only experienced surgeons are implanting the device, the panel recommended that the device initially only be implanted at certain centers and that surgeons be required to undergo a training program to familiarize them with the procedure.

FDA's Yustein tells WebMD that surgical complications generally decrease as surgeons become more experienced with a new device or procedure.

Loitz, whose condition had failed to improve following multiple surgeries, recently underwent a revision surgery to replace her first device. She's completely recovered and says she can't even feel the device.

She says the device is "pretty easy to use" and has allowed her to return to an active lifestyle.

Yustein says the device is already available in Europe, Australia, and Israel. No significant concerns with the device have been identified in those countries.

The FDA generally follows the advice of its advisory panels but is not bound by their recommendations.