FDA Panel Gives the Nod to Bowel Control Device
"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.