FDA Panel Gives the Nod to Bowel Control Device
WebMD News Archive
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.