Assessment of a novel implantable artificial anal sphincter

PURPOSE: The aim of the study was to test a new implantable artificial anal sphincter in the porcine model. METHOD: The artificial sphincter, which includes an inflatable expander that compresses and flattens the bowel against a pillow, was implanted in 16 animals and studied for periods of up to 20 weeks. The anal sphincters were destroyed, and the efficacy of the device in rendering the animals continent was studied. RESULTS: Of the 11 animals in which the artificial sphincter was regularly closed, 8 completed the study and were continent during 85 percent of activation times. There was no evidence of ischemic injury. Major complications were related only to failure of the control pumps of the device. CONCLUSION: This study suggests that this neosphincter produces fecal continence without intestinal ischemia. At present reliability is limited only by the performance of the pump.