How can expulsion of the device be prevented?
Proper positioning, and maintenance of proper positioning, of the retention balloon are keys to prevention of expulsion. Maintenance of proper positioning can be achieved by observing changes in the location of the position indicator line to determine movement of the balloon in the rectum. If the position indicator line moves down, ie., away from the anus, this may indicate that the device may expel. In such cases, the balloon should be deflated, removed, and reinserted. Patients with very weak sphincter muscles may not be able to hold the device in place. In the clinical trial, Flexi-Seal® FMS was retained in all subjects but one who had poor sphincter tone prior to entering the study.
