An improved mechanical device for control of urinary incontinence.

Results of tests on implantable artificial sphincters with a subcutaneous control unit encased in a plastic envelope were previously reported. The plastic deteriorated and in 12 to 18 months caused instrument failure. To obviate this failure, (control) units of titanium alloy with protruding levers were tested in 17 animals for a period of up to 6 months to determine whether fibrosis and tissue ingrowth would hamper the function of the control levers. The device was placed around the urethra distal to the bladder neck. It was set to obstruct the urethra against pressures varying from 40 to 80 cm of water. Erosion of the urethra did not take place. In no instance was the action of the subcutaneous control levers hampered by tissue ingrowth or fibrosis.