Initial experience with the Rosen incontinence device

During a 25-month period, beginning in May 1977, 19 patients had Rosen incontinence devices implanted. During the 9 to 34 months of followup 26 additional operations were required for urethral compression balloon leakage, urethral compression balloon aneurysm, tubing kinks, reservoir malfunction and urethral erosion. Currently, 7 devices are in place, 6 of which are functioning and 3 of which have aneurysms of the urethral compression balloon. The 6-month failure rate of the first device was 44 per cent. During the 247 months that the devices were in place the patients were dry for 89 months, and required pad protection for 118 months and condom or an external urethral clamp for 40 months.