Inflatable penile prosthesis: site-specific malfunction analysis.

The purpose of this study was to analyze retrospectively the exact site(s) of device failure of a large series of Mentor Alpha I inflatable penile prostheses. The study consisted of 442 patients implanted over a 12-year period. Only those patients who developed a device malfunction and returned for re-evaluation by the author were included. The exact site(s) of device malfunction were obtained from a review of operative reports. The average length of follow-up in this series was 63 months, ranging from 1 to 138 months. In all, 22 (4.98%) patients developed device malfunction and returned for evaluation, including six (3.9%) of the 154 infrapubic devices and 16 (5.6%) of the 288 scrotal devices. Of these 22 patients, three declined revision and 19 were reoperated on by the author. The exact site of malfunction differed in the infrapubic vs scrotal implants. Most malfunctions of the scrotal device involved tubing fractures at the pump strain reliefs, whereas infrapubic device malfunctions typically involved the cylinders or the reservoir. A review of these malfunction patterns may assist the manufacturer in further improving the reliability of this prosthesis, and may assist implanting surgeons in planning operative procedures.