Inflatable penile prosthesis: site-specific malfunction analysis

Abstract

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.

Inflatable penile prostheses for the treatment of erectile dysfunction

“…Debocq and colleagues reported that the Alpha I IPP had a 96% cumulative proportional survival at 63 months, versus an 84% CPS for the Ultrex and CX models [28]. The author of this review carried out a site-specific malfunction analysis for a series of 442 Alpha I IPPs; the most frequent site of malfunction was at the junction of the silicone tubing with the pump strain reliefs [29].…”

“…The most common sites of device failure in this author's series are the junctions of the silicone tubing with the strain reliefs (reinforced areas where the silicone tubing is attached to the pump) [29]. Other authors have also noticed this propensity [30].…”

Clinical experience with the mentor alpha-1 inflatable penile prosthesis: Report on 65 patients

“…This has been described previously as the weakest part of the Mentor Alpha-1 IPP [7,8]. The Mentor Corporation has tried to solve this problem by releasing a new model that has been strengthened at this site [8].…”

Does a replacement or revision of an inflatable penile prosthesis lead to decreased patient satisfaction?

“…Garber et al looked at 442 cases and found that 5.0% developed device malfunction, with the majority of device failure occurring at 48-59 months. 9 Their study design was to determine the site of mechanical failure, which demonstrated that half of their scrotal implants malfunctioned at the junction where the tubing and the pump strain relief of the Mentor Alpha I meet.…”