(042) Reasons For and Time to Failure Associated with Inflatable Penile Prosthetics: A Multi-Center, High, Volume Experience
R Griggs, A Stuart, G Henry, E Karpman- Urology
- Reproductive Medicine
- Endocrinology
- Endocrinology, Diabetes and Metabolism
- Psychiatry and Mental health
Abstract
Introduction
Despite technological advancements in the composition material, pump design, and infection retardant coatings, inflatable penile prosthetics (IPPs) remain prone to mechanical failure due to pump malfunction and/or fluid loss.
Objective
We aim to distinguish IPP component failure etiologies at the time of device replacement and/or repair between the two most common manufacturers: American Medical Systems/Boston Scientific (BSCI) and Coloplast (CP).
Methods
We performed an IRB approved, retrospective chart review of two private, high volume IPP surgeon revision and virgin cases (CPT codes 54405, 54408 and 54410) from January 2018 to May 2023. Mechanical revision indications were stratified by manufacturer and component location (pump, tubing, cylinder, and reservoir). Non mechanical revision cases were excluded (planned upsizing, patient dissatisfaction, herniation without replacement, impending erosion/eroded, crossover, and infection). Other exclusions included missing data (reason for failure, device type, op note, patient specific data, and/or prior institution operative details).
Results
Between the two surgeons, we identified a total of 646 cases during the study period. 120 were revision IPP cases, 66 of which, met inclusion criteria (57 BSCI and 9 CP). Of the BSCI mechanical inflatable penile prosthetic failures, 24/57 (42%) were due to cylinder rupture, 5/57 (9%) were due to tubing leaks, 3/57 (5%) were associated with reservoir perforation, 5/57 (9%) were due to cylinder aneurysm, and 20/57 (35%) were due to pump failure. Coloplast device mechanical failure was predominantly due to tubing fracture 7/9 (77.8%) while reservoir rupture and cylinder aneurysm each were 1/9 (11.1%). Between manufacturers, cylinder rupture and pump failure were more common in BSCI devices (25/57 vs 0/9, p=0.036; CI 95%) and (21/57 vs 0/9, p=0.064; CI 90%). While tubing fracture was more common in CP devices (5/57 vs 7/9, p=0.002; CI 95%). Cylinder aneurysm and reservoir rupture did not significantly differ between manufacturers. Similarly, log rank analysis illustrates similar time to mechanical failure between BSCI and CP (median 48 vs 41months respectively, p=0.277; CI 95%).
Conclusions
BSCI and CP device time to failure appears to be similar; this was also shown in recent published literature. BSCI pump failure appears to be greater than the previously described rate of 2% during their recall period from 2018-2020 and they fail significantly more than CP devices. BSCI devices most commonly fail due to cylinder rupture then other component failure. CP devices fail most commonly due to tubing rupture and this adds to the prior published literature. Further, multi-center studies are needed to validate these findings.
Disclosure
Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast and Boston Scientific Consultant.