(144) LONG TERM SAFETY OF FILLING HYDROPHILIC COATED IMPLANTS WITH AN ANTISEPTIC: THE KINDER EGG EFFECT WITH IRRISEPT IN TITAN HYDROPHILIC COATED IMPLANTS
Authors: Karpman E , Griggs R , Vasylieva V , Henry GD 
Published: December 2024

Abstract

Introduction
Biofilms affect virtually all implantable materials in the body including penile implants. The risk of infection after mechanical failure revision surgery is much higher (7-18%) than after virgin implant operations (1-3%). The most common point of failure for Titan implants, and almost exclusively, is the tubing. The fluid leaks out and can usually be found around the pump and tubing within the fibrous capsular sheath at the time of revision surgery. Since this is not an emergency, revision surgery usually takes place several weeks after the first onset of mechanical failure. According to published data, the median time to failure of a Titan□implant is 41 months. Irrisept has been evaluated by the manufacturer for up to 36 months for shelf life stability without any deterioration of efficacy. So, can we reduce infections during revision surgery by affecting the biofilm pre-operatively?

Objective
To evaluate the components of a Titan hydrophilic coated implant after priming and filling with Irrisept after 6 months.

Methods
Titan Classic and TitanTouch penile implants were filled using Irriseptand were stored for 6 months in a saline bath at 98.6°F (37°C) to simulate body temperature environment. Each implant was cycled on a weekly basis and evaluated for any dysfunctionality. Three (3) Titan Classic 20 cm implants (P/N ES89202400) and 3 Titan Touch 20 cm implants (P/N ES29202400) were used for testing. Samples were assembled with 75 cc reservoirs (P/N ER80752400) and filled using Irrisept solution (Table 1). All IPP implants and reservoirs were 1x EtO sterilized prior to testing. Implants were primed and filled with Irrisept under sterile conditions and stored in a saline bath at 98.6°F (37°C) for 6 months to simulate body environment. Once per week, devices were cycled to simulate use of the implant – each pump was compressed until the bladders were inflated to an erect state, followed by completely deflating the cylinders back to the initial state. Samples were evaluated for any dysfunction or difficulty during cycling. Following the 6-month period, the Irrisept was drained aseptically from each implant. Each implant was dissected and evaluated by Coloplast engineers for crystallization or any untoward effects from the Irrisept.

Results
No dysfunctions were observed during weekly cycling of the implants throughout the 6- month period. All implants inflated and deflated as intended. Images are shown below of a Titan Classic and Titan Touch pump (Figs. 1 and 2). No crystallization was observed. There were no anomalies, irregularities, corrosion, or material degradation of any kind found within the pump bulb, reservoir, tubing, cylinder bladder, or pump body channels.

Conclusions
During this 6-month period, no dysfunctions were observed across all implants. Filling Titan implants with Irrisept may serve as an adjunct to other maneuvers to help reduce the relatively high rate of penile implant infections after revision surgery for mechanical failure. Future studies are needed to better understand the flow of effluent out of the ruptured tubing and the extent of efficacy of Irrisept solution on microbial species over more prolonged periods of time.

Disclosure
Yes, this is sponsored by industry/sponsor: Coloplast.
Clarification: Industry funding only - investigator initiated and executed study.
Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast, Irrimax.