The Hydrophilic-Coated Inflatable Penile Prosthesis: 1-Year Experience

Abstract

Introduction Penile prosthesis infections are a devastating complication for both patient and surgeon. Efforts to reduce the risk of infection from these elective procedures are a major focus of research and development by the major prosthesis companies. The Titan inflatable penile prosthesis (Mentor Corporation, Santa Barbara, CA) is coated with polyvinylpyrrolidone (PVP), a hydrophilic substance that reduces bacterial adherence and absorbs and elutes the antibiotics the device is immersed in intraoperatively. The Titan device was introduced to the American market in September 2002. This study reports the 1-year experience in the U.S. with the Titan and compares infection rates with the noncoated Alpha-1 IPP made by Mentor. Materials and Methods Two thousand three hundred and fifty-seven Titan prostheses were implanted in the U.S. from September 2002 to August 2003, compared with the 482 noncoated Alpha-1 IPPs implanted over the same time period. Infection rates were compared, along with bacterial culture data. All data were collected from Mentor's internal database, as generated from the FDA's mandatory reporting of explanted medical devices, and available on the internet. Results The infection rate for the coated Titan IPP was 1.06% (25/2357). During the same time period, the infection rate for the Alpha-1 noncoated prosthesis was 2.07% (10/482). Staphylococcus species predominated in both groups (9/25 Titan, 6/10 Alpha-1). Conclusions At 1 year of follow-up, the data demonstrate that the hydrophilic coating on the Titan IPP confers a significant advantage in reducing the rate of infection over the noncoated device. Long-term follow-up on this first year database is needed before this innovation is accepted as the standard of care for prosthetic surgery. Nevertheless, the theoretical reduction in bacterial adhesion conferred by the hydrophilic PVP surface and the ability to choose which antibiotic the device is immersed in intraoperatively gives the implanting surgeon distinct advantages with this new product.

Current use of penile implants in erectile dysfunction

“…The hydrophilic coating adsorbs 23 times its weight in water, and the theory is that when a coated implant is soaked in an antibiotic-containing solution, the antibiotics adhere to the surface of the device. There are not any clinical studies available as of yet, however, a manufacturer data-bank study shows a decreased rate of implant infection when compared with Coloplast's uncoated devices [20]. Coincident with the introduction of the new-coated Titan prosthesis, the tips of the cylinders were changed to a more physiologic tapered shape rather than the former blunt appearance.…”

Salvage surgery for penile prosthesis infection

“…Polyvinylpyrrolidone (PVP) reduces bacterial adhesion and absorbs the antibiotics in which the prosthesis is submerged by the surgeon just before implantation. In a report comparing 2357 hydrophiliccoated devices with 482 noncoated controls, the infection rate was 1.06% in the treated group and 2.07% in the control group [ 15 ].…”

Complications after penile implant surgery

“…Принцип действия заключается в применении специ-ального гидрофильного покрытия протезов, которое пропитывается растворами антибиотиков с последую-щей длительной их экспозицией в гидрофильном слое. Имплантация протеза Coloplast Titan продемонстри-ровала низкую частоту инфицирования его компонен-тов [25].…”