The hydrophilic-coated inflatable penile prosthesis: 1-year experience

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.