This consensus statement will be a valuable reference for the penile prosthetic implanter to consult to prevent and manage penile prosthesis infection. The authors are made up of leaders in sexual medicine and an authority in infectious disease. With up to 25,000 patients undergoing penile prosthesis implantation and an expected infection rate of 2%–3%, or higher in complex cases, managing infection is a considerable challenge, and we are best served by avoiding it altogether when possible.1,2 The fact that the authors did not assign levels of evidence to their recommendations speaks to the quality of the available evidence. In most cases, expert opinion is the best guidance we have. The authors point out methodological challenges of performing randomized trials with limited case numbers and a relatively rare outcome.
All urologists whether they implant prosthetics should be concerned about the epidemic of antibiotic resistance and the paucity of new antimicrobial drugs in development. Fewer new antimicrobials are being delivered to the market place. Between 1962 (nalidixic acid) and 2000 (linezolid) no new classes of antimicrobials were developed; drugs that entered the market place during this time were simply modifications of available molecules.3 Most large pharmaceutical companies no longer invest in antimicrobial research and development, given the long lead time to market place (up to 20 years), the cost ($1 billion), and a market potentially limited by regulatory constraints.
The Health and Human Services Department of the United States is providing $40 million to drug maker GlaxoSmithKline to help develop agents that will combat antibiotic resistance or those used for bioterrorism.4 The government program could give up to $200 million over the next 5 years to the company. A similar program in Europe is underway with AstraZeneca and GlaxoSmithKline with companies working together to pool resources and research data. In addition, creating a stream-lined, faster drug approval process similar to those used for orphan drugs to treat rare conditions is being considered for antimicrobials. Finally, tighter regulation of distribution and marketing will be needed to protect these new antimicrobials from overuse and the development of resistance. Urologists will want to monitor the landscape of antimicrobial development and resistance closely as this dilemma evolves.
References
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