Latest Medical Devices for Treating ED

Penile implants remain the gold standard third-line treatment for erectile dysfunction (ED) when first and second-line therapies fail or are contraindicated. According to the 2025 EAU Guidelines, these devices are recommended for patients who do not respond to less-invasive treatments due to their high efficacy, safety, and satisfaction rates.¹ Modern implants have evolved significantly, with mechanical failure rates of less than 5% after 5 years of follow-up for the most commonly used three-piece prostheses.² The EAU Guidelines identify two main categories of penile implants currently available: malleable (semi-rigid) and inflatable (2-piece and 3-piece) prostheses. Three-piece inflatable devices provide the most natural erection and flaccidity states, offering optimal concealment and rigidity.³ These devices consist of paired cylinders implanted in the corpora cavernosa, a pump placed in the scrotum for activation, and a fluid reservoir positioned in the retropubic space. Malleable implants, while offering easier surgical implantation and lower mechanical failure rates, provide less natural results but remain valuable options for certain patient populations.⁴ Regarding durability, a meta-analysis cited in the guidelines shows impressive implant survival rates: 93.3% at 1 year, 91.0% at 3 years, 87.2% at 5 years, 76.8% at 10 years, 63.7% at 15 years, and 52.9% at 20 years.⁵ The two primary complications are mechanical failure and infection. Infection rates have been reduced to 2-3% with primary implantation in low-risk patients at high-volume centers through careful surgical techniques and appropriate antibiotic prophylaxis.⁶ Advanced antimicrobial coatings have further reduced infection rates to 1-2% with antibiotic-impregnated prostheses or hydrophilic-coated prostheses.⁷ The guidelines emphasize that patient selection is crucial for optimal outcomes. Diabetes mellitus has been identified as a risk factor for penile prosthesis infection, highlighting the importance of careful patient evaluation.⁸ Additionally, patients with spinal cord injury have a higher risk of complications, with up to 16% reporting prosthesis infection in published series.⁹ Despite these considerations, the guidelines confirm there is no difference in terms of efficacy and safety among different penile implants available or surgical approaches used.¹⁰ Perhaps most importantly, the EAU Guidelines highlight that penile implants significantly improve sexuality and sexual well-being in both patients and their partners after surgery.¹¹ Psychological counseling before and after penile implant surgery can further enhance these outcomes. Patients should maintain realistic expectations regarding the natural appearance and function of the device, understanding that while these implants provide reliable erections for sexual activity, they do not alter penile length beyond what was present before ED developed.¹² For patients concerned about penile size, the guidelines specifically address that penile implants do not increase length beyond the patient’s original dimensions prior to developing erectile dysfunction. This is an important consideration during pre-operative counseling to ensure appropriate expectations.¹³ The guidelines emphasize that proper device sizing and surgical technique are essential to maximize functional outcomes while minimizing complications.¹⁴