Operative Procedure: complications

Survival of implants ranges between 78 and 95% after 10 years. In a long-term study involving 2,384 patients who underwent penile prosthesis implantation, estimated 10-year revision-free survival was 68.5% and the 15-year revision-free implant survival was 59.7%. In 1992, the Mentor Alpha-1 (now the Coloplast Titan) device added pump reinforcement to fore-stall mechanical breakage which improved 10-year survival from 65.3% to 88.6%.

In January 2001, AMS CX added parylene coating to the cylinders that has increased 3-year mechanical survival from 88.4% to 97.9%.

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Since 1973, improvements have been made in penile prosthesis design. Notwithstanding these improvements, complications or adverse events can still occur, including infection, hematoma, urethral perforation, persistent pain, mechanical failure, malposition of components, and patient dissatisfaction. Extremely rare complications include erosion of reservoir into the bladder or bowel, penile gangrene, sepsis, glans necrosis, and hernia. The complication rate has decreased substantially from approximately 50% in the earliest models to 1–12% in the more recent devices. Regardless of the type of prosthesis used, meticulous surgical technique and surgeon’s experience are important factors in determining the final outcome.

A major postoperative concern for most implanting surgeons is the development of infection. Signs or symptoms of infection include a purulent exudate, increasing pain instead of gradual improvement, worsening erythema and induration, or low-grade fever. Most infections present within the first 3 months after surgery and the vast majority manifest within the first year, although delayed infections beyond 1 year occasionally occur. The literature lists several risk factors for infection, such as inadequate perioperative antibiotic prophylaxis prolonged hospitalization, concurrent urinary tract infection, prolonged operative time, repeat implantation procedures, and combined operations (hernia repair, circumcision, artificial urinary sphincter implanation) with penile prosthesis surgery. Some patients, such as diabetics, and patients with spinal cord injury may have a decreased host defense. Local factors which increase infection risk include capsule formation around a foreign body, which diminishes blood supply to the area, and biofilm production. These factors provide a protective cavity in which bacteria may remain in a low metabolic state with no systemic antibiotic contact. The severity of infections may range from simple superficial infections that can be managed by conservative measures and wound care, to penile gangrene and sepsis which may be life threatening. Penile gangrene is rare and may be due to gram-negative organisms with or without anaerobic superinfection.