What are the risks and complications of different penile implant types?
Executive summary
Penile implants come in two broad clinical categories—inflatable devices (three-piece or two-piece) and non‑inflatable/malleable or augmentation implants—and each carries overlapping but distinct risks: infection (commonly cited at roughly 1–3%), mechanical failure (a leading reason for reoperation), erosion/extrusion, and intraoperative injuries such as urethral or visceral perforation (reports cite urethral perforation in about 1–3% of cases) [1] [2] [3]. Recent literature emphasizes that infection and device malfunction remain the most frequent drivers of revision surgery, while augmentation-specific devices (e.g., subcutaneous silicone Penuma) report additional cosmetic complications such as distal protrusion, sensation change, and deformity leading to explant in some series [4] [5] [6].
1. Inflatable implants: mechanical failures and reservoir/ pump problems
Inflatable penile prostheses (IPP)—the gold‑standard surgical option for refractory ED—offer more natural flaccidity and erection control but carry long‑term risk of mechanical failure: cylinder leaks, pump or reservoir malfunction, and tubing failures that often necessitate replacement of the device and account for a large share of reoperations [2] [4]. Survival series report good 5‑ and 10‑year device survival (roughly 90.8% and 85% in some reviews), but mechanical failure remains nontrivial and tends to require revisional surgery when it occurs [2]. Center‑level analyses repeatedly list mechanical failure as a top cause for reoperation [4].
2. Infection: rare but catastrophic, and influenced by patient and surgical factors
The reported infection rate for penile prostheses in contemporary series is low—commonly cited between about 1% and 3%—but infections are among the most feared complications because they usually lead to device removal and complex salvage procedures [1]. Reduction strategies such as antibiotic‑coated implants and “no‑touch” surgical techniques have driven infection rates down in experienced centers, but literature still flags revision surgery, substance use, homelessness, diabetes, and other medical comorbidities as strong risk enhancers for infectious complications [7] [8] [1].
3. Erosion, extrusion and corporal integrity problems: tissue breakdown and perforation
Devices can erode through tissue or extrude, producing pain, exposure and the need for explantation. Urethral perforation during corporal dilation or modeling is reported in roughly 1–3% of implantations and constitutes an immediate intraoperative complication that can alter the surgical plan [3]. A recent study highlighted “poor corporal integrity” (including crossover, perforation, and erosion) in a small but meaningful percentage of patients, showing this is a measurable and clinically important risk factor for implant failure [9].
4. Cosmetic/augmentation implants: unique deformity and sensation risks
Penile augmentation implants and subcutaneous silicone devices such as the Penuma were developed for cosmetic gains, not ED, and carry a distinct complication profile: distal protrusion, skin erosion, decreased sensation, dorsal/ventral curvature and penile shortening are common reasons for explant in published series [5] [6]. Prospective and case series report removal rates for silicone augmentation devices up to about 10% and a substantial burden of post‑explant deformity in some cohorts [10] [6].
5. Bleeding, hematoma, glans ischemia and visceral injury: early postoperative hazards
Early postoperative complications include bleeding and scrotal or penile hematoma; several contemporary registries and multicenter reports call attention to hematoma as an early complication that can threaten wound healing and increase infection risk [11]. Reservoir placement, especially after prior pelvic surgery or radiation, risks visceral injury (bowel or bladder) that may require aborting the implant procedure and immediate repair [2].
6. Patient selection, psychosocial risks, and the cost of revisions
Clinical and psychosocial patient factors affect outcomes. Diabetes, cardiovascular disease and other comorbidities increase perioperative risks and wound‑healing problems [12] [1]. Psychosocial issues—unrealistic expectations, dissatisfaction, “surgeon shopping”—emerge in the literature as non‑technical drivers of perceived failure and repeat procedures [13]. Revision surgery itself markedly raises infection risk because biofilms form on explanted hardware [8].
7. What the studies disagree on and where evidence is limited
There is consensus that infection and mechanical failure dominate complications, but studies disagree on precise incidence rates and predictors; several analyses note a lack of consistently validated predictors for infection or mechanical malfunction despite large device registries and MAUDE reports [14]. Evidence for augmentation devices is thinner and dominated by single‑center or short‑follow‑up series; true long‑term explant rates and functional sequelae for cosmetic implants remain incompletely defined [5] [10].
Limitations: available sources do not mention detailed comparative failure‑rate percentages by specific device model in a single, definitive dataset; individual risk depends heavily on surgeon volume and technique, patient health and whether the surgery is primary or revision [2] [4].
If you want, I can summarize complication rates for specific implant models or draft questions to bring to a surgeon to assess individual risk.