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Non-Infectious Complications of Penile Prosthesis Surgery

Infection, the most consequential complication, is covered in its own article. Revision-specific scenarios (SST, crossover, perforation) are covered in revision scenarios.

The Cocci systematic review of 151 studies (92,777 patients) summarizes contemporary complication evidence.[2]

PHOENIX data correction — July 23, 2026

The registry investigators removed 38 incorrectly registered patients, which changed the cohort from 1,072 to 1,034 and revised the numerical results.[1][6]

Rate Summary​

The ranges below come from heterogeneous literature.

ComplicationRateTiming
Acute postoperative pain (severe)46.2% on postoperative day 2 and 11.1% on day 30 in one prospective 96-man penoscrotal IPP cohort[36]Early
Infection0.03–14.3% across studies, mostly under 5%[2]Weeks to months
Mechanical failureAbove 15% in about half of studies with 5–11 years of follow-up[2]Late
Prosthesis erosion0.02–32.5% across studies, most below 5%[2]Weeks to years
Pump erosionUncommonYears
Reservoir erosion (bladder)RareVariable
Cylinder aneurysm or bulge0.7% (2/300) in the AMS 700 pivotal trial[13]110–1,780 days (mean 945 days)
Penile shortening (subjective)Highly variableImmediate
Glans ischemia/necrosisRare1–14 days
Chronic painPoorly characterizedWeeks to years
Sensory change2.3% (7/300) decreased penile sensation in the AMS 700 pivotal trial; approach-specific rates remain uncertain[13]Variable

Manufacturer label data (AMS 700). The pivotal trial enrolled 300 men with devices that did not carry InhibiZone and reported, across the study, urogenital pain 53.3%, edema 35.3%, ecchymosis 10.0%, reservoir encapsulation 6.3%, auto-inflation 5.7%, mechanical malfunction 4.3%, impaired urination 3.7%, decreased penile sensation 2.3%, infection 2.0%, penile curvature 1.7%, erosion or extrusion 1.3%, device migration 1.0% and cylinder aneurysm 0.7%.[13] Among 126 men followed to 5 years and 16 additional men revised before that exam, 22 of 142 (15.5%) underwent 26 revisions; mean time to first revision was 15 months, and mechanical malfunction was the commonest reason (7 of 26).[13] The MS pump and TENACIO pump were not available when the trial ran. Separate manufacturer revision tables (parts-replacement forms, 2019 label edition) gave 5-year revision rates of 11.6% for the CX (n = 12,080) and 9.8% for the Ultrex, including mechanical revision 5.6% and 4.8%, removal for infection 2.2% and 2.0% and removal for erosion 1.4% and 1.0%; these rely on voluntary reporting and probably undercount.[13][14]

Erosion and Extrusion​

Cylinder erosion through the glans or urethra​

Distal glans erosion (cylinder tip protrudes through the glans) presents as visible device, glans pain, bleeding, or bloody discharge. Urethral erosion presents as hematuria, dysuria, recurrent UTI, palpable cylinder in the urethra on exam, or cylinder visible on cystoscopy.[3] In a single-surgeon retrospective cohort of 797 IPP placements, 26 impending or complete cylinder extrusion events (about 3%; two occurred in the same patient) were identified: 46.2% lateral shaft, 34.6% distal urethral, 7.7% glanular, 7.7% midshaft and 3.8% coronal-sulcus.[16] Mean time from initial placement to repair was 8.4 years (median 5.5); 17 of 26 (65.4%) underwent repair or replacement and 9 (34.6%) had device removal.[16]

Risk factors:

  • Diabetes. Impaired tissue integrity.
  • Pelvic radiation. Reduces tissue quality and is a recognized risk factor.
  • Spinal cord injury with impaired sensation, so the patient does not feel the developing erosion.
  • Aggressive distal dilation with cylinder oversizing.
  • Long-indwelling catheter against the cylinder.
  • Prior glanular or urethral surgery reducing local vascular supply.
  • Poorly fitted rear-tip extenders creating distal cylinder pressure.

Management:

  • Confirmed distal erosion through the glans: cylinder explantation on the affected side; contralateral cylinder may be retained or explanted depending on the scenario. The glans is allowed to heal 3–6 months before considering reimplantation.
  • Urethral erosion: complete device explantation, primary urethral repair if feasible (versus marsupialization or urethrostomy), Foley drainage, delayed reimplantation 3–6 months after complete healing.
  • Counseling: reimplantation carries a higher risk of re-erosion, particularly after radiation or in severe diabetes.

Impending distal extrusion​

Several repair options have been described for a threatened distal cylinder tip before it fully erodes through the glans or urethra:

  • Capsule-based redirection. Mulcahy's distal corporoplasty opens the existing fibrotic capsule and creates a new, more medial and secure cavity for the cylinder behind the back wall of the capsule; in the original 14-patient series, all had a satisfactory result with no recurrence at up to 2 years.[17] Carson and Noh compared this approach (18 men) with Gore-Tex windsock reinforcement (10 men) in 28 patients with impending extrusion: no infection or recurrent extrusion occurred after corporoplasty, versus one infection and two extrusion recurrences (at 6 and 18 months) after windsock repair, with a shorter mean operative time for corporoplasty (52.8 versus 89.6 minutes).[18] The comparison was not randomized and had no stated overall follow-up.[18]
  • Distal anchoring stitch. Antonini and colleagues extract the distal cylinder through a lateral subcoronal corporotomy, create a new true distal corporal channel, and anchor the cylinder in it with a 4-0 PDS suture passed through the glans and buried. In a 53-patient series (14 distal crossovers, 39 lateral extrusions), 2 patients (3.8%) had recurrent lateral herniation at median 46.8-month follow-up, with no infection, wound-healing defect or device replacement for extrusion, infection or mechanical failure reported.[19]
  • Distal biologic cap. Karpman and colleagues describe checking for urethral microperforation by cystoscopy, then folding a graft of at least 4 x 2 cm over the distal cylinder tip to provide about 1.5 cm of coverage, oversewing the lateral edges. In a small case series undergoing IPP replacement, none had recurrent impending erosion or loss of function at short-term follow-up.[20]
  • Proximal extracapsular tunneling. For impending erosion related to corporal dilation, Clavell-Hernández describes opening the surgical capsule, exposing sinusoidal tissue behind its posterior wall, and developing a new extracapsular plane before cylinder replacement; in a 6-patient series (mixed indications including impending erosion, glans hypermobility and cylinder aneurysm), none had recurrent malposition, malfunction or infection at mean 6.6-month follow-up.[21]

These are small, uncontrolled or single-comparison reports; none establishes one technique as superior, and none changes management of confirmed erosion, urethral involvement or infection.

Delayed reconstruction after complete distal erosion​

For a deficient distal tunica after complete erosion, Egydio and Kuehhas describe a "double-windsocks" reconstruction: the neurovascular bundle is elevated through a circumcision incision, lateral 3- and 9-o'clock tunical incisions are made, and paired neocorporal channels are fashioned over dilators from polypropylene mesh (malleable implants) or a polypropylene/PTFE composite (IPP), separated by a nonabsorbable septum to prevent crossover, with Buck's fascia and the neurovascular bundle covering the mesh. In their 69-patient series (45 prior distal erosions, 24 other corporal fibrosis; 57 malleable and 12 inflatable devices), mean follow-up was 22.5 months (range 6–48), satisfaction was 88.4%, and no extrusion, infection or skin dehiscence was reported; delayed orgasm occurred in 17 patients (24.6%) and recovered within about 4 months.[22]

Pump erosion​

Less common than cylinder erosion; presents as tender, erythematous scrotal skin tenting or frank erosion. Risk factors include thin scrotal tissue, radiation, and pump migration up against a poorly-dependent scrotal pocket.

Management: assess for implant infection and plan operative treatment of exposed hardware. Complete device removal with delayed reimplantation is one option; in a six-patient retrospective pilot, all IPP components were removed and a malleable implant was substituted immediately in men without penile pain on palpation or overwhelming sepsis.[37]

Reservoir erosion into the bladder​

Rare but severe. Presents as hematuria, cystitis-like symptoms, device deflation, or findings on cystoscopy. Managed with reservoir explantation, cystorrhaphy, Foley drainage, and delayed reimplantation; see reservoir placement.

Extrusion at the wound​

Cylinder or tubing visible through a wound dehiscence. Usually managed by explantation and delayed reimplantation; simple debridement and closure over exposed device rarely succeeds.

Purulent drainage, or an early opening with bloody hematoma clots from a scrotal hematoma, calls for a return to the operating room for source control.[23] For carefully selected clean, nonpurulent wound separation without those features, office closure with oral antibiotics has been reported to preserve the implant: one high-volume implanter’s experience preserved the device in 13 of 14 selected patients. A separate observational series of 15 patients with localized clinical wound or implant infection used close observation and oral antibiotics without immediate surgery; 13 had total symptom resolution over 21 to 141 days (mean 76.2), two remained under observation, and nine bacterial isolates were recovered from seven cultured patients.[33]

Glans Ischemia and Necrosis​

Clinical picture​

Glans pallor, cyanosis or frank necrosis typically presents as a dusky glans on the first postoperative day.[4][8] Onset is occasionally delayed to 7–14 days. Ischemia may involve part of the glans (dorsal tip pallor) or the entire glans.

Mechanisms​

  • Distal cylinder oversizing. Mechanical compression of glans vasculature.
  • Dorsal neurovascular bundle injury. Partial or complete transection during dissection.
  • Glans crossover. Cylinder perforating the glans or crossing the midline through the septum.
  • Aggressive distal dilation. Direct arterial injury.
  • Preexisting glans hypovascularity. In Wilson's 21 cases, atherosclerotic cardiovascular disease (90%), diabetes (81%), smoking (81%), prior explantation (57%) and prior radiation (48%) were common.[4]
  • Adjunctive maneuvers. The same series found a subcoronal incision (86%), an occlusive elastic penile wrap (62%), a sliding technique for lengthening (33%) and concurrent distal urethral repair (29%).[4] Park reported no glans ischemia or necrosis in 898 subcoronal implants by one surgeon.[4][7]
  • Hematoma compressing the glans from within.

Management​

  • Immediate recognition. Deflate the device, remove a compressive penile dressing, and remove a urethral catheter if feasible; reassess glans color and sensation promptly.[8] Persistent ischemia warrants urgent consideration of explantation, with removal within 24 hours advised in the case literature: in Wilson's 21-case series, 17 men managed expectantly with the device in place lost glans tissue, whereas four who underwent immediate removal healed without sequelae.[4][8]
  • Hyperbaric oxygen therapy. Reported as an adjunct to debridement in one post-implant penile gangrene case.[34]
  • Warm compresses, topical nitroglycerin. Adjuncts with limited evidence.
  • Urgent prosthesis removal. When glans ischemia develops, urgently consider removal of the entire implant; the cited 21-case series found major glans loss in 17 of 21 patients managed with device preservation versus no sequelae in four who underwent immediate removal.[4]
  • Glans debridement or partial amputation only if necrosis is established and unsalvageable. Counsel the patient about the cosmetic consequences.

Prevention​

  • Careful distal corporal dilation to the subcoronal recess, not through it
  • Preservation of the dorsal neurovascular bundle in infrapubic and subcoronal approaches
  • Appropriate cylinder sizing with intraoperative measurement
  • Avoiding occlusive elastic penile wraps and high-risk adjunctive maneuvers (sliding technique, concurrent distal urethral repair) in patients with the risk factors above[4]
  • Postoperative glans assessment at the end of the case and again at 2 hours and 24 hours

Cylinder Aneurysm​

Definition​

Focal bulging or ballooning of the cylinder wall, visible and palpable during inflation. The cylinder shell has developed a weak point where fluid pressure expands the wall beyond its original contour.

Presentation​

Patient notices an abnormal asymmetry or focal bulge during erection. May be painful. Most commonly reported several years after implantation in heavily cycled devices.

Management​

Management is cylinder replacement (isolated cylinder exchange, or complete device replacement if other components show wear). Aneurysms do not resolve and progressively enlarge.

Four intraoperative photographs of a right cylinder aneurysm, a septal defect, redundant tunica marked for excision and tunical closure

Revision for a Titan cylinder aneurysm. (A) Right cylinder aneurysm. (B) Septal defect showing communication between the right and left sides. (C) Redundant tunica marked with a pen for excision. (D) Tunical closure with 6-0 polydioxanone (PDS) sutures. From Tavares C, et al. Cent European J Urol. 2021;74(2):255-258, Figure 2 (CC BY-NC-SA).[12]

Prevention​

Appropriate cylinder sizing and avoidance of overly aggressive inflation during patient use. Aneurysms have been reported as case reports with contemporary parylene-coated AMS 700 CX and Coloplast Titan cylinders.[11][12]

Reservoir Vascular Compression​

A reservoir placed too laterally, or overfilled, can compress an adjacent external iliac vessel. Venous compression may present days to weeks after surgery with ipsilateral leg edema and progress to iliac-vein thrombosis; arterial compression has caused acute limb ischemia in a case report.[39] Case reports describe successful thrombectomy or vein repair combined with repositioning the reservoir more medially, to the contralateral side, or to an ectopic location.[24][25] New unilateral leg edema or ischemic symptoms after IPP warrant urgent vascular evaluation.

Mechanical Failure​

Rates​

  • Mechanical failure rates exceed 15% in about half of studies with 5–11 years of follow-up, and neurological comorbidity is associated with a higher risk of mechanical failure.[2] A long-term multicenter study of 372 AMS 700CX recipients (implanted 1987–1996, up to 134 months of follow-up, median 47.7 months) reported device malfunction in 17.5% and mechanical reliability of 92.1% at 3 years and 86.2% at 5 years.[15]
  • In a 2,384-patient series of first-time implants spanning older device generations, estimated all-cause revision-free survival was 68.5% at 10 years and 59.7% at 15 years.[31]
  • Coloplast Titan and AMS 700 have comparable long-term mechanical reliability in most reported series

Failure modes​

  • Cylinder tubing disconnection or rupture. Fluid loss; device does not inflate
  • Reservoir-to-pump tubing disconnection. Device does not inflate, or inflates partially
  • Reservoir-to-pump tubing torsion ("telephone cord syndrome"). Patient cannot inflate the device; a 5-year multi-institutional experience of 974 implants (612 with alternative/ectopic reservoir placement, 362 with traditional space-of-Retzius placement) described 4 cases, mostly involving ectopic reservoirs, with caudal tubing migration and increased abdominal-wall pressure proposed as a contributing mechanism.[26]
  • Pump valve failure. Fluid cycles asymmetrically; device does not deflate fully
  • Cylinder shell rupture. Progressive aneurysm followed by rupture; loss of inflation
  • Reservoir leak. Gradual deflation over weeks to months
  • Autoinflation. In devices without a lock-out valve, increased abdominal pressure can move reservoir fluid into the cylinders.[40] The TENACIO pump's valving resists elevated reservoir pressure but does not eliminate postoperative autoinflation; the earlier AMS 700 pivotal trial, predating the MS and TENACIO pumps, recorded 17/300 events (5.7%).[13] Confirm deflation technique and assess reservoir position and filling before attributing autoinflation to valve failure.[13]

Management​

  • Complete mechanical workup: imaging (ultrasound of pump, x-ray of reservoir with contrast in selected cases), direct test of each component
  • Isolated component replacement versus complete device exchange is a judgment call; many surgeons replace the entire device after 10+ years of service. In a systematic review of 11 studies of revision for noninfected malfunction, partial exchange (n = 234) had infection in 6.3% and overall complications in 23.9%, versus 2.7% and 11.3% after complete exchange (n = 12,202); these nonrandomized groups had differing follow-up.[38]

Urinary Retention​

Incidence​

Approximately 5–6% of patients require postoperative catheterization for retention, usually within 24–48 hours of surgery.[2]

Causes​

  • Narcotic analgesics
  • Local edema near the bladder neck
  • Prior BPH or mild BOO revealed in the perioperative period
  • Reservoir compression (usually mild, rarely the primary cause)

Management​

  • Intermittent catheterization (one or two insertions usually sufficient)
  • For patients with BPH symptoms: tamsulosin 0.4 mg orally once daily is the labeled BPH dose; a fixed 7–14-day post-implant course is not established.[35]
  • Rarely requires prolonged catheter drainage

Hematoma​

Scrotal hematoma​

Most common early complication location. In a prospective single-center cohort using chlorhexidine-alcohol skin preparation and fibrin sealant without a drain, hematoma occurred in 1.0% (1/103) versus 5.2% (6/115) in historical controls using povidone-iodine preparation and routine drains.[5]

  • Compressive scrotal dressing is standard.
  • Partial device inflation for 24 hours to 2 weeks reduces dead space and is used by many implanters for hematoma reduction.
  • Fibrin sealant. A historical-cohort comparison reported fewer hematomas with a bundled protocol using Evicel, chlorhexidine-alcohol preparation and no drain (1/103 versus 6/115).[5]
  • Drains are omitted in many contemporary protocols. In a retrospective comparison of 410 primary three-piece implants, a 24-hour closed-suction drain was not associated with lower hematoma or infection rates, and hematoma was associated with infection (OR 29.0 on postoperative day 3).[9] A multi-institution series of 425 implants with 12–24 hour scrotal drainage reported a 3.3% infection rate and 0.7% hematoma rate.[10]

Pelvic hematoma​

Associated with infrapubic approach or difficult reservoir placement; typically self-limited. CT imaging if concern for ongoing bleeding or expanding hematoma.

Management​

  • Small or stable: observation, compressive dressing, ice, appropriate analgesia
  • Large, expanding or infected: operative evacuation, reassessment of bleeding source, device evaluation

Chronic Pain​

Persistent pain after penile prosthesis implantation can range from pain only during activation to daily pain with the device inactive. Its incidence beyond 6 weeks is poorly characterized.[27]

Causes​

  • Inadequate distal cylinder seating: glans pain with inflation
  • Pump or reservoir positioning causing neuralgia or dartos irritation
  • Chronic corporal inflammation or sterile bursa formation around components
  • Unrecognized Peyronie's disease with incomplete correction
  • Psychological pain amplification

Management​

  • Expectant management for mild pain; most improves over 6–12 months
  • Pump or cylinder repositioning for component-localized pain
  • Pudendal nerve block as a diagnostic or therapeutic maneuver in selected cases
  • Device exchange or explantation in refractory cases when pain does not resolve. In a retrospective two-center series, pain persisted in 18 of 31 patients (58%) after revision or explantation undertaken for chronic pain; improvement occurred only in those with device malposition.[32]

Sensory Changes​

Rates and mechanism​

  • Infrapubic approach carries the highest sensory-change risk; the dorsal neurovascular bundle is in the direct dissection field
  • Penoscrotal approach has the lowest rate; the dorsal bundle is not routinely exposed
  • Subcoronal approach carries moderate risk; the bundle is exposed during degloving but visible throughout

Decreased penile sensation was reported in 7 of 300 men (2.3%) in the AMS 700 pivotal trial.[13]

Management​

  • Counseling preoperatively about the risk
  • Expectant management; most improve over 3–12 months
  • Refractory complete sensory loss has no effective surgical solution

Penile Shortening​

Subjective shortening varies by cohort and may occur despite no significant change in measured stretched flaccid length, as in the prospective cohort described below.[28] In a 20-man prospective IPP cohort, 14 men (70%) had shorter measured penile length at 6 weeks when postoperative inflated length was compared with preoperative pharmacologically induced erect length; median individual loss was 0.5 cm.[41] Subjective complaint and objective measurement often differ, so preoperative measurement and counseling address the complaint directly. In one prospective cohort of 56 men measured before and 1 and 6 months after first-time implantation, 72% reported a subjective decrease in penile length, but there was no statistically significant difference in measured stretched flaccid length compared with preoperative measurements; men who complained of length loss had lower treatment-satisfaction scores despite similar erectile-function scores.[28]

Addressed by​

  • Length-expanding cylinder (AMS 700 LGX; Rigicon Infla10 Pulse AX). The AMS 700 IFU cautions that LGX cylinders in Peyronie's disease may not give a satisfactory result.
  • Preoperative traction therapy (vacuum device, penile traction device): limited evidence but used by some practices
  • Adequate corporal dilation to maximal stretched length at primary implant
  • Early implantation after acute ischemic priapism. It may limit fibrosis-associated shortening; discuss its risks and benefits against delayed placement .[30]

The Counseling Framework for Complications​

Effective consent discussion frames complications in three groups the patient can understand:

  1. Things that resolve on their own (most hematomas, most pain, most retention, most sensory change)
  2. Things that require another operation (mechanical failure, autoinflation, malposition, cylinder aneurysm, most infections)
  3. Things that end the implant journey for this patient (severe erosion with irreparable tissue loss, profound glans necrosis, unsalvageable infection with multiple failed salvage attempts)

Revision is common over the life of the device (see the revision rate under Mechanical Failure) and is part of the normal device lifecycle.

Documentation After Complications​

Every non-routine postoperative event should generate a note that captures:

  • Date of primary operation, device details (manufacturer, model, size, RTE)
  • Date of presentation and clinical findings
  • Imaging and labs obtained
  • Decision and treatment provided
  • Patient-expressed concerns in their own words
  • Plan and follow-up interval

Contemporaneous documentation of informed consent, technique, timely recognition and management supports the medicolegal record.

Implantation After PFUI Urethroplasty​

Chapter authors describing their own single-center experience report 41 men who received a penile implant after pelvic fracture urethral injury (PFUI) anastomotic urethroplasty between 2013 and 2023 (38 semirigid, 3 three-piece inflatable devices; mean interval after urethroplasty 47 months). They report two intraoperative septal perforations and one proximal crural perforation; postoperative events were two hematomas, two glans extrusions described only as salvaged without further detail, and one proximal urethral erosion leading to implant removal. Mean IIEF-5 rose from 3.27 before to 21.88 after implantation, without a stated follow-up interval.[29] The cohort was uncontrolled.[29]

See Also​

Videos​

Managing Complications Following Penile Implant Surgery
Grand Rounds in Urology (2019)
Repair of Midline Septal Defect with Crossover Penile Implant Cylinder
Wang C, et al. Urology Video Journal 2023 (CC BY-NC-ND 4.0)
Open source videoRead the article
Proximal Perforation of a Penile Prosthesis After Pelvic Trauma
Nguyen V, et al. Urology Video Journal 2023 (CC BY-NC-ND 4.0)
Open source videoRead the article

References​

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