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Penile Prosthesis Infection — Evolution, Evidence, and Modern Controversies

Inflatable penile prosthesis (IPP) implantation is associated with high patient satisfaction in most series, and infection is its most serious complication.[16] An infected device usually means explantation or salvage surgery, with the risks of cavernosal fibrosis, penile shortening and a return to the operating room.

The infection rate was 1.9% across primary and revision cases combined in a retrospective multicenter cohort of 5,261 patients.[1] In a 2025 analysis of 18,475 men undergoing IPP surgery, the infection rate was 3.1% at a median of three years, and 2.5% occurred within the first six months.[2] It was 5.6% in patients with three or more risk factors versus 2.8% in those with none.[2] Coated-device registry comparisons reported infection of 0.68% versus 1.61% at 180 days for original AMS implants and 1.06% versus 2.07% at one year for Titan implants; a separate Coloplast registry reported infection-related revision of 1.4% versus 4.6% with different follow-up periods (see Historical Evolution).[4][6][7]

See also: Penile Implants overview, Inflatable Penile Prosthesis (biomaterial), Artificial Urinary Sphincter.


Historical Evolution​

The trajectory of IPP infection over the last fifty years follows three inflection points.

Pre-coating era (1970s–2001)​

Early series of first-generation inflatable devices reported infection rates in the 8–11% range, falling to 3–5% by the early 2000s with gradual improvements in perioperative antibiotic protocols, sterile technique and patient selection.[3] Registry data for uncoated devices in the same period reported 1.61% infection at 180 days for AMS devices and 4.6% infection-related revision over up to 11 years for Coloplast devices.[4][7] Coagulase-negative Staphylococcus, particularly S. epidermidis, dominated the microbial profile. Infections were framed as failures of sterile technique, a paradigm that would shift substantially with the recognition of biofilm biology.

Antibiotic-coating era (2001–2002)​

The second major inflection came with the introduction of antibiotic-impregnated devices.

  • American Medical Systems (now Boston Scientific) released the InhibiZone coating, a factory-applied combination of rifampin and minocycline that elutes locally after implantation. In a rabbit implantation model, InhibiZone devices kept larger zones of inhibition against S. aureus than vancomycin-dipped Titan implants through day 14.[30]
  • Mentor (now Coloplast) followed in 2002 with the hydrophilic Titan, which uses a polyvinylpyrrolidone surface that absorbs whatever antibiotic solution the surgeon chooses to dip the device in immediately before placement.[6]

Carson's 2004 analysis of manufacturer-collected forms for 4,205 original AMS 700 implants found infection at 180 days of 0.68% with InhibiZone and 1.61% without.[4] Wolter and Hellstrom's 2004 manufacturer-database analysis reported 1.06% (25/2,357) for the coated Titan and 2.07% (10/482) for the uncoated Alpha-1 at one year.[6] Voluntary manufacturer registry data reported infection-related revision in 4.6% of uncoated Coloplast primary implants over up to 11 years versus 1.4% of hydrophilic-coated implants over up to 8 years; InhibiZone original implants had follow-up extending to 7.7 years.[5][7] These are retrospective, voluntarily reported data.

Coated IPPs entered U.S. practice in the early 2000s, but current U.S. ordering information lists non-InhibiZone AMS 700 systems and components.[4][6][49]

No-touch + antifungal era (2015–present)​

The third inflection, more gradual and ongoing, came over the last decade through three convergent forces:

  • Widespread adoption of the no-touch surgical technique
  • Recognition of the biofilm paradigm
  • Emerging understanding that antifungal coverage matters

Infection rates in high-volume series are now around 1%. Eid's single-surgeon series of 3,342 implants (2002–2014) reported a fall from 5.3% in 2002 to 1.99% with antibiotic-impregnated devices and to 0.44% after adding the no-touch technique in 2006.[8]


The Microbial Landscape Shift​

Wilson and Costerton proposed that coated implants reduced infections with indolent coagulase-negative Staphylococcus and left a residual infection population of more virulent organisms.[3]

Gross and colleagues' 2017 multicenter analysis of 227 intraoperative cultures from infected three-piece IPPs (25 centers, 2002–2016) described the organisms involved:[9]

  • No growth occurred in 33% of cultures.[9]
  • Gram-positive and gram-negative organisms were found in 73% and 39% of positive cultures, respectively.[9]
  • Candida species, anaerobes and MRSA were found in 11.1%, 10.5% and 9.2% of the 153 positive cultures, respectively; these categories may overlap in polymicrobial cultures.[9]
  • Multi-organism infection occurred in 25% of positive cultures.[9]

The organisms were not covered by the AUA and EAU guideline regimens in at least 14% to 38% of cases.[9] A review of fungal IPP infections found diabetes in 69% of them and Candida albicans in 62% of isolates.[10]

Prophylaxis regimens designed for the older spectrum may therefore leave some causative organisms uncovered.


Drivers of Decline (Ranked by Impact)​

Six factors are credited with the decline. No study has ranked them, so the order below is approximate.

1. Antibiotic-coated devices​

Registry analyses reported lower infection rates at 180 days with InhibiZone (0.68% vs 1.61%) and at one year with hydrophilic Titan (1.06% vs 2.07%); a separate Coloplast registry found fewer infection-related revisions with coated than uncoated devices (1.4% vs 4.6%) over up to 8 and 11 years, respectively.[4][6][7]

2. The no-touch technique​

Developed by J. François Eid, this uses an adhesive barrier drape after skin preparation to ensure that neither the surgeon's gloves nor the implant ever contacts the patient's skin during placement.[8] Combined with separate gloves and instruments for skin and device-handling phases, frequent glove changes, and minimization of operative time and OR traffic, this protocol accompanied an infection rate of 0.44% in Eid's single-surgeon series, which compared eras.[8]

3. Modern skin antisepsis​

2% chlorhexidine gluconate in 70% isopropyl alcohol (ChloraPrep) was used for skin preparation in a prospective primary-IPP cohort.[11] In a randomized trial of 100 patients undergoing genitourinary prosthetic surgery, post-preparation skin cultures were positive in 8% with chlorhexidine-alcohol and 32% with povidone-iodine.[32] A prospective cohort study combining ChloraPrep, fibrin sealant hemostasis and no drain reported 0 infections at 12 months in 103 primary IPP cases versus 3.5% (4/115) in historical controls, who had povidone-iodine preparation and routine drains.[11]

4. Patient optimization​

  • Glycemic control. An HbA1c threshold of 8.5% was proposed to identify elevated infection risk in a mixed penile-implant cohort.[43]
  • MRSA screening and decolonization with mupirocin and chlorhexidine body washes for known carriers is institutional practice. ASHP 2013 advises adding a single preoperative vancomycin dose for patients known to be MRSA colonized, and its data on mupirocin decolonization are limited.[34]
  • Smoking cessation for at least four weeks preoperatively

Diabetes is associated with approximately 1.7-fold increased infection risk in multivariable analysis.[1]

5. Center-of-excellence effect​

In a national claims cohort of 18,475 men selected to approximate de novo IPP placement, coded infection was lower at high-volume than low-volume hospitals (2.4% versus 3.7% over median three-year follow-up); among the 70.2% with surgeon-volume data, the surgeon-volume comparison was not statistically significant (2.7% versus 3.2%).[52] Brant's national cohort found high-volume surgeons were more likely to use AUA-adherent regimens (OR 2.21).[13]

6. Antibiotic stewardship​

Retrospective data indicate that extended IV courses and postoperative oral antibiotics are not associated with lower infection rates. In the 2025 PUMP analysis, IV prophylaxis beyond 24 hours (P = 0.2) and postoperative oral antibiotics (P = 0.5) showed no protective association, and Dropkin's single-institution series of 222 men found similar infection outcomes with and without postoperative antibiotics.[1][20]


The AUA Guideline Controversy​

The American Urological Association published its Best Practice Statement on urologic surgery antimicrobial prophylaxis in 2008 (reviewed in 2011 and archived in 2019). The current statement is the 2020 Best Practice Statement.[12] For implanted prosthetic devices, including IPPs, the AUA table lists an aminoglycoside or aztreonam paired with a first- or second-generation cephalosporin or vancomycin, for no more than 24 hours.[12] A table footnote states that routine vancomycin is not recommended. The alternatives column lists aminopenicillin/β-lactamase-inhibitor agents, including ampicillin/sulbactam; it does not list clindamycin monotherapy for implanted prosthetic devices.[12]

Brant and colleagues noted that no level-1 evidence supports the vancomycin-gentamicin combination for IPP surgery.[13]

Practice adoption​

In Brant and colleagues' analysis of 26,574 IPP surgeries in a national database, 67% received an AUA-adherent regimen, with a 42% relative increase in use after the 2008 statement, particularly of vancomycin and gentamicin. Nonadherence to the recommended regimen was not independently associated with 90-day explant (OR 1.16, 95% CI 0.78–1.71).[13]

The PUMP reassessment​

The Prosthetic Urology Multi-Institutional Partnership (PUMP) is a multi-institutional collaborative (institutions in North America, Europe and Korea) whose retrospective analyses have challenged the AUA regimen.

Barham et al., 2023 (J Urol, 4,161 primary IPP cases, retrospective) compared vancomycin plus gentamicin alone (2,411 patients) with all other regimens (1,750). Crude infection rates were similar (1% vs 1.2%). In the adjusted model, vancomycin plus gentamicin alone was associated with a higher infection hazard (HR 2.7, 95% CI 1.4–5.4, p = 0.004).[14] Barham defined the AUA regimen as vancomycin plus gentamicin alone, a narrower regimen than the several combinations in the AUA statement.

Abou Chawareb et al., 2025 (retrospective, 5,261 patients at 16 centers) reported:[1]

  • Perioperative IV antifungal use was associated with lower infection risk (OR 0.22, p < 0.001).[1]
  • Postoperative oral antibiotics (P = 0.5) and IV prophylaxis beyond 24 hours (P = 0.2) showed no protective association.
  • Diabetes (OR 1.68) and prior IPP infection (OR 4.67) were the independent patient-level risk factors.[1]

A multicenter retrospective cohort of 804 diabetic patients undergoing primary penile prosthesis surgery (18 institutions) found more device infections with AUA-recommended prophylaxis than with nonstandard prophylaxis (5.6% vs 1.9%; OR 2.8, 95% CI 1.1–7.3).[15] Common nonstandard regimens were vancomycin-gentamicin-fluoroquinolone, clindamycin-fluoroquinolone and vancomycin-fluoroquinolone.

One small randomized trial compared oral ofloxacin with intravenous gentamicin plus cefazolin followed by oral cephradine in 20 patients; it reported no implant loss or reoperation in either arm.[51] The 2020 AUA statement predates these analyses. The 2025 Sexual Medicine Reviews recommendations from the 5th International Consultation on Sexual Medicine are the most recent expert consensus document.[16]


Antifungal Prophylaxis — Observational Evidence and Uncertainty​

In the 2023 PUMP analysis, antifungal use was associated with a markedly lower infection hazard (HR 0.08, 95% CI 0.03–0.19).[14] The 2025 cohort found a smaller association (OR 0.22 for IV antifungal use).[1] Both analyses are retrospective; in a separate PUMP revision-only cohort of 453 noninfected IPP revisions, antifungal prophylaxis was not independently associated with postoperative infection.[53]

A systematic review of nine retrospective studies reported that Candida accounted for 11.1% of 153 positive cultures in a salvage/explantation series and concluded that antifungal prophylaxis is warranted.[17] A 2024 review supports antifungal use, particularly in high-risk populations.[10]

A 2024 narrative review lists oral fluconazole 400 mg one hour before surgery followed by 200 mg daily for 14 days as a proposed prophylaxis regimen, while acknowledging that optimal agent and route remain untested.[10] If this extended course is used, review renal dosing, QT-prolonging medications and warfarin interactions.[54] In the retrospective PUMP cohort, perioperative IV antifungal use was associated with lower infection odds (OR 0.22), but the cohort did not test that oral schedule.[1] That review reserves liposomal amphotericin B for established infections.

Adoption patterns​

A 2025 multicenter survey of SMSNA, SUPS, and GURS members found antifungal use in:[18]

  • 25.9% of responding implanters reported perioperative antifungal use for primary IPP surgery
  • 72.3% of responding implanters reported perioperative antifungal use for diabetic IPP surgery
  • 65.2% of responding implanters reported perioperative antifungal use for salvage surgery
  • 48.2% of responding implanters reported perioperative antifungal use for revision IPP surgery

In vitro data show that adding fluconazole or amphotericin B to dipping solutions does not reduce antibacterial activity on hydrophilic surfaces.[19]


The Modern Antibiotic Regimen​

There is no universally agreed best regimen, and no randomized controlled trial has identified one. The following principles reflect the PUMP investigators' expert practice, not a guideline recommendation:

Principle 1 — Tailor to your local antibiogram​

When the PUMP investigators applied this principle to three surgeons at three different institutions, they found three different ideal regimens. Pulling the institution's Candida and gram-negative resistance data should be a first step in any new practice.

Principle 2 — Cover MRSA, gram-negatives broadly, and Candida​

A reasonable contemporary regimen:

AgentCoverage
VancomycinMRSA + gram-positive
Gram-negative agent*Gram-negatives
Fluconazole (selected protocols)[10]Candida

*Gram-negative options: gentamicin, piperacillin-tazobactam, or ceftriaxone, depending on local sensitivity patterns. The 2024 review describes an adopted regimen of vancomycin plus piperacillin-tazobactam plus fluconazole based on local antibiograms.[10] The 2020 AUA statement states that routine vancomycin is not recommended.[12] The 2013 ASHP guideline advises adding a single preoperative vancomycin dose when MRSA colonization is known.[34]

Principle 3 — End prophylactic dosing at wound closure​

2025 PUMP data show no association between extended IV courses or postoperative oral antibiotics and lower infection.[1] The 2020 AUA statement also advises against postoperative continuation of prophylaxis.[12]

Principle 4 — Timing within 60 minutes of incision​

For cefazolin or cephalosporin-based regimens. Start vancomycin within 120 minutes before incision because it requires a longer infusion.[34]

Principle 5 — Skip routine postoperative oral antibiotics​

Retrospective series found no protective association with postoperative oral antibiotics.[1][20] The AUA statement notes that prolonged prophylaxis has not shown benefit in randomized trials of other procedures.[12] Older and procedure-specific protocols describe longer postoperative oral-antibiotic courses, for example one week after penile length-restoration surgery or after standard implant placement in a 2008 textbook's own practice.[38][39]


Dipping Solutions — Device-Specific​

The choice of dipping or irrigation solution is fundamentally device-specific.

AMS 700 InhibiZone​

The AMS 700 instructions for use state that InhibiZone components should not be soaked in saline or other solutions before implantation, and may be briefly rinsed or dipped in a sterile solution immediately before implantation. They also warn that contact with alcohols, acetone and other nonpolar solvents can remove the antibiotics.[33] The antibiotic is applied during manufacture, so surgeons typically irrigate the field around the device with:

  • Sterile saline
  • Antibiotic-fortified saline (vancomycin and gentamicin)
  • Or 0.05% chlorhexidine gluconate, based on bench compatibility data and a retrospective cohort (see Irrisept discussion below)[24][26]

The label's own evidence is a manufacturer patient-information-form analysis of US AMS 700 implants from May 2001 to September 2007 (more than 43,000 patients). Revision for infection was 1.2% (338 events) with InhibiZone versus 2.5% (84) without in original implants (p < 0.0001), 1.4% versus 4.0% in original implants in diabetic men (p < 0.0001) and 2.5% versus 3.7% in revision implants (p = 0.0252).[35] Revision rates for mechanical failure, fluid loss, erosion and dissatisfaction did not differ. The analysis is voluntary manufacturer reporting without randomization.[35] The IFU states that a complete device carries at most 33 mg rifampin and 12 mg minocycline (under 2% of an oral course), that the coating does not replace routine prophylaxis, and that it is contraindicated in allergy or sensitivity to rifampin, minocycline or other tetracyclines and in systemic lupus erythematosus.[35] It advises caution with hepatic or renal disease, monitoring of prothrombin time in men taking warfarin, renal monitoring with methoxyflurane, and caution with thionamides, isoniazid and halothane. The current MS Pump IFU adds that any effect of temporary exposure to the antibiotics on male fertility is unknown. If a hypersensitivity reaction develops, the label says to remove the prosthesis.[35][36]

Coloplast Titan (hydrophilic)​

The device is dipped in the chosen antibiotic solution immediately before placement, commonly for at least 30 seconds. In Towe et al.'s retrospective diabetic Titan cohort, vancomycin plus gentamicin was the most commonly used dip.[21] In Towe et al.'s 2020 retrospective cohort of 468 diabetic men receiving a Titan, this dip was associated with lower rates of infection (1.4% vs 6.4%), explantation and revision than all other dips combined, and rifampin-containing dips trended toward more infection (P = 0.057).[21]

In vitro, adding fluconazole or amphotericin B to the dip did not reduce antibacterial activity on the hydrophilic surface.[19]


Irrigation — What NOT to Use​

Several solutions historically used in IPP surgery should now be avoided in the wound:

Povidone-iodine (Betadine) wound irrigation​

Associated with increased infection rates. In Manka et al.'s retrospective single-surgeon study (217 patients), half-strength betadine irrigation was associated with more infections than vancomycin-gentamicin irrigation (adjusted OR 9.3, p = 0.025).[31] The same institution's later report found a relative risk of 16.9 with betadine irrigation (infection 0.9% after it was discontinued).[22] Povidone-iodine is used for skin preparation and has also been used for wound irrigation; the studies above compare 5% irrigation with vancomycin-gentamicin.[31][22]

Hydrogen peroxide​

Despite its historical inclusion in the original Mulcahy salvage washout protocol, it is now generally avoided because of concerns about:

  • Tissue cytotoxicity
  • Impaired wound healing
  • Corporal air embolism

Bacitracin-polymyxin and TMP-SMX-gentamicin combinations​

As primary dipping solutions, the grouped non-vancomycin-gentamicin dips were associated with more infections than vancomycin-gentamicin in Towe's diabetic cohort.[21]

0.05% chlorhexidine gluconate (Irrisept) on hydrophilic devices​

Discussed in detail below.


Irrisept — Introduction and Mechanism​

Irrisept is supplied as a single-use 450-mL bottle of 0.05% chlorhexidine gluconate in sterile water. The cited FDA-cleared wound-solution kit has a nonsterile bottle exterior and sterile pouched accessories for manual or powered irrigation.[45] It has FDA 510(k) clearance for mechanical wound cleansing and removal of debris, including microorganisms.[45] It was adopted in orthopedic and breast reconstructive surgery before prosthetic urology.

One described intraoperative technique applies CHG to the meatus during Foley placement and irrigates each corpus after dilation.[37]

The proposed advantages of CHG irrigation in IPP surgery are these:

  • The cationic CHG molecule binds to anionic components of microbial cell walls and disrupts membrane integrity, and in vitro it reduced colony counts 3 to 6 log10 for aerobes, anaerobes and Candida on Titan discs.[23]
  • Mechanical lavage may help disrupt biofilm; the cited FDA clearance addresses wound cleansing, not disruption of penile-implant biofilm.[45][47]
  • The FDA 510(k) summary reports biocompatibility testing for limited contact (up to 24 hours) with a breached surface.[45]
  • CHG is not an antibiotic.

Irrisept Evidence — InhibiZone (AMS) Devices​

No increase was detected in the available observational data, which have limited follow-up and few infection events.

  • Im et al. 2024 (bench study): the InhibiZone surface retained its antimicrobial activity after 2-minute exposure of reservoir discs to 0.05% CHG, compared with saline and vancomycin-gentamicin.[24]
  • Razdan et al. 2023 (4 men who had infected three-piece IPPs salvaged with Irrisept irrigation and malleable prostheses, median follow-up 4.8 months): no infections. Hypothesis-generating only.[25]

Ivan et al. 2026 (J Sex Med, 761 antibiotic-impregnated IPP cases at 14 institutions, retrospective) found that 0.05% CHG was not associated with infection requiring explantation (1.9% versus 2.0%, p = 0.9).[26] This is the largest clinical dataset on CHG with impregnated devices. Follow-up was shorter with CHG (median 4 vs 8 months), the comparator was historical and infections were few, so the study has limited power to exclude a difference.


Irrisept Evidence — Hydrophilic Titan Devices: The 2026 Pivot​

A preliminary randomized comparison in 100 recipients of de novo inflatable penile prostheses (CX700, Titan or Ambicor) reported infection requiring explantation in 1/50 with 0.05% CHG irrigation and 1/50 with antibiotic irrigation through up to one year of follow-up; all received two weeks of postoperative oral antibiotics.[50] The larger 2026 hydrophilic-device retrospective cohort reported that intraoperative 0.05% CHG was associated with more explantation for infection than antimicrobial irrigation and dip.[27]

Ivan et al. 2026 (J Urol, 2,150 hydrophilic IPP cases at 14 institutions, retrospective) found that intraoperative 0.05% CHG was associated with a higher rate of explantation for infection than antimicrobial irrigation and dip (OR 2.07, 95% CI 1.37–3.76):[27]

SubgroupCHGAntibiotic-only
Overall hydrophilic IPP4.6%2.1% (p < 0.001)
Primary surgery3.5%—
Revision surgery12%—

The authors concluded that caution with 0.05% CHG is warranted in hydrophilic IPP surgery pending prospective evaluation.[27]

Two other studies point the same way:

  • Helo et al. 2025 (J Sex Med, retrospective, Titan implants) compared a period of antibiotic dip and irrigation (0 of 320 infected) with a period of 0.05% CHG dip and irrigation (13 of 377 infected, p < 0.001). Within the CHG cohort, diabetes, revision surgery and longer operative time were independent predictors of infection.[28]
  • Simhal et al. 2024 (in vitro): vancomycin-gentamicin dipping gave approximately 5.5 log reduction of bacterial adhesion to hydrophilic surfaces, while 0.05% CHG dipping gave approximately 1.5 log. Irrigation with CHG or saline removed the dip solution adsorbed to the surface.[29]

Karpman et al. found 3 to 6 log10 reductions with Irrisept on Titan discs in vitro, but compared it only with saline, not with antibiotic dips.[23]


Why the Device-Specific Difference?​

The two coating chemistries differ in how they respond to CHG irrigation.

InhibiZone​

Rifampin and minocycline are impregnated into the silicone components during manufacture and elute over time. In vitro, InhibiZone retained its antimicrobial activity after CHG exposure, and the clinical cohort found no association with infection.[24][26]

Hydrophilic Titan​

The antibiotic protection on a Titan comes from the surgeon-applied dip absorbed by the polyvinylpyrrolidone coating. In vitro, CHG or saline irrigation removed the dip solution from the surface, and CHG alone gave much less bacterial reduction than the antibiotic dip (about 1.5 vs 5.5 log).[29]

Practical implication: the authors of the 2026 hydrophilic-device cohort advise caution with 0.05% CHG pending prospective data; infection was reported in 12% of CHG-exposed revision cases.[27]


Revision and Salvage​

Revision and salvage surgery carry higher infection risk than primary implantation.[1] Historical infection risk after penile-implant reoperation was reported as 7–18%; in a 2005 multicenter study of noninfectious revisions, infection followed complete removal and washout in 4/140 (2.86%) versus 5/43 (11.6%) without washout over 6–33 months.[44] Prior IPP infection was the largest patient-level risk factor for subsequent infection in the 2025 PUMP cohort (OR 4.67).[1]

Modified-Mulcahy salvage washout protocol​

Brant, Ludlow and Mulcahy (1996) described the prosthesis salvage operation, immediate replacement of the infected penile prosthesis at initial presentation, in 11 patients. Necrotic infections, diabetic patients with purulence in the corporal bodies, rapidly developing infections and cylinder erosion were contraindications.[41] With one salvage repeated after reinfection, overall success was 91% at a mean follow-up of 21 months (range 9–42); Staphylococcus epidermidis was the infecting organism in 75%.[41] A later single-surgeon series did not exclude tissue necrosis or severe diabetes, included 4 patients with exposed hardware and 9 with purulence, and reported reinfection in 2/26 salvage cases.[48] Expanded criteria still require case selection: instability, extensive tissue damage including glans necrosis, or unusually high reinfection risk may preclude immediate replacement; prioritize source control when clinically urgent.[47]

  1. Explant all components
  2. Irrigate both corporal spaces, the scrotal pump compartment and the prior reservoir site after explantation.[25] Vigorously irrigate all former implant spaces; no antiseptic solution or sequence has established superiority. Avoid hydrogen peroxide because of cytotoxicity and gas-embolism concerns; if povidone-iodine is used, the review favors dilute solution with brief implant-space contact.[47]
  3. Change all gloves and instruments
  4. Re-prep and re-drape the field
  5. Replace with a new, appropriately antimicrobial-prepared implant; an immediate malleable device can maintain corporal space when an inflatable replacement is not chosen. A 2024 systematic review reported infection-control success of 80%–100% across 15 salvage reports; functional outcomes were limited, and 20%–33% of malleable recipients later converted to an inflatable device.[42] A subsequent 30-center VA retrospective cohort reported reinfection in 29.5% of 61 malleable salvage recipients, illustrating a wider outcome range across practice settings.[46]

Post-explant wound management​

When components are explanted without immediate replacement, one author group argues against leaving the wound open for secondary-intention healing and favors primary closure after irrigation, reasoning that removing the colonized foreign body and disrupting residual biofilm accomplishes source control.[40]

Contemporary considerations (2026)​

  • Culture available wound drainage, aspirate, and implant-space material, including capsule or pseudocapsule samples when obtained, to guide treatment; next-generation sequencing remains an emerging adjunct.[9][47]
  • Fresh antibiotic-coated device used even in presumed non-infectious revisions
  • Consider antifungal prophylaxis in selected revision cases according to patient risk and local protocol; a retrospective primary-and-revision cohort found an association with lower infection odds.[1]
  • 0.05% CHG is avoided by some surgeons in revisions involving hydrophilic devices, given the 12% infection rate with CHG in this subgroup of the Ivan 2026 cohort[27]

Practical Synthesis — What to Do in 2026​

Preoperatively​

  • MRSA screening with mupirocin and chlorhexidine decolonization in carriers (institutional practice)
  • Glycemic control (HbA1c 8.5% was a proposed infection-risk threshold in a mixed penile-implant cohort)[43]
  • Smoking cessation ≥4 weeks
  • ChloraPrep skin antisepsis

Perioperative antibiotics​

  • Perioperative prophylaxis. Select gram-positive and gram-negative coverage using the local antibiogram. Consider antifungal prophylaxis for selected higher-risk patients using the local protocol’s route, agent, dose and duration; the retrospective PUMP cohort associated IV antifungal use with lower infection odds (OR 0.22).[1][10][12]
  • Give antibacterial prophylaxis perioperatively, usually as a single dose; the 2020 AUA Best Practice Statement says prophylactic dosing should end at wound closure, including when a drain is used.[12] Antifungal duration, if used, follows the selected protocol.[10][12]
  • Skip postoperative oral antibiotics

Device selection​

  • Consider an antibiotic-impregnated AMS device or a hydrophilic-coated Titan device prepared with an antimicrobial dip, according to the device and clinical setting.[4][6]
  • InhibiZone: do not soak; a brief rinse or dip immediately before placement is allowed
  • Titan: submerge in the selected antimicrobial dip immediately before implantation, using the current device preparation instructions. In diabetic primary cases, vancomycin plus gentamicin was associated with fewer infections than other dips; antifungal addition follows the local protocol.[21]

Surgical technique​

  • No-touch barrier drape protocol
  • Frequent glove changes
  • Minimize OR traffic and operative time
  • Copious antibiotic-saline irrigation throughout

Irrisept use — device-specific​

DeviceCHG (Irrisept)
AMS 700 InhibiZoneNot associated with infection in one retrospective cohort[26]
Coloplast Titan (hydrophilic)Associated with more infections in two retrospective cohorts; caution[27][28]
Revision of hydrophilic IPPHighest signal (12% infection with CHG)[27]

For hydrophilic devices, consider an antimicrobial dip and irrigation protocol consistent with device instructions and local microbiology.[10][21][27][28]

Postoperatively​

  • Avoid prolonged IV antibiotics
  • Skip routine oral prophylaxis after implantation without infection.[1][12] After infected-device salvage, continue therapeutic antibiotics guided by intraoperative cultures when available; duration follows the clinical course and local protocol.[47]
  • Track outcomes in a personal infection registry from the first case; the PUMP analyses come from surgeons' tracked outcomes.

Future Directions​

  • The 2020 AUA Best Practice Statement predates the PUMP analyses of prophylaxis regimens.[1][12][14]
  • NCT06489431: Irrisept versus traditional antibiotic irrigation for virgin penile prosthesis placement, a Phase 3 randomized trial at Rush University Medical Center (estimated 200 participants; active, not recruiting; primary completion listed as May 2026).
  • Optimal antifungal strategy (universal versus risk-targeted) remains debated; stewardship considerations remain relevant.[1][14]
  • Next-generation sequencing of biofilms is revealing distinct microbiome signatures that may eventually enable individualized salvage protocols
  • Surface engineering beyond antibiotics (anti-adhesion coatings, silver, hydrogels, quorum-sensing inhibitors) is under investigation.

Bottom Line​

In a 2025 claims cohort of 18,475 men selected to approximate initial IPP placement, coded infection occurred in 2.5% by six months and 3.1% over median three-year follow-up.[2] Manufacturer registries reported fewer infections with coated devices, and a single-surgeon era comparison reported fewer infections after no-touch adoption.[4][6][7][8] Patient optimization remains relevant because diabetes was associated with infection in a contemporary cohort.[1] A randomized skin-preparation trial showed fewer positive skin cultures with chlorhexidine-alcohol.[32]

Infected devices show more MRSA, anaerobes and Candida than older series, and in 4,161 primary IPP cases vancomycin plus gentamicin alone was associated with a higher adjusted infection hazard than nonstandard regimens (HR 2.7).[9][14] Prospective data are lacking.

Antifungal prophylaxis was associated with lower infection risk in retrospective PUMP analyses (HR 0.08 in 2023; OR 0.22 in 2025).[14][1]

CHG irrigation differs by device. In one retrospective cohort of 761 antibiotic-impregnated IPPs, infection-related explantation was 1.9% with CHG and 2.0% in historical controls, with median follow-up of 4 versus 8 months; two retrospective analyses of hydrophilic devices associated CHG with more infection.[26][27][28] In vitro, CHG or saline irrigation removes the antibiotic dip from the hydrophilic surface.

Local antibiogram data and a personal infection registry support regimen choice.


Videos​

Penile Implant Salvage for Corporal Fibrosis After Infection
Dr. Andrew Kramer (2025)

References​

1. Abou Chawareb E, Hammad MAM, Azad B, et al. Perioperative Antimicrobial Strategies in Inflatable Penile Prosthesis Surgery: Associations Between Antifungals, Oral Antibiotics, and Intravenous Antibiotic Duration, and Infection Outcomes. J Urol. 2025;214(6):642–653. doi:10.1097/JU.0000000000004716

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3. Wilson SK, Costerton JW. Biofilm and Penile Prosthesis Infections in the Era of Coated Implants: A Review. J Sex Med. 2012;9(1):44–53. doi:10.1111/j.1743-6109.2011.02428.x

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