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Fact check: How does diabetes or smoking affect penile implant complication risk?
Executive Summary
Diabetes and smoking are consistently identified as risk factors that raise the likelihood of complications after penile prosthesis implantation, particularly infection, wound breakdown, and tissue necrosis; however, recent data show variability in measured effect sizes and suggest that perioperative management can materially change outcomes. Large database analyses and meta-analyses find statistically significant increased risk for infection in diabetic patients, while newer single‑center and contemporary-cohort studies report smaller or non-significant differences, highlighting the importance of glycemic control, smoking cessation, device coatings, and surgical technique in modifying risk [1] [2] [3] [4].
1. Why some studies say diabetes raises infection odds while others don’t — the numbers matter
Meta-analyses and large administrative-database studies report that diabetes is an independent risk factor for inflatable penile prosthesis infection, with effect sizes in the range of roughly 1.3 to 1.5-fold increased risk; for example, a systematic review reported an odds ratio of 1.53 and a statewide database reported a hazard ratio of 1.32, quantifying a modest but consistent elevation in infection risk among diabetic patients [2] [1]. In contrast, a more recent study published in 2025 found no statistically significant difference in device-related complications between diabetic and non-diabetic patients, reporting infection rates of 2.8% versus 3.4% respectively, and emphasizing that perioperative hyperglycemia, rather than diabetes per se, might drive complications in some cohorts [3]. These divergent findings reflect differences in study design, sample size, patient selection, diabetes severity and control, and contemporary infection-mitigation measures such as antibiotic coatings and no‑touch techniques.
2. Smoking amplifies local tissue risk and interacts with other comorbidities
Multiple narrative reviews and recent cohort analyses identify smoking as a contributor to worse local healing — increasing risks of wound dehiscence, necrosis, and surgical-site infection — and list smoking among the stepped risk factors alongside diabetes and immunosuppression [5] [4]. Smoking’s mechanistic impact on microvascular perfusion and wound oxygenation creates an environment less capable of resisting bacterial invasion and more prone to tissue breakdown, raising the baseline chance that an implanted device becomes exposed or infected. Contemporary prevention strategies lower infection rates overall, but smoking remains a modifiable patient-related risk that surgeons commonly consider when counselling patients and planning perioperative optimization [6] [4].
3. Prevention strategies change the landscape — coatings, antibiotics, and ‘no‑touch’ matter
Advances in device technology and surgical technique materially alter infection incidence: the adoption of antibiotic-coated implants, standardized preoperative parenteral antibiotics, and the no‑touch surgical technique are repeatedly credited with lowering infection rates to the 1–3% range in primary implants, though revision cases still exceed 10% in many series [5] [4]. Contemporary narrative and systematic reviews document these interventions as effective modifiers that can blunt the relative impact of patient-level risk factors such as diabetes and smoking. As a result, large databases analyzing older cohorts or institutions without uniform mitigation protocols may show higher baseline complication rates attributable to comorbidities, whereas modern single-center studies with aggressive preventive protocols can report smaller or non-significant differences by comorbidity status [6] [3].
4. Clinical takeaways: optimization before surgery reduces measurable excess risk
Studies emphasize preoperative optimization as the practical lever to reduce complications: improving glycemic control and treating perioperative hyperglycemia, encouraging and facilitating smoking cessation, screening for Staphylococcus aureus carriage, and applying proven operative prophylaxis are all associated with lower postoperative infection and complication rates [3] [5] [7]. Several published analyses specifically recommend delaying elective implant surgery when diabetes is poorly controlled or active smoking is ongoing, because risk reduction strategies correlate with better wound healing and fewer explantations. The evidence does not support absolute exclusion of diabetics or smokers but supports individualized risk assessment and documented optimization prior to implantation [1] [8].
5. Reconciling perspectives and what research still needs to settle
The literature shows a clear consensus that diabetes and smoking increase baseline risk, but disagreement remains about magnitude in the context of modern prophylactic measures; some recent cohorts report minimal differences, suggesting that institutional protocols can largely mitigate added risk, while meta-analyses and large databases still find statistically significant increased odds and hazards [2] [1] [3]. Outstanding questions include which glycemic thresholds best predict infection risk, optimal timing and duration of preoperative smoking cessation to meaningfully lower complications, and the comparative effectiveness of different device coatings and perioperative bundles. Policymakers and clinicians should weigh both lines of evidence: baseline risk is elevated with diabetes and smoking, but active optimization and modern surgical prevention strategies substantially reduce that excess risk [4] [3].