What are the complication and revision rates for penile implants and phalloplasty in peer‑reviewed studies?
Executive summary
Peer‑reviewed literature shows markedly higher complication and revision rates for penile prostheses placed after gender‑affirming phalloplasty than for penile implants in cisgender men: reported complication ranges after phalloplasty cluster between roughly 20% and 80%, with many series describing prosthesis‑specific complication rates around one third and revision or explantation rates often in the tens of percent; by contrast, contemporary inflatable penile prostheses in cisgender men report substantially lower long‑term mechanical failure and revision rates (e.g., >87% mechanical survival at 5 years) [1] [2] [3]. The evidence base for post‑phalloplasty implants is heterogeneous and generally graded low to very low, so precise point estimates remain uncertain and depend on study, device, and surgeon factors [4].
1. What peer‑reviewed studies report about complication frequency after phalloplasty implant placement
Narrative and systematic reviews of implants placed in neophalluses document broad complication ranges—most authors cite 20%–80% total complication rates—because anatomy, flap type, and device adaptation vary widely; a systematic review found 36.2% of patients with a prosthesis reported at least one prosthesis complication and only 60% still had their original implant at follow‑up (mean follow‑up ~3 years) [1] [2].
2. Types of complications driving those rates
The chief complications after phalloplasty prosthesis placement are infection requiring explantation, erosion/extrusion, device malposition or migration, inadequate rigidity or mechanical failure, urethral injury, and flap‑related problems including partial flap loss; these issues are more common after phalloplasty than after implantation in natal penises because there is no native corpora cavernosa and anatomy is variable, requiring adaptation of devices not originally designed for neophalli [1] [5].
3. Revision, explantation and device survival metrics reported in studies
Individual series report high revision/explantation burdens: one retrospective unit reported surgical revision in 40% of patients (12/30) after malleable prosthesis placement, other series note a 5‑year implant survival of about 78% in pooled series while another large review found up to 41.1% needing removal or revision in one cohort; meta‑analytic efforts underscore wide variability and limited certainty [6] [7] [2] [4].
4. How those rates compare with cisgender penile implant literature
In cisgender men treated for erectile dysfunction, contemporary three‑piece inflatable penile prostheses show much lower mechanical failure and revision rates in many series—mechanical survival >87% at 5 years in multicenter data—and single‑center cohorts report revision rates around 10–12% over intermediate follow‑up, illustrating a substantial gap between outcomes in natal penises and neophalli [3] [8].
5. Risk modifiers, evidence quality and caveats
Key modifiers include device type (inflatable versus malleable), prior urethral or phalloplasty complications, number of prior revisions (infection risk rises with each revision), surgeon experience/volume, and patient factors such as diabetes or device exposure risk; the literature on post‑phalloplasty implants is dominated by retrospective, heterogeneous series and a recent meta‑analysis rated available studies as low or very low GRADE, so estimates should be interpreted cautiously [9] [10] [4].
6. Patient‑reported outcomes and the counterpoint to higher complication rates
Despite frequent technical complications and comparatively high revision rates, multiple reports document high overall satisfaction and functional milestones—many patients achieve penetrative intercourse and report high satisfaction—so risk‑benefit conversations remain individualized and many centers advocate staged approaches, correction of urethral problems before implant, and careful counseling about higher risk after phalloplasty [11] [2] [1].