This study investigated the impact of preoperative, intraoperative and postoperative factors on hematoma formation following IPP implantation. We found that the risk of developing a clinically significant scrotal hematoma requiring operative evacuation was statistically higher in complex cases (revisions, removal/replacement or concomitant surgeries) while primary cases were successfully managed expectantly. All complex IPP patients who required operative evacuation were taken to surgery within 24 hours of diagnosis and successfully maintained all device components without secondary device failure or infection23-24. No intraoperative factors were linked to hematoma formation in either cohort. Furthermore, primary IPP recipients were more likely to be on anticoagulants/antiplatelet therapy at the time of presentation with a clinically significant scrotal hematoma than were complex counterparts.
Despite advancements in prosthetic devices, surgical techniques and postoperative management strategies over the past decade, hematoma formation remains a major postoperative complication5, 7, 11, 25– 26. Our series demonstrates an overall rate of 5% hematoma formation, and we further identify complex IPP cases as a risk factor for clinically significant scrotal hematoma formation with an incidence of 10% among complex IPP cases27. Studies assessing hematoma formation following augmentation mammoplasty or revision arthroplasty may provide important insight into these findings. In breast surgery, hematoma after breast enhancement is attributed to a chronic inflammatory reaction to the implant with bleeding in response to the rupture of vulnerable vessels in the tissue capsule28. Similarly, revision arthroplasty has reported that mechanical friction between the textured surface of the implant and the high vascular capsule may result in an intracapsular hematoma formation29-30. Analogously, a majority of complex IPP cases included removal of a previously placed implant along with its pseudo-capsule. Due to the capsular formation, complex procedures inherently require additional scrotal manipulation with an increased surface area involved, introducing the opportunity for increased bleeding.
Other surgical specialties and subspecialties, including neurosurgery, orthopedics, and urologic oncology, have examined means to reduce postoperative bleeding complications associated with a variety of procedures. The use of hemostatic agents in conjunction with standard hemostatic strategies has demonstrated promising results in this area17, 31– 33. In prosthetic surgery specifically, the use of oxidized regenerated cellulose pledgets at corporotomy sites for primary IPPs has demonstrated successful reduction in postoperative scrotal bleeding without risk of device infection or explanation34-36. This series highlights contrasting management strategies utilized for hematoma formation following complex and primary cases. An initial strategy consisting of conservative management proved successful in the primary IPP setting. Importantly, expectant management did not lead to device failure or infection necessitating secondary procedure for revision or removal/replacement during the study period.
Implanters ought to have a heightened awareness when confronting a “complex” penile implant recipient for several reasons. First, our work demonstrates these patients to face a substantially increased risk of hematoma formation than virginal counterparts. Second, most hematoma patients in the complex penile implant cohort ultimately developed a clinically actionable hematoma within 72 hours of implantation, despite experiencing acceptable postoperative drain outputs within the first 24 hours. In this hematoma cohort, all ultimately proceeded with definitive surgical decompression within 24 hours of diagnosis based on patient symptoms and surgeon concern that delayed intervention would place the implant at untoward risk. Due to the surgical take-back risk and patient morbidity, complex IPP recipients may best be served by referral to specialized centers with experienced surgeons 9, 25, 37.
Standard approaches to minimize hematomas postoperatively after IPP include watertight corporotomy closure, meticulous hemostasis, use of a Mummy wrap, and partial device inflation5, 6, 11, 38. Other factors remain controversial. Some have argued that early removal of CSD (less than 72 hours), reduced degree of device inflation, and early deactivation increase risk of bleeding complications by introducing reduced tamponade and increased scrotal manipulation10, 14, 39. We did not identify any intraoperative factor as an independent risk factors for hematoma formation in either primary or complex hematoma group40. Nevertheless, these results provide compelling evidence that early and swift action with surgical intervention is advisable in management of hematoma formation in complex IPP recipients.
Scrotal hematoma formation following penile implant surgery has often been attributed to premature anticoagulation resumption, noncompliance with postoperative activity limitations, and scrotal support instructions. We found the risk of bleeding associated with blood thinner status appeared higher in primary cases. Current recommendations regarding anticoagulation/antiplatelet therapy in prosthetic surgery are based on evidence derived from other surgical specialties. The American Urological Association has published guidelines pertaining to shock wave lithotripsy, ureteroscopy, percutaneous nephrolithotomy as well as higher risk procedures including radical prostatectomy and partial nephrectomy41. Suspension plans are based on the risk for hemorrhagic complications secondary to the procedure (low or high) paired with the patient’s cardiovascular risk category. In general, it is recommended that in elective, higher-risk procedures, medications like warfarin or clopidogrel be stopped at least 5 days preoperatively while NOACs be discontinued 2–5 days prior. Anticoagulation/antiplatelet guidelines for prosthetic surgery do not exist beyond stating therapies can be resumed based on clinician gestalt42. Furthermore, the AUA guidelines on the surgical management of ED do not provide clarity in labelling implant surgery as either a low or high-risk procedure for hemorrhagic complications41. This study suggests judicious consideration of prolonged anticoagulation suspension may be warranted to reduce hematoma formation in the primary setting.
Our study is not without limitations. As a retrospective analysis, the data may have captured the clinically significant scrotal hematomas without identifying the true incidence of hematoma within the cohort. Second, the time-frame of our study was from February 2018 to December of 2020, which includes the COVID-19 pandemic lockdown period. As such, operative volume was significantly lower and standardized protocol shifted to adhere to clinical care changes. Furthermore, the lockdown’s impact on postoperative activity levels during the recovery phase is unknown.