The Baltimore Criteria for an ethical approach to penile transplantation: a clinical guideline.

Significant advances and increasing acceptance of vascularized composite allotransplantation (VCA) have contributed to emerging success of penile transplantation. The aims of penile transplantation are fourfold: adequate urinary function, enabling natural erections, restoration of erogenous sensation and appearance of external male genitalia. Successful penile transplantation also requires limiting risks and managing complications of lifelong immunosuppression. Given the limited experience with this procedure, potential recipients must understand that penile transplantation is not currently standard of care and long-term functional outcomes are unknown. Moreover, these transplants are associated with complex ethical issues. Nevertheless, as the efficacy and safety of penile transplantation are being evaluated, clear indications for transplant are needed. Although preliminary recommendations have been proposed, a more comprehensive framework is needed. We performed a literature review for English language publications related to penile transplantation and ethics. Based on the results of the search, a review of prior recommendations, and our experience performing the first whole male genital allotransplantation including penis, scrotum and abdominal wall; screening and identifying potential donors and recipients for the procedure; and addressing the associated ethical issues, we propose guidelines for responsible penile transplantation: The Baltimore Criteria for an Ethical Approach to Penile Transplantation.