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

Abstract

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.

Lessons learned from the first 15 years of penile transplantation and updates to the Baltimore Criteria

“…To address these limitations, our group previously produced ethical guidelines for penile allotransplantation, dubbed the Baltimore Criteria 28 (Box 1 ). These criteria did not inform the worldwide experience of penile transplantation, but rather considered previous challenges and successes to suggest best practices.…”

“…The first Cape Town patient was 21 years old at the time he received an allograft from a 36-year-old, brain-dead donor — a much larger age differential than the maximum 5 years recommended by the original Baltimore criteria 3 . Although the Baltimore criteria do not offer an explanation for this age differential, it encourages the selection of a physiologically matched graft, with further consideration of ethical and biological barriers to using an immature graft from a donor under 16 years of age 28 . The recipient from Boston was 64 years old with a history of penile cancer treated with partial penectomy, who underwent rigorous psychosocial screening and received an allograft from a 27-year-old brain-dead donor with no known genitourinary history 4 years later.…”

Addressing ethical confusion in deceased donation and transplantation research: the need for dedicated guidance

“…Training and guidance are needed to support researchers and HRECs in designing, evaluating and conducting RDDT. Furthermore, variations to existing protocols and novel procedures may not always be recognized as constituting research as such, or may initially require ethical governance under the clinical innovation framework [44–47]. Dedicated HRECs at the regional or national level may be helpful in ensuring sufficiency of expertise to provide oversight of studies that are likely to be relatively rare in the experience of most HRECS, and help to address issues that may arise when multiple HRECS are involved in review of studies with differing levels of expertise.…”

Conventional surgical techniques and emerging transplantation in complex penile reconstruction

“…Two years following this procedure, the recipient reported the ability to urinate and to achieve erections, orgasms, and ejaculation [53] . In 2017, the same group in South Africa performed its second penis transplantation [54] . In the United States, a partial penis transplant from a deceased donor to a 64-year-old man following oncologic amputation was performed in 2016 [8] .…”