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Adverse Occurrence type:
Rare; Review article written in response to single case report of melanoma transmission following keratolimbal allograft. No existing reports in literature documenting melanoma transmission from corneal transplant. Based on the case report a moratorium on use of ocular tissue from donors with melanoma (restricted from all use) and donors with metastatic solid tumors (not to be released for use of vascular components) was issued in February 2016 to be reviewed by the Eye Bank Association of America in October 2016. Most recent risk assessment for melanoma (Council of Europe, 2022): Due to the very aggressive behaviour of this tumour, it is considered an unacceptable risk for organ donation. Malignant melanoma in the donor history: Due to the lack of exhaustive data, transplanting organs from donors with treated malignant melanoma must still be considered to be associated with a high transmission risk. If precise donor data about staging, therapy, follow-up and recurrence-free survival are available, and evaluation by the dermato-oncologist concludes there is a low probability of recurrence and metastasis, organ donation might be considered for selected recipients.
Time to detection:
Alerting signals, symptoms, evidence of occurrence:
Recipient developed ocular melanoma within two months of surgery.
Demonstration of imputability or root cause:
Donor had history of malignant melanoma.
Suggest new keywords:
Li JY. Donors with melanoma history: the risk to ocular tissue recipients. (www.eyebankingjournal.org) Int J Eye Banking 4(1):1-4, March 2016
Expert comments for publication:
Article was written as a review at the time of active discussion regarding the appropriate response to the cited case report. It is pointed out that donors with solid tumors constitute 30-40% of the ocular donor pool. In the case of melanoma, micrometastases raise concern for the possibility of transmission, but in practice this has not been seen. Possible factors contributing to the absence of known transmissions include the avascular nature of cornea and absence of immunosuppressive drugs. It is also noted that vascularized ocular components (such as keratolimbal allografts) also require immunosuppression and may have tumor transmission risks more similar to solid organ transplants. The article discusses the need to balance restoring sight and patient safety in the difficult setting of limited available evidence.