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Medical, Legal and Ethical Issues in Corneal Transplantation

Organ and tissue transplantations carry various medical, legal and ethical issues, and the transplantation of corneas in ophthalmology is not exempt from these matters. Eye banks from around the world harvest cadaver corneas for full and partial transplantation transnationally. Patients who are losing their sight because of damaged or diseased corneas are faced with the decision of going under the knife or possible blindness and, even with surgery, patients still may suffer from drastic vision loss or need further surgical intervention. Alternatively, with all transplantation, donors, families, patients and physicians are all faced with the ethics and laws surrounding donating tissue after death. And, as with many aspects of life and medicine, criminals will do whatever it takes to make money, even if it means resorting to human trafficking to steal and sell human cells, tissues and organs.

Medical Issues

Corneal transplantation is when an ophthalmologist removed a damaged cornea and replaces it with a new human donor or artificial cornea (Artificial Cornea Devices, n.d.). Depending on the severity of the damage, patients can undergo either a full or partial corneal transplant, or keratoplasty, but the use of artificial corneas for surgery are typically reserved for those who have had previous failed attempts at the surgery (Artificial Cornea Devices, n.d.). Keratoplasties are one of the most successful kinds of transplantation with many experiencing 80-90% visual clarity one year post operatively (Lee et al, 1989). However, patients that reject the donated cornea or have otherwise failed transplants do the choice to receive another human cornea, artificial cornea or to not undergo further surgeries as long as the ophthalmologist finds further procedural options potentially beneficial.

Ethical Issues

Unlike most other transplantable organs and tissues, corneas can be harvested hours after death, as they do not require blood flow (Lee et al, 1989). Though the cornea can survive for much longer than other tissue posthumously, eye banks have an ethical obligation to ensure that donated tissues are stored properly to maintain the specimen (Jones et al, 2017). The authors of the 2017 paper Ethical Issues in Transnational Eye Banking states the importance of adhering to the ethical principles of non-maleficence and beneficence, noting that eye banks have the duty to protect patients from potential harm while promoting potential benefits from transplantation of the corneas that they hold (Jones et al, 2017).

Organ transplantation can be either be elected by the donor prior to death or determined posthumously by family members. Prior to the 1960’s common law dictated that all decisions related to the deceased person and their body were in the sole hands of the spouse or, if not married, the next of kin (Lee et al, 1989). In 1968, the Uniform Anatomical Gift Act was drafted to legally define who is allowed to decide whether or not a deceased person’s organs are to be donated; though this is not a federal law, all 50 states have adopted a form of this act since its inception (Lee et al, 1989).

The dark spot in transplantation is human trafficking. Criminals around the world kidnap and kill others for organ and tissue harvesting. Traffickers sell or trade tissue and illegal outfits, like those often found in Istanbul, offer surgical procedures at a lower cost than many other countries offer, but most nations have made the ethical decision to criminalize and penalize all parties found responsible for taking a part in this corrupt network (Dalal, 2015).

Legal Issues

While certain tissue and organs can be donated by living donors, corneas cannot be harvested until after one has died (Lee et al, 1989). With that in mind, it is of great importance that we remember that tissue donated by the deceased is not just tissue and that this tissue is from a person, even if they are not still living (Mattioli, n.d). Donors who agree to donating parts or the whole of their bodies exercised a right to do so, so that others can have a chance of living or having a better quality of life (Mattioli, n.d.). The need for organ and tissue for transplantation is ever increasing and the respect for the donor’s rights must be legally adhered to (Dalal, 2015; Mattioli, n.d.).

State law oversees the usage of cadaver organs and there is no federal law that blankets over transplantation (Lee et al, 1989). There is, however, regulations on national and transnational levels. Many of these regulations pertain to the donor tissue specifically, In Istanbul, the Declaration of Istanbul, dictates against “transplant tourism”, where those in search of a procedure travel beyond borders in search of organs and tissue, specifically with body parts stolen via human trafficking; internationally, the Guiding Principles on Human Cell, Tissue and Organ Transplantation, created by The World Health Organization, outlines steps to help make the retrieval and transplantation of human tissue as transparent as possible (Dalal, 2015).

Ethics Committee Perspectives

The American Academy of Ophthalmology, the nation and world’s largest association of eye surgeons, has an overseeing Ethics Committee consisting of five to nine members who have been appointed by their Board of Trustees (Code of Ethics, n.d).  Patients who feel that they were not cared for in an ethical manner can also contact the Ethics Committee, who then would investigate the matter and escalate the situation with a hearing if deemed necessary. Hypothetically, if a corneal graft rejected and the patient was given the option to have another operation but suspected that the surgeon purposefully botched the procedure to gauge said patient of money, they could contact the Committee who would investigate the claim. If, say, a hospital saw a pattern in rejected or infected keratoplasties with corneas from the same eye bank and within a short time period, the hospital and surgeons could contact the Ethics Committee in regards to eye bank charging suspected storage or handling issues.

Procedural Outcomes

Over all, corneal transplants are one of the most common successful transplants in the US with patients seeing up to 90% clarity after the procedure (Lee et al, 1989). In the event that a procedure fails or a graft rejects, some patients can elect to have an artificial cornea transplant, or keratoprosthesis (Artificial Cornea Devices, n.d.). Studies are currently underway to determine the effectiveness of keratoprostheses after failed keratoplasty, but the ethical need to maintain non-maleficence and beneficence are the same—further surgeries should only be considered after discussion the options with the patient, keeping their safety in mind. By adhering to protocols that ensure that donor corneas where procured ethically and stored in a safe and qualitative manner, physicians are more likely to perform successful operations (Jones, 2016).

Community Impact

While overseen on a state level, organ and tissue transplantation is viewed on a national scope, meaning that a patient in Delaware in need of a heart transplant is on a national list and could receive their donated organ from the west coast if that is where the first one became available. Areas with smaller populations can also receive much needed transplants and transfusions without being passed over by larger metropolitan regions by collaborating with other local communities (Jones et al, 2017). By banding together, communities ensure that everyone in need can have the organs, blood and tissues that they need in a timely fashion.

Reflection

Transplant surgeries, including keratopathies, have seen drastic changes over the past century. The Uniform Anatomical Gift Act removes all assumptions about who is to decide whether or not a deceased person will have their organs and tissue donated. Today, this seems almost like common sense, but this act removed the grey area of who makes posthumous medical decisions, lightening the ethical load but potentially causing legal issues if family members cannot come to agreement. Luckily, healthcare systems and national healthcare initiatives have done a fantastic job educating the public on organ and tissue donation, so that an autonomous decision can be made by people prior to their passing. Human trafficking is one of the biggest challenges internationally in the scope of transplantation, but there are governing bodies all over the planet who are trying to eliminate this issue. It is unfortunate that before people can get the healthcare they need, we still need to make sure people are not pirating other humans, but numerous countries are working together to punish those who traffic and ensure that donor tissue has been donated by people or their families and not through a criminal operation. Every day, researchers are studying, testing and getting closer to growing human tissue fit for transplantation, but we are years ahead of seeing this science at this time. As long as the donor cornea is from an honest source, most patients who have keratopasties have a smooth surgical process with good results.

Even with the vast medical, ethical and legal issues in cornea transplantation, the procedure is largely successful with patients from around the globe regaining vision from virtual blindness. Both the autonomy of the patient and the altruism of the donor deserve the utmost respect by physicians, hospitals and eye banks. Even with state, national and international dictums in place to help eliminate human trafficking, people are still killed every year for their body parts, but, with vigilance, this crime and the network of transplant tourism that fuels it will hopefully diminish in time. When physicians, surgery centers and eye banks work with one another to ensure the integrity of the donor corneas, both physically and ethically, everyone benefits. The laws and regulations that set out to provide transplants in small, local settings also make sure that people do not have to travel for illegally procured tissue. Perhaps scientists will one day learn to grow human tissue, like corneas, for transplantation, but until then, patients, healthcare professionals and even government bodies have to work toward safer surgeries together.

Artificial corneal devices versus human donor corneas for people undergoing repeat corneal transplantation. (n.d.). Retrieved from the Cochrane website on 4/15/2019 at https://www.cochrane.org/CD009561/EYES_artificial-corneal-devices-versus-human-donor-corneas-for-people-undergoing-repeat-corneal-transplantation

Code of Ethics of the American Academy of Ophthalmology. (n.d.). Retrieved from the AAO website on 4/13/2019 at https://www.aao.org/ethics-detail/code-of-ethics

Dalal A. R. (2015). Philosophy of organ donation: Review of ethical facets. World journal of transplantation, 5(2), 44–51. doi:10.5500/wjt.v5.i2.44

Jones, G., Kelly, R., Machin, H., Martin, D. & Pollock, G. (2017). Ethical issues in transnational eye banking. Cornea, 36 (2), 252-257.

Lee, P., Stark, W. & Yang, J. (1989). Cornea donation laws in the United States. Arch Ophthalmol, 107, 1585-1589.

Mattioli, M. (n.d.). Legal aspects of transplantation of organs. Retrieved on April 12, 2019 at http://www.hottopos.com/harvard3/matti.htm

 

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