The issue of uterine transplantation has raised serious interdisciplinary concerns. Many ethicists have called for a public debate on the issue of uterine transplantation that would examine all aspects of it including the ethical and moral implications. These issues include whether uterine transplants should be from live donors or deceased donors. The advantages of using deceased donors, as stipulated above, include eliminating surgical risks to live donors, and the ability to harvest more blood vessels from the organs as compared to a live donor organ. Proponents argue that dead-donor transplantation can increase the supply of organs, but there is always the concern that organ donors may not fully understand this type of non-life-threatening organ donation. Other issues that arise are the complications to the recipient of this nonessential and temporary procedure, the potential side-effects of the immunosuppressants for the mother and the fetus and finally the cost factors. If this is going to be an open debate with all parties participating, then all options must be placed on the table, including the option that we should not proceed with uterine transplantations. To determine if this procedure is ethical, the principles of respect for persons, beneficence, nonmaleficence and justice will be applied to this procedure and its consequences.
Respect for persons
This principle incorporates two ethical convictions: first, that persons should be treated as autonomous agents; and second, that persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy.[1] Respect for human persons refers to the right of a person to exercise self-determination and to be treated with dignity and respect. All people deserve autonomy and to be treated with dignity and respect. Failure to provide any person with adequate health care, which includes clinical research and trials, violates this basic right of respect for persons. Appropriate funding for clinical research will increase our understanding of UFI, which will inform future research, and hopefully should result in the development of new, more effective therapies. These therapies could provide the potential to be a third viable option for women with UFI that allows them to carry and deliver their own biological babies.
Second, as an autonomous agent an individual has the right of informed consent. Patients/research subjects have the right to know all information about their diagnosis, prognosis, treatment and care plan. The elements of informed consent include:
- A fair explanation of the procedures to be followed, including an identification of those which are experimental;
- A description of the attendant discomforts and risks;
- A description of the benefits to be expected;
- A disclosure of appropriate alternative procedures that would be advantageous for the subjects;
- A offer to answer any inquiries concerning the procedures;
- An instruction that the subject is free to discontinue participation in the project or activity at any time.[2]
In a specific sense, the surgeons who want to perform the uterine transplants have an ethical obligation to give an objective, non-biased assessment of all materially relevant information pertaining to the success of uterine transplants, risks/benefits, alternatives and consequences. In addition, the rates of rejection, the costs of surgery and immunosuppressant drugs, potential side-effects of the immunosuppressant drugs on the patient and fetus and the psycho-social issues, must be carefully stated and explained to the patient. The surgeons are also responsible to verify, to the best of their ability, that the patient can comprehend and has comprehended the information and has not engaged in “selective hearing.” Under the circumstances, it is not uncommon for patients to engage in “selective hearing,” that is, taking in all information about potential benefits and filtering out all information about potential risks. In addition to this, surgeons must be vigilant against their influence over subjects, who may unwarily treat the surgeon with the same deference as they treat their primary care physicians. Dr. Robert Levine, professor of Medicine at Yale University, describes the surgeon/researcher’s obligation as one of “forthright disclosure.” This includes preliminary evidence and data from animal studies and previous human clinical trials that indicate the risks and benefits as well as the safety and efficacy of these controlled studies.[3] Patients need to have information that a prudent person would require to make well-reasoned decisions that will protect their personal interest.
The problem is determining what sort of knowledge translates to what degree of risk to patients. This is a value judgment that must be made by the surgeons. The concern is that the judgment of some surgeons may be biased by considerations of career self-interest and even financial gains.[4] “The potential for coercion can be difficult for surgeons. On the one hand, most accept that the final choice for surgery should be left to the patient. On the other hand, surgeons want what they believe to be best for their patients. Therefore, there is ample room for unintentional coercion through selecting information for disclosure that overtly reinforces the surgeon’s beliefs.”[5] There is also the problem of forming an “innovative alliance.” Patients may encourage their surgeons to try any new and promising technique to improve their quality of life or prospects for survival and surgeons also may be eager to apply a promising new technique for the same reasons. It is the duty of the surgeons to decide whether responsible behavior lies in attempting an innovative technique or in concluding that the background research is not sufficient to warrant its use, even when the patient consents.[6] The surgeon has the responsibility to act in the best interest of the patient. The belief that this experimental surgical procedure will not cause too much harm to too many people or that society will benefit at the possible expense of particular individuals violates the duty of the surgeon/researcher to act in the best interest of the patient. To determine whether that duty has been breached, a surgeon/researcher’s actions should be measured against the accepted practice as set by professional norms. Those researchers whose treatments fall below the professional standards and cause harm to patients may be held civilly liable for that failure.[7] Various ways have been proposed that ensure individuals going into research protocols are giving informed consent, these include: written and oral forms of consent so that the patient has time to read and reflect on the risks and benefits; someone other than a member of the surgical team obtains the informed consent; obtaining second opinions from other knowledgeable physicians regarding the feasibility of such a procedure; and appointing an objective advocate who would accompany the patient during the decision-making process. These advocates would ensure that the patient is capable of understanding the information and comprehends all the information, that researchers do not overestimate potential benefits and underestimate potential risks, and that all viable options are given, even the option of no transplant. These are not only excellent safeguards; they should be implemented with every research protocol.
Medical advances are necessary for society, and experimental surgeries are important tools to bring about these advances. But these advances can never be at the expense of denying individuals their basic dignity and respect. If patients are made aware and comprehend the success data, short-term and long-term risks and benefits, alternatives and possible consequences and safeguards are put in place to avoid the potential for coercion, then informed consent can be obtained ethically for this procedure.
Beneficence/Nonmaleficence
Beneficence involves the obligation to prevent and remove harm and to promote the good of the person by minimizing the possible harms or risks and maximizing the potential benefits. Beneficence includes nonmaleficence, which prohibits the infliction of harm, injury, or death upon others. In medical ethics this principle has been closely associated with the maxim Primum non nocere: “Above all do no harm.”
Proponents of uterine transplants argue that this surgery is a viable option for women to escape the emotional burdens associated with infertility. This procedure is the only biological option for women with UFI to become pregnant and to experience the emotions of carrying a child in their womb. The research is quite clear that using deceased donors is safer than living donors. There is no donor risk, surgical dissection time is shorter, larger diameter blood vessels can be used to simplify the uterine transplantation procedure and there is the opportunity to increase the supply of uteruses for women. Opponents to uterine transplants in general argue this is a non-life-saving procedure that places these women at great risk. The surgical transplantation surgery can take up to 10 hours exposing the patient to serious side effects of lengthy exposure to general anesthesia. There are possible surgical complications such as the presence of leaks in the anastomosis line, complications of bleeding during surgery, the potential for infection such as Enterococcus faecalis experienced by a recipient at the Cleveland Clinic and the potential effects of immunosuppressive drugs on the patient and the fetus. As stated above, there are complications but if deceased donors are utilized and surgeons use robotic-assisted uterine transplantation to decrease the time of the recipient’s surgery, some of the potential surgical complications can be minimized. To address the possibility of potential infections, donors will need to be screened more carefully and all further trials will involve the administration of antifungal medications. The immunosuppressive drugs do present potential risks, but the transplanted uterus is temporary. The amount of time the patients will be on these drugs will be far less than if the patient had a kidney, lung or heart transplant. To date, no children born from a uterine transplant have experienced any genetic defects due to the immunosuppressive drugs. In regards to obstetric complications, the most common complications include preterm delivery and low-birth rate. In the majority of deliveries to date, most women experienced premature births mostly between 35-37 weeks via a caesarian section. These medical complications are not insurmountable. Children have been born safely and free of any genetic anomalies or physical complications.
Many opponents to uterine transplantation will argue that the unnecessary medical complications that could lead to death, outweigh any benefit to these patients. This is a non-essential and temporary procedure that places both mother and child at unnecessary risks. In addition, there is a viable option for these women, which is adoption. This option would not only benefit the children in need of adoption, but those women who desire to be parents and society as a whole. However, after reviewing the facts concerning the state of our knowledge regarding the rate of rejection, possible medical complications, the effects of immunosuppressant drugs on mother and child, and the inevitable psychological impact on the recipient, it is clear that this surgery does everything possible to minimize the risks incurred by these patients. Yes, this surgery does expose them to unnecessary risks that have the potential for injury and harm; however, their desire to be a biological parent would outweigh these risks and complications. This is an experimental, non-lifesaving surgery with serious risks but it is also a surgery with substantial benefits. Arguably, it appears that this surgery does not fail the test of beneficence or the test of nonmaleficence. No one will dispute that balancing the benefits and risks is difficult. Some will continue to argue that the risks outweigh the benefits. However, if these women truly have informed consent and understand the risk/benefits, alternatives and consequences of uterine transplants, then they have the right to agree to this experimental procedure. For many women, their desire to be a biological mother clearly outweighs the possible medical risks to them.
Justice
The principle of justice recognizes that each person should be treated fairly and equitably, and be given his or her due. The issue of experimental uterine transplants also focuses on distributive justice: the fair, equitable, and appropriate distribution of medical resources in society. At a time when reforming healthcare in this country has become a high priority, failure to initiate preventative measures and clinical research that would save medical resources and possibly human lives in the long-run violates the principle of distributive justice.
The principle of justice can be applied to this situation in two ways. First, questions of justice have been raised about whether those patients who have UFI might be classified as vulnerable individuals and whether this type of experimental surgery is a form of exploitation. No one seems to dispute that surgeons have the skills and techniques needed to perform this transplant surgery. However, opponents argue that there seems to be a competition present among the surgical teams worldwide. This debate cannot and must not be framed within the aspirations of the surgeons. There must be equality between the surgeons and the possible recipients. To allow these charismatic surgeons to present this form of transplantation in the media in such a way that seems to trivialize the side-effects and downplay the possibility of rejection and even death, is to exploit these recipients and use them as a means to an end. At the present time the debate among the transplant surgeons is on how they should proceed. Advancing this experimental surgery can lead to a viable option for woman with UFI. Failure to make surgical advances delays the necessary knowledge these surgical teams need to perfect and advance this procedure. Opponents argue that with this attitude, how objective and unbiased will the information about the surgery and its possible benefits and risks be that will be disclosed to potential recipients? Are these potential recipients not in some cases desperate to be biological mothers? How will surgeons know when the potential vulnerability of some patients is unduly influencing their willingness to consent? Proponents argue these transplant surgeons have suggested ways they believe will ensure informed consent. Yes, this is a non-life-saving transplant and there are other viable options, however; one could say it is unjust to deny women who have UFI a viable option that has been successful and would allow them to carry and deliver their own babies.
Second, the issue of justice pertains to uterine transplantation specifically in regards to distributive justice, which concerns the fair and equitable allocation of medical resources. The main issue here is research priorities. Should funds be used to support uterine transplantation surgery now when the risks seem unreasonable and even deadly? The amount of money spent on these surgeries, which is estimated at $200,000 for the surgery, $20,000 for IVF and $10,000-$14,000 per year for immunosuppressive drugs, could certainly be invested in new ways to resolve infertility problems that impact thousands of women worldwide. This could potentially benefit many women especially those who are without insurance and could not afford these expensive surgeries. Also, immunosuppressant drugs cost tens of thousands of dollars a year. Will this not limit the individuals who would qualify for this surgery? If so, this now becomes a social justice issue, because those who would have access to this technique would logically be those who are privileged. The poor, the uninsured, the underinsured, and many middle-class individuals would never be viable candidates for this surgery, because they could not afford the cost of the immunosuppressant drugs. In addition, presently, this surgery is not available to transgender women. Is this not a form or injustice? As a matter of social justice, who this surgery would benefit and whether it is a fair and equitable allocation of medical resources is an important ethical issue. Medical professionals have an ethical obligation to use available resources fairly and to distribute them equitably. However, critics have used and continue to use these arguments for all experimental procedures. These are the same arguments that were used when organ transplants were proposed. Unless research is advanced, medicine will never meet the needs of individuals and society as a whole. Yes, at the beginning these procedures will be expensive, but as the procedures are perfected, and new research is advanced, it is inevitable that more and more people will benefit from these clinical trials. The issue of transgender women not being accepted into these clinical trials is a justice issue but the argument is that until the procedure is perfected, it would not be beneficial to include these women at the present time. Yes, transgender women are excluded now from this experimental procedure, but once this procedure is determined to be safe and effective, these individuals may benefit the most from uterine transplants. As a matter of social justice, who this surgery would benefit and whether it is a fair and equitable allocation of medical resources is an important ethical issue. Medical professionals have an ethical obligation to use available resources fairly and distribute them equitably. As a matter of justice, medical professionals believe that uterine transplants are safe and effective and have the potential to help women with UFI and other conditions to have their own biological children. One can argue that this is a fair and equitable use of medical resources and thus meets the test of the principle of justice. At the present time, if uterine transplantation is being shown to be an effective way of treating women with UFI and the risk-benefit ratio is reasonable, and safeguards are put in place to assure patients have informed consent, then physicians have an ethical obligation to perfect the safety and efficacy of this technique.
[1] National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, U. S. Government Printing Office, Washington, D.C., 1979: B-1.
[2] Title 45 C.F.R & 46.116 (a)
[3] Levine, RJ. “The Use of Placebos in Randomized Clinical Trials.” IRB: A Review of Human Subjects Research. 1985; 7:1-4.
[4] Schafer, A. “The Randomized Clinical Trial: For Whose Benefit? IRB A Review of Human Subjects Research. 1985; 7:4-6.
[5] Working Party Report: The Royal College of Surgeons of England: Face Transplantation. 2003:1-24.
[6] Siegler, M. “Ethical Issues in Innovative Surgery: Should We Attempt A Cadaveric Hand Transplantation In A Human Subject.” Transplantation Proceedings. 1998; 30: 2279-2282.
[7] Freedman, B. Glass, KC, Weijer, C. “Placebo Orthodoxy in Clinical Research: Ethical, Legal and Regulatory Myth.” Journal of Law, Medicine and Ethics. 1996; 24:252.259.