Uterine transplantation: a step too far?

Non-life-sustaining allotransplants and uterine transplantation

Allotransplants used to be reserved as a last resort for patients who would die without one.^7,16,17 Despite advancements in medical knowledge, transplantation still remains the only option for individuals in heart, lung and liver failure as the potential risks of the transplant and long-term immunosuppressive drugs are considered to be outweighed by the benefits of prolonged life. Not all transplants are life-saving, such as corneal and renal; however, these are still relatively uncontentious as the benefits to the recipient and society are clear.

There have been many non-life-sustaining allotransplants over the last few decades. The first human hand transplant took place in 1998, the first face in 2005 and the first penis in 2006. Many of the first recipients of these types of transplants developed psychological issues following their transplants, and have since had them removed.^18–20 These ‘firsts’ in transplantation have raised new ethical concerns and dilemmas, and each new ‘first’ brings with it its own unique concerns.

Although the risks of the transplantation surgical procedure have been reduced, the requirement to maintain a lifelong immunosuppression regimen has not been removed. Non-life-sustaining allotransplants are becoming more and more common; however, unlike traditional allotransplants, they run the risk of turning what may be an extremely distressing condition into a life-threatening one.^7,18

The FIGO Committee made it clear that uterine transplantation is not a life-sustaining procedure. ⁹ It stated that it does not offer an improved survival and quality of life, that it causes substantial risk to both mother and child, and that it should not be considered in humans until adequate research has occurred in appropriate large animal models, including primates. ⁹ As per these guidelines the approval of two attempts of uterine transplants in macaques has recently been given. Surgeons at a New York downtown hospital wish to continue further trials in primates; however, they are so confident that they will be successful they are already selecting possible recipients for the second human transplant.^7,21

One of the potential recipients undergoing the medical candidacy interview process to become a uterine transplant recipient is Sarah Luiz. ²² As one of the first well-known transgender women, Sarah Luiz has highlighted the emergence of a reason other than infertility to require a uterine transplant. Obviously transgender women have no ‘natural’ ability to become mothers as they have no female reproductive system at all, not just an absence of the uterus. As a ‘woman’, however, it could be argued they have the same desires to carry a child as other women. The reasons behind this desire may or may not be different, but the desire seems to be there all the same.

There is currently an expectation that infertility is a disease that should be treated. However how far this expectation reaches is unclear. Should anything be accepted to provide somebody with a child? Should a child be grateful for its life however it is brought into the world?

A major part of the General Medical Council's role is its responsibility for ensuring the good conduct of the medical profession. Its guideline Good Medical Practice: Duties of a Doctor sets out the principles and values on which good practice is founded, and incorporates many of the principles of the Hippocratic Oath. ²³ These principles of beneficence, balancing the benefits of treatment against the risks involved, and non-maleficence, avoiding causing harm, cannot be ignored when discussing non-life-sustaining allotransplants. Many treatments involve a degree of risk or harm in the form of side-effects, and the principle of non-maleficence would imply that this harm should not be disproportionate to the benefit of the treatment. Doctors on the ‘frontline’ are required to balance the evidence of harm, not just to an individual but also the wider public in terms of resource allocation, against the benefits, before rationalizing a treatment option. Although governing bodies alleviate this difficult decision to a degree, often these more clinical-based decisions are left to clinicians. The current trend in decision-making around non-life-sustaining transplants appears to be no different, and unless certain transplants are judged as unethical or illegal it will be left to individual clinicians to make these often difficult decisions.

Informed consent

For consent to be valid and lawful it must be given competently, un-coerced and with full understanding. ²⁴ To have full understanding it could be argued that a patient needs to be fully informed - but how much information needs to be disclosed for this to occur? There is a general consensus that doctors are obliged to be honest about what they do and do not know about potential risks of a treatment option, and how probable they may be. ²⁰ Within English law the ‘Bolam‘ test has been universally applied for many years and asks whether a doctor has acted in accordance with the practice accepted as proper by a body of medical professionals. ²⁵ Utilizing Bolam, a doctor would not be found negligent regarding lack of information disclosure as long as another medical professional agreed they would not have disclosed. In Sidaway, however, it was agreed by the House of Lords that the duty to disclose information is part of a doctor's ordinary duty of care. ²⁶

Over the years English law has moved away from this strict Bolam approach and in Bolitho v City and Hackney HA the Bolam test was modified by emphasizing the need for a doctor's conduct to not only be supported by medical practice, but also be capable of withstanding logical analysis. ²⁷ Jackson ²⁴ states that it is clear that the ‘doctor knows best’ approach is no longer dominant and that there is a possibility that the law is moving towards the prudent patient test: to deliver to all patients that which most patients would want to know, rather than the reasonable doctor test as found in Bolam. There are many professional guidelines and codes that indicate to medical practitioners what is classed as best practice, and these are generally referred to in practice.^28,29 Within these guidelines it is clear that a doctor should ascertain patients’ wishes, share information and disclose possible adverse outcomes. ²⁹ Although they are not based in law, the likelihood is that a reasonable doctor would follow this guidance.

Uterine transplantation is clearly not currently a routine operation, and so far has been unsuccessful in producing a live birth in a human recipient. Therefore, as with facial tissue transplantation in the UK, it is suggested that it should be classified as both clinical research and experimental. ²⁰

Certain clinical research can only be considered justifiably ethical if a state of uncertainty exists about which treatment is better, simply known as equipoise. ³⁰ Therefore it would be unethical for a doctor to include a patient in a research study when they were fully aware that the treatment the patient would receive would be of a lower standard than current routine treatment. Even if a patient were to be given all the information informing them of this and then wished to participate, the doctor would be breaching the codes of practice relating to research. ³¹ Often research is conducted into completely new medical treatments rather than improvements to current ones due to the lack of treatment options available for certain conditions or diseases. In this situation equipoise is of no real concern as there are no other treatment options to offer a patient, since they simply do not exist.

It is suggested that higher-risk experimental procedures demand a higher level of information disclosure - the purpose of this being to enhance the capacity of an individual, maximize their autonomy and allow them to make a choice that is meaningful to them. This includes disclosure of what is not known as well as what is known.^20,32 In terms of new and developing techniques, the surgeons involved will inevitably be enthusiastic. When providing information to obtain consent for medical research, there needs to be awareness on the surgeon's part that there is no unintentional coercion due to their own inherent enthusiasm.^20,23

To ensure that consent for non-life-sustaining allotransplants is fully informed, medical teams not only have to work within legal frameworks, but also adhere to basic guidance on consent from the General Medical Council and the Department of Health, and both research and professional transplantation bodies’ guidance.^34,35

A basic requirement of valid consent is that it is given voluntarily. But can anyone ever give consent truly voluntarily? It could easily be argued, for instance, that no one would choose voluntarily to undergo major surgery unless there was a pressure that they may die without it. Garrett et al. ³⁶ state that non-coercion and freedom can be difficult when not only outside pressures such as family are involved, but also common natural factors are present. Often exaggerated fears and magical hopes of the desperate distort and affect an individual's understanding. Although many of these findings are based on individuals with serious illnesses, a woman considering a uterine transplant to provide her with a baby could easily be classed alongside the desperate.

Many comparisons around gaining consent for uterine transplantation can be made with facial tissue transplantation. In 2006 a Working Party for the Royal College of Surgeons, including surgeons, ethicists and psychologists produced a second report examining all the issues around facial transplantation, including informed consent. ²⁰

One of their concerns was that it may be possible for an individual's ability to provide informed consent to be affected by the overwhelming despair associated with the experience of facial disfigurement.^20,23 They suggested that specialist psychiatrists and psychologists evaluate any potential recipient's ability to provide informed consent prior to any transplant. The first facial transplantation programme within the UK has only four potential recipients and it is suggested that facial transplantation is only going to be suitable for a very small number of patients. ³³ Due to the small numbers, this amount of presurgery preparation may therefore be feasible. If there were larger numbers of potential recipients, as in uterine transplantation, it could be argued that there would not be adequate resources within the NHS to provide this.

Although not all desperate patients have life-threatening illnesses, their desperation is nonetheless very similar. Individuals with chronic illnesses or chronic pain for instance can often be desperate research volunteers, and are therefore automatically placed in a vulnerable position. ³⁷ This does not necessarily mean, however, that because of their desperation they should not be responsible for making their own decisions, or that they are not capable of assessing their own best interests. It is obvious that no one is completely free from pressures; however it is a health-care professional's responsibility to assess if any of these influences affect a person's ability to make a free choice. Health-care professionals need to be vigilant in ensuring that any consent given by desperate volunteers is in fact valid and lawful.

The first human uterine transplant highlighted the desperation of the recipient clearly. As mentioned previously, in 2002 a previously healthy 26-year-old woman underwent major abdominal surgery, and all the risks this entailed, for a uterine transplant. ¹⁴ The procedure had only minimal success in animal studies, there had been no live births following and it had never been performed in humans. This young woman obviously had strong beliefs that the procedure would work, but the evidence to support this belief was clearly to the contrary. This initial human transplant could easily be classed as unethical as it failed to meet many bioethical and medical frameworks to protect volunteers such as equipoise, informed consent and the protection of patients in being exposed to harmful treatments. ³⁸

Allmark and Mason ³⁸ state that if a patient is in a dire situation, even if they have no idea whether a treatment may turn out to be effective, they may still want it. No matter how distant the hope may be, to that person it is better than no hope at all. ³⁸ This hope often obscures reality, however. Desperate volunteers are patients who strongly believe in the efficacy of a treatment but who lack the evidence for that belief, as seen in the first uterine transplant. Findings based on randomized controlled trials also found that many participants often have a misplaced belief that doctors will give them the ‘best treatment available’. This is again another indication of patients’ expectations that doctors only offer treatments or the option to enter research studies if it is in their best interests.

Uterine transplantation raises many obstacles with regards to obtaining informed consent. Realistically doctors will not be able to provide information on what is known, as there is such limited knowledge, but merely what is not known (although there is clearly known information concerning current allotransplants and the risks to a potential fetus which can be related). I believe another concern is purely the number of potential recipients. The Royal College of Surgeons report provided a very comprehensive procedure for ensuring informed consent was obtained from facial transplantation recipients. ²⁰ I am not convinced that if uterine transplantation became a reality, this in-depth procedure would be able to be put in place due to the numbers of possible recipients.

However, can we say that uterine transplantation should not be carried out purely on the grounds that the potential recipients cannot provide full informed consent? As Jackson points out, without research, medical progress would be impossible. ²⁴ All medical findings have to some degree needed to undergo the initial process of research, and to adopt such a ‘thick’ precautionary approach would hinder medical progress. ²⁴ It is clear that whenever possible the inclusion of desperate volunteers should be avoided in medical research. By the very nature of some of the research that is undertaken however, the only patients who can participate in the research are those who are desperate, such as in uterine transplantation. ³⁸

Is there a right to ART and therefore uterine transplantation?

Although by no means universally agreed, the major health-care bodies in both the UK and worldwide categorize infertility as a disease that needs to be treated.^2–4 However, does this mean that the right to raise a family overrides all other considerations? Should individuals be provided with ART irrespective of others? And is there a requirement for uterine transplantation to be offered when it becomes a feasible treatment option?

Libertarians make the distinction between positive and negative rights. A negative right obliges inaction, in that a person should not be prevented from doing something and in general there is always a way for society to act so that a negative right is not violated, such as implementation of legislation. A positive right obliges action and can conflict with others, in that by ensuring one individual's right is fulfilled another's may be violated. ³⁹

Tannsjo ³⁹ , rightly I feel, argues that the right to pro-creative freedom is a negative right, and that nobody should intentionally prevent an individual from this freedom unless it harms another. Tannsjo also argues that an individual's negative right to procreative freedom encompasses the negative right to ART, and suggests that if society does not actively provide ART for an individual their procreative freedom is breeched. ³⁹ By classifying it as a negative right I would argue however that, like procreative freedom, there should simply be no interference by the state to prevent individuals accessing privately funded ART if they wish to do so. Only a positive right should suggest positive action.

So if ART is seen as a positive right, individuals should not only be allowed to access it but it should be both provided and subsidized by the state so that all are able to access it, irrespective of financial means, as long as there is no conflict with another individual's rights.

Would provision of ART conflict with others rights? I suggest that there are many reasons why it may, the most obvious being resource allocation; however, due to the scope of this paper this will not be discussed further.

The Human Rights Act (HRA) came into effect in 1953 and protects the human rights and freedoms of citizens within Europe, and in 1998 became law in England, Wales and Northern Ireland. ⁴⁰ Within the Convention there are two main categories of rights, which can easily be compared with negative and positive rights. The first are absolute rights that cannot be breached under any circumstances, such as right to life, which are comparable to negative rights. The second are qualifying rights that can lawfully be interfered with in certain circumstances. Usually there are set criteria which guide when a qualifying right can be breached, for instance in accordance with the law or when it is necessary for a democratic society, similar to positive rights. There are two articles within the Act that have great significance in relation to ART, article 8 and 12. Article 12 of the HRA is the right to marry and found a family. Traditionally the basis of this right was that the government was not allowed to interfere with a couple's decision to either have or not have a child. This meant that the government could not, for instance, force an individual to be sterilized or ban contraception. This article is a qualifying right rather than an absolute right meaning that the rights of the individual need to be balanced with the needs of the wider community or state. If it is felt that the needs of others would be compromised then it can be restricted or refused. Article 8, the right to respect for private and family life, is also a qualifying right; however unlike article 12, limitations to this article can only be made for specific reasons such as economic well-being or public safety.

It could be argued on the one hand that by not allowing uterine transplantation, article 8 and 12 would be violated as the right to found a family and to a family life is prevented. By not providing ART or uterine transplantation, however, the state would not actually be removing an individual's procreative freedom, merely not acting positively in aiding that individual's family life.

It is true that articles 8 and 12 of the Act refer to the rights to found a family, however these provisions do not entail the existence of an absolute right to infertility treatment. ⁴¹ As Evans ⁴² suggests, these Acts merely state a right not to be prevented from having a child, they do not entail the right to be provided with a child. Ryan ⁵ goes some way in supporting this, stating that because assisted reproduction requires medical resources, the questions of distributive justice can be legitimately applied.

In relation to article 12, Wall J in Hadley and Evans also clearly stated that in vitro fertilization (IVF) can only amount to the right to have access, and can be qualified by availability, suggesting there is no given right to be provided with ART, merely a right to access it. ⁴³

I believe there is a negative right to a family life in that no individual should be prevented from accessing ART and founding a family if they so wish. However, articles 8 and 12 are qualifying rights for a reason; they can be restricted if they risk compromising the rights of others. I would argue that there are some that question whether even ‘traditional’ ART should be offered within the Act. However, even if there is a consensus around the provision of ART, I believe that a line needs to be drawn on the ‘slope’ at some point and uterine transplantation is currently that point. As a qualifying right, it is clear that an individual's right to a family life does not veto all others.