Medical ethics

Clinical trial or therapy? India does not have any rules for uterus transplants yet

Uterus transplants are not necessary life-saving surgeries and the medical community advises caution before proceeding.

This week, two women will undergo surgeries that have never been performed in India before. The women, who have medical conditions that have prevented them from getting pregnant, will get transplanted uteruses donated by their mothers . Only a handful of uterus transplants have been performed in the world and all the successful surgeries have been in Sweden. In September 2014, the first baby was born to a woman who got a transplanted uterus.

While India has regulations for organ transplants in general, there are no specific rules for uterus transplants – procedures that are still considered experimental and elective and are not life-saving, necessary surgeries. This has left the medical community divided about Indian doctors undertaking the procedure.

Dr Shailesh Puntambekar, medical director of the Galaxy Care Hospital in Pune, is leading a team of doctors in performing the two uterus transplants this week. Puntambekar is a cancer surgeon who has not performed gynaecological or transplant surgeries before. He became interested in uterus transplants after hearing Dr Mats Brannstrom – a Swedish surgeon who has been the only one to conduct successful uterus transplants so far – give a lecture about it while he was in the United States of America. Six babies have been born to women on whom Brannstrom has performed uterus transplants and two of his patients are pregnant currently.

As a surgeon who has operated on many cervical cancers, Puntambekar feels he is surgically more skilled than gynaecologists to perform a uterus transplant and is going to attempt to “harvest” the donor uterus laparoscopically.

Under whose medical authority?

Puntambekar has got permission from the Maharashtra health department to conduct the surgeries.

Under the Transplantation of Human Organs Act, a state government committee evaluates and grants permission for kidney, liver and heart transplants from donors not related to the recipient. If the donor and recipient are related, a committee at the hospital where the transplant is supposed to take place evaluates the case to ensure that the organ donation is taking place free of pressure or coercion.

The health department director Dr Satish Pawar considers uterus transplants to be like any other organ transplant and said that permissions for the procedure fall within the jurisdiction of the state health department. But, as Puntambekar pointed out: “Until, we applied for permission, the application form did not mention uterus.”

Pawar said that after receiving the application from Galaxy Care hospital, he instituted a committee, which he said closely looked into the details of the two cases and permitted the team to go ahead with the transplants.

“More than the surgery, we are worried about the implications the surgery will have on society,” he said. “There are lot of questions – who decides when the uterus should be removed following the transplant, in case the woman is unable to conceive?”

He said that the government will closely monitor the cases.

Puntambekar, who is a cancer surgeon and has never performed a transplant before, does not think that the first uterus transplants need to be conducted as clinical trials because the end goal is known – for a woman to have a biological child whose gestation takes place in her body

“You do a clinical trial when you don’t know (the outcomes),” he said.

In medicine, clinical trials are conducted to explore whether a medical strategy, treatment, or device is safe and effective for humans. The fact that so few uterus transplants have been performed means that there is not enough evidence as to the efficacy of the procedure and the various circumstances under which it may fail or be unsafe.

“The question is whether informed consent is taken since it is a rare procedure,” said Dr Sanjay Nagral, a transplant surgeon and the publisher of the Indian Journal of Medical Ethics.

Proper informed consent for a uterus transplant might involve informing the patient that there is a small but definite risk of dying and also mentioning other options to have children like surrogacy and adoption, said Nagral.

However, even if women consent, Nagral said that, as a surgeon, he would not do such a procedure. “I recognise that women are often doing this out of societal and family pressures and not necessarily out of her own volition. And therefore the informed consent may also actually not be an independent decision.”

The National Organ and Tissue Transplant Organisation set up under the aegis of the health ministry not only coordinates organ recovery, distribution of organs across India but also lays down guidelines and protocols selection of donors and rules for organ allocation from donated cadaveric organs. The organisation’s director Dr Vimal Bhandari said that health is a state subject and so, permissions acquired from the local authorities for procedures like uterus transplants are valid. “The matter has not been officially referred to me,” he said reserving his comments on the specific details of the cases.

Meanwhile, fertility specialist Dr Kamini Rao of Milann Clinic in Bengaluru is planning to perform uterus transplants in June and will do so in consultation with Brannstrom. She has sought and received permission from the Indian Council of Medical Research to conduct two transplants as part of a clinical trial.

Dr Kamini Rao with the Swedish team of doctors. Photo credit: Kamini Rao.
Dr Kamini Rao with the Swedish team of doctors. Photo credit: Kamini Rao.

The Indian Council of Medical Research itself has no clear guidelines for the procedure. However, the council’s head Dr Soumya Swaminathan said that doctors should be cautious while undertaking the surgery for which protocols are still being established. She emphasised the need for informed consent from patients who are opting to try the procedure.

The Directorate of Medical Education has compiled a list of organs and tissues that can be transplanted that does not mention the uterus. It is unclear if the Medical Council of India does not have any guidelines on new and experimental procedures.

The ambiguity about permissions has led Brannstrom to withdraw from consulting on the Pune surgeries with Puntambekar. “It is dangerous for these doctors to go ahead with the surgery,” said Brannstrom. “I withdrew after I learnt they don’t have the clinical research agency’s permission.”

Experimental, not therapy

Even before doctors have performed a single uterus transplant, both Puntambekar and Rao have lists of couples who have shown interest in the procedure. Eleven women at the Pune hospital and 31 women at the Bengaluru clinic are ready to opt for uterine transplants, the doctors said.

At present, doctors all over the globe classify uterine transplant as an experimental procedure, including Dr Mats Brannstrom who has performed the only successful uterus transplants to far.

Said Nagral: “Many developed countries where transplantation is much more advanced have actually done a few & stopped. It would be educative to analyse why they did so.”

One reason, Nagral said was that of the ethics of such of procedure, which was cloudy. “In the Indian scenario where regulation and the ethics discourse is in any case weak and a woman’s free choice is a mirage, this procedure is a huge slippery slope,” he said.

In February last year, the first woman in the US to receive a uterus transplant developed complications two days after the procedure and had to have the organ removed immediately.

Several doctors are not in favour of encouraging uterus transplant as therapy with a view that such surgeries are not necessary and life-saving procedures.

“There is no problem in encouraging research on uterine transplant but I am not sure if we are at the stage where it can be offered as therapy,” said Dr Ashok Anand, head of the gynecology department at Grant Medical College in Mumbai.

Uterus transplants may be offered to women with conditions like Asherman’s syndrome where adhesions on the uterus make it impossible to conceive or Mayer-Rokitansky-Küster-Hauser syndrome where the woman is born without a uterus. A woman may also have a dysfunctional uterus or had her uterus removed due to cancer or other conditions.

Infertility specialist Dr Anjali Malpani said that uterus disorders affect a very small percentage of patients who suffer from infertility. An estimated three to five percent of all infertile couples will benefit from the transplant. “It is encouraging that Indian doctors are taking such bold steps,” she said. “But, I think if the mother is ready to give her uterus, why not make her the surrogate instead?”

Malpani believes that a surrogacy is a far more established and less risky procedure compared to uterus transplants, which involves three major surgeries – harvesting the uterus from the donor, transplantation into the recipient followed by childbirth and a hysterectomy to remove the transplanted uterus so that the patient can be brought off immunosuppressant drugs that might be harmful in the long term.

Dr A Charmila, head of the clinical research committee of the Federation of Obstetric and Gynaecological Society of India, said that guidelines need to be framed for regulating uterine transplants to avoid potential exploitation of donors, as has been documented in cases of in vitro fertilisation and surrogacy.

Who benefits?

Transplants such as of heart and liver are life-saving and without it the patient will die. The same is not the case with uterus transplant, where the goal is to fulfil a woman’s desire to carry a pregnancy and have a child.

“It is all about experiencing motherhood,” Dr Indira Hinduja from Mumbai, one of the pioneers of India’s test tube baby procedure.

“There was very little awareness and no laws (in 1988),” she said, referring to when the first test tube baby was created. “India still does not have a legislation to regulate and monitor the booming infertility industry.” The proposed Assisted Reproductive Technology (regulation) Bill is in the draft stage and has not been tabled in parliament yet.

In fact, a couple wanting a uterus transplant has also approached Hinduja.

However, others still advise caution. “The cost versus benefit is really important,” said a doctor who did not wish to be named. “Here, I see more cost and less benefit for these women.”

This is the second of a two-part series on the first uterus transplants in India. Read the first part here.

We welcome your comments at letters@scroll.in.
Sponsored Content BY 

How sustainable farming practices can secure India's food for the future

India is home to 15% of the world’s undernourished population.

Food security is a pressing problem in India and in the world. According to the Food and Agriculture Organization of the UN (FAO), it is estimated that over 190 million people go hungry every day in the country.

Evidence for India’s food challenge can be found in the fact that the yield per hectare of rice, one of India’s principal crops, is 2177 kgs per hectare, lagging behind countries such as China and Brazil that have yield rates of 4263 kgs/hectare and 3265 kgs/hectare respectively. The cereal yield per hectare in the country is also 2,981 kgs per hectare, lagging far behind countries such as China, Japan and the US.

The slow growth of agricultural production in India can be attributed to an inefficient rural transport system, lack of awareness about the treatment of crops, limited access to modern farming technology and the shrinking agricultural land due to urbanization. Add to that, an irregular monsoon and the fact that 63% of agricultural land is dependent on rainfall further increase the difficulties we face.

Despite these odds, there is huge potential for India to increase its agricultural productivity to meet the food requirements of its growing population.

The good news is that experience in India and other countries shows that the adoption of sustainable farming practices can increase both productivity and reduce ecological harm.

Sustainable agriculture techniques enable higher resource efficiency – they help produce greater agricultural output while using lesser land, water and energy, ensuring profitability for the farmer. These essentially include methods that, among other things, protect and enhance the crops and the soil, improve water absorption and use efficient seed treatments. While Indian farmers have traditionally followed these principles, new technology now makes them more effective.

For example, for soil enhancement, certified biodegradable mulch films are now available. A mulch film is a layer of protective material applied to soil to conserve moisture and fertility. Most mulch films used in agriculture today are made of polyethylene (PE), which has the unwanted overhead of disposal. It is a labour intensive and time-consuming process to remove the PE mulch film after usage. If not done, it affects soil quality and hence, crop yield. An independently certified biodegradable mulch film, on the other hand, is directly absorbed by the microorganisms in the soil. It conserves the soil properties, eliminates soil contamination, and saves the labor cost that comes with PE mulch films.

The other perpetual challenge for India’s farms is the availability of water. Many food crops like rice and sugarcane have a high-water requirement. In a country like India, where majority of the agricultural land is rain-fed, low rainfall years can wreak havoc for crops and cause a slew of other problems - a surge in crop prices and a reduction in access to essential food items. Again, Indian farmers have long experience in water conservation that can now be enhanced through technology.

Seeds can now be treated with enhancements that help them improve their root systems. This leads to more efficient water absorption.

In addition to soil and water management, the third big factor, better seed treatment, can also significantly improve crop health and boost productivity. These solutions include application of fungicides and insecticides that protect the seed from unwanted fungi and parasites that can damage crops or hinder growth, and increase productivity.

While sustainable agriculture through soil, water and seed management can increase crop yields, an efficient warehousing and distribution system is also necessary to ensure that the output reaches the consumers. According to a study by CIPHET, Indian government’s harvest-research body, up to 67 million tons of food get wasted every year — a quantity equivalent to that consumed by the entire state of Bihar in a year. Perishables, such as fruits and vegetables, end up rotting in store houses or during transportation due to pests, erratic weather and the lack of modern storage facilities. In fact, simply bringing down food wastage and increasing the efficiency in distribution alone can significantly help improve food security. Innovations such as special tarpaulins, that keep perishables cool during transit, and more efficient insulation solutions can reduce rotting and reduce energy usage in cold storage.

Thus, all three aspects — production, storage, and distribution — need to be optimized if India is to feed its ever-growing population.

One company working to drive increased sustainability down the entire agriculture value chain is BASF. For example, the company offers cutting edge seed treatments that protect crops from disease and provide plant health benefits such as enhanced vitality and better tolerance for stress and cold. In addition, BASF has developed a biodegradable mulch film from its ecovio® bioplastic that is certified compostable – meaning farmers can reap the benefits of better soil without risk of contamination or increased labor costs. These and more of the company’s innovations are helping farmers in India achieve higher and more sustainable yields.

Of course, products are only one part of the solution. The company also recognizes the importance of training farmers in sustainable farming practices and in the safe use of its products. To this end, BASF engaged in a widespread farmer outreach program called Samruddhi from 2007 to 2014. Their ‘Suraksha Hamesha’ (safety always) program reached over 23,000 farmers and 4,000 spray men across India in 2016 alone. In addition to training, the company also offers a ‘Sanrakshan® Kit’ to farmers that includes personal protection tools and equipment. All these efforts serve to spread awareness about the sustainable and responsible use of crop protection products – ensuring that farmers stay safe while producing good quality food.

Interested in learning more about BASF’s work in sustainable agriculture? See here.

This article was produced by the Scroll marketing team on behalf of BASF and not by the Scroll editorial team.