The Indian Council of Medical Research (ICMR) has given permission to a Bengaluru-based hospital to carry out the much-debated uterus transplant procedure. This is the first time that the technology is being brought to India.
Uterus or womb transplant is carried out on women who are born without a uterus (a congenital abnormality called MRKH Syndrome), or on those who have lost their uterus to a disease.
A promising development, the surgery enables women to get pregnant and bear children.
However, the procedure is still in an experimental phase with just a handful of surgeries that have borne positive results.
Milann, a fertility clinic in Bengaluru, has collaborated with Dr Mats Brannstron, Professor of Obstetrics and Gynaecology at the University of Gothenburg in Sweden, to perform uterus transplants in India.
Dr Brannstrom and his team were the first in the world to perform the procedure with a living donor successfully in 2012. Since then, they have conducted the surgery on nine women, of which five have successfully given birth.
"The proposal came to ICMR and we approved it as an experimental procedure. This is a clinical study and we have to check the feasibility of the procedure," Dr RS Sharma, Scientist & Head, ICMR, said.
Dr Gautham TP, Senior Vice President Operation, Milann, said every woman has the right to experience pregnancy and this procedure will enable them to do just that.
"Over 6 lakh women in India are born without a uterus. Surrogacy has also been a subject of debate of late. This procedure, if established, can serve as an alternative to surrogacy for persons who want to give birth," he says.
Milann had first collaborated with Dr Brannstrom in the year 2011. The organization later asked him if he'd be interested in performing the procedure in India to which the doctor agreed.
"This is considered an experimental procedure because the experience is limited to just one group in the world right now. People don't know much about the repercussions," he states.
Dr Gautham says while they sought permission to conduct the procedure on nine women, they have been allowed to perform it on two women. These will be conducted under strict regulations and depending on the results, the ICMR will decide on the next course of action.
Currently, the team is looking for two candidates from among 40 who will be eligible for a uterus transplant and the surgery is expected to be carried out in June.
Another hospital in Pune will reportedly be performing the same procedure some time in May. The Times of India reported that the Galaxy Care Laparoscopy Institute (GCLI) has been granted a licence by the state's health directorate for carrying out the procedure.
GCLI medical director and oncosurgeon Shailesh Puntambekar told ToI that after conducting the procedure on human cadavers in Germany and the US, they too had met the Swedish team to learn the actual procedure.
It is however not clear if the licence has been given for a clinical procedure or a regular one, and whether or not they are collaborating with another organisation.
"Any scientist who wants to have an international collaboration has to submit an application to ICMR for evaluation and for approval," Dr RS Sharma of ICRM said, adding that they had no clue of the permissions granted to the Pune hospital.
Ethical concerns
While advancement in the field of medicine is necessary, many experts from across the world have expressed concerns about a procedure that is still in its nascent stage.
One of the concerns often raised is that a uterus transplant, unlike a more established liver or kidney transplant, is not a life-saving measure. Also, whether or not such a procedure should be promoted even when other viable options such as adoption and surrogacy are available to people. Some say it reinforces the idea that a "real" woman must be able to give birth.
Then there are questions about ethics, science, strict regulations, protocol violations, health risk and safety of patients after the surgery as well as that of the baby following pregnancy.
"This is a novel concept and no one should shy away from doing something new because how else will we invent and discover things. But this procedure is also extremely risky and needs to be pushed with caution. It has a significant failure rate. It has to be done as an experimental procedure under the supervision of ethical agencies and other bodies," said Dr Anand, an e-regulatory and ethical expert.
"These bodies should have a say in every step so that they can prevent greater damage if something were to go wrong, both at an individual level and also at a society and community level so that people aren't exploited or are given false hopes unnecessarily," he added.
Dr Anand also points out the "uniqueness" of the procedure. Unlike in regular transplants where the organs are left in the recipient's body unless the body rejects it, in this procedure, the transplanted uterus of the woman is removed after she bears children.
It has taken decades before common transplants today, such as liver, kidney, cardiac became regular and these too don't guarantee cent percent success rate.
"Cardiac transplants started some 60-70 years ago. Then it took nearly three decades for it to become a routine procedure and guidelines were made to regulate it. If someone calls uterus transplant a routine procedure now, I would just put it as reckless," Dr Anand cautions.
(GCLI refused to comment stating they will not be taking any questions before the surgery is performed in May. The Deputy Director of Health Services in Pune could also not be reached for a comment on the nature of license that has been granted to GCLI.)