India's first uterus transplant caught in controversy, as ICMR says no nod sought
In what was considered a major achievement for the medical field in the country, as India's first uterus transplant was conducted in Pune last week, the procedure now seems to have come under the shadow of a controversy.
The Indian Council of Medical Research (ICMR) has raised concerns about the procedure as it has reportedly said that prior permission for it was not taken from the council. ICMR director general Dr Soumya Swaminathan has reportedly told a leading national daily that no permission was sought by the hospital and that till now ICMR has approved of such a procedure only as an experimental procedure under a research protocol. And such a permission has only been granted to a Bangalore-based facility.
Swaminathan is reported to have added, "According to current guidelines, nobody needs ICMR's permission for any other established procedures. However, when it comes to a uterus transplant the protocol is otherwise. As it is mostly tried as an experimental procedure for research purpose in our country, for which permission is granted based on ethical protocols, and the transplant involves several risks with only a few procedures emerging successful, ICMR's approval is necessary before it is tried on any patient."
Earlier last week, the surgery was performed at the Pune's Galaxy Care Laparoscopy Institute (GCLI) in which a 21-year-old woman who suffers from a congenital absence of the uterus since birth, which rendered her incapable of conceiving, was operated on to transplant her 44-year-old mother's organ to her. It was conducted by a team of 12 doctors headed by Dr Shailesh Puntambekar, medical director of the hospital.
As per reports, the protocol for uterus transplant requires approval from a registered ethics committee as well as from ICMR. And it has been alleged that GCLI only got a licence from the Maharashtra's directorate of health services, and has not been approved from the ICMR.
Pune's GCLI, where the transplant was performed, has insisted that no such permission is required for clinical procedures. With Dr Puntambekar reported to have said, "ICMR's permission is required only in case of experimental procedures and not for clinical procedures as informed to me by ICMR itself. We have approval from the state government, hence, there has been no protocol violation. Several senior doctors from ICMR were informed about the transplant and following the state government's nod for the transplant, ICMR ensured we could go ahead with the procedure."
But another senior doctor from ICMR is reported to have said, "In case of other transplants like kidney, liver and heart, ICMR's permission isn't required and state governments can give direct approval under the Transplant of Human Organs Act (THOA). However, in uterus transplant, which is rare, less successful and risky, ICMR's permission should have been sought to ensure patients' safety."
This is not the first instance of the transplant conducted, which is considered a rare procedure around the world, to have been criticised.
Earlier Dr Mats Brännström, who was the first doctor to perform such a procedure in Sweden in 2012, which resulted in the birth of the world's first baby from a transplanted uterus in 2014, had reportedly criticised the Indian procedure for its lack of proper preparation and for the risk that it would put both donor and receiver at. He reportedly said, "What is planned in Pune is a dangerous escapade of surgical cowboys wanting to be the first in their country and to get publicity and fame easy."
On the risks of such a surgery, he pointed at the recipient's death following a similar procedure conducted two months ago in China by the country's top laparoscopy surgeon.
Though according to Dr Puntambekar, his team had travelled to Sweden to learn the transplant procedure and practised on human cadavers in Germany and the US. But Dr Brännström reportedly said that his own team had practised on various live animals for 15 years before taking their first human case, which has been totally ignored by the Indian doctors. "That is the great difference. We advise all groups around the world to choose one large animal for team and surgery training," he reportedly added.