As ethical debate rages on, experts urge for rules on uterus transplants
MUMBAI CITY NEWS: The two uterus transplants have prompted a debate on whether they should be treated as regular organ transplants or medical trials as for the latter requires approvals from various authorities and takes longermumbai Updated: May 21, 2017 00:08 IST
Even as infertile women are anxiously waiting to see the results of the two uterus transplants performed by a hospital in Pune, the surgeries are likely to set the stage for the standard operating procedure, which involves getting approvals from state and central authorities, for such medical interventions. Currently, there is no law which regulates uterus transplants, said experts.
It took almost two years for Galaxy Care Hospital, where Dr Shailesh Puntembekar and his team transplanted two uteruses, to receive the permission from Maharashtra’s Directorate of Health Services and prepare groundwork by visiting other countries. They told the authorities that the surgeries were regular organ transplants.
For an organ transplant, the approval from the state government is relatively easier and faster compared to medical trials.
Sceptics have approached the Indian Council for Medical Research (ICMR), which grants approvals for medical trials, to clear the air on uterus transplants.
The two surgeries have prompted a debate on whether they should be treated as regular organ transplants or medical trials. Section 11 of the Transplantation of Human Organs and Tissues Act, 1994, stipulates that organs shall be harvested only to improve health of recipients, in other words for therapeutic or life-saving purposes.
Unlike other transplants, uterus transplants aren’t for therapeutic purposes, said experts. “It is an experimental or elective procedure to explore medical science and open one more door for infertile women to conceive,” said Dr Kamini Rao, medical director of Milann in Bangalore. Milann is the first hospital in the country to get ICMR’s approval for a uterus transplanttrial
Explaining the approval procedure for medial trials, Dr Rao said it took them two-and-a-half years for the sanction, which involved vetting from different committees and experts attached to state and union government as well as ICMR.
After an initial review by organ transplantation committees of the state, the application is screened by two separate teams — ethical and scientific — of Drug Controller General of India. It then reaches ICMR along with available scientific evidence, results of prior medical trials on animals and statistics collated by researchers. After reviewing the application for months, ICMR takes the final call on the trial.
“During this entire period, none of the researchers are allowed to attend the meetings. While the procedure is time consuming, it leaves no room for doubt,” said Dr Rao, who has assisted Dr Mats Brännström, a doctor from Sweden. Dr Brännström performed the world’s first uterus transplant in 2012. He has carried out nine successful surgeries.
On Thursday, Galaxy hospital performed country’s first uterus transplant on a 21-year-old woman who failed to conceive. She received the organ from her mother. The next day, it conducted another transplant on a 24-year-old woman from Baroda. She also got the organ from her mother.
Swedish doctor says Pune hospital is after publicity
Talking to Hindustan Times, Dr Mats Brännström appealed to all surgeons to conduct clinical trial on animals for uterus transplants
Clinical trials on animals can provide exposure to surgeons to more enclosed and precise pelvic region, which is different from other organs such as heart, kidneys and liver, said Dr Kamini Rao, medical director of Milann hospital in Bangalore
“Since animals have a horizontal anatomy, it’s more difficult to access the surgical area and organs. It trains surgeons to get the architecture of incision right, which is a crucial part of the surgery,” said Dr Rao.
“We had first performed womb transplants on animals, including sheep, pigs and baboons for 15 years. What is planned in Pune is a ‘dangerous escapade of surgical cowboys who want to be the first in their country and to get publicity,” said Dr Brännström.
He pointed out that the surgeons in Pune had attempted the surgery without enough exposure to animal models