Women's health

Beyond surrogacy: The stigma of infertility drives an assisted reproduction industry rife with risk

Thirty-eight years since the first IVF birth in India, the industry remains unregulated.

The death of Sushma Pandey in 2010 was a reminder of the risks faced by women in the assisted reproductive technology industry. Pandey had undergone hormone injections for the extraction of oocytes or eggs to be used for in vitro fertilisation at a Mumbai IVF clinic. Investigations revealed that she was just 17. It also turned out that she had already undergone at least two oocyte retrievals, or extractions, in the previous 18 months. Each time she would have been given hormone injections to stimulate the development of multiple oocytes, and paid only after she went through the surgical procedure to extract them.

The hormones used for ovarian stimulation must be administered in controlled dosages with careful monitoring, and a known risk of these drugs is ovarian hyper-stimulation syndrome. But there is no mention in various guidelines and draft legislations that ovarian hyper-stimulation can be fatal.

In 2014, Sama Resource Group for Women and Health in Delhi filed a complaint with the Delhi Medical Council when 23-year-old Yuma Sherpa died soon after an oocyte extraction procedure at a clinic in that city. A post-mortem found that she had suffered internal bleeding, possibly during oocyte retrieval which is a surgical procedure conducted under anaesthesia. Her ovaries were swollen, indicating overdose of the hormones. Sama has criticised guidelines and draft legislations on assisted reproductive technologies for their pro-industry bias, and has led health activists in a call to regulate the industry.

It has been almost 40 years since the first IVF baby was born in a private hospital in Kolkata in 1978. Over these decades, clinics have been established all over the country using IVF and other assisted reproductive technologies, or ARTs as they are called. ARTs – as well as other infertility treatments – cash in on the tremendous pressure that Indian women of all economic backgrounds face, to conceive and give birth to a biologically related child. Anxious to meet family and social demands to conceive, burdened by the notion that they will not be fulfilled without motherhood, and even fearing violence and abandonment if they fail in this duty, thousands of women are compelled to seek medical help.

Booming baby industry

According to the Indian Society for Assisted Reproduction, the ART industry in India was worth Rs 3,000 crore in 2014 and is set to go up to Rs 20,000 crore by 2018, though such numbers are only speculative. Still, there are 887 ART clinics listed in the National Registry of ART Clinics and Banks as of October 2015; the actual number is likely to be much larger as registration is not compulsory. The ISAR believes that India has great untapped potential for ART use. This is not a medical service so much as an industry.

Indeed, a 2015 report by professional service Ernst & Young states that the “addressable demand is estimated at 9 to 12 times the current market”. The report, which proposes various strategies to meet this “addressable demand”, also notes that endometrial tuberculosis and sexually transmitted infections are important clinical reasons that prevent pregnancy. Rather than address such conditions, the industry looks at medical procedures for conception.

A long list of risks

And the industry has flourished largely unregulated, though it subjects vulnerable women to drugs and painful procedures that have major, sometimes life-threatening complications. ART pregnancies are high risk, to the mother as well as the foetus. They are more likely to be multiple pregnancies because doctors prefer to transfer more than one embryo to increase the chances of pregnancy and, when multiple pregnancies occur, perform foetal reduction to keep just one viable foetus. Women face the risk of ovarian hyper-stimulation. There is a high rate of the life-threatening ectopic pregnancy. IVF pregnancies also have a higher risk of spontaneous abortion. Delivery must often be conducted by caesarean section which has its own risks.

Such discomforts and risks remain largely unreported. Women seeking these services are silent, fearing the stigma being seen as “infertile”. Women who undergo these procedures for payment are economically vulnerable and rarely in a position to go public. It has been left to advocacy organisations like Sama to call for action in specific cases, approaching bodies such as the human rights commissions and the medical councils.

The regulators’ limited focus

In the absence of a comprehensive law and regulatory apparatus specific to the industry, individuals must file complaints against doctors and clinics, possibly making use of the Code of Medical Ethics or the Consumer Protection Act. The Preconception and Prenatal Diagnostic Techniques (Prohibition of Sex Selection) Act has been used to act against clinics advertising sex selection through IVF.

The government’s major focus so far has been directed at the surrogacy industry. After cases of children being abandoned by commissioning parents, the home ministry ordered foreigners seeking surrogacy services to apply for a medical visa with proof of a contract with the surrogate, evidence that a local guardian would take responsibility of the baby if needed, confirmation that surrogacy was permitted in their country, and assurance the child born of the surrogacy would be admitted in that country as their child. In 2010, it barred single people and gay couples from using surrogacy. In November 2015, all foreigners were banned from commissioning surrogacy in India. The Surrogacy Bill, 2016, which was cleared by the Cabinet last month, bans all commercial surrogacy.

In 2005, the Indian Council for Medical Research and the National Association of Medical Sciences drafted “non-binding” guidelines for accreditation, supervision and regulation of ART clinics in India. The Assisted Reproductive Technology (Regulation) Bill was drafted in 2008, with revisions in 2010 and 2014. But these have remained drafts and guidelines.

In any case, the guidelines and draft legislation have largely been about protecting the ART industry, including surrogacy, and the interests of commissioning parents. For example, they prohibit the use of the surrogate’s own ova, so that she cannot lay claim to the baby she bears. So she must necessarily go through IVF, with all the attendant risks. They require the surrogate to sign a contract with commissioning parents, but do not giving her legal support for this purpose. The birth certificate is to be issued in the names of the commissioning parents, and the surrogate must relinquish all rights to the child after its birth.

On the other hand, the guidelines do not offer any protection to the women undergoing these technologies. For example, the informed consent template in the draft 2010 rules for women undergoing IVF or oocyte retrieval says that “the drugs that are used to stimulate the ovaries to raise oocytes have temporary side effects like nausea, headaches and abdominal bloating. Only in a small proportion of cases, a condition called ovarian hyperstimulation occurs, where there is an exaggerated ovarian response. Such cases can be identified ahead of time but only to a limited extent.” The consent form does not explain what an “exaggerated ovarian response” is, let alone that it can be fatal. The ground realities may be worse, and one has no idea if even this scrap of information is given in a language known to the woman.

Large and sometimes fatal gaps

All the women in the ART industry face risks without their informed consent, whether oocyte donors, surrogates or women who pay a clinic for ART and other medical services relating to conception. Oocyte donors have been subjected to high doses of hormones so as to yield the maximum number of oocytes. Sushma Pandey and Yuma Sherpa died, but many more will have suffered serious complications without it coming to public attention. Women undergo repeated cycles of unsuccessful IVF in the hope – usually based on doctors’ advice – that it will eventually work. Clinics do not publish their statistics in any meaningful format, so an individual has no way of understanding the actual probability of her giving birth to a child after ART. Doctors do not counsel people on the possibility of adopting a child or on choosing not to be a parent. So the industry thrives, on patriarchy, poverty and, of course, media hype.

It is clear that the ban on surrogacy is motivated by interests other than a concern for the women involved. It will not solve the problems faced by women in the ART business as well as the larger “fertility” industry. The current approach to regulation of the industry seems to reinforce women’s vulnerabilities in the guise of addressing their needs.

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