All that M. Harinaatchi wanted was a child. When the engineering graduate couldn't conceive after being married for a year and a half, she approached a fertility clinic in Chennai. But on October 26, soon after she was administered anaesthesia for a fertility test, the 23-year-old woman died.
'I wish I had never taken her to the clinic,' her mother Bhagyam Murugesh laments. 'She was worried about not being able to conceive and look where it led her.'
Her death is not an isolated incidence. An unchecked growth in the number of fertility clinics in the country has led to widespread complaints about medical negligence, fuelling a debate on the safety measures followed by such clinics.
It was at one such clinic in Kochi that Shiny Winner, 44, died of complications relating to surgery carried out for the treatment of infertility in February. Her relatives have blamed the clinic for her death.
On October 6, Rashi Sharma — a lecturer of English in Jalandhar — died while receiving treatment for infertility at a local fertility clinic. The 36-year-old woman and her advocate husband were childless even after 12 years of marriage. They had hoped that the clinic would help her conceive. Instead, she died following botched up surgery. The man who treated her was not a doctor — a fact that he chose not to reveal to the Sharmas.
Across the country, concern over the mushrooming of clinics that function without professional experts or adequate equipment is mounting. According to one estimate, a new fertility clinic is set up every tenth day.
'Because of the lack of formal regulations and a watchdog, a thriving baby-making industry has developed,' says Amulya Nidhi, health activist and co-convener of an Indore and Pune-based health activist group, Swasthya Adhikar Manch. Dr Aleyamma T.K., head of the reproductive medicine unit, Christian Medical College and Hospital, Vellore, confirms this when she says, 'Over the last few years there has been a rapid increase in the number of infertility clinics.'
She, however, attributes this to 'a significant increase in the incidence of infertility'. According to a September 2013 survey by a pharmaceutical company of 2,562 people in nine Indian cities — Calcutta, Delhi, Mumbai, Chennai, Kochi, Agra, Bangalore, Hyderabad and Ahmedabad — around 46 per cent of Indian couples aged 31-40 years are infertile.
Infertility is not just a medical problem, but for many, a serious social failing as well. A paper on the findings of research on female partners of 200 infertile Indian couples conducted by the Chandigarh-based Post Graduate Institute of Medical Education and Research said: 'One or more social problems were present in 34 per cent of couples, of whom 53 per cent faced abandonment. Sixteen per cent of the women had a strained relationship with their husbands.'
So predictably, people, especially women, flock to fertility clinics. Chennai gynaecologist and reproductive medicine specialist Geetha Haripriya says she gets 400-500 new patients every month at her clinic.
To many, such clinics are easy money-making propositions. 'Infertility clinics are a very lucrative option in medical practice,' agrees Dr Aleyamma. Indeed, while fertility treatment costs differ from place to place, they can range from Rs 1 lakh to Rs 4 lakh.
To be sure, scores of clinics are run by qualified medical practitioners who have turned many a childless couple into happy parents. But the problems arise when fly-by-night clinics start to attract footfalls.
The Indian Council of Medical Research (ICMR) says there are some 1,200 assisted reproductive technology (ART) clinics in India. Only 177 of these, however, have enrolled with the ICMR. 'We very well know that we have ART clinics of both extremes,' ICMR deputy director-general R.S. Sharma says. 'While some have top-class facilities, others are really bad in terms of infrastructure and technical expertise.'
Indeed, some aggrieved patients have gone to the police and courts.
In July last year, a complaint was filed at Bangalore's Koramangala police station against a gynaecologist at a prestigious city hospital. In his complaint, V. Damodharan, said that his wife Rani, 31, was undergoing infertility treatment for over two years. In July, she underwent a laparoscopy procedure — a part of the infertility treatment — after which she developed abdominal pain. The doctor prescribed painkillers. When the medicines didn't work, Rani was taken for an ultrasound, where it was found that she had a perforation in the large intestine — that might have occurred during laparoscopy. An emergency procedure was conducted at the hospital to seal the perforation. But a series of complications followed. And within a few days Rani was dead.
In her defence, the gynaecologist said perforations can occur during laparoscopy and this was mentioned in the consent letter signed by the patient's family.
In 2004, Anitha Jayadevan sued an infertility clinic in Kerala, alleging that she had been impregnated by the gamete of another donor who was not her husband. The doctor at the clinic said the patient and her husband had given their oral consent to the use of donor ova. Jayadevan later wrote a book Malicious Medicine: My Experience with Fraud and Falsehood in Infertility Clinics.
'The time has come for us to rectify this issue,' says Kamini Rao, who runs a fertility clinic in Bangalore. 'The recent spurt in the number of fertility clinics is because of the absence of regulations. Till the Assisted Reproductive Technology (Regulation) Bill gets passed, there cannot be any limit on the number of clinics coming up.'
Once the bill becomes a law, clinics will have to follow a strict set of guidelines. All ART clinics will have to enrol themselves in a national register before they are allowed to operate. 'Only clinics that meet certain physical infrastructure requirements and have prescribed technical expertise are allowed to enrol in the registry,' Sharma says. The medical licences of doctors connected with clinics violating the law can be revoked.
Till then, dodgy clinics will continue having a merry time. Many of these clinics operate in small spaces with outdated equipment. A visit to two such clinics in Chennai reveals that the clinics are brimming with patients. But experts complain that they have no emergency management systems and lack trained gynaecologists, skilled staff and health assistants.
For a clinic to run professionally, it needs at least one reproductive medicine expert, an embryologist and an andrologist, asserts Alex C. Varghese, president of the Academy of Clinical Embryologists. 'As regards facilities, in addition to a clean environment, the centre should have a quality incubator which is used for mating eggs and sperm and multiplying embryos. Besides, it should have a storage facility to preserve embryos in frozen conditions,' he stresses.
Many of the top clinics meet these requirements.
Experts advise people with infertility problems to ensure they go to professionally run, registered clinics that follow safety measures. 'Just as one researches different colleges before taking admission or you scrutinise job applications before giving a job to a suitable candidate, couples seeking treatment need to scrutinise clinics' information either through friends or through the Internet before choosing the place,' holds obstetrician and gynaecologist Kamala Selvaraj, infertility specialist and associate director at the GG Hospital in Chennai.
But the situation on the ground is far removed from the ideal conditions that the doctors recommend. In the Harinaatchi case, the family was kept in the dark about her deteriorating condition and got to know about her death only three hours after she had expired. Winner's death, reports quoting the police say, was caused by internal injury and bleeding.
'Drug overdose, injury to blood vessels, excessive stimulation of the ovaries, water and electrolytes imbalance and kidney failure are some of the major causes of death in patients,' says Sudip Kumar Saha, professor of obstetrics and gynaecology at the Calcutta-based Institute of Post Graduate Medical Education and Research.
Nidhi rues that action is seldom taken against errant clinics. 'There is a lack of evidence against these clinics because they try to manipulate their unethical actions. We also don't have a proper regulatory mechanism to monitor their activities. That apart, there is a lack of a strong protest, by social and health activists, against clinics involved in unethical practices.'
Some intervention is taking place. Last year, the Bombay High Court pulled up the police for not probing the role of a fertility centre where a 17-year-old girl, who had been an egg donor since she was 15, had died — two days after visiting the Mumbai clinic.
Meanwhile, it's business as usual in the clinic where Harinaatchi died.
The simple building is teeming with people. New patients have to fork out Rs 1,200 as registration fee and fill forms before they can meet a doctor. Asked about a death that took place in the clinic, the staff brushes it aside uneasily — nothing like that happened, they say.
Check list
The patient should be aware of the qualifications and experience of the clinician and the embryologist
Should understand the procedure
Should check if the clinic follows ART guidelines
The clinic should have a realistic success rate
The couple should inspect the laboratory and see if the facilities are clean
They should question if any service is outsourced
They should be given updates about the treatment
They should seek referrals from other patients who have visited the clinic
Avoid clinics which advertise too much
