Last week, a report was published on why a woman receiving IVF treament died. Theresa Judgereports on an unregulated sector
Guidelines governing IVF treatment issued by the Royal College of Obstetricians and Gynaecologists in Britain are often "years out of date" and not a reflection of best international practice in a rapidly changing field of medicine, according to a leading IVF specialist.
Dr Tony Walsh of the Sims Clinic in Dublin is calling on Irish health authorities to draw up guidelines based on consultations with Irish practitioners and taking into account developments in the US and other developed countries.
"It is not good enough just to bring in what the royal college in London is saying. We need to take a bigger look at the developing field of reproductive medicine across many developed countries," he says.
Walsh argues that the system used by the RCOG (Royal College of Obstetricians and Gynaecologists) to decide on best practice is slow and cannot keep pace with developments in reproductive medicine. "Guidelines need to be constantly updated," he says.
Concern over the management of fertility treatment and the lack of State regulation of the sector has again been raised over recent days with the publication of an independent report into the death of a young woman resulting from IVF treatment.
It is now more than two years since the Commission on Assisted Human Reproduction reported and recommended that a regulatory body be established by the Oireachtas to regulate all Assisted Human Reproduction (AHR) services. However, there is still no sign of legislation being introduced. The commission had been deliberating for five years before issuing its report and the urgent need for regulation was stressed.
In the absence of regulation, there is no register of clinics, no law preventing anybody from setting up a clinic or to ensure that those working in them are properly qualified, no independent reviews of success rates and there is no way of ensuring that children born from donor sperm or eggs will be able to identify their genetic parents.
There is also uncertainty regarding the legal status of the embryo and the fundamental issue of who the legal parents are of a child born when donor sperm or eggs are used or when surrogacy is involved.
Jacqui Rushton (32) died in January 2003 after developing complications during IVF treatment at the Rotunda Hospital in Dublin. An independent report into her death, which was commissioned by the HSE after sustained lobbying by her family and issued last Wednesday, was very critical of the Rotunda, saying there was "evidence of lack of senior control over, and overall accountability" for her care. It also found there was "inconsistent compliance with Royal College of Obstetricians and Gynaecologists [ RCOG] guidelines".
A sister of Rushton, Collette Vincent, says she is angered by the response of the Rotunda Hospital to the report. In a statement, the master of the Rotunda said RCOG guidelines in place at the time of the death were followed. These guidelines dated from 1996 and the royal college subsequently updated its guidelines in 2006. The newer guidelines recommend a different approach to the treatment of the condition that caused Rushton's death - ovarian hyperstimulation syndrome (OHSS).
While Walsh points out that guidelines that are updated only every 10 years are inadequate in such a rapidly changing field of medicine, Vincent says she believes says the Rotunda did not even follow the 1996 guidelines correctly in the treatment of her sister for OHSS.
And this was clearly the view of the two expert authors of the report who are based in the UK.
Vincent describes the family's anguish of knowing Rushton was deteriorating rapidly and of suspecting she was not receiving the correct care.
"I was on the phone to Jacqui - I couldn't visit her because there was a winter vomiting bug in the hospital and only her husband was allowed in - and she could hardly breathe. She kept getting worse and she felt nobody was taking responsibility for her.
"OHSS is life-threatening but it can be managed. Her death was unnecessary. I think the hospital basically thought it would resolve itself but it didn't," says Vincent.
Rushton's family is angry that she was not under the care of an IVF specialist from the time she had to be transferred from the Rotunda's Hari (Human Assisted Reproduction Ireland) fertility unit into the main hospital. The statement from the Rotunda tried to counter the critical findings of the independent report regarding the "lack of senior control and accountability" by saying she was seen on a daily basis by at least one experienced staff member.
However, Vincent points out that these were not IVF specialists and OHSS is a condition associated only with IVF treatment.
The report found that "appropriate and early management" of fluids in her system would have prevented her subsequently developing severe respiratory problems which led to her death.
Tony Walsh, whose Sims clinic is one of the leading fertility clinics in the State along with the Rotunda's Hari unit, was one of the first to call for an independent inquiry into Rushton's death.
He says it is of concern that a death occurred in Ireland after a relatively small number of IVF treatments compared with Britain where IVF has been offered since 1978 and where there have been a "minuscule number of fatalities".
"It is important for everybody to straighten up and take a look at things," Walsh says.
The Rotunda stresses it has learned from the tragedy, has implemented measures to reduce the risk of OHSS developing in patients and is now following the 2006 RCOG guidelines.
A Medical Council fitness to practice inquiry into the then director of the Hari unit, Prof Robert Harrison, found he had no case to answer in relation to Rushton's death. He has since retired.
Walsh stresses that the risks of severe OHSS developing are very small - 0.2 per cent, while 2-6 per cent of women undergoing IVF develop a minor form of the condition.
He says he believes "the biggest risk of IVF is what happens between people's ears" in that when they see an embryo being created they start to believe they are going to have a baby "no matter how much you have told them about success rates". When the treatment is then unsuccessful, "the psychological impact is huge", Walsh says.
The success of IVF is determined mainly by the age of the woman, he stresses. For a woman aged 43, the success rate is only about 9 per cent but for women under 35 it is about 40 per cent. Using a donor egg increases the success rate.
Collette Vincent says the family's main concern was to get to the truth of what happened to Rushton and to try to ensure that no other woman would die. "IVF is great as long as it is properly managed," she says. The family is now dropping legal proceedings against the Rotunda saying they are not interested in compensation and only wanted the facts of the case to emerge.
However, they have been left exhausted by their efforts and say they were obstructed by "a veil of silence" among medics. Vincent adds: "You can't get real justice when you're dealing with the medical profession - it's not like anybody is ever going to go to jail. All we wanted was to ensure the truth came out."