‘It felt like a business': Patients unsettled over IVF bungles and an industry that controls itself
A spokesperson for Melbourne IVF and IVF Australia said they were aware of the matters and take them seriously but could not comment on individual cases due to confidentiality.
The organisations said they always looked for opportunities for improvement and take learnings from feedback seriously, incorporating them into its systems and internal processes.
Monash IVF has apologised over its two embryo bungles and launched a review to be overseen by Fiona McLeod, SC.
Galea, named Victoria's Mother of the Year 2024 for more than 10 years' support of single mothers who use IVF, is a strong advocate of the technology for all the good it brings.
But she agrees with campaigners such as Katherine Dawson and Anastasia Gunn who argue that that fragmented regulation must be rectified and independent oversight established. Dawson learned that due to poor sperm-donor vetting, she may have 700 half-siblings, while Gunn, with her partner, paid to have three children via IVF with the same sperm donor, but the wrong sperm was used for one.
More than 300,000 Australians have been born through IVF, around 20,000 babies a year, per the 10-year Fertility Roadmap published last year by former health minister Greg Hunt and Dr Rachel Swift.
Now, parents in Galea's forums, including the new not-for-profit, Assisted Reproductive Technology Families Australia, are discussing whether to verify children's heritage through DNA testing (she cautions against it).
Galea is among advocates, researchers and specialists who believe there is a long-overdue need for uniform, national IVF laws.
This is on the table as part of a rapid review announced after federal Health Minister Mark Butler met with his state counterparts on Friday.
The IVF industry is governed by more than 40 pieces of legislation in nine jurisdictions, and its codes are effectively self-regulated via the Fertility Society of Australia and New Zealand's Reproductive Technology Accreditation Committee (RTAC).
One of the six-member committee which licenses clinics and audits adherence to codes, Dr Richard Henshaw, is also a Monash IVF board member. The seventh RTAC position, Consumer Representative, is vacant.
Consumer confidence was not enhanced by RTAC's refusal to release individual clinic audit results in its 2023-24 annual report which found 172 Australian breaches of codes of practice, including an increase in breaches of identification and traceability, 'an area of concern'.
Despite the high-profile problems, IVF in Australia is as safe as ever, said long-time University of Adelaide research leader and professor for reproductive and periconceptual medicine, Robert Norman.
'But trust is now the issue,' he said.
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In the early days, 'there was continual mixing and talking and a great deal of trust: mistakes were made but identified and rectified very early, risk factors were managed because embryologists and doctors all got on well', said Norman.
'Now you've got corporate bodies whose primary loyalty is to the shareholders and making profits.'
The workload expected of embryologists, who have been blamed for the 'human error' behind the mix-ups, is sometimes excessive, he said.
'They are being lambasted, being labelled incompetent – I have the greatest sympathy for them because embryologists are being put under enormous pressure by the companies,' he said.
'Some days they've got far more work than they should be doing.'
Norman said industry governance 'needs to be radically changed' and focused on independent oversight, not shareholders or industry employees.
'And it needs to have a lot of teeth,' he said.
It got to the point where I started to feel like this was just a commercial business.
Alice Almeida, IVF patient and founder of the fertility support group The Amber Network
Sydney woman, Alice Almeida, started her own infertility support group after finding herself feeling 'isolated, ill-informed, disconnected and depressed' by IVF treatment in a system she did not believe offered adequate mental health support.
An initial specialist who described the mental health issues and marital stress she raised as 'mumbo-jumbo' left Almeida questioning the quality of care: 'You are not explained [to about] all the things that could possibly go wrong,' she said.
'You are also not counselled about the financial implications; it got to the point where I started to feel like this was just a commercial business,' said Almeida.
'I was forking out more for tests I didn't know what they were for, there was no understanding of the financial burden.'
Since founding her support group, The Amber Network, she has heard heartbreaking stories about people spending their house deposit on treatments.
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She wants any new laws to include more provision for counselling, more accountability about success rates and better communication about the cost-benefit of tests or add-ons.
Former IVF lab embryologist in Melbourne, Lucy Lines, reiterated Norman's point that the people handling eggs and sperm, lab scientists, are often 'overworked and under-rested'.
Lines, now a fertility educator and IVF client advocate, attended the two-day Scientists in Reproductive Medicine meeting in Sydney in May, and said a presentation was made on the ideal formula for staffing levels in IVF labs to handle workloads smoothly. But it did not match operating reality.
Lines said colleagues still at the coalface are overworked, under-appreciated, under-rested and underpaid.
'It doesn't surprise me that there are mistakes happening,' she said, adding that the level of anxiety in patient forums is 'very high'.
Her direct messages are 'filled with people wondering if they should have their baby DNA-tested, if they should cancel their cycle tomorrow ... one girl messaged me saying 'I'm on my way home from my embryo transfer at Monash IVF, what the hell?'
'It does rock people's faith in what has previously been a very trusted system.'
'I have spent the last 25 years reassuring people this could never happen and explaining why it could never happen in Australia.'
Lucy Lines, former IVF lab embryologist
Alex Polyakov, associate clinical professor in medicine and health sciences at Melbourne University and medical director at Genea Fertility, disputes claims that embryologists are at times heavily overloaded and believes the latest bungles were 'devastating' but not a systemic issue.
'I do feel it's a black swan. It's something that is so rare, and so unpredictable: it really isn't a systemic issue,' he said.
'It looks to me that there must have been breaches of protocol. If the protocols that are in place were followed, this shouldn't have happened.'
But he acknowledged concern being expressed by patients is understandable.
'If you look at the numbers of embryo transfers per year [there were more than 111,000 IVF cycles performed in Australia in 2023] and how long it's been since one of these incidents, it's so exceedingly rare it's probably one in a million.'
Polyakov likens such events to air crashes and said, 'it's tragic when it happens, but we don't think twice about getting on a plane'.
He said the industry would benefit, however, from a national regulatory system.
'At the moment, I would not get the information as to what actually transpired, and what improvements or checks should be done,' Polyakov said. 'Clearly that should be happening so we have an idea of what are the points of weakness and how to address them.'
Private equity investment in IVF had increased funding for new science, Polyakov said, but doctors were not told how to practise medicine to benefit the business: 'I have never been told that your allegiance should be to the owners,' he said.
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'They've never said you should do clinical medicine this way because it makes more money.'
Nonetheless, Rebecca Kerner, chair of the Australian and New Zealand Infertility Counsellors Association (ANZICA), confirmed Galea and Lines' belief that patients are unsettled.
'People are scared and understandably anxious; when you undergo any form of fertility treatment it's a daunting prospect … of course, trust is everything in this space, and people are unnerved,' she said.
'It's important to note there are great clinics out there doing excellent work, and relatively speaking … Australia still remains a very safe place to do fertility treatment. But when things like this emerge we must have rigorous investigations and really attend to it.'
Dr Sarah Lensen, research fellow with Melbourne University's Department of Obstetrics and Gynaecology, reassures patients the local industry is 'at the top of the world'.
But she said information on clinic websites is often 'inaccurate not based on evidence, misleading, overselling potential benefits, not mentioning costs or benefits'.
Lensen launched The Evidence-based IVF website through the university in April, to try and counter what she said is the widespread use of unproven IVF add-ons to emotionally vulnerable patients.
She added her voice to the chorus wanting independent IVF regulation: 'So families can be reassured that if something goes wrong, it's going to be rectified, and it's not going to turn into a commercial issue: it will be dealt with the compassion it deserves.'
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