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Microscope on IVF giant over 'inexcusable' embryo error

Microscope on IVF giant over 'inexcusable' embryo error

The Advertiser18 hours ago

A second embryo blunder from a major private fertility clinic has raised fresh fears about system flaws.
Staff at a Monash IVF laboratory in Melbourne on Thursday transferred the wrong embryo to a woman, giving her one of her own rather than one from her partner, as they had requested.
The pair is believed to be in a same-sex relationship.
The company, which is based in Melbourne but has clinics around Australia, apologised to the couple and launched an internal investigation.
But the Victorian Health Regulator has swooped in with its own probe of Monash IVF and how the error occurred at its Clayton site.
State Health Minister Mary-Anne Thomas said the mistake was "completely unacceptable" and the company must provide answers.
"This will be quite devastating for the couple at the heart of this," she told reporters on Tuesday.
"We all know that the IVF journey can be a very long, torturous one. It can be very expensive as well."
In a notice to the stock market, Monash IVF said it would set up additional verification processes and patient confirmation safeguards.
It has informed the Reproductive Technology Accreditation Committee certifying body and insurers, declaring it expects the mix-up to fall within its insurance coverage.
The company's profit guidance remains unchanged but the news sent its share price tumbling by more than 26 per cent to below 55 cents as of 3pm AEST.
Monash IVF revealed in April a woman at a Brisbane facility had another patient's embryo incorrectly transferred to her because of "human error".
The mistake was picked up in February after the birth parents asked for their remaining embryos to be transferred elsewhere and an extra embryo was found in storage.
Monash IVF apologised, expressed confidence it was an isolated incident and hired leading barrister Fiona McLeod to lead an independent review, which has now been expanded.
Alex Polyakov, a fertility specialist at Melbourne's Royal Women's Hospital, said the latest stuff-up was also likely because of human error.
He said the mistake in Melbourne was easier to make than the one in Brisbane but equally serious.
"You have the couple's names on every embryo," the Genea Fertility Melbourne medical director told AAP.
"It's not just the patient or the egg provider, it's also their partner.
"I could see how this would happen."
About one in 18 babies is born via IVF in Australia.
Associate Professor Polyakov said the two transfer errors were the first he was aware of in Australia since the IVF industry began operating 40 years ago, although there have been high-profile cases in the US and Israel.
He called for more vigilance and extra layers of protection but conceded no system could be made foolproof from a "black swan event".
Shine Lawyers medical law Victorian practice lead Daniel Opare said alarm bells should be ringing across the industry.
Known errors disclosed by Monash IVF raise questions about potential issues at other clinics that do not have the same reporting obligations, the medical negligence expert argued.
He said Monash IVF could be exposed to lawsuits for failing in its duty of care to the patient, on top of breach of contract if the couple signed an agreement setting out which embryo was due to be transferred.
The two separate errors disclosed by Monash IVF were "up there in terms of severity" compared to other previously known industry errors, he said, including embryos being damaged after trays were dropped in laboratories.
"It's inexcusable," Mr Opare told AAP.
Pink Elephants support group founder Samantha Payne was concerned about the impact on other couples undergoing IVF and called for a wider discussion about how clinics are run.
"You'd be terrified if you were going through a round of IVF now," she said.
A second embryo blunder from a major private fertility clinic has raised fresh fears about system flaws.
Staff at a Monash IVF laboratory in Melbourne on Thursday transferred the wrong embryo to a woman, giving her one of her own rather than one from her partner, as they had requested.
The pair is believed to be in a same-sex relationship.
The company, which is based in Melbourne but has clinics around Australia, apologised to the couple and launched an internal investigation.
But the Victorian Health Regulator has swooped in with its own probe of Monash IVF and how the error occurred at its Clayton site.
State Health Minister Mary-Anne Thomas said the mistake was "completely unacceptable" and the company must provide answers.
"This will be quite devastating for the couple at the heart of this," she told reporters on Tuesday.
"We all know that the IVF journey can be a very long, torturous one. It can be very expensive as well."
In a notice to the stock market, Monash IVF said it would set up additional verification processes and patient confirmation safeguards.
It has informed the Reproductive Technology Accreditation Committee certifying body and insurers, declaring it expects the mix-up to fall within its insurance coverage.
The company's profit guidance remains unchanged but the news sent its share price tumbling by more than 26 per cent to below 55 cents as of 3pm AEST.
Monash IVF revealed in April a woman at a Brisbane facility had another patient's embryo incorrectly transferred to her because of "human error".
The mistake was picked up in February after the birth parents asked for their remaining embryos to be transferred elsewhere and an extra embryo was found in storage.
Monash IVF apologised, expressed confidence it was an isolated incident and hired leading barrister Fiona McLeod to lead an independent review, which has now been expanded.
Alex Polyakov, a fertility specialist at Melbourne's Royal Women's Hospital, said the latest stuff-up was also likely because of human error.
He said the mistake in Melbourne was easier to make than the one in Brisbane but equally serious.
"You have the couple's names on every embryo," the Genea Fertility Melbourne medical director told AAP.
"It's not just the patient or the egg provider, it's also their partner.
"I could see how this would happen."
About one in 18 babies is born via IVF in Australia.
Associate Professor Polyakov said the two transfer errors were the first he was aware of in Australia since the IVF industry began operating 40 years ago, although there have been high-profile cases in the US and Israel.
He called for more vigilance and extra layers of protection but conceded no system could be made foolproof from a "black swan event".
Shine Lawyers medical law Victorian practice lead Daniel Opare said alarm bells should be ringing across the industry.
Known errors disclosed by Monash IVF raise questions about potential issues at other clinics that do not have the same reporting obligations, the medical negligence expert argued.
He said Monash IVF could be exposed to lawsuits for failing in its duty of care to the patient, on top of breach of contract if the couple signed an agreement setting out which embryo was due to be transferred.
The two separate errors disclosed by Monash IVF were "up there in terms of severity" compared to other previously known industry errors, he said, including embryos being damaged after trays were dropped in laboratories.
"It's inexcusable," Mr Opare told AAP.
Pink Elephants support group founder Samantha Payne was concerned about the impact on other couples undergoing IVF and called for a wider discussion about how clinics are run.
"You'd be terrified if you were going through a round of IVF now," she said.
A second embryo blunder from a major private fertility clinic has raised fresh fears about system flaws.
Staff at a Monash IVF laboratory in Melbourne on Thursday transferred the wrong embryo to a woman, giving her one of her own rather than one from her partner, as they had requested.
The pair is believed to be in a same-sex relationship.
The company, which is based in Melbourne but has clinics around Australia, apologised to the couple and launched an internal investigation.
But the Victorian Health Regulator has swooped in with its own probe of Monash IVF and how the error occurred at its Clayton site.
State Health Minister Mary-Anne Thomas said the mistake was "completely unacceptable" and the company must provide answers.
"This will be quite devastating for the couple at the heart of this," she told reporters on Tuesday.
"We all know that the IVF journey can be a very long, torturous one. It can be very expensive as well."
In a notice to the stock market, Monash IVF said it would set up additional verification processes and patient confirmation safeguards.
It has informed the Reproductive Technology Accreditation Committee certifying body and insurers, declaring it expects the mix-up to fall within its insurance coverage.
The company's profit guidance remains unchanged but the news sent its share price tumbling by more than 26 per cent to below 55 cents as of 3pm AEST.
Monash IVF revealed in April a woman at a Brisbane facility had another patient's embryo incorrectly transferred to her because of "human error".
The mistake was picked up in February after the birth parents asked for their remaining embryos to be transferred elsewhere and an extra embryo was found in storage.
Monash IVF apologised, expressed confidence it was an isolated incident and hired leading barrister Fiona McLeod to lead an independent review, which has now been expanded.
Alex Polyakov, a fertility specialist at Melbourne's Royal Women's Hospital, said the latest stuff-up was also likely because of human error.
He said the mistake in Melbourne was easier to make than the one in Brisbane but equally serious.
"You have the couple's names on every embryo," the Genea Fertility Melbourne medical director told AAP.
"It's not just the patient or the egg provider, it's also their partner.
"I could see how this would happen."
About one in 18 babies is born via IVF in Australia.
Associate Professor Polyakov said the two transfer errors were the first he was aware of in Australia since the IVF industry began operating 40 years ago, although there have been high-profile cases in the US and Israel.
He called for more vigilance and extra layers of protection but conceded no system could be made foolproof from a "black swan event".
Shine Lawyers medical law Victorian practice lead Daniel Opare said alarm bells should be ringing across the industry.
Known errors disclosed by Monash IVF raise questions about potential issues at other clinics that do not have the same reporting obligations, the medical negligence expert argued.
He said Monash IVF could be exposed to lawsuits for failing in its duty of care to the patient, on top of breach of contract if the couple signed an agreement setting out which embryo was due to be transferred.
The two separate errors disclosed by Monash IVF were "up there in terms of severity" compared to other previously known industry errors, he said, including embryos being damaged after trays were dropped in laboratories.
"It's inexcusable," Mr Opare told AAP.
Pink Elephants support group founder Samantha Payne was concerned about the impact on other couples undergoing IVF and called for a wider discussion about how clinics are run.
"You'd be terrified if you were going through a round of IVF now," she said.
A second embryo blunder from a major private fertility clinic has raised fresh fears about system flaws.
Staff at a Monash IVF laboratory in Melbourne on Thursday transferred the wrong embryo to a woman, giving her one of her own rather than one from her partner, as they had requested.
The pair is believed to be in a same-sex relationship.
The company, which is based in Melbourne but has clinics around Australia, apologised to the couple and launched an internal investigation.
But the Victorian Health Regulator has swooped in with its own probe of Monash IVF and how the error occurred at its Clayton site.
State Health Minister Mary-Anne Thomas said the mistake was "completely unacceptable" and the company must provide answers.
"This will be quite devastating for the couple at the heart of this," she told reporters on Tuesday.
"We all know that the IVF journey can be a very long, torturous one. It can be very expensive as well."
In a notice to the stock market, Monash IVF said it would set up additional verification processes and patient confirmation safeguards.
It has informed the Reproductive Technology Accreditation Committee certifying body and insurers, declaring it expects the mix-up to fall within its insurance coverage.
The company's profit guidance remains unchanged but the news sent its share price tumbling by more than 26 per cent to below 55 cents as of 3pm AEST.
Monash IVF revealed in April a woman at a Brisbane facility had another patient's embryo incorrectly transferred to her because of "human error".
The mistake was picked up in February after the birth parents asked for their remaining embryos to be transferred elsewhere and an extra embryo was found in storage.
Monash IVF apologised, expressed confidence it was an isolated incident and hired leading barrister Fiona McLeod to lead an independent review, which has now been expanded.
Alex Polyakov, a fertility specialist at Melbourne's Royal Women's Hospital, said the latest stuff-up was also likely because of human error.
He said the mistake in Melbourne was easier to make than the one in Brisbane but equally serious.
"You have the couple's names on every embryo," the Genea Fertility Melbourne medical director told AAP.
"It's not just the patient or the egg provider, it's also their partner.
"I could see how this would happen."
About one in 18 babies is born via IVF in Australia.
Associate Professor Polyakov said the two transfer errors were the first he was aware of in Australia since the IVF industry began operating 40 years ago, although there have been high-profile cases in the US and Israel.
He called for more vigilance and extra layers of protection but conceded no system could be made foolproof from a "black swan event".
Shine Lawyers medical law Victorian practice lead Daniel Opare said alarm bells should be ringing across the industry.
Known errors disclosed by Monash IVF raise questions about potential issues at other clinics that do not have the same reporting obligations, the medical negligence expert argued.
He said Monash IVF could be exposed to lawsuits for failing in its duty of care to the patient, on top of breach of contract if the couple signed an agreement setting out which embryo was due to be transferred.
The two separate errors disclosed by Monash IVF were "up there in terms of severity" compared to other previously known industry errors, he said, including embryos being damaged after trays were dropped in laboratories.
"It's inexcusable," Mr Opare told AAP.
Pink Elephants support group founder Samantha Payne was concerned about the impact on other couples undergoing IVF and called for a wider discussion about how clinics are run.
"You'd be terrified if you were going through a round of IVF now," she said.

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‘Completely unacceptable': Minister lashes Monash IVF after second embryo transfer bungle
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The Melbourne mix-up comes just six weeks after Victoria's Health Regulator renewed the licence of several Monash IVF centres, including its Clayton clinic. Health Minister Health Mary-Anne Thomas slammed Monash IVF and said it was required to fully co-operate with an investigation from the regulator. 'Families should have confidence that the treatment they are receiving is done to the highest standard,' Thomas said. 'It is clear Monash IVF has failed in delivering that – which is completely unacceptable.' Last year, Monash IVF paid $56 million in compensation to settle a class action involving 700 families over a bungled genetic test, which may have cost dozens of families the chance to have children. Loading President of the Fertility Society of Australia and New Zealand Dr Petra Wale moved to reassure the public that Australia's assisted reproductive technology (ART) systems were among the 'safest, most transparent, and tightly regulated in the world'. 'Although the embryo transferred was the patient's own, we acknowledge the emotional toll this has taken and extend our heartfelt sympathies to those involved,' Wale said. 'While these incidents are deeply difficult for those affected, they are exceedingly rare and must be taken seriously, without losing sight of the overwhelming positive contributions made by the sector.' Victoria's 24 licensed ART clinics are required to report all adverse events to Victoria's Health Regulator. But while it details the number of adverse events relating to 'clinical' errors, the regulator does not provide additional details, such as whether incorrect embryos have been transferred. IVF pioneer Professor Gab Kovacs, who was the medical director of Monash IVF before retiring more than a decade ago, said the sheer number of ART procedures taking place made it likely that mix-ups would occur on rare occasions, and it was unlucky that Monash IVF had been involved twice in such a short period. 'It is human error and it will happen again, it's just because Monash IVF is a public company that any adverse incident has to be reported to the exchange, so they become public,' Kovacs said. 'Probably, there are other mix-ups at other clinics that we don't know about. 'It is sad news for everybody, for the patients involved, for the staff who made the mistake, and for the company. Loading 'It is impossible to avoid human error. Unfortunately, while there are humans working things will go wrong.' University of Melbourne Associate Professor Alex Polyakov, who is also the medical director at Genea Fertility Melbourne, said greater transparency was required to limit the chances of errors reoccurring. 'If an incident like this comes into [the] public domain for whatever reason, it would be important for the regulator to provide information to clinics as to the specifics of the incident,' he said. 'We need to know why it happened, how it happened, and how to prevent it from happening in the future. I think that's the role of the regulator.' No.1 Fertility owner and medical director Dr Lynn Burmeister said the latest incident required deeper examination. 'Patients trust that when they are with a clinic, there are watertight procedures in place to protect them,' she said. 'With more than one such incident now identified, it is time for an independent review into how this could have occurred.' Monash IVF's share price began trading on Tuesday at 74 cents, but dropped to 54 cents following disclosure of the Clayton embryo error.

Second IVF bungle admitted by major Australian clinic
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Samantha Donovan: First this evening, a major Australian in vitro fertilisation clinic has admitted once again to mistakenly transferring the wrong embryo to a patient. It's the second time in three months that Monash IVF has admitted to making an error. In the earlier incident, a Queensland woman unknowingly gave birth to somebody else's baby. The news has prompted an outcry, with those currently going through IVF calling for better regulation of the sector. Rachel Mealey reports. Rachel Mealey: It seems an unlikely place to admit to a mistake like this, but because Monash IVF is a listed company, it made the announcement to the Australian Stock Exchange. The statement said it had mistakenly implanted the wrong embryo in a patient. Victorian Health Minister Mary-Anne Thomas says the mistake is unacceptable. Mary-Anne Thomas: So it appears that Monash IVF, which is a private fertility service here in Victoria, has not followed the treatment plan that was agreed with a couple that are receiving treatment from them. Now this is completely unacceptable. Rachel Mealey: Today's admission comes just two months after Monash IVF said it was responsible for a Brisbane woman giving birth to a baby who was genetically unrelated to her. In the latest incident, a patient's own embryo had been implanted instead of one created from her partner's egg. Mary-Anne Thomas says the Victorian Health Regulator will begin an immediate investigation. Mary-Anne Thomas: This will be quite devastating for the couple at the heart of this. I mean, we all know that the IVF journey can be a very long, torturous one. It can be very expensive as well. And to not be respected, not have your treatment plan followed, I can't even really imagine how that couple are feeling right now. But I want them to know that my thoughts are with them. Rachel Mealey: The Federal Health Minister Mark Butler has also flagged more regulation of the IVF sector and says he's put the topic on the agenda for this week's Health Ministers' Meeting. Associate Professor Alex Polyakov is the Medical Director of Genea Fertility and a fertility specialist from the University of Melbourne. Alex Polyakov: I do know that all the labs in Victoria and in Australia in general would have very similar protocols for these things. There are two embryologists identifying all biological samples when they're transferred. We check with the patient when the embryo is about to be transferred. And so I still feel that the system, while it may appear to be broken, actually works very well. But unfortunately those two incidents came to light in a very short period of time. Rachel Mealey: He says the latest incident involves a same-sex couple who've both generated embryos, and that's added a layer of complexity to the case. Alex Polyakov: What I can understand from the media release from Monash is that they both had IVF and created embryos from both sets of eggs. And the embryos usually belong to a couple. And so then they express the preference for a particular embryo to be transferred to one of the partners. And that instruction may not have gotten through unaltered from the doctor to the lab or from the lab to the patient. And so the couple received their own embryo. It just wasn't from an egg that they specified. Rachel Mealey: Sarah Jefford is a fertility law expert. She says systems need to be reviewed to reassure anyone currently going through IVF. Sarah Jefford: I think the clinic and all fertility clinics really need to be concerned about making sure that their treatment is accurate. We're really playing with people's lives here and not just the patients themselves but any person born. And that there's not really a lot of room for error. I know that all clinics have their protocols for making sure they're using the right eggs and sperm and embryos. But when mistakes like this happen, they have lifelong consequences for everyone involved. Rachel Mealey: She says there's room for a national regulator within the sector. Sarah Jefford: At a national level, we don't actually have consistent laws around fertility treatment. Every state and territory has their own laws. And there is no national regulator in that respect. We do have the National Health and Medical Research Council which distributes ethical guidelines. But we also generally allow for clinics to manage their own protocols and treatment standards. We don't have anything at the national level that really regulates them. Samantha Donovan: That's fertility law expert Sarah Jefford. That report from Rachel Mealey.

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