By Grant McArthur
The emotional, legal and ethical fallout of a Monash IVF embryo mix-up is expected to take years to resolve, however, the clinic responsible might not face any penalties due to a gap in regulation.
Monash IVF confirmed it was supporting two families after a woman gave birth to a stranger’s baby due to an embryo mix-up caused by “human error” at its Brisbane fertility clinic.
Monash IVF said an embryo from a different patient had been incorrectly thawed and transferred to the birth parent.Credit: Getty Images
The fertility giant became aware of the bungle in February and notified both affected families, but it has released few other details of how the error occurred or whether all processes were followed during the bungled embryo transfer.
“An embryo from a different patient had previously been incorrectly thawed and transferred to the birth parents, which resulted in the birth of a child,” a Monash IVF statement released on Thursday said.
A Victorian government spokesperson said it had asked Monash IVF to explain how the incident had occurred.
“What’s happened in Queensland is absolutely horrifying. It is our strong expectation that the Queensland regulator is investigating this incident and will share its findings with Victoria,” the spokesperson said.
“We want all Victorian families to have confidence that the treatment they are receiving is done to the highest standard.
“The Victorian Health Regulator has requested information from Monash IVF about their operations and procedures to ensure they are following our strict rules and safeguards and to prevent an incident like this occurring here.”
Sources within Australia’s fertility and regulation industry have now raised questions about the appropriateness of Monash IVF’s safety measures.
In a response to questions from this masthead, Monash IVF said it “adheres to strict laboratory safety measures to safeguard and protect the embryos in our care”.
“Despite these rigorous protocols, the initial investigation into the incident has found that it was the result of human error,” the Monash IVF statement said.
“Monash IVF commissioned Fiona McLeod, AO, SC, to conduct an independent investigation into the incident, and we are committed to implementing all recommendations from this ongoing independent investigation.
“While we understand the public interest in this matter, the privacy of the families involved – including the child – has been our priority. The information we have provided regarding this incident has been done in a de-identified way.”
Under Australia’s complex health regulation system, each state and territory is responsible for licensing and regulating the fertility clinics operating in its jurisdiction.
But up to late last year, Queensland clinics had been operating with far fewer regulations and oversight than those in other states.
A senior source within Australia’s fertility regulation system, who was not authorised to speak publicly, described Queensland’s fertility oversight as “the Wild West of regulation”.
To beef up its oversight, Queensland parliament last year passed legislation in handing regulation of the assisted reproductive technology industry to Queensland Health from September 10, 2024.
But a Queensland Health spokesperson confirmed that although it had been advised of the embryo transfer mix-up in February, the incident occurred before the new regulation efforts were enacted.
“The Brisbane clinic became aware of the incident in February 2025 and it was reported to Queensland Health, as the new assisted reproductive technology (ART) regulator,” the spokesperson said.
“However, the embryo transfer occurred prior to Queensland Health becoming the ART regulator.
“We will work with Monash IVF to reinforce safeguards in their Queensland clinics and ensure any risks are identified and mitigated.”
Queensland introduced its strengthened ART regulation following a major investigation by the state’s Office of the Health Ombudsman found the state had low levels of regulation compared with other jurisdictions.
Having helped overhaul Victoria’s fertility industry oversight in 2019, lawyer Michael Gorton, AM, was commissioned by the health ombudsman to help investigate Queensland’s regulation system.
Speaking to this masthead following news of the embryo mix-up, Gorton said the new Queensland regulator would be able to take action to ensure Monash IVF did not present an ongoing risk to future clients, but would not be able to penalise the company for an incident that had occurred before the legislation was enacted.
“They can’t give it a slap over the wrist for what happened before, but I can take action to ensure it is meeting requirements now,” he said.
A review led by health lawyer Michael Gorton is prompting significant reform of the assisted reproduction industry in Queensland.
“In Victoria, you can take away their licence, and in NSW and most of the other states, there could be repercussions.
“But I think the greatest motivation here will be the legal case that comes out of it because it will be squillions.
“Monash says it is human error, but the whole point of the exercise is that you have systems and processes to prevent human error.
“You have double-checking of labels and other measures, so I do not know what the human error was, but they should have systems and processes to eliminate human error. That is the whole point.”
One of the world’s leading fertility clinics, Monash IVF spruiks it has “helped bring more than 50,000 babies into the world” since it was formed in 1971.
Gorton said that if the families could not resolve the highly emotional parenthood issues arising from the birth, it might ultimately fall to the Family Court to decide on an unprecedented matter.
“This is the first time it has occurred, and we have had IVF in Australia for more than 30 years. I am aware of reports of two cases in America, so it is incredibly rare,” Gorton said.
“The Family Court would have jurisdiction over parenthood, and the court would start with the presumption that the birth mother is the birth mother.
“It would be a landmark [case] because they would have to consider these particularly unique circumstances where the child is biologically the child of other people.
“They have never had to consider that before.
“The fact it may take several years for any custody case to get to court would also make the matter more heartbreaking and fraught, due to the long-term relationship the child would have established with its birth mother.
“The longer it goes on, the worse it gets.”
Multiple fertility clinics contacted by this masthead confirmed they use radio frequency technology to track the movement of embryos during the transfer processes to ensure no errors occur.
No.1 Fertility medical director Dr Lynn Burmeister said her clinics electronically tracked the movement of every embryo and gamete during every step of the transfer process.
“In addition to our highly trained staff manually double witnessing procedures, we utilise the industry-leading ‘RI Witness’ electronic witnessing system for every gamete and embryo movement in our laboratories, providing extra security for our team and peace of mind for our patients,” Burmeister said.
Monash IVF faces a huge financial hit over the bungle. Its share price dropped by 36 per cent on Friday, closing the day at 0.69¢, down from $1.07 on Thursday.
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.
The latest mix-up comes as Victoria’s Health Department evaluates licence extensions required to allow Monash IVF’s clinics to continue operating in the state, with current licences for its Clayton, Geelong, Sunshine, Sale and Cremorne clinics set to expire on April 30.
While a fertility clinic must be accredited by Australia’s Reproductive Technology Accreditation Committee, each clinic must also apply for a licence to operate in each state. As part of the licence review process, the secretary of the Health Department may impose specific conditions or even suspend a provider’s registration.
IVF pioneer Gab Kovaks, who was the medical director of Monash IVF before retiring a decade ago, said it was impossible to completely eliminate human error from the IVF process.
“It’s a terrible, life-altering citation for the two couples involved,” he said.
“Everyone has sympathy for them, but the next person who is probably suffering the most is the scientist who is involved in the mistake.
“If you look at the data, there are more than 100,000 cycles of IVF in Australia every year now, so every few years there will be some sort of human error mistake, and it has happened all over the world.”
Most previous incidents around the world have arisen by the incorrect sperm being used to fertilise an egg, rather than a completely incorrect embryo being transferred.
Kovaks said double-checking processes have always been the cornerstone of IFV process since the first procedures were undertaken, but the sheer volume of births now meant that mistakes would happen.
“I think it is inevitable that if you do large numbers of patients, and when people are doing it, and it is not robots, there will always be mistakes – unfortunate as it is for everybody concerned.”
Start the day with a summary of the day’s most important and interesting stories, analysis and insights. Sign up for our Morning Edition newsletter.