Fertility sector regulation in spotlight after second Monash IVF embryo mix-up
Fertility company Monash IVF has reported a second major bungle in which the wrong embryo was implanted into a woman, prompting governments to urgently examine regulation of the sector.
State and federal health ministers will meet on Friday to urgently discuss regulation of the IVF sector after listed fertility company Monash IVF reported a second mix-up that resulted in the wrong embryo being implanted in a woman.
Monash IVF on Tuesday morning notified the Australian Stock Exchange of its latest bungle, confirming it had mistakenly transplanted a Melbourne patient’s own embryo to her instead of her partner’s embryo as the couple had planned. The incident occurred at the company’s Clayton laboratory last Thursday.
Federal Health Minister Mark Butler described the event as “incredibly distressing”, while his Victorian counterpart, Mary-Anne Thomas, said it was “completely unacceptable”.
The second incident comes just two months after the heartbreaking revelation in April that a woman in Brisbane had given birth to a child unaware that she had been mistakenly implanted with another couple’s embryo.
That error was discovered only after the baby was born, when the birth parents requested their remaining frozen embryos be transferred to another IVF provider. Both couples were understood to be heartbroken, and considering their legal options.
News of the second incident sent Monash IVF shares plummeting on Tuesday, down from 74c at the start of the day to 55c at the close. In August last year the company was trading at $1.42, and in April, ahead of the public disclosure of the Brisbane error, it was at $1.08.
After the first incident the ASX demanded Monash IVF explain why the error wasn’t disclosed to shareholders when the company first became aware of it.
Monash on Tuesday morning issued a statement to the ASX apologising to the couple over the second error, saying the incident would be investigated.
“Monash IVF has extended its sincere apologies to the affected couple, and we continue to support them,” the statement said.
“Monash IVF is conducting an internal investigation into the incident. It has also extended the scope of the independent review being conducted by Fiona McLeod AO SC in relation to the Brisbane incident, noting that the different incidents occurred some years apart.
“Commencing immediately, Monash IVF will implement interim additional verification processes and patient confirmation safeguards over and above normal practice.”
Mr Butler said that in the wake of the latest incident he and state and territory ministers would discuss “regulation of the sector” at their meeting on Friday.
“It is incredibly distressing that this has happened to another family,” he said. “My heart goes out to them. This should never have happened.
Mr Butler said the federal government would monitor the progress of the independent review and he expected its findings to be made public.
Ms Thomas said families should be confident they were receiving the highest standard of fertility treatment.
“It is clear Monash IVF has failed to deliver that, which is completely unacceptable,” Ms Thomas said.
She said Victoria’s Health Regulator would be investigating the incident.
“Monash IVF are required to co-operate fully with this investigation and provide clear answers on how this happened” she said.
Monash IVF said it had disclosed the latest incident to the Reproductive Technology Accreditation Committee, the industry’s certifying body, and the Victorian Health Regulator.
The RTAC falls under the Fertility Society of Australia and New Zealand. Its president, Petra Wale, released a statement on Tuesday saying Australia’s fertility care system “is among the safest, most transparent and tightly regulated in the world”.
“Our thoughts are with the family directly affected by this event. 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,” Dr 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.”
Shine Lawyers medical law practice leader Daniel Opare said the latest mistake could potentially lead to a civil claim, including for psychological harm.
“You can only imagine the impact of receiving news like that we’ve seen from these recent failures. It could be life-shattering,“ Mr Opare told the Herald Sun.
“Alarm bells must be ringing across the industry. Regulators and providers clearly have work to do to ensure these mistakes stop happening.”
University of South Australia bioethicist Hilary Bowman-Smart said “trust is everything” in reproductive care.
“This mix-up, the second reported incident at Monash IVF, risks shaking confidence not just in one provider, but across the entire fertility sector,” Dr Bowman-Smart said.
“As more and more people are turning to commercial IVF providers when they make reproductive decisions, we need consistency and oversight in regulation across Australia. Accountability and transparency are critical to maintain trust.”
Consultant obstetrician and University of Melbourne clinical associate professor Alex Polyakov said the “report of a second embryo transfer error is profoundly troubling and, while still extremely rare, shifts this issue from an isolated anomaly to one demanding broader reflection”.
“Although human error can never be entirely eliminated, incidents like this are not indicative of widespread system failure,” Associate Professor Polyakov said. “Instead, they highlight the need to review how even robust systems respond to rare but serious breaches.”
To join the conversation, please log in. Don't have an account? Register
Join the conversation, you are commenting as Logout