Monash IVF keeping details of embryo mix-up a secret. Even the minister thinks that’s not good enough

The federal health minister has joined fertility advocates in calling for Monash IVF to end its secrecy and publicly reveal its findings into two embryo mix-ups in different states.

In an announcement to the Australian stock exchange on Wednesday, Monash IVF confirmed Fiona McLeod, SC, had completed her review into cases of patients being implanted with the wrong embryos at its Brisbane and Clayton clinics, but it has provided few details of the report’s findings.

The fertility giant said the review had found “human error” was at the heart of both embryo mix-ups, but refused to release further details of the findings or recommendations, claiming patient privacy must be protected.

Anger at continued secrecy over how the bungles occurred, and what steps are needed to ensure they are not repeated, amplified calls from patient advocates and others within the fertility sector for a new national regulator to force clinics to be more accountable.

Federal Health Minister Mark Butler also called for greater transparency from Monash IVF.

“Monash IVF should make their report public to keep faith with families across Australia,” Butler told this masthead.

“This was a very distressing series of stories, and it should never have happened to these families.”

After news of the second Monash IVF embryo bungle was disclosed in June, Australia’s health ministers launched a rapid review of the regulation and accreditation arrangements governing the assisted reproductive technology (ART) sector and IVF clinics.

The Victorian government is leading the review to identify opportunities for improvement and action, and Butler said ministers will consider the outcomes “in the coming months, as a matter of priority”.

Monash IVF initially commissioned McLeod to conduct an independent investigation on March 4, after it became aware in February that an embryo transfer error at its Brisbane facility had resulted in a Queensland woman giving birth to a stranger’s baby.

Within two months, the company asked McLeod to expand the review after the company admitted a different woman had been implanted with the wrong embryo during a procedure at its Clayton clinic on June 5.

In Wednesday’s announcement to the ASX, the company said the review found that although there were stark differences in the circumstances of the embryo bungles at its Brisbane and Clayton clinics, human error was at the heart of both incidents.

Monash IVF said the review found that the two incidents were unrelated, different in nature and had occurred years apart. It found that both of the cases involved non-standard IVF treatment and circumstances that would not typically arise in the majority of procedures.

It said McLeod had found that the Brisbane incident was the result of human error alone.

She found that the Clayton mix-up had resulted from a range of factors, including human error at multiple stages, as well as limitations in the IT system. The review found that those limitations ultimately made the transfer process more vulnerable to human error.

Acting chief executive Malik Jainudeen said the company had already implemented many of the independent review’s recommendations, and it was committed to implementing the remainder of the proposed measures – but he did not reveal details of what the recommendations or measures were.

“To the affected patients and everybody who entrusts Monash IVF with their dreams of building a family, we are deeply sorry for the distress these incidents have caused,” he said.

“We have implemented, or will be implementing, the recommendations of the independent review and have taken additional measures to reduce the risk of such incidents occurring in the future because the care and safety of our patients is and will always be at the heart of everything we do.”

The Fertility Society of Australia and New Zealand (FSANZ) – which acts as a self-regulator for the fertility industry – said that because Monash IVF was a publicly listed company it was legally obliged to release market-sensitive information to the stock exchange. It means the ASX takes greater priority than regulators or health authorities.

“This can mean that critical information of great public interest is made available to financial markets before it has been properly reviewed by the Reproductive Technology Accreditation Committee (RTAC), or health regulators,” FSANZ said.

“This gap highlights a serious weakness in Australia’s regulatory framework for assisted reproduction. Currently, oversight varies state by state and does not provide a uniform national safeguard. To strengthen transparency and protect patients, FSANZ believes a national approach is required.

“This would ensure that findings from serious incidents are notified to the peak body and regulators prior to market announcements, so that responses can be coordinated in the public interest.”

Fertility patient advocate Michelle Galea, who established the support group Assisted Reproductive Treatment Families, said the government must listen to pleas for greater transparency into IVF clinics.

“These are not isolated incidents – Monash IVF is not the only clinic where serious mistakes have occurred,” she said.

“We are creating humans. There are more embryo mix-ups than reported publicly. Many families are silenced by non-disclosure agreements and claims that the IVF clinics are protecting their privacy, but the government must demand full transparency.”

Dr Sarah Lensen, research fellow with Melbourne University’s Department of Obstetrics and Gynaecology, said Monash’s IVF’s failure to release more information about the errors undermined confidence in the wider fertility sector.

“I think it’s disappointing that Monash IVF hasn’t given more detail about how the embryo mix-up occurred. The transparency would go a long way to reassure the public that our Australian IVF clinics are putting patient interests ahead of all else,” she said.

“While the clinic has cited privacy considerations, it is difficult to see how a clearer explanation of the nature of the error would necessarily compromise the privacy of the individuals involved.”

A Victorian government spokesperson said Monash IVF had agreed to engage an independent external expert to provide oversight and assurance of its systems and processes separate to the McLeod review, over which the department-based health regulator would have oversight.

“The Victorian health regulator’s investigation into the recent incident at Monash IVF is ongoing. Monash IVF are required to cooperate fully with this investigation and provide clear answers on how this happened,” the Victorian government spokesperson said.

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