Experts weight in on Monash IVF embryo mix-up

A second embryo mix-up has raised fresh concerns over clinical safeguards and regulatory oversight in Australia’s fertility sector. In a statement to the ASX, Monash IVF admitted, “a patient’s own embryo was incorrectly transferred to that patient, contrary to the treatment plan which designated the transfer of an embryo of the patient’s partner.”

This latest incident follows a high-profile case earlier this year, in which a woman gave birth to a genetically unrelated child after an embryo mix-up at a Monash IVF clinic in Brisbane – an event that drew national attention and prompted scrutiny of IVF protocols.

Experts say the latest failure is no longer just an isolated event, but a signal that the industry must face uncomfortable truths.

“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,” said Associate Professor Alex Polyakov, Gynaecologist and Fertility Specialist at the Royal Women’s Hospital, Melbourne, and Medical Director of Genea Fertility Melbourne. “This should prompt open investigation, continued transparency, and renewed commitment to patient safety. Australians can remain confident that the systems governing IVF are strong, and that they will continue to evolve in response to emerging challenges.”

The question now confronting the sector is whether Australia’s regulatory frameworks and compliance mechanisms are fit for purpose or in urgent need of overhaul.

A/Professor Kuldip Sidhu, co-founder and director of CK Cell Technologies and Conjoint with UNSW Medicine, warned that “continued mishappenings in IVF are of serious concern to patients, and it calls for more rigorous compliance required for this industry.”

He pointed to international comparisons, noting that “while in New Zealand, embryologists are registered with the Health Practitioners Competence Assurance Act, there is no such provision in Australia for embryologists, and they are not currently registered under a national scheme. This would help in adding another layer of responsibility to check such mishappenings in the IVF industry. Although NATA oversees the IVF industry in Australia, more stringent management for inventory is required to minimise the risk of mix-up by implementing ISO 9001 system more rigorously.”

Legal experts have also weighed in, highlighting the different regulatory environments across Australian states.

Dr Christopher Rudge, Deputy Director of Sydney Health Law Centre and Lecturer at the Sydney Law School, explained the legislative context. He said, “This error, which occurred in Victoria, is governed by the state’s Assisted Reproductive Treatment Act 2008, a legislative framework that has been in place for over a decade. By contrast, the error reported earlier this year at a Monash IVF clinic in Queensland occurred before Queensland’s new, more robust ART laws of 2024 became fully operative; previously, the industry in that state operated under what was described as a ‘self-regulatory regime’.”

According to Dr Rudge, this Victorian incident presents a much clearer case where the regulatory authority “…now the Secretary for the Department of Health, following the cessation of VARTA’s operations at the end of 2024, can fully exercise established monitoring and disciplinary functions. Critically, the Victorian Act mandates explicit patient consent for the specific kind of treatment procedure. Transferring an embryo different from the one designated in the treatment plan represents a breach of this consent requirement.”

He added that the law is equipped with real enforcement power, noting that the “Act empowers the Secretary to impose conditions on the ART provider’s registration or even suspend it if there are reasonable grounds for doing so, such as a contravention of registration conditions or a clear risk to patient welfare.

“The Victorian legislation also provides for penalties against designated officers for failures in their duties. This power to hold individuals accountable underscores the Department of Health’s crucial role in ensuring patient safety and upholding public confidence in ART services in Victoria.”

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