Monash IVF hit with conditions after Melbourne embryo mix-up

Victoria’s health regulator has ordered Monash IVF to ensure genetic material is clearly tracked after the fertility giant mistakenly transferred the wrong embryo into a patient.

The Victorian Health Regulator said it would also require Monash IVF to implement “rigorous verification and patient checks” and better record-keeping.

The conditions were announced on Friday in response to a high-profile bungle in which a Melbourne patient’s own embryo was mistakenly transferred to her in June, during a procedure in which she was supposed to receive her partner’s embryo.

This mix-up came two months after Monash IVF was forced to admit that an error at its Brisbane clinic resulted in a Queensland woman giving birth to a stranger’s baby.

As part of its investigation, the regulator met with Monash IVF several times, conducted site visits and ordered the IVF company to hand over documents, which the company complied with.

In a statement to the ASX on Friday, Monash IVF went into further detail about the regulator’s conditions, and said it included specific actions for confirming the intended biological sources for each IVF cycle, and staff training.

Monash IVF said it would also undergo periodic auditing and reporting to the Victorian Department of Health.

The fertility giant said it had already implemented the health regulator’s conditions.

It said “enhanced safety protocols” had been introduced following the company’s internal investigation into the bungle and the independent review conducted by high-profile barrister Fiona McLeod, SC.

Monash IVF said it did not expect the conditions to have a material impact on existing operations or the company’s earnings forecast.

“The company will continue to prioritise the care and safety of its patients and will keep ASX informed of any material developments in accordance with its disclosure obligations,” it said.

Health Minister Mary-Anne Thomas said Monash IVF had failed to deliver assisted reproductive treatment to the highest standard.

“The conditions will remain in place until the health regulator is confident that Monash IVF has met its compliance obligations,” Thomas said.

Associate Professor Neera Bhatia, the director of Deakin University’s law, health and society research unit, said public confidence in IVF clinics was at an all-time low.

“People don’t have confidence that the gametes [egg and sperm] being transferred are their actual gametes,” she said.

She said the conditions imposed on Monash IVF sounded quite broad, and there was a need for greater oversight and a wholesale review of the fertility sector.

“This would help to ensure that the profound and significant risks and harms that have eventuated don’t occur again,” she said.

Dr Petra Wale, the president of the Fertility Society of Australia and New Zealand, said the two mix-ups at Monash IVF had distressed the families involved and shaken public confidence.

Wale said the current accreditation and licensing system, administered by the Reproductive Technology Accreditation Committee, was constrained and reduced the ability of authorities to respond swiftly to issues.

But despite these concerns, Wales insisted that Australia’s fertility services were among the safest and most effective in the world.

Michel Margalit, the managing principal of Margalit Injury Lawyers, said she continued to hear heart-wrenching stories of substandard IVF treatment by providers across Australia.

Her firm ran a successful class action lawsuit against Monash IVF after the fertility giant was accused of incorrectly classifying embryos as abnormal in 2019 and 2020 due to faulty genetic testing.

“There have been significant problems with the standard of medical care provided by Monash IVF for over five years,” Margalit said.

Karin Hammarberg, an adjunct senior research fellow at Monash University, said all fertility clinics should be required to meet the same conditions imposed on Monash IVF.

“The whole identification of who gets what in IVF couldn’t be more important,” she said. “We are dealing with life-changing treatments and if things go wrong, they are life-long.”

In September, federal Health Minister Mark Butler announced that an independent accreditation system would be established for IVF clinics as part of a push to boost transparency.

The accreditation system was the recommendation of a rapid review of the fertility sector announced in June following two separate embryo mix-ups by Monash IVF. It will be provided by the Australian Commission on Safety and Quality in Health Care and rolled out by January 2027.

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