The IVF industry is under the microscope after Monash IVF apologised for a second embryo bungle. How rare is a mistake?
Monash IVF has admitted to two IVF bungles at labs in Brisbane and Melbourne. (AAP image: James Ross)
The IVF industry is under the microscope after major fertility provider Monash IVF apologised for a second embryo bungle.
Days after the company told the stock market about the latest case, its chief executive officer resigned.
It followed revelations in April that one of Monash IVF's Brisbane patients had been mistakenly implanted with another woman's embryo in 2023 and gave birth to a baby who had no genetic links to her later that year.
An independent review is ongoing.
Approximately 20,000 babies are born from IVF treatment in Australia every year, according to the Australian and New Zealand Assisted Reproduction Database.
So, what is the process, what are the checks and balances, and how rare are such bungles?
During IVF treatments, an egg is fertilised with sperm in a lab before being implanted into the uterus. (Supplied: Adobe)
What is IVF?
In vitro fertilisation — or IVF — is one of the most common assisted reproductive technology procedures (ART).
The process involves collecting a donor or patient's eggs, then fertilising them with sperm in a Petri dish in a lab.
A fertilised egg — known as an embryo — is then implanted into the woman's uterus.
What are the checks and balances?
Fertility educator and IVF patient advocate Lucy Lines has previously worked as an embryologist — a scientist who specialises in developing embryos.
She says whenever eggs, sperm or embryos are moved in the lab, the dishes and paperwork are all labelled with the patient's name, their ID number, and date of birth.
In some labs, they are allocated a colour code as well, she says.
"At minimum, there are three points of reference for each client inside the lab," she says.
"So then when anything is moved from one dish or tube to another dish or tube, a second embryologist will come along and audibly repeat [the patient's name, date of birth, and the ID number].
"That is the historical way that it was done.
"In some labs they've added an extra level, a barcode that requires a scanner to read the barcode, or in some other labs they have an RFID (Radio Frequency Identification) label, which has an auto-reader on the bench top or workspace and that reader will sound if there are things on that bench that don't match each other."
Advocates are urging parents considering IVF to "arm yourself with knowledge" about the process. (AP: Sang Tan)
What are the regulations?
It varies.
There are more than 40 "different pieces of legislation" governing ART and IVF across the country, according to the Fertility Society of Australia and New Zealand (FSANZ).
For example, laws to regulate ART providers in Queensland only passed parliament last year.
By comparison, Victoria has had laws in place for years.
FSANZ’s Reproductive Technology Accreditation Committee (RTAC) is responsible for setting performance standards and granting licences to fertility providers across the country.
The society and RTAC are currently operated on a "volunteer basis by professionals within the sector who have taken on additional responsibilities".
FSANZ is calling for the establishment of RTAC as an independent statutory authority to "strengthen oversight and trust in the sector".
That is backed by the Victorian Health Minister Mary-Anne Thomas who said yesterday it was concerning that the body that currently accredits fertility care providers is made up of fertility care providers.
Yesterday, all Australian states and territories agreed to undertake a review into the implementation of an independent verification body for fertility providers.
What are there calls for?
There are growing calls for national fertility legislation to replace the "fragmented" state and territory laws and provide "consistent, enforceable standards".
IVF activist Anastasia Gunn is among those pushing for change.
Anastasia and Lexie Gunn's three sons were conceived through the IVF process. (Four Corners: Ron Foley)
"We're asking for federal legislation of the industry, which the industry itself are asking for that," she says.
"We're asking for a federal donor conception registry [as] historically gametes and embryos have been moved interstate.
"Donor conceived people have a right to know their biological and medical history if they choose to.
"We're choosing to ask for external regulation of the industry."
Are embryologists registered?
No, there is no licensing or registration of embryologists in Australia — unlike other professions such as doctors and nurses.
It is something the FSANZ would like to see changed.
"We continue to advocate for robust professional recognition of embryologists in Australia — both to uphold standards and to protect the public," a FSANZ spokesperson said in a statement.
"The medical laboratory professionals in Australia chose to set up this self-regulated scheme because the Australian Government decided not to include Medical Scientists and Technical Officers in the professions covered by the Australian Health Practitioner Regulation Agency (AHPRA) when it was established in 2010.
"Most comparable countries do have formal regulation of Medical Scientists and Technical Officers to protect the public and set minimum standards for ongoing assessment of competency and continuing professional development.
"It would require the Australian Government to legislate mandatory registration."
How often do these mistakes happen?
The industry insists they are rare.
But others — such as Sydney Law School lecturer Christopher Rudge — acknowledge it is also difficult to know without specific data.
"The recent history of IVF mistakes and errors is somewhat clouded by reported settlements, private settlements, so it is hard to know the true frequency of these errors," Dr Rudge told the ABC earlier this week.
Monash IVF is a publicly listed company, which means it has "disclosure obligations".
Monash IVF has made two statements to the ASX regarding embryo mix-ups in as many months.
Over the past two months, it has made statements to the ASX — and its shareholders — about the two embryo incidents.
However the ASX also issued Monash IVF a 'please explain' about the timing of the Brisbane announcement — which came weeks after the company said it became aware of the mix-up.
Monash IVF's chief financial officer said the company did not expect the bungle would affect its share price "as it was an isolated incidence of human error".
The company's share price plummeted from $1.08 to 69 cents after the Brisbane bungle was made public in April.
An independent review is ongoing into two separate IVF bungles at Monash IVF this year. (Supplied: Adobe)
What should patients be asking their clinic?
Ms Lines says it was complex.
"My only answer is, if you're looking down the barrel of IVF, arm yourself with the knowledge of what's actually involved … so that you can empower yourself to ask the questions that you need the answers to," she says.
"As a culture, we're very used to going to our doctor and doing what we're told. You should be doing that, but you should also be an active participant in your care."