By REBECCA KRISPIN
Andrea*, 34, was alone when she went in for her third frozen embryo transfer at a Melbourne IVF clinic earlier this year. Her husband was away on a work trip.
She was shaky, but hopeful. This was just one of her three remaining embryos, and the expensive add-on tests she had paid for showed they were in good shape.
She wasn’t prepared for the news she received.
She had given permission for only a single embryo to be used for this transfer, but her specialist told her all of her embryos had failed to thaw.
“On that day I lost all three embryos and had nothing left … they defrosted three embryos without telling me or seeking permission,” she said.
She was unceremoniously ushered out the door.
“I was left walking back through the waiting room in tears,” she said.
Andrea followed up with her doctor and the head of the laboratory, but found they quickly shifted the fault onto her embryo quality in a “blame game”.
She never received a clear explanation about what happened that day, and has not yet made a formal complaint.
Andrea’s story is just one of many. Questions are emerging about poor practices and mistakes in IVF and other forms of assisted reproductive treatment (ART) in Victoria. The Health Complaints Commissioner (HCC) is in the final stages of an inquiry into ART, looking into "dodgy, dangerous and unethical practices", which is due to report in the next few weeks.
Similar concerns are being raised with the Victorian ART Association (VARTA), the state regulator. They are also appearing in recent government inquiries and reports, and in people seeking action under the law.
VARTA was notified of 80 adverse incidents - in which something went wrong during treatment - during 2018-19. According to its latest Annual Report, 58 of these related to clinical care, and 22 were in ART laboratories.
Of the clinical incidents, nearly half involved moderate to severe overstimulation of the ovaries from IVF hormones. This condition is painful and can result in hospitalisation, and even death, in severe cases.
The laboratory incidents included 14 cases of accidental embryo loss and five of egg losses.
VARTA’s figures reveal only one in every 300 ART cycles has an adverse incident. According to CEO, Louise Johnson, this means fertility treatment in Victoria is safe. Nearly 4,000 live babies were born here from ART during 2017-18.
But Ms Johnson also recognises IVF treatment is "emotionally and financially costly, and when human error occurs, it has an impact".
Joanne*, 40, experienced this impact during an IVF mishap at another Melbourne clinic. She longed for another child to complete her family, and had already undergone many cycles without success.
After several failed embryo transfers, a scan revealed she had a fluid-filled scar pocket from an old caesarean section in her uterus. This condition can prevent pregnancy, but her specialist insisted it was not a problem.
She was devastated when her last embryo was flushed away by this fluid and lost. This error was not acknowledged or followed up by the clinic.
Joanne has filed a complaint with the health commissioner.
The HCC inquiry was launched following reports published by an Independent Review of ART in Victoria during 2018-19.
The review highlighted “growing patient concerns with ART and its regulation over the last 10 years” and “a small number of cases of unethical practices”.
These included laboratory errors and equipment failures which led to embryo loss. There was also an incident in which a doctor knowingly transferred a non-viable embryo into a patient. In all of these cases, patients were not told the truth about what happened.
It also reported employees at some IVF clinics had been threatened with disciplinary action for speaking out about problems.
In addition, the review team found many ART mishaps were not reported by patients, who either didn’t know how to make complaints, or feared repercussions in their ongoing treatment.
The review recommended stronger protections for whistleblowers, better complaints handling and improved reporting of adverse incidents.
The government has yet to respond.
The HCC inquiry received more than 120 submissions, mostly from patients reporting problems.
At a public consultation session for the inquiry in Melbourne just before submissions closed in September, around 15 people shared their stories in an atmosphere of raw emotion.
Concerns raised included a black-market in donor eggs through unregulated websites, patients feeling like they were just a number in clinics performing thousands of IVF cycles per year, inadequate communication, poor support services, people selling their houses to pay for treatment, and clinical mistakes with devastating results.
ART patients are also raising treatment mistakes with lawyers. Some of Victoria’s biggest medical malpractice firms report receiving regular and increasing numbers of inquiries about ART mishaps.
According to Emily Hart of Maurice Blackburn, recent complaints have included laboratory and administrative mix-ups. Some of these led to the wrong tissue being used to create embryos, or the loss or destruction of embryos or gametes.
Clients have also complained about errors in procedures.
“Dropping embryos in the middle of transfer is not that uncommon,” she said.
Only about 10 percent of ART complaints can be investigated, Ms Hart said. The rest are people who feel angry or frustrated, but whose complaints are unlikely to result in any outcome.
Anne Shortall of Slater and Gordon said only a small number of ART cases proceed, and most of these settle out of court. Medical negligence cases are expensive to run, and carry the risk of legal costs being awarded against the complainant.
Compensation payouts in ART settlements don't usually exceed $200,000, Ms Shortall said. The exception is when the birth of a disabled child is involved, in which case compensation can run into the millions.
Dr Alex Polyakov, a fertility specialist at Melbourne IVF, said clinics generally try to pre-empt legal and other complaints by negotiating with affected patients. This often includes offers of free treatment cycles to compensate for errors.
This is in-line with the commercial nature of ART in Victoria, a multimillion-dollar industry that protects its business interests. The state’s eight ART providers include companies listed on the stock exchange, and those owned by overseas conglomerates.
But it is of little consolation for Andrea or Joanne, for whom the clinics failed to acknowledge mistakes or offer compensation.
However, Dr Polyakov said Victorian patients were protected from the most serious ART errors by stringent clinical, reporting and registration protocols. These protocols have thus far prevented disastrous mistakes, such as babies being born to the wrong parents, from happening here.
VARTA’s incident reporting protocols require clinics to report “any incident which is or is likely to be harmful to the health or wellbeing of patients, gametes or embryos”. This is part of the general conditions of registration for Victorian ART providers.
All Australian IVF clinics must also report “Serious Notifiable Adverse Events” to the Reproductive Technology Accreditation Committee (RTAC), the federal licensing body for ART providers in Australia and New Zealand.
Professor Michael Chapman is President of the Fertility Society of Australia (FSA), which oversees RTAC. He estimates only 10-20 serious adverse incidents are currently reported to RTAC per year Australia-wide.
This figure, which is much lower than VARTA’s, shows state and federal reporting criteria for adverse incidents are wildly different. It also indicates many ART mistakes are going unreported at a federal level.
Emma*, 36, experienced a serious treatment error when she moved to a bulk-billing IVF clinic in Brisbane, in a desperate bid to conceive after 12 failed cycles and embryo transfers at her previous clinic.
Her new specialist recommended Intracytoplasmic Sperm Injection (ICSI), a procedure in which sperm is injected into the eggs. This is used to increase fertilisation rates in couples with male factor infertility.
“I made it very clear that I needed to have ICSI this time, and all the nurses knew it,” she said.
“It was written on my file, in critical notes, highlighted, and I also made sure I repeated myself every time I went there, including on the very day of egg collection, I said it to two different nurses.”
But when Emma rang the clinic two days later to check the outcome, she was told just one out of the nine eggs collected had fertilised. The scientist apologised, and told her that they had failed to check her file and “forgot” to do ICSI.
“I couldn't believe what was happening, and I was devastated, more than ever before,” she said.
The clinic promised to investigate the mistake, but she never received any follow-up, and doesn’t know if the incident was reported.
Dr Polyakov said some degree of error in IVF is inevitable. There are currently more than 24,000 ART cycles performed per year in Victoria.
There is no doubt, on an international level, Australian standards for ART are high. Other countries are adopting our standards, and there are now Australian-certified ART providers in six Asian countries. Ms Johnson said this was due to Australia’s reputation for excellent ART care, stringent protocols and relatively low rate of adverse incidents.
But the complaints, inquiries and reports show there is room for improvement in reducing ART mistakes. These incidents can have a severe impact on patients already stressed by infertility and difficult treatments.
In the meantime, it is evident ART mistakes are not a deterrent to those seeking help to conceive. VARTA’s figures show nearly 13,000 people accessed ART in Victoria in 2018-19, and one in every 20 children in this state is now born with assisted reproduction.
After their mishaps, both Andrea and Joanne changed clinics to Dr Lynn Burmeister’s No. 1 Fertility. They are now both pregnant under the guidance of the renowned “baby whisperer”.
Emma was also recently surprised to discover she is finally pregnant, after many years of IVF.
“We are very happy,” she said.
*Names have been changed to protect the identity of patients.