There are growing calls for tighter regulation of US fertility clinics after a string of devastating mix-ups, as advocates describe the US$2 billion-a-year industry as a "Wild West".
Mistakes at centres across America have resulted in some heart-wrenching situations, such as a woman unknowingly giving birth to the babies of two couples who were complete strangers — a bungle branded the "worst embryo-related tragedy in history" — and a faulty temperature alarm on a clinic's freezer resulting in the destruction of more than 4000 eggs and embryos.
Now high-profile lawsuits are shining a light on the lucrative and mostly self-regulated industry, as a lack of transparency makes it ripe for negligence and abuse.
Currently, fertility clinics in the US are required to report some statistics, such as success rates, to the Centres for Disease Control and Prevention (CDC), but there are no consequences if they do not comply. The CDC also does not request information on many aspects, such as incidents of genetic samples being destroyed, rendering it almost pointless.
The Food and Drug Administration (FDA) regulates the drugs and medical devices used in assisted reproductive technology (ART) clinics, but almost everything else, like processes and practices, falls outside FDA jurisdiction.
Research by the University of San Diego recently found that in the US, the ART industry "operates free of regulation about serious and preventable kinds of errors … such as the destruction, contamination, misdiagnosis, and switching of materials".
"Elsewhere in healthcare delivery," the report said, "these kinds of mistakes — surgery on the wrong body part or patient, for example — are publicly reported … but no system exists to track similar transgressions when they take place at fertility clinics, sperm banks, egg vendors or surrogacy agencies."
According to American law firm Peiffer Wolf Carr & Kane, which specialises in representing families affected by fertility clinic misconduct, the US "imposes more local, state, and federal oversight of nail salons" than it does fertility clinics, resulting in "a near Wild West situation".
One reason for this hands-off approach, according to a recent US report, is a 1995 law that stops the US Department of Health and Human Services from funding the creation or destruction of human embryos for research purposes.
Advocates are calling for an independent regulatory body like the UK's HFEA, which imposes, among other things, reporting procedures, lab inspections and licensing requirements.
In Australia, there is less oversight than in the UK. However, fertility clinics operate under national guidelines and a mandatory accreditation that intersect with laws at the state level.
Australia's Reproductive Technology Accreditation Committee (RTAC) has provided a quality assurance scheme for the industry, and ART clinics are also required to be accredited and to be compliant with National Health and Medical Research Council ethical guidelines.
But in America, where ART is responsible for more than 69,000 births a year, experts fear if the industry remains unchecked as it continues to grow — there are currently almost 500 fertility centres across the country — easily preventable mistakes will continue to devastate families.
Last Christmas, Rebecca Cartellone, 24, decided to buy DNA testing kits from a popular website for her and her family to trace their ancestral roots. A bit of lighthearted fun became a shattering bombshell when Ms Cartellone and her parents Jennifer and Joseph, from Ohio, learned the 24-year-old shared no DNA with her father.
Rebecca was conceived at the Institute for Reproductive Health in Cincinnati in 1994, where the family now alleges Mr Cartellone's sperm was swapped with someone else's when the couple underwent fertility treatment.
"Never in my worst nightmare did I think that the Christmas gift of DNA testing for my family would unveil this kind of abuse of our trust by the very professionals from whom we sought help," Mr Cartellone said.
"Rebecca's DNA has none of my or my Italian family's genetic make-up. She has no idea who her biological father is. She knows nothing about half her biological background."
He added his wife Jennifer was "profoundly disappointed that she can no longer give birth to a child with both of our genetics" but said the most devastating impact of all is on Rebecca, who has experienced serious psychological distress as she grapples with her identity.
The Cartellones have demanded to know the identity of Rebecca's biological father.
"As consumers, we think of fertility clinics as highly professional organisations governed by strict rules and staffed by caring experts, and some of them are indeed well-meaning and well-run," Cartellone family lawyer Adam Wolf said.
"But the truth is that some of them are simply businesspeople making billions of dollars in profits. The bottom line is that self-regulation for fertility centres is just not working."
'THE WORST EMBRYO-RELATED TRAGEDY IN HISTORY'
Last month, a New York couple came forward about the horrifying mix-up whereby the woman gave birth to baby boys she believed were their own biological twins — only to discover they were of a different ethnicity.
The babies have since been reunited with their biological parents, leaving the New York couple, who spent $US100,000 ($A143,600) on fertility treatment, with "permanent emotional injuries from which they will not recover".
They are now suing the fertility centre, along with Anni and Ashot Manukyan, one of the other couples embroiled in the debacle.
The "heartbreaking" mix-up occurred in August last year when the embryos of three separate couples, who were all being treated at the Los Angeles CHA Fertility Centre on the same day, were implanted into the wrong women.
Anni and Ashot Manukyan, who are biological parents of one of the baby boys, revealed that not only was their embryo given to the wrong person, Anni was implanted with yet another stranger's embryo in its place. However, this procedure did not result in a pregnancy.
The Manukyans, of Glendale, California, are now suing the Los Angeles CHA Fertility Centre after the clinic placed two embryos — one belonging to them and one to another couple — into the woman from New York.
The shocked parents, who also have an older daughter, said they didn't even know that they had a son until after he was born on March 30.
Disturbingly, they were only able to meet their biological son Alec more than a month later after winning a turbulent custody battle.
Alec was 6 weeks old by the time they met him for the first time, an encounter that happened in the lobby of a hotel.
"Who wants to meet their child in the lobby of a hotel?" Anni said through tears at a press conference last month.
"It was heartbreaking. It was terrible," she sobbed. "It is important to us as a family that this never happens again."
This story was first published on news.com.au.