Last month, an in vitro fertilization (IVF) embryo mix-up that allegedly led two women to unknowingly deliver each other's baby made national news. Both women had undergone egg retrieval, implantation, and full-term pregnancy in 2019 only to give birth to—and bring home—another family's child.
"Every time I felt a kick or spoke to her, it was someone else's baby," Daphna Cardinale shared during a November news conference. She's one of the mothers who underwent IVF at a reproductive health center in California and later discovered she'd given birth to and brought home the wrong baby girl. "We came to [IVF] with incredible vulnerability and trust in our doctor and in the process. We had no idea at the time that this greatest potential for joy would bring us such enduring pain and trauma."
What-Patients-Should-Know-About-Fertility-Clinics-and-Their-Room-for-Error-GettyImages-924297554 . What did that mean about the whereabouts of their own embryo? They wondered if their embryo had also been implanted in the wrong woman. A few weeks later, the Cardinales and the other couple affected by the mix-up learned that they had been implanted with each other's embryo. Eventually, the couples switched back their biological children and, living just 10 minutes from each other, have remained close, according to PEOPLE.
Now, Cardinale and her husband are suing their fertility clinic for medical malpractice, negligence, and fraud for the alleged mix-up, PEOPLE reports. They're suing the owner of the clinic, too, as he also owns the third-party embryology lab to which the clinic allegedly outsourced the handling of the embryo. Whatever the case outcome, the couple's trauma will stay with them. "It was torture that shook me to my core and forever changed who I am. I was robbed of the ability to carry my own child," Cardinale said during the conference.
It's no wonder families might think twice about trusting fertility centers after hearing a story like this. But many people who struggle with infertility, who want to preserve their fertility through egg retrieval and freezing, or who visit a fertility center for a multitude of other reasons have no choice but to put their trust in medical professionals and hope they'll get it right. So what can you do to protect yourself from this kind of error when visiting a fertility clinic? Here's what experts say.
How common are fertility center errors?
Errors happen in every arena of medicine—and embryology is no exception. The thing is, there's no way to compare the error rates of fertility centers vs other medical practices. That's because while success rates of assistive reproductive technology (ART) centers are a matter of public record, there's no public database that accounts for errors, in part because it is an area of medicine that's practiced and paid for privately, Josephine Johnston, a lawyer with a master's degree in bioethics and health law and the director of research at The Hastings Center, a New York-based nonprofit bioethics research institute, tells Health. (For what it's worth, absence of data around error rates isn't uncommon in other areas of medicine. For example, "dermatologists aren't asked to report errors," Johnston notes.)
Chances are, whatever errors involving IVF mix-ups or failure may happen probably fly under the radar. "We don't routinely do genetic testing on IVF babies as a follow-up to an IVF birth; we don't know how often mix-ups happen," Johnston says. And because there are many instances when patients just don't get pregnant from intrauterine insemination or IVF, it's often impossible to tell whether a clinic is to blame. "There is a good amount of mystery in what makes an assisted reproductive cycle work, so we're always dealing with probabilities."
Despite the dearth of genetic testing after IVF, there are other routine tests, like blood type testing, that could tip a parent off to an embryo mix-up, James Grifo, MD, PhD, director of the NYU Langone Health Fertility Center, tells Health. (He did not treat the Cardinales and has no ties to their fertility center or case.) Dr. Grifo hasn't seen a single blood test deliver unwelcome results.
That's not to say the Cardinale's case was one-of-a-kind.
"I've seen hundreds of misconduct cases," Adam Wolf, partner at the California-based law firm Peiffer Wolf Carr Kane & Conway and the lawyer representing the Cardinales, tells Health. Wolf has helped patients seek retribution from fertility centers that have destroyed eggs and embryos without permission, dropped eggs and embryos on the ground, and fertilized eggs with the wrong sperm. He's even sued doctors who've inserted their own sperm into patients without consent. "When something goes wrong, it goes seriously wrong," he says. "It causes lifelong consequences to the victims."
Fertility doctors are well-aware of what's at stake here. "We have the great privilege of being able to change people's lives, and we have to respect it," Dr. Grifo says. "It's a huge responsibility we take on every day." With 30 years of experience and an estimated 50,000 IVF cycles under his belt, he's never had a patient report an embryo mix-up. "This specialty is filled with serious doctors who recognize one of these errors could harm a patient and their family, but also themselves. If you make one mistake, your life is changed forever. Most people in our field feel very, very strongly about making sure they are never featured in one of these stories."
The most critical thing, Dr. Grifo says, it to keep things in perspective. "There have been millions of babies born through IVF," he says. "While any number of errors isn't acceptable, I'd estimate there's no more than one in as many as five million."
Who’s making sure fertility centers are doing the right thing?
When families like the Cardinales make the news, it's natural to call for more regulation in the ART industry to protect unsuspecting patients. But "ART is already one of the most highly regulated of all medical practices in the United States," according to the American Society for Reproductive Medicine (ASRM), a nonprofit that works toward advancing reproductive science and medicine.
The Centers for Disease Control and Prevention (CDC) collects and publishes success rates of individual fertility clinics, which are publicly available; the US Food and Drug Administration maintains control of drug approvals, including those involved in the IVF process, and has jurisdiction over the screening and testing of reproductive tissues, like donor eggs and sperm; the Centers for Medicare & Medicaid Services is responsible for laboratory test quality, all according to ASRM. On the state level, all doctors need to be licensed to practice.
And as is the case in many medical communities, there's also a fair amount of self-regulation in the ART industry. Reproductive specialists must be MDs who are certified by the American Board of Obstetrics and Gynecology or the American Board of Urology after completing residency training and passing examinations. Accreditation from the College of American Pathologists (CAP) only goes to facilities that follow ethical guidelines and best practices set forth by ASRM. CAP also offers a reproductive laboratory accreditation program for embryology labs designed to "make laboratory processes more fail-safe and reduce risk of errors in patient identification, specimen labeling, handling of embryos and gametes and cryo storage conditions to protect your patients," according to the CAP website. The Society for Assisted Reproductive Technology (SART), which is comprised of reproductive technology industry members, monitors the member clinics of its affiliate, ASRM, to make sure they're upholding best practices.
On-site, peer-based inspections conducted by practicing professionals who've taken a CAP inspector training program occur every two years to assess compliance; complaints may prompt additional investigation, which could lead to CAP's Complaints and Investigations Committee putting the clinic on probation, which could lead to that clinic's accreditation being revoked, according to Richard Scanlan, MD, a fellow of CAP and chair of the CAP Council on Accreditation.
When it comes to safety, the secretary of Health and Human Services develops non-federal embryo laboratory certification programs for states to follow voluntarily since embryology doesn't fall under any federal regulation but some parts of reproductive medicine—like andrology and endocrinology—do, according to Dr. Scanlan. Separately, CAP/ASRM and SART have released guidelines on best practices for how many embryos to transfer to avoid multiple births, which increases the risk of complications in birthing people and their fetuses.
So how do errors still occur with all this oversight? "The overarching guidelines are voluntary and enacted through voluntary organizations via opt-in," Wolf explains, who claims to see the guidelines "violated constantly."
But don't forget that fertility clinics themselves are highly invested in avoiding slip-ups. After all, one mistake could destroy a clinic's reputation and eliminate a doctor's entire career. "Procedure and policy are absolutely critical to error reduction," Dr. Grifo says. "It's about having systems in place that protect you from making human error and having backups to those systems so errors are caught before they're a problem."
In Dr. Grifo's place of work, patients are engaged in identifying themselves and their embryos by looking at their own charts and confirming their names and birthdays. "No embryo is touched without two people cross-referencing and identifying it," he says. "Errors don't happen when you follow high-quality practices. I have a 30-year track record of not making a mistake."
Let’s talk accountability
Because there is no public errors database, the media is often the only record-keeper when a clinic's mess-up makes the news. The thing is, Google results aren't always enough to keep clinics accountable. "I've settled so many cases with confidentiality agreements that no one would know about a lot of them," Wolf says, suggesting that there's literally no way to find out about certain clinics' misdoings.
By and large, experts that Health spoke to agree that the best way to improve ART industry safety and create more accountability for fertility center errors is overarching insurance coverage for infertility treatments, which are still seldom covered by insurers. This would put insurers in a position of power to require adherence to ASRM guidelines in exchange for coverage—and deter practitioners from implanting multiple embryos, a practice that may stem from a patient's financial pressure since one IVF cycle can run six figures out-of-pocket, Johnston says.
And there's no question as to whether a public record of error rates could help patients protect themselves—and incentivize fertility clinics to do better. After all, minimizing fertility center errors begins with understanding how things go wrong in the first place, and it's not necessarily as simple as pointing a finger at a careless lab technician. "Systems and human error go together," Wolf says. "If you have the right protocols in place and you follow them, it should minimize instances of human error. Fertility centers owe it their customers to have safeguards in place."
Expert tips to help you pick a responsible fertility clinic
Hearing about the recent news may be unsettling for you. But remember: You can be your own advocate. Wolf and Johnston agree that ticking the following boxes can help you find the safest possible fertility clinic:
- Get a referral. Make sure that referral is a consensus, Johnston suggests. Whether you're relying on a Facebook group, anonymous message board, or Yelp reviews, it's best to get multiple perspectives on your primary fertility doctor and the overall facility before making an appointment.
- Check accreditation. While accreditation doesn't necessarily guarantee every facility employee follows every guideline, it's one way to make sure a clinic is committed to quality-control and quality-management procedures and meets federal regulations that pertain to the particular laboratory's services. You can look up a clinic to see whether it's one of the 350 that are CAP-accredited here.
- Prioritize volume. Although you might think a smaller practice might lead to more attention to detail, Johnston suggests that practitioners who handle a higher volume of patients may be preferable. "I'd encourage any person considering IVF to look at the CDC records of ART success rates and go to a clinic that does a lot of cycles per year [relative to alternative local options] since a high volume suggests there are good systems in place," Johnston says.
- Make sure you're heard. You should look for a clinic where you feel respected and heard—where you feel like the medical providers listen to you and take your needs seriously—rather than a busy one where you feel lost inside.
- Take success rates with a grain of salt. Although success rates largely depend on which patients a clinic chooses to take, you should look for a success rate that's higher than the national average for your age group in any given year, Johnston says. Although clinics may be mindful of their success rates in order to stay competitive, the numbers offer a limited picture since there's no way to tell whether a clinic messed up in the cycles that didn't lead to pregnancy.
- Avoid clinics known for multiple pregnancies. "Choose a clinic that is experienced without a terribly high multiple birth rate, which suggests they aren't being careful or following good practices," Johnston says. This number should be lower than other options in your area.
- Google it. While this won't surface unlisted information, it will help you sidestep certain clinics that have garnered bad press.
- Ask away. "Clinical success rates don't tell you about negligence or when standard practice wasn't followed," Johnston says. "But customers can ask about the systems used to prevent errors." When asking questions, you'll want to be specific. "You don't just need to know the overall risk, you need to know the risk of it happening at your clinic," she says, adding that you should be directing questions toward senior staff rather than a receptionist.
Wolf acknowledges that it's not always easy for a patient to ask a well-intentioned doctor tough questions. "It could come across as antagonistic or make them feel like you have reservations about their abilities," he says. But it's the only way to gauge a clinic's safety—assuming you get answers, since doctors aren't legally required to share the information you probably want to know. If they do answer, though, they have to do so honestly. "Otherwise, they're committing fraud," Wolf says.
Dr. Grifo says he welcomes patients' questions—bring them on. "I wouldn't be insulted if a patient asked me about my facility's error rates," he says. "My job as a doctor is to serve patients. There's no treatment without trust."
The experts say to ask these questions to cover your bases:
- Have you/this clinic ever misplaced or lost an embryo?
- Have you/this clinic ever been accused of discarding an embryo without permission?
- Have you/this clinic ever transferred the wrong embryo into someone?
- What procedures are used for tracking eggs, sperm, and embryos?
- What procedures do you use to reduce embryo loss during freezing and thawing?
- What protocols are in place for freezer alarm system response during and outside of business hours?
- When was the last time [any procedural risk you're concerned about, like an egg retrieval uterine wall puncture] happened at this clinic?
At the end of the day, many of us need modern medicine to have children, meaning we have to put our trust in whoever we chose. So it's a good thing that there many, many fertility clinics with well-intentioned doctors who do life-changing work. "It's an incredible industry that allows people to have families that they would otherwise not be able to enjoy," Wolf acknowledges.
That said, it's important to advocate for yourself and remember that, sometimes, it's just hard for certain couples to get pregnant. "Just because it takes multiple rounds of an awful process that can be physically draining and disappointing doesn't mean a clinic has messed up," Johnston says. "Human error is probably not the biggest factor."
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