WHAT CONSUMERS NEED TO KNOW BEFORE GOING TO A FERTILITY CLINIC

In two separate incidents this month, equipment failures at fertility clinics have destroyed thousands of frozen eggs and embryos — and potentially many patients’ hopes of becoming parents. But these debacles have a silver lining: they’ll help clarify the legal gray area surrounding fertility treatments such as in vitro fertilization, experts say.

More than 4,000 frozen eggs and embryos were affected by the incident at University Hospitals Fertility Center in Cleveland in early March, the hospital said in a letter sent to patients this week, nearly twice as many eggs and embryos than initially estimated. A remote alarm system on a storage tank had been turned off, leaving the clinic’s staff unaware that the temperature was rising in the tank.

Days after the incident in Ohio, Pacific Fertility Center in San Francisco experienced a similar malfunction in which a loss of liquid nitrogen in a tank allowed the temperature to rise. As in the Cleveland case, thousands of eggs and embryos were potentially destroyed in the mishap, though the center said that some tissue stored in the tank was still viable. “Our patients and the safety of their eggs and embryos are our highest priorities,” the center said in a statement.

Cryopreservation, as the process of freezing eggs and embryos is formally known, has become an extremely lucrative industry in recent years. In particular, egg freezing has caught on particularly among women who are having children later in life. And some employers have offered to offset the costs of these procedures for their workers for years now.

Since 2009, the number of women who’ve elected to freeze their eggs has grown from 900 to an estimated 76,000 total, according to Time magazine.

The process is expensive: retrieving and freezing eggs costs anywhere from $7,000 to $15,000 per cycle, though some clinics offer discounts to patients who go through multiple cycles. Patients then must pay an annual fee of between $350 and $1,500 to store their eggs or embryos. And when it’s time to go through in vitro fertilization, that will cost between up to around $5,000.

Here’s what to know before considering it:

Understand the risks involved in cryopreservation

Malfunctions like those in Ohio and California are extremely uncommon, experts say. “Tank failures are extremely rare and devastating for all involved, but obviously most distressing for patients actively planning to have a family using stored embryos or eggs that may not be viable,” said Susan Crockin, a lawyer and scholar at Georgetown University’s O’Neill Institute for National and Global Health Law.

Aside from those types of mishaps, prospective patients should be aware of other risks. “Some risks may simply be inherent to the process and may not be an indication of error,” said Margaret Swain, a lawyer and director of the Assisted Reproductive Technology practice at the American Academy of Adoption and Assisted Reproduction. These include:

• Not having enough high-quality eggs to freeze

• Embryos not developing normally or being unsuitable for freezing

• Embryos and eggs not surviving the pre-fertilization or pre-transfer warming process

And even if the freezing process is successful, that’s not a guarantee of a successful pregnancy. In 2015, less than half — 44% — of women under 35 who used in vitro fertilization with frozen eggs had a successful pregnancy within a year, according to the Society for Assisted Reproductive Technology. For women over the age of 42 though, the live birth rate was only 24.4%.

There are also other risk factors associated with human error beyond tank-related issues, Swain said. Eggs and embryos can be mislabeled or power outages could affect tanks, for instance.

Don’t expect laws to protect you when something goes wrong

There are very few laws outlining what precaution fertility clinics must take during the cryopreservation process and what, if any, recourse patients have if problems arise, said Mary Catherine Barrett, an assisted reproductive technology and adoption attorney in Cleveland, Ohio. “We’re still in the wild, wild West,” Barrett said. “When things like this happen, that’s what establishes the law. We will probably be creating new laws about this in the coming years.”

Generally speaking, Barrett said any lawsuits arising from the two most recent incidents would most likely be personal injury, and not wrongful death, cases.

Patients’ legal outcomes will depend on the paperwork they signed at the beginning of the treatment process. Patients and IVF physicians are supposed to discuss the risks associated with cryopreservation and sign an “informed consent” document afterward, Swain said. “The details contained in this document may be a factor in determining exactly what remedies may be available to patients who have lost stored eggs or embryos because of a storage mishap,” Swain said.

Ask the fertility clinic as many questions as possible

Mishaps and malfunctions are rare, but there are resources available to help patients do their due diligence and ensure that a fertility clinic is up to snuff. Consumers considering egg or embryo freezing should determine whether a facility is a member of the Society for Assisted Reproductive Technology — this group has a set of standards that clinics must meet to join.

Furthermore, they should ask whether the clinic follows the standards laid out in the the Fertility Clinic Success Rate and Certification Act of 1992. Prospective patients can also find out a given clinic’s success rate through the Centers for Disease Control and Prevention’s website.

And consumers should ask to see the clinic’s policy regarding labeling tissue, fail-safes and emergency plans, Swain said. They should also ensure that the clinic notifies patients when materials are being moved to a different tank or if they become damaged. “Compliance with industry guidelines and recommendations, including informed and thoughtful preparation for any emergency is the best defense against loss of irreplaceable eggs and embryos,” Swain said. “The consumer should ensure that the fertility center and any subsequent storage facility have fully complied with those safeguards.”