After the incident at its fertility center near Cleveland last year, University Hospitals described in a letter to patients a problem with its Custom Biogenic Systems tank similar to those in the previous incidents. Its letter stated that the tank’s automatic filling system had “difficulty” and was “not working.”
Again, no warning or alert from the FDA.
Custom Biogenic Systems responded to NBC News queries last year with a series of statements. The company denied that issues with the auto-filling mechanism of its tank at University Hospitals constituted a “malfunction” or an underlying “technical problem,” questioned University Hospitals’ method for filling the tank with liquid nitrogen, and noted that an alarm system was off.
The company also noted that the United Kingdom alert “involved a prior design of the unit which was discontinued in 2003,” and was later withdrawn by regulators. It also claimed that the incident at the University of Florida Health facility “was caused by human error,” contrary to media reporting at the time, which was affirmed by a University of Florida Health spokesperson in an email to NBC News.
Custom Biogenic Systems has not yet replied to an NBC News query for this story.
Amy Sparks, president of the Society for Assisted Reproductive Technology and director of the University of Iowa Health Care’s In Vitro Fertilization and Reproductive Testing Laboratory, said there was no source of information for fertility center managers or the general public to find out whether storage tanks had technical issues or had been involved in previous “adverse events.”
“There needs to be monitoring,” Sparks said. “I don’t know that [regulation is] the avenue. You could still have the FDA approve the tank and the lab fail to do due diligence in monitoring and filling it.”
“It would be very helpful to have full knowledge of why things go wrong,” she added.
“I feel incredibly sad for these patients,” Sparks said, her voice catching. “Just know that there are a lot of us that are working very hard to improve things.”
The incident at the Pacific Fertility Center in San Francisco involved a storage tank manufactured by Georgia-based Chart Industries Inc.
The center sent patients who lost reproductive material an email more than a month later, telling them that the findings of an investigation indicated that the incident “likely involved a failure of the tank’s vacuum seal.”
According to an amended complaint in a federal lawsuit filed on behalf of the patients, four days after the date of that email, April 23, 2018, “Chart recalled several of its cryopreservation tanks, citing ‘reports of a vacuum leak or failure that could compromise the product.’”
NBC News searched for publicly available alerts about the Chart recall and found none from the FDA or other U.S. agencies, but there were several on government regulatory websites of other countries, including the actual recall document, posted on the Kingdom of Saudi Arabia’s Food and Drug Authority’s National Center for Medical Devices Reporting.
Although the technical problem described to the Pacific Fertility Center’s patients and in the recall notice seem similar, Chart Industries CEO Jillian Evanko said that “the tank involved in the incident at the Pacific Fertility Center was not part of the recall.”
Two months after the incident at the Pacific Fertility Center, a Chart Industries tank that had been part of that recall allegedly malfunctioned in Canada, according to a public filing by the company with the U.S. Securities and Exchange Commission.
According to the filing, that alleged failure has led to “purported class action lawsuits filed in the Ontario Superior Court of Justice against the company and other defendants.”
Chart is also one of the defendants in a class action lawsuit filed in the U.S. District Court for the Northern District of California, involving the incident at the Pacific Fertility Center.
In a new public filing with SEC last month, Chart stated that the tank in that incident “has been out of our custody for the past six years” since “it was sold to the Pacific Fertility Center through an independent distributor.”
Pacific Fertility Center is also a defendant in that lawsuit. Pacific Fertility Center did not respond to an NBC News email and phone call.
In its online “Cryopreservation” catalog for the product line that includes the exact model of liquid nitrogen freezer storage tank involved in the incident at Pacific Fertility Center, MVE 808AF-GB, Chart Industries describes a primary intended use as the storage of semen and embryos, but for the agricultural breeding industry.
“The MVE Stock Series,” the catalog description states, “provides the ultimate in security for the breeding industry and are primarily used to store semen and embryos.”
HAS ANYTHING CHANGED?
With no immediate plans for increased oversight or regulation, American consumers — and some embryo laboratory directors who are not privy to internal industry reporting — have been left in the dark about previous adverse incidents and warnings about storage equipment and practices.
Wendy and Rick Penniman filed one of at least 82 lawsuits against University Hospitals over the loss of their three embryos, which they had planned to use to create siblings for their two children.
Wendy Penniman said the disclosures about equipment malfunctions and lab mismanagement made public by the incident, and the subsequent media reports and litigation, have changed her views from a year ago.
After going through the initial stages of grief and sadness, she said, now she is angry.
“After the incident, it was like, ‘Oh, it must have been an accident,’” she said. “There’s a lot more visibility now into culpability.”
“It’s changed my perspective on the fertility industry as a whole, and on University Hospitals,” Wendy Penniman said. “It makes you bitter.”
You have to go into this with the assumption that any structure can fail. We just have to have something in place so that the inevitable failure of the tank will not result in the loss of an embryo.
Dr. Zev Williams
A University Hospitals spokesperson said the hospital system “is limited” in what it can say because of pending litigation, but expresses sorrow in a statement given to NBC News. The statement reads in part, “… we have made significant enhancements at the Fertility Center, provided affected patients with ongoing, free fertility services tailored to their individual clinical needs, and we continue to reinforce a culture that encourages our physicians, nurses and staff to speak up when they see ways to further increase the quality of care we provide to patients.”
Fertility center operators elsewhere have also begun to react to the damage to their reputations.
“Lab directors started thinking, ‘Could this happen here?’” said Barb Collura, president of RESOLVE: The National Infertility Association, a national patient advocacy organization.
Collura said she noticed clinics highlighting safety protocols and backup plans on their websites within days of the breakdowns in California and Ohio.
In the months after last year’s incidents, members of the American Society for Reproductive Medicine worked with the accrediting organizations to update the checklists.
The revised checklists added more specific questions probing how facilities using liquid nitrogen storage tanks measure and monitor levels to make sure they are correct, and whether they have backup systems, including empty-but-prepared “standby” tanks in case the primary tanks fail.
Sparks, of the University of Iowa, said those actions were in direct response to the March 2018 incidents to include more specific questions about monitoring and measuring levels of liquid nitrogen in storage tanks.
“Those are some of the things that the inspectors are now looking for,” she said.
The College of American Pathologists released its revised checklists last August.
Accredited labs had previously been required to have “an emergency procedure to provide backup units with adequate storage capacity” in case the ones in use fail.
But the CAP’s revised checklists added new requirements, including that facilities visually inspect storage tanks, and monitor liquid nitrogen levels continuously, as well as maintain enough additional liquid nitrogen supplies onsite to fill a backup unit.
The new checklists also add a requirement that laboratories show how the alarm system works and how they will respond to alarms. They also have to check the alarm systems at least four times a year, an increase from the previous annual requirement.
The American Society for Reproductive Medicine is also developing practice guidelines for the storage of reproductive material at very low temperatures, including in liquid nitrogen tanks, which could prompt other changes in how fertility centers handle and store it.
A senior official with knowledge in the cryostorage industry, speaking on condition of anonymity, told NBC News that industry groups are now working with trade associations to develop new standards for the tanks and their monitoring and maintenance.
“There are a lot of additional potential safeguards that could be in place that I think the industry is moving towards,” the official said.
One center says it has created a new safeguard already. The Columbia University Fertility Center in New York has developed a second, redundant monitoring system in addition to temperature alarms. The new system weighs storage tanks to determine if levels of liquid nitrogen are falling.
“When you have even a little bit of nitrogen left, the temperature is still perfect,” Dr. Zev Williams, director of the center, explained. “It’s only when the nitrogen is essentially completely gone that the temperatures start to rise.”
The laboratory tested the system on unused tanks, recreating various types of malfunctions. The scales, it found, were able to detect problems a month before temperature-based alarms did — before the liquid nitrogen was almost depleted.
“That gives you time to identify the problem, fix it, and there’s no harm caused,” Williams said.
“It’s scary to think that currently (in other labs), the first alarm is when the temperature is not optimal,” he added.
The Columbia University Fertility Center uses storage tanks manufactured by Chart Industries — the same company that made the tank that malfunctioned at the Pacific Fertility Center.
Williams said any tank used in any lab might become compromised. “You have to go into this with the assumption that any structure can fail. We just have to have something in place so that the inevitable failure of the tank will not result in the loss of an embryo,” he said.
PATIENTS SEEK ANSWERS
Deborah Anderson-Bialis, 33, and her husband, Jake, of San Francisco, struggled to start a family and went to three different fertility laboratories. The process was draining — emotionally and financially. Just one in vitro fertilization round can cost an estimated $20,000, and many patients go through more than one round.
“The mindset of people trying to conceive and can’t — it’s really dire,” Jake Anderson-Bialis, 39, said. “Your relationship may be on the ropes. The life that you’re shooting for isn’t unfolding like you had hoped. Money and time feel like they’re flying out the window.”
“You’d imagine there’d be a great resource to lead you through probably the most important decision in your life, which is how you’re going to have a healthy child,” he said. “But what’s out there available to patients — and we suffered from this — is really a diet of information that’s full of inaccuracies.”
The mindset of people trying to conceive and can’t — it’s really dire. Your relationship may be on the ropes. The life that you’re shooting for isn’t unfolding like you had hoped. Money and time feel like they’re flying out the window.
To address the problem, the couple started an online platform called FertilityIQ. Its mission is to educate fertility patients — no matter where they are in their process of planning a family. The website relies on verified patient experiences. To date, it has more than 300,000 patient participants, with 26,000 reviews on fertility physicians.
The couple ended up having two children on their own, without the help of IVF. Their son, Lazer, is 2 and their daughter, Yara, just turned 1. But they’d always imagined using three embryos they’d stored at a fertility center back in 2013. The couple has chosen not to identify the laboratory, and has not taken legal action.
Deborah was home, nursing Yara, when an email from one of the centers they’d visited came through at 4 a.m. one day last March.
“Writing to inform you about a very unfortunate incident in the laboratory…” the email began. The couple’s embryos were no longer viable — destroying their hopes of adding to their family.
Deborah says the moment was surreal.
But unlike so many other heartbroken, would-be parents who had lost eggs or embryos, she felt lucky. “Thank God, I am holding this baby,” she recalled saying.
A year later, Katelynn Gurbach, who learned of the malfunction from that Facebook post, has settled her lawsuit with University Hospitals. She still dreams of becoming a mother. But her vision of motherhood has changed. She is reluctant to go through the assisted fertility process again.
“Eventually, I will adopt if that’s what God’s plan is,” she said. “I don’t know, maybe I am called to be a foster mom and will get to bless lots and lots of children.”