Heartbreak, anxiety, lawsuits: The egg-freezing disaster a year later

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noted that the United Kingdom alert “involved a prior design of the unit which was discontinued in 2003,” and was later withdrawn by regulators.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.”

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