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More than three weeks after a tank failure at a fertility center in Cleveland, the Fertility Center of the University Hospitals now says that 4,000 frozen eggs and embryos were lost, twice as much as the hospital initially reported.
Nearly 1,000 patients at the University Hospitals Fertility Center are receiving letters apologizing once again and acknowledging some of the reasons for the which the storage tank failed. The hospital now blames humans for the loss of those frozen embryos and ova, some of which have been stored for decades.
At the same time, NBC News has discovered a history of malfunction in other tanks of the same manufacturer.
In shocking news for affected patients, it is unlikely, says the hospital in its new letter, that any stored ova and embryos will be viable.
In a detailed draft draft for NBC News, the University Hospital Fertility Center says the remote alarm system in the tank, which should have alerted an employee to changes in temperature, was closed. The center does not know who turned it off, but it was off during the weekend of March 3.
Despite the 11 miscarriages, Wendy and Rick Penniman had two healthy children with the help of the University University Fertility Center. But now, there is no hope of using their frozen embryos to have a third child.
"It's devastating, I think, for us, but it's more devastating because it takes something away from our children," said Wendy Penniman, 41.
Christina and Marc Ellis wanted to use their two remaining embryos in the center to give their daughter, now 2 years old, a brother.
"I do not know if I can continue the whole process again, and what will be the result?" Christina Ellis told NBC News. "
Both couples are now suing." So are at least 16 other groups of plaintiffs, all claiming negligence and breach of contract.
And there may be an underlying technical problem, one that has happened before.
An investigation by NBC News found that the The manufacturer of this particular storage tank, Custom Biogenic Systems, has a history of prior failures dating back almost 15 years.
In 2003, Rachel Southwood's husband, Andrew, had frozen sperm in the United Kingdom after The couple from Tauton, England, had a child and hoped they could have another.
"He gave the sample and, as far as we knew, we could potentially have more children," Southwood said. Ijo.
But less than a year later, the freezer that stored his sperm did not work properly, making the sperm no longer viable. Andrew Southwood finally died of cancer.
"They just said there had been a technical failure in the unit that stored my husband's sperm," said Southwood, who was 30 years old when the malfunction occurred.
In 2003, British regulators warned that freezers manufactured by CBS, a Michigan company, had problems with their automatic filling mechanisms.
The manufacturer is aware of 21 incidents "in the UK, regulators said.
" The alert was withdrawn, "according to a statement from the Regulatory Agency for Medicines and Health Products of the UK to NBC News. "The UK provider informed MHRA that 95% of the devices in the United Kingdom had been returned and updated. The other 5% will be completed in 2006. Therefore, this problem should no longer affect the United Kingdom. MHRA has not received any more reports since September 2005. "
But two years later, after the warning was issued for the first time, a similar incident occurred in Gainesville, Fla. Up to 60 male patients, many with cancer, they lost stored sperm when a tank manufactured by the same manufacturer failed.
Experts estimate that there are around 500 specialized clinics in assisted reproduction throughout the country, according to a 2015 report on the state of reproduction assisted by the Centers for Disease Control and Prevention, which included a list of 451 clinics that had provided them with data and 35 that did not.
'Almost no regulation'
The lack of reliable data on procedures and clinics in the United States The states – and the possible problems with their frozen ovules and embryos – have contributed to a "regulatory vacuum" river, "says Dov Fox, director of the Center for Legal Policy and Bioethics at the University of San Diego.
" There is almost no regulation or supervision of any kind that directly relates to the prevention of errors like these "said Fox, who is working with one of the plaintiffs in the Cleveland case.
" And it's not just the fertility clinics, it's the sperm banks, egg sellers, subrogation agencies, in All of these areas, we do not know how common are the errors, because there are no reports, there are no monitoring agencies. "
NBC News contacted federal regulatory agencies and organizations that provide accreditation for fertility laboratories . When the NBC News Investigative Unit asked who was ultimately responsible, the majority said it was not them.
The only government agency that told NBC News that it could technically regulate storage tanks is the Food and Drug Administration, or FDA. But because freezers in fertility clinics have not been marketed specifically as medical devices, that's not the case.
Members of the assisted reproduction industry say tank failures like Ohio's would not have been avoided with more regulations.
"The autocomplete tanks still require periodic periodic controls by laboratory personnel to ensure they function properly," said Dr. Alan Penzias, fertility specialist at Boston IVF, an associate professor of obstetrics, gynecology and reproductive biology at Harvard Medical School. , and chair of the practice committee of the American Society for Reproductive Medicine, or ASRM.
"I spoke with staff members in my laboratory who informed me that this is common knowledge."
The fear of lawyers may have played a role in arresting broader reports of prior failures in the US. UU., Says Dr. Mark Jutras, director of laboratory and physician at Advanced Reproductive Concepts in Charlotte, NC.
"In general, institutions are flawed and their lawyers will not allow outsiders to analyze the situation to find the root cause of the problem and how it could have been prevented," Jutras said.
That's little consolation for patients who lost their frozen eggs and embryos at the University Hospitals Fertility Center.
"Who else has the tanks?" Wendy Penniman asked. "And how many babies are at risk now while we sit, while we talk?"
The draft of the letter from the University Hospitals told the patients that the facility had obtained another storage tank and that it had planned to move Frozen eggs and embryos to that extra tank and had planned to move frozen eggs and embryos in that extra tank before the weekend of March 3, but that process had not begun when the failure occurred. The fertility center has offered to pay for treatments for any patient who wants them.
The Ellises are considering it. The Pennimans declined the offer.
NBC News repeatedly appealed to the CBS manufacturer and declined to comment. In a user manual obtained by NBC News Medical Unit, the manufacturer devotes a full page to "Best practices recommended in the industry for the safe storage of samples".
In a section titled, "Why do I need a Secondary or backup alarm?", The manufacturer also warns: "Your freezer could malfunction." By having a secondary or backup alarm, you can minimize the possibility of a loss due to to a malfunction. "
Courtney McGee, Jane Weaver, Susan Wagner and collaborator Linda Carroll contributed to this report from NBC News