Scores of women have been affected by the use of a faulty freezing solution at fertility clinics in London and Sheffield, with frozen eggs and embryos potentially destroyed as a result, the fertility regulator has said.
The Human Fertilisation and Embryology Authority (HFEA) confirmed the issue was limited to Guy’s and St Thomas’ assisted conception unit in London, and Jessop Fertility in Sheffield.
The clinics received a batch of faulty freezing solution from CooperSurgical, a US company.
The regulator said it was satisfied that Jessop “undertook a thorough investigation when they first became aware of the issue and contacted and supported any patient affected”.
Sheffield teaching hospitals NHS trust, where the clinic is based, said it had identified 29 people who had eggs or embryos frozen in August 2022, when the particular product batch was used.
However, only one of these people had the faulty fluid used to freeze her eggs or embryos, and that person “was contacted at the time and did not require further actions to be taken”.
The statement came after the leading London hospital Guy’s and St Thomas’ apologised to 136 women after their eggs and embryos were probably damaged during the freezing process at its NHS-operated clinic.
The hospital contacted the women after discovering it may have inadvertently used some bottles of the faulty freezing solution in September and October 2022.
Among the women were cancer patients who have since undergone treatments such as hysterectomies. The clinic said it did not know the liquid was defective at the time.
Guy’s and St Thomas’ NHS foundation trust said the manufacturing issue may adversely affect the survival chances of a frozen egg or embryo during thawing.
The spokesperson said: “We were made aware of a manufacturing issue with some bottles of a solution that may have been used to freeze eggs and embryos in our assisted conception unit in September and October 2022.”
The HFEA previously said that the incident was being investigated and that although it was aware the affected product could have been distributed to other fertility clinics, it was not aware of any other clinics where patients had been affected. The fertility regulator has since said that the issue is limited to just the two clinics in London and Sheffield.
The HFEA is investigating Guy’s over its handling of delays in informing patients of the incident.
One patient at Guy’s told the Times: “The doctor informed me that the eggs I had frozen are unlikely to be viable, due to a faulty freezing process. It has been devastating.
“Many of the women have now missed their chance to preserve their fertility. Some are cancer patients who have since had hysterectomies. It is traumatising for those poor women to be told their frozen eggs cannot be used.”
In a statement, Rachel Cutting, the director of compliance and information at the HFEA, said: “Our ongoing investigation only relates to Guy’s as we are satisfied that Jessop’s undertook a thorough investigation when they first became aware of the issue and contacted and supported any patient affected.
“The company supplying the product directly to clinics will know exactly where it has gone through their traceability processes. The company is also obliged to report any problems to the MHRA [Medicines and Healthcare products Regulatory Agency].
“Any patients likely to have been affected will have been notified by their clinic. We hope this provides reassurance to anyone concerned.
“We share field safety notices as required and every clinic is expected to act on the information provided. It is a legal requirement for clinics to report any incident to the HFEA in accordance with our clinical governance procedures, and in line with our code of practice.
“Fertility treatment in the UK is generally very safe, our most recent report shows that out of the almost 100,000 treatment and storage cycles which took place in 2022-23, more than 99% were conducted without any incidents occurring.”
The HFEA added that for this and all aspects of fertility treatment, more information on support can be found at its website.
Guy’s hospital has now set up a dedicated phone line for any patients affected. The clinic also said that those affected can seek support through its counselling service.
