FROZEN EGGS: Guy’s & St Thomas’ Assisted Conception Unit, London, Jessop Fertility in Sheffield, CooperSurgical

It was revealed this week that two UK fertility clinics, Guy’s & St Thomas’ Assisted Conception Unit, London and Jessop Fertility in Sheffield had contacted over 100 women to apologise after discovering they may have inadvertently used some bottles of a faulty freezing solution manufactured by US firm CopperSurgical. Both clinics treat NHS and private patients.

CooperSurgical issued an urgent media field safety corrective action on 23 February 2023 in relation to one batch of its SAGE Vitrification Media Kit, LOT 211112-002333 (the Product). The Product is used to quickly freeze eggs and embryos in the IVF process. CooperSurgical issued the recall because the Product may contain mislabelled vials which may impact the viability of embryos meaning it is possible they would not survive the thawing process.

It is understood that Guy’s & St Thomas’ Hospital contacted 136 women who may have been impacted by the inadvertent use of the Product at their facility between September and October 2022. It is believed that some of the women affected have later had cancer treatment which may have left them infertile and unable to conceive naturally.

Notice of the Product recall was originally issued to all registered clinics by the regulator, the Human Fertilisation & Embryology Authority (HEFA) in February 2023 yet despite this it is believed Guy’s & St Thomas’ Hospital did not tell the women affected by the issue for almost a year. They have since apologised for the delay in notification and any distress this may have caused, but they remain under investigation by HEFA.

Jessop Fertility in Sheffield which has also been affected is believed to have acted more promptly in notifying affected women and investigating matters. They have confirmed that the Product was used in 29 cases, however only one woman was found to have been given the faulty Product and due to a change in her personal circumstances, she was not directly affected.

Rachel Cutting, Director of Compliance and Information HEFA said in a HFEA statement:

“The HFEA can confirm that this issue is limited to two clinics in the UK: Guy’s and St Thomas’ Assisted Conception Unit, London and Jessop Fertility, Sheffield.

“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’s gone through their traceability processes. The company is also obliged to report any problems to the MHRA.

“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.”

HEFA has stressed that women who have undergone treatment at other clinics should not be concerned, no other clinic in the UK is believed to have had the affected batch.

What will be the outcome for those affected?

This is a tragedy, as a mother of two young children I cannot even begin to comprehend what these women are currently going through and all the unanswered questions they will have. What is certain however is HEFA and the MHRA need to take a firm stance on the matter and complete quickly the ongoing investigation at Guy’s & St Thomas’ Hospital.

Whilst events are unfolding and the true scale of those impacted is unknown, any woman who has been notified she is affected by this Product recall is entitled to compensation.

More women than ever are turning to fertility clinics on either medical grounds or to prolong their options over having children later in life. Whilst these cases are likely to be very complex, disputes may arise over who is ultimately accountable and the fact the success of IVF diminishes as women age, those responsible must be held accountable; we need reassurance from both regulators and fertility clinics that processes are stringently followed when things do go wrong.