Guy's and St Thomas' Assisted Conception Unit, London, is the subject of an investigation by the Human Fertilisation and Embryology Authority (HFEA) into delays in informing women that their frozen eggs and embryos could be affected by a manufacturing error.
The clinic, which serves NHS and private fertility patients, learned in March 2023 that a manufacturing error meant some vials of freezing fluid had been mislabelled. 136 women were informed by the clinic only in February 2024 that their frozen eggs and embryos may have been treated with the wrong freezing fluid, and may therefore not be viable.
For some of these women, who had frozen their eggs before undergoing cancer treatment or hysterectomies, further egg collection will not be possible.
Rachel Cutting, director of compliance and information at the HFEA, said: '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 eggs and embryos that may have been affected at Guy's were frozen in August, September and October 2022, before manufacturer CooperSurgical issued a notice about the error via the Medicines and Healthcare Products Regulatory Agency on 23 February 2023. Two weeks later, on 10 March 2023, the HFEA issued a notice to all of the clinics that it licenses in the UK.
Jessop Fertility (a clinic at Sheffield Teaching Hospitals NHS Foundation Trust) initially identified 29 potentially affected NHS and private patients, but was then able to narrow this list down to a single affected patient, who was informed of the issue last year.
A spokesman for Guy's and St Thomas' NHS Foundation Trust said: 'We have contacted all of those affected and apologised for the delay in doing so and any distress this may have caused. We are supporting those who may have been impacted, including through our counselling service, and would urge anyone with concerns to speak to us directly via the dedicated phone line we have set up.'
The investigation into why the delay occurred is ongoing, HFEA confirmed.
Sarah Norcross, director of PET (the Progress Educational Trust), called the delay in informing patients 'appalling'. She said: 'If women affected by this incident have undergone medical treatment which has compromised their fertility, then their opportunity to have a biologically related child may have been lost.
'If women affected by this incident had sought to extend their reproductive choices by freezing their eggs, then they too may have lost their best opportunity to have a family, if the quality of their eggs has declined during the period that has elapsed.'
CooperSurgical is currently facing lawsuits in the USA, where it is based, following a separate recall notice issued in December 2023, when embryo culture media was found to be faulty (see BioNews 1221).
Sources and References
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London hospital and Sheffield clinic affected by faulty egg-freezing products
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Updated: HFEA statement: Incident at Guy’s and St. Thomas' Assisted Conception Unit
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HFEA statement: Incident at Guy’s and St. Thomas’ Assisted Conception Unit
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Fault at NHS clinic means patients' frozen eggs may not be viable
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Second NHS fertility clinic named in frozen egg scandal
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Frozen eggs may have been damaged by faulty liquid at London clinic
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