Updated: HFEA statement: Incident at Guy’s and St. Thomas’ Assisted Conception Unit

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 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.

“As with any aspect of fertility treatment, more information on support can be found here.”

Ends

Notes to editors

• All products and medicines which have safety concerns or require a product recall is reported to the MHRA in the UK. It is The MHRA not the HFEA who regulate medicines and medical device products.
• Any patients likely to have been affected will have been notified by their clinic. We hope this provides reassurance to anyone concerned. Anyone with further queries or concerns should contact their clinic, who will be best placed to help. This specific batch was supplied to 2 clinics in the UK. Patients at other clinics should not be concerned regarding this problem.
• It is a legal requirement for clinics to report any incident to the HFEA in accordance with Standard Licence Conditions and in line with our Code of Practice.
• Our annual State of the Sector report summarises our regulatory work during the year, including information about incidents. In our most recent report from 2022/23, we found that there are over 100,000 treatment and storage cycles each year and over 99% of these are carried out without any incidents being reported.
• Our Licence Conditions (T118) state that the centre must establish, implement and comply with documented procedures to report, investigate, register and transmit information about serious adverse events and serious adverse reactions that occur on any premises to which a licence relates and any relevant third party premises.
• An ‘adverse incident’ is any event, circumstance, activity or action which has caused, or has been identified as potentially causing harm, loss or damage to patients, their embryos and/or gametes, or to staff or a licensed centre.
• The centre must ensure that an accurate, rapid and verifiable procedure is in place, which will enable it to recall from distribution any product that may be related to a serious adverse event or reaction (Licence Condition T122).