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 is aware of and investigating an incident at Guy’s and St. Thomas’ Assisted Conception Unit through our robust clinical governance incidents reporting system.

“The Medical and Healthcare Products Regulatory Agency (MHRA) published a Field Safety Notice via the government website in February 2023, at the same time the HFEA issued its own alert to ensure all HFEA-licensed clinics had the information. The investigation at Guy's and St. Thomas’ ACU is ongoing, and we will take any further action required as a result of this investigation, in line with our standard incidents process. We are aware that this affected product may have been distributed to other UK clinics, although the HFEA is currently not aware of any other licensed clinic where patients have been affected.

“We appreciate any incident may be concerning to patients. We advise patients to contact their own clinic to raise any queries or concerns as the clinic is best placed to advise individuals on how they may, or may not have been, affected. Patients can also access further support through the clinic’s counselling service.

“The HFEA investigates incidents in clinics to make sure that everything is done to understand what went wrong and, crucially, to take steps to ensure it does not happen again. We also share learning and notify other clinics of potential issues.”