Faulty egg-freezing solution ‘may have been distributed to other clinics’

A faulty egg and embryo-freezing solution used at a London fertility centre “may have been distributed to other UK clinics”, the fertility regulator has said.

But the Human Fertilisation and Embryology Authority (HFEA) said it is aware only of patients being affected at Guy’s Hospital in London.

The hospital has contacted 136 patients whose chances of having children may have been compromised because of a faulty liquid used to freeze eggs and embryos during fertility treatment.

Medical negligence lawyers said women across England and Wales have been in touch with concerns that they have also been affected.

In February 2023, US firm Cooper Surgical issued an urgent safety notice about its freezing solution, saying that one “lot” of the product “may contain mislabelled vials” which “may impact the viability” of the eggs or embryos.

A spokesman for Guy’s and St Thomas’ NHS Foundation Trust said that its assisted conception unit (ACU) may have used the product a few months before the warning was issued – in September and October 2022.

The spokesman added: “While we did not know about the potential issue at the time eggs or embryos were frozen, this manufacturing issue may adversely impact the chance of frozen egg or embryo survival during thawing.

“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 phoneline we have set up.”

The fertility regulator confirmed that it is investigating the incident.

Rachel Cutting, director of compliance and information at the HFEA, said: “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.”

Egg or embryo freezing are a standard part of fertility treatment.

Some women choose to freeze eggs for fertility preservation so they can have families later in life while others may do so before undergoing medical treatment for conditions such as cancer.

Embryos are routinely frozen after IVF cycles – either to delay treatment for medical reasons or to give couples the option of more treatments in the future.

Catherine Slattery, a specialist group actions medical negligence lawyer at law firm Irwin Mitchell, said: “This is a very worrying incident which could potentially have devastating consequences for women, especially those who have had to go through the physical and psychological impact of cancer treatment.

“We’ve been contacted by a number of women possibly affected and are looking into their concerns further. Some women are based in London and received treatment at Guy’s Hospital, while others are based elsewhere in England and Wales.

“It’s vital that women receive the care and support they may need to get through this difficult time while this incident is investigated further.

“If any failings are identified during the HFEA and MHRA (Medicines and Healthcare products Regulatory Agency) investigations, it’s vital that lessons are learned to prevent issues like this arising in the future.”

Sarah Norcross, director of the Progress Educational Trust, added: “It will be distressing for women with frozen eggs to learn that, due to problems outside their control, their eggs may not survive the thawing process.

“When a woman freezes her eggs, time is of the essence. In all cases, the quality of eggs declines upon reaching a certain age. Additionally, in cases where women are freezing eggs for medical reasons – for example, imminent cancer treatment – they will not want their treatment to be delayed.

“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.

“We need to understand more about what precisely has gone wrong, whether patients at other clinics are affected, and what the relevant regulators – including the HFEA and the MHRA – are doing about it.

“We also need reassurance, from regulators and clinics alike, that processes are in place to notify patients in a timely way when things go wrong.”

Cooper Surgical has been approached for comment.