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Patients take legal action to save frozen embryos after admin error
At least 15 fertility patients are taking legal action to prevent their frozen embryos being destroyed after administrative errors left them at risk of losing their chance to have children.
The group includes people with cancer and fertility problems who froze gametes (eggs and sperm) or embryos to improve their chances of conceiving later on, but were told they had not renewed consent in time due to clinic mistakes.
Some only discovered the problem when they approached clinics about plans to start a family — for some, their only hope of conceiving naturally.
Others were contacted by clinics after internal audits revealed the errors and were told they could only extend storage through a court order.
The errors relate to two legal changes: one in 2022 that extended the maximum storage period for embryos and gametes from 10 to 55 years for personal use, provided consent is renewed every 10 years; and a temporary two-year extension introduced during the coronavirus pandemic in 2020.
In several cases, clinics failed to contact patients about renewing consent, recorded incorrect expiry dates or medical details, or did not follow up on reminders.
Some patients missed emails that did not make the urgency clear, while others continued to make annual storage payments, assuming everything was in order.
James Lawford Davies, a partner at LDMH Partners representing the group, said that although the fertility law change had been “positive and well intentioned”, both clinics and patients had found the new rules “difficult to understand and apply.”
He said: “The cases before the court have arisen as a result of errors, oversights and misunderstandings surrounding the new rules.
“The applications are hugely significant for all the patients involved and, for many, this represents their only chance of having their own genetic child.
“We hope that, going forward, the guidance and process for storage consents can be clarified and simplified for patients and clinics alike.”
Appearing in the high court this week, Emma Sutton KC, representing the applicants, said they felt “emotional” and “distressed” as they “would have given their consent had the process been put into effect in the way it should have.”
She added that the patients had been left “in limbo” for nearly a year, with “time of the essence” for some couples because of age or health problems.
She argued that destroying the embryos would conflict with article 8 of the Human Rights Act, which gives people the right to a family life, and said allowing extensions “would not undermine a fundamental objective of the statutory scheme – namely the requirement for consent.”
Barristers representing the Human Fertilisation and Embryology Authority (HFEA) and the Department of Health and Social Care supported case-by-case consideration and proposed that, where clinics failed to notify people, patients should be given six months to arrange consent renewal.
Jeremy Hyam KC, for the Department of Health and Social Care, expressed concern that the law’s focus on effective consent could be undermined if there were a “free for all”, leading clinics to adopt a “default position of indefinite storage” out of fear of liability for miscommunication.
He said cases in which patients had been notified but made errors — such as failing to open emails, update addresses or log into online portals — should not automatically be granted extensions.
Ravi Mehta, for the HFEA, expressed the regulator’s “sympathy” for the patients and praised clinics for their “candour” in admitting mistakes.
He noted that under UK fertility law, clinics — not patients — are responsible for securing consent.
“[The patient’s] wishes now are sufficient – no one is asking for open-ended relief, that takes consent now as opening the door to everything.”
Mrs Justice Morgan, who heard the case, will deliver a written judgment in the coming months.
A new ovarian cancer drug has been approved for NHS use in England, offering hundreds of women with hard-to-treat disease a life-prolonging treatment.
Elahere is the first new drug for chemotherapy-resistant ovarian cancer to be approved by the NHS for more than 20 years.
Ovarian cancer is the 18th most common type of cancer globally, affecting more than 300,000 women a year.
More than three-quarters of patients are diagnosed at an advanced stage, making the disease harder to treat.
Prof Ruth Plummer, national clinical lead for cancer drugs at NHS England, said: “This represents the most significant breakthrough in NHS treatment for these hard-to-treat ovarian cancers in over two decades – and we’re delighted it will now offer hundreds of women much-needed hope of precious extra time with their loved ones.”
Standard treatment for ovarian cancer usually involves surgery and chemotherapy, but about 80 per cent of patients with advanced disease relapse and most eventually develop resistance to chemotherapy.
According to the National Institute for Health and Care Excellence, patients with folate receptor-alpha-positive platinum-resistant epithelial cancers have until now had limited options when their tumours stop responding to standard chemotherapy.
Now NICE has approved mirvetuximab soravtansine, also known as Elahere, for patients with epithelial ovarian, peritoneal or fallopian tube cancer that has become resistant to platinum-based chemotherapy and whose tumours contain the FRα protein that the drug targets.
FRα is a protein found on the surface of some cancer cells.
NHS England said up to 400 women a year in England could benefit, in what it described as a major milestone for treatment.
Mirvetuximab soravtansine is given through a drip once every three weeks.
A global clinical trial involving eight NHS hospitals found that the treatment delayed cancer progression and prolonged survival by an average of four months, compared with chemotherapy alone, with more manageable side-effects.
Cancer progression means the disease is growing, spreading or worsening.
In 37 per cent of patients, tumours shrank by at least 30 per cent, compared with 16 per cent of those given chemotherapy.
The drug, made by AbbVie, combines a “homing” antibody, which seeks out the FRα protein on the surface of cancer cells, with a cancer-killing molecule that destroys the cell from within.
Experts said the decision was a seminal moment and could significantly improve the quality of life of affected patients.
Rachel Downing, head of policy and external affairs at Target Ovarian Cancer, said: “This is a hugely important moment for women with platinum-resistant ovarian cancer and their families, who have faced limited effective treatment options for far too long. Today’s announcement offers real hope of improved quality of life.”
Victoria Clare, chief executive of the charity Ovacome, said: “Today marks a landmark moment. Being told that platinum-based chemotherapy is no longer working can bring anxiety and uncertainty, particularly when the disease is at an advanced stage, where time and options are limited.
“This recommendation is the first in over 20 years to offer the ovarian cancer community an additional choice at a critical stage, with the potential to make a real difference to patients and their families.”
Helen Knight, director of medicines evaluation at NICE, said: “We heard clearly from patients and clinicians about the very limited options available at this stage of the disease and the substantial burden that chemotherapy places on women’s lives.
“We are pleased that, following a robust process and a new commercial arrangement with AbbVie, we are now able to recommend this treatment for NHS use.”
Female sex may not raise stroke risk across all atrial fibrillation (AF) patients, with higher risk mainly seen in women aged 75 and older, a study suggests.
Researchers said stroke prevention for women with the condition should be more personalised, especially for patients under 75.
Dr Amitabh C Pandey, director of cardiovascular translational research at Tulane University School of Medicine, said: “For years, female sex has been included as a risk factor along with other factors such as high blood pressure and diabetes, meaning women were more likely to be prescribed anticoagulants.
“Our study shows younger women may not have as much added stroke risk as previously thought, while older women, particularly those over 75, appear to have a higher risk that deserves close attention.”
The new Tulane University study challenges a long-standing assumption in heart care that being female automatically increases stroke risk for patients with atrial fibrillation.
Atrial fibrillation, often called AF, is a common heart rhythm disorder that causes the heart to beat irregularly.
It is associated with a higher risk of stroke and is often treated with anticoagulants, also known as blood thinners.
The study found that stroke risk did not increase equally across all female patients with AF.
Instead, researchers said being female may act more as a risk modifier, with increased stroke risk seen primarily among women aged 75 and older or those with a greater burden of other health conditions.
Clinicians often use a scoring system to decide whether people with AF should be prescribed blood thinners.
The system gives points for factors including age, heart failure, diabetes, previous stroke, vascular disease and high blood pressure.
Women also receive one point for sex alone.
Researchers said this can mean women with AF become eligible for blood thinners earlier or more often than men with otherwise similar risk profiles.
While blood thinners can help prevent clot-related strokes, they can also increase the risk of bruising, prolonged bleeding, gastrointestinal bleeding and other serious complications.
The researchers analysed approximately 950,000 patients with AF using TriNetX, a large anonymised electronic health record database.
They compared stroke outcomes between male and female patients across three age groups: younger than 65, 65 to 74, and 75 and older.
Male and female patients were matched based on age, other health problems and whether they had been prescribed anticoagulation medicine.
Among patients younger than 75, the study found no significant difference in one-year stroke risk between men and women.
However, among patients aged 75 and older, women had a modest but statistically significant increase in stroke risk compared with men.
In patients aged 75 and older with no additional risk factors beyond age, women had about one additional stroke per 629 patients compared with their male counterparts.
The findings support growing interest in a newer AF risk score, known as CHA2DS2-VA, which removes sex as a standalone risk factor.
However, researchers said more studies are needed and medical guidance remains inconsistent.
Han Feng, assistant professor at Tulane University School of Medicine, said: “This general approach came from women being underrepresented in AFib trials and studies comprising only about one-third of study populations.
“Our study shows not all women with AFib have the same risk profile, and these decisions should be individualised.
Pandey said: “These findings highlight the need for modern tools and approaches that can personalise risk profiles to individuals.
“The goal is not to undertreat patients who need stroke prevention, but to better identify who is most likely to benefit from anticoagulation and who may be exposed to unnecessary risk.”
AI may help speed breast cancer diagnosis for high-risk women after abnormal mammograms, a study suggests.
Women with abnormal mammograms often wait weeks to learn whether they have breast cancer.
Researchers at UC San Francisco and UC Berkeley said an AI-guided workflow could help reduce that wait by quickly identifying those most likely to have the disease. Some women could move from imaging to evaluation, and sometimes biopsy, in a single day.
Dr Maggie Chung, first author of the study, said: “This is a really an exciting time.
“This moves us closer to personalised care, where we can tailor a plan so that each patient gets the right intervention at the right time.”
The study used an open-source AI model called Mirai.
The model was trained on hundreds of thousands of mammograms linked to patients’ cancer outcomes.
A mammogram is an X-ray scan of the breast used to look for signs of cancer. A biopsy involves taking a small tissue sample to test for disease.
The AI tool is designed to detect subtle patterns in screening mammograms and predict a woman’s cancer risk.
Researchers at UC San Francisco and UC Berkeley applied the model to more than 4,100 screening mammograms at Zuckerberg San Francisco General Hospital and Trauma Center.
Mirai identified 525 women, about 12.7 per cent of screened patients, as high risk.
Those patients could receive an interpretation of their mammograms immediately after the scan and have additional diagnostic imaging for suspicious areas on the same day.
Some women who needed biopsies were also able to have them on the same day.
The researchers said Mirai reduced the wait time for diagnostic evaluation from several weeks to about an hour.
For women who were ultimately diagnosed with breast cancer, it reduced the average wait for biopsy from more than two months to fewer than 10 days.
The researchers stressed that Mirai does not replace radiologists or make diagnoses on its own.
Instead, it acts as a triage tool to help physicians identify the patients who can benefit most from accelerated care.
The team analysed more than 114,000 archival mammograms before launching the programme, to ensure the model would capture enough high-risk patients without overloading the clinic with too many expedited evaluations.
The researchers said they hope AI will support a more personalised approach to breast cancer screening tailored to each patient’s breast cancer risk.
Chung said: “Right now, many women follow the same screening schedule but their individual risk can be very different.
“AI risk assessment gives us the chance to identify the women most likely to benefit from expedited care and get them what they need.”
Adam Yala, senior author of the study and a data scientist at UC Berkeley, said: “This is a powerful example of how AI can be a collaborative partner for physicians.
“It shows how we can improve care when we bring clinicians and data scientists together to design these systems.”
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