A government ordered review into a range of medical treatments primarily targeting women has uncovered serious wrongdoing by healthcare professionals.
The Independent Medicines and Medical Devices Safety Review was ordered by former health secretary Jeremy Hunt in 2018 to investigate the impact three treatments have had on patients. The review covers hormone pregnancy tests including Primodos, the anti-epileptic drug sodium valproate and pelvic mesh implants.
Both Primodos and sodium valproate are thought to have caused complications during pregnancy for many women, resulting in birth defects, miscarriages and developmental delay in children.
Patient advocacy groups have been campaigning to have pelvic mesh implants investigated for years after women have called out about the devices’ often life-changing complications. Campaign group Sling the Mesh have led many of the campaigns, raising widespread awareness into the range of complications women have faced after having mesh implants. Pelvic mesh devices are used to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI), typically after childbirth.
The two-year review was led by Baroness Julia Cumberlege and is based on over 700 patient accounts, mostly from women, alongside those in the healthcare system. This includes both NHS and private healthcare clinicians; regulators and professional bodies; pharmaceutical and medical device manufactures; and policymakers.
The review particularly takes into account patient experiences and features harrowing stories of how their lives have been adversely affected by these treatments. For these patients, it tells a story of their concerns not being listened to by healthcare officials, and of the life-changing complications that have put pressure on their families and their livelihoods.
For mesh patients, side-effects have included chronic pain, organ erosion, nerve damage, psychological harm and more.
A major theme throughout the review is the healthcare system’s inability to know just how many women have been affected by the treatments.
“The lack of such vigilant, long-term monitoring has been a predominant thread throughout our work. Its absence means that the system does not know the scale of the problems we were asked to investigate,” the review reads.
In the case of Primodos, the review states that the system does not know how many women took hormone pregnancy tests between the 1950s before it was withdrawn in 1978. The lack of information means that the review was unable to discern how many complications occurred after women took the medication.
The report also tells an almost universal account of women not being taken seriously when reaching out for help. In the report, mesh patients tell of clinicians being dismissive of the excruciating pain they faced, with some clinicians putting the complications down to them being ‘women’s issues'.
“If there was no reason for my symptoms I was just a wuss, not trying hard enough to get better, being soft… I could not at first contemplate getting an assessment and opening myself up to any further rejection by my medical colleagues, when they don’t listen you feel like a fraud. So, to my former medical colleagues I say this - I do accept for the majority of women this [mesh implant] is a successful procedure. I do however believe there is a huge unconscious negative bias among you all towards middle aged females in chronic pain. As more information is now coming out about the risks of mesh some of you are still choosing to downplay or actually disbelieve these facts,” one former GP and mesh affected patient says in the report.
Based off its findings, the report makes nine recommendations, including the appointment of a Patient Safety Commissioner to improve patient experiences around the use of medicines and medical devices.
Other recommendations include a patient-identifiable database for medical devices which can help audit the outcomes of the device safety and patient reported outcomes measures.
The report also calls for the register of the General Medical Council (GMC) to be expanded to include a list of financial and non-financial interests for all doctors, particularly those with clinical specialisms. This recommendation is intended to reduce the conflicts of interests between doctors receiving financial benefits from pharmaceutical and medical device companies.
The Medicines and Healthcare products Regulatory Agency (MHRA) is also mentioned as needing substantial revision, with the recommendation of improving how it documents adverse events and regulates medical devices.
For pelvic mesh, the report does not recommend a ban, but says that specialist centres should be established in which operations can take place, but only as a last option for women needing SUI surgery.
As it stands, since 2018 mesh devices used to treat SUI have been placed on pause by the National Institute for Care and Excellence (NICE) and can only be used in specific circumstances. A number of conditions are attached to lifting the pause, such as surgeons being appropriately trained to undertake operations for SUI and a cohesive register of operations which can track every procedure and woman who has undergone the surgery.
Baroness Julia Cumberlege, chair of the Independent Medicines and Medical Devices Safety Review, said: “We have seen NHS staff rise to the enormous challenge posted by the Covid-19 pandemic and we applaud them for their amazing commitment. I’m afraid, however, that our report makes for uncomfortable reading, including for the hard-working, compassionate people who do excellent work in our health service.
“I have conducted many reviews and inquiries over the years, but I have never encountered anything like this; the intensity of suffering experienced by so many families, and the fact that they have endured it for decades. Much of this suffering was entirely avoidable, caused and compounded by failings in the health system itself.
“The first duty of any health system is to do no harm to those in its care; but I am sorry to say that in too many cases concerning Primodos, sodium valproate and pelvic mesh, our system has failed in its responsibilities. We met with people, more often than not women, whose worlds have been turned upside down, their whole lives, and often their children’s lives, shaped by the pain, anguish and guilt they feel as the result of Primodos, sodium valproate or pelvic mesh. It has been a shocking and truly heart-rending experience. We owe it to the victims of these failings, and to thousands of future patients, to do better.
“That is why, having spent two years listening to these stories of acute suffering, “First Do No Harm” is an appropriate title and a necessary reminder not just to doctors but to the whole healthcare system. We are urging the system to do what it should have done years ago, to help those who have suffered and put in place the processes that will enable it to learn from past mistakes so that we spare other families from such anguish.
“The system’s response - or lack of one - has added to the pain - both physical and mental - of those affected. The system and its leaders need to acknowledge what has gone so badly wrong. Our major recommendations, together with a number of actions for improvement we call for in our report, are wide ranging and radical. Given what we have witnessed, we are clear that is what is needed now.
"I want to express my heartfelt thanks to my exceptional team. Their dedication, wisdom and sheer hard work has been absolutely invaluable. This has been a team effort.”