The Government must act quicker to enable women and children avoidably harmed by medical intervention to receive compensation said a report from a highly critical review by The Health and Social Care Committee (HSCC). The review was on the Government's progress in implementing the recommendations of the Independent Medicines and Medical Devices Safety (IMMDS) review's report, First do no harm, published in July 2020.
The report also said that: "More needs to be done to provide support for women and children affected by these medical interventions."
The HSCC's report received a mixed reception from those campaigning on behalf of victims, with patient-led campaigns that, in some cases, have gone on for decades. Some campaigners were "happy", while others felt the review didn't actually address the issues.
The review, headed by Baroness Cumberlege, whose findings were accepted by the Government, examined how England's healthcare systems responded to reports of harmful side effects from medicines and medical devices, and future action that should be taken, in the cases of the use of vaginal surgical mesh, sodium valproate in pregnancy, and hormone pregnancy tests.
The HSCC’s report said that: "Although the Government made a full public apology to those affected, after being recommended to do so in the IMMDS review report, we are concerned about the speed at which the Government is progressing against its commitments."
It added: "It is important that the Government makes significant progress soon."
Healthcare System 'Cannot be Relied Upon'
The review had noted: "On the face of it, we were being asked to investigate three disparate interventions governed by two different product regulatory frameworks in the one review. It soon became apparent, however, that far more binds these interventions than separates them:
- They were all are taken or used by women and, in the cases of valproate and hormone pregnancy tests, usage was during pregnancy
- Patients affected by each tell similar and compelling stories of their battles to be listened to when things go wrong
- Patients turned to each other for help and mutual support
- Patients campaigned for years, if not decades, to achieve acknowledgement, resorting to the media and politicians to take up their cause because the healthcare system "did not"
The authors noted that they were aware that many people were disappointed that the review could not also consider their concerns about other medications and devices on the market. "The list is long – Essure (a contraceptive device), Roaccutane (a treatment for severe acne that can cause birth defects if used in pregnancy), Poly Implant Prostheses (PIP) breast implants, cervical cancer vaccination, in utero exposure to hormones, valproate use in children," as well as mesh used in hernia repair.
Taken together, such concerns "point to a healthcare system that cannot be relied upon to identify and respond promptly to safety concerns".
'First Do No Harm' Should be a Guiding Principle
The Baroness said in the review: "Having spent 2 years listening to heart wrenching stories of acute suffering, families fractured, children harmed, and much else, I and my team thought it [First do no harm] an appropriate title. It is a phrase that should serve as a guiding principle, and the starting point, not only for doctors but for all the other component parts of our healthcare system. Too often, we believe it has not."
She said that the review team had found the healthcare system – the NHS, private providers, regulators and professional bodies, pharmaceutical and device manufacturers, and policymakers – to be "disjointed, siloed, unresponsive, and defensive. It does not adequately recognise that patients are its raison d’etre. It has failed to listen to their concerns and when, belatedly, it has decided to act, it has too often moved glacially.
"Indeed, over these 2 years we have found ourselves in the position of recommending, encouraging, and urging the system to take action that should have been taken long ago. The system is not good enough at spotting trends in practice and outcomes that give rise to safety concerns."
The review noted that while valproate was an effective anti-epileptic drug, it causes "physical malformations, autism, and developmental delay in many children when it is taken by their mothers during pregnancy". The report had called for "better communication to inform women of the risks of sodium valproate in pregnancy".
The HSCC report said that Government guidance stipulated that: "Sodium valproate must not be used in any woman or girl able to have children unless there is a pregnancy prevention programme (PPP) in place". Yet, since April 2018, 286 women had been prescribed valproate while they were pregnant – 17 of them in the most recent 6 months (data from October 2021 to March 2022).
"Some of those 17 women are likely to give birth to children harmed by the teratogenic effects of this medication," the report noted. "It is unacceptable that children are still being born to mothers who were not properly advised and supported to change their medication to one less likely to harm their unborn child."
Without Redress, People Will 'Continue to Suffer'
Asked to comment on the valproate part of the HSCC report, Janet Williams MBE and Emma Murphy of the Independent Fetal Anti-Convulsant Trust[SM1] & FACS Syndrome Association (IN-FACT/FACSA), both of whom presented evidence to the Committee, told Medscape News UK: "INFACT were very happy with the hearing from the health select committee in December and hope that healthcare professionals prescribing valproate to women will ensure their patients all receive the Pregnancy Prevention Program and follow it to the letter. So many women have been failed by a system that failed in itself to be rigorous enough.
"However, we feel somewhat let down by the report's conclusions and recommendations. Although we appreciate the time given by the Health Select Committee to investigate the subject of valproate, we are disappointed that it is suggesting more discussions around a 'review for redress'. Since the Cumberlege review, which took 2 years with its report issued in 2020, the Government has had ample time to make its own investigations as to the cost of redress for valproate, yet chose not to.
"With the timescale for the Patient Safety Commissioners 'review' not given, those affected and their families will continue to suffer until that decision is made and redress given, and it is important to bear in mind there is around 200 babies still harmed every year, which all adds to the cost of the public purse and can be avoided by healthcare professionals play their part in the uptake of the PPP. Therefore, we encourage both the Patient Safety Commissioner and the Health Minister to approach the topic of valproate redress with some urgency."
Mesh 'Rushed to Market' on Flimsy Evidence
The review also called for better care and support for women who experienced adverse effects from pelvic mesh implants, used in the surgical repair of pelvic organ prolapse and to manage stress urinary incontinence. "Its use has been linked to crippling, life-changing complications", the review said.
Campaigners gave evidence on behalf of the 'Sling the Mesh' campaign, which claimed that plastic mesh was "rushed to market using the flimsiest of evidence". The campaign details how surgical mesh can fragment, twist, degrade, or shrink to slice into nerves, tissue, and organs, leading to ongoing pain, infections, and sexual problems. It can also cause autoimmune diseases and trigger allergic reactions, including psoriasis, fibromyalgia, IBS, lichen sclerosus, lupus, food allergies, and intolerances. Although it may be removed via major surgery, not all women improve as a result.
The campaign alleged that: "New products continue to be approved using a flawed medical device approval system known as equivalence." MPs were said to be examining whether a current pause in the use of vaginal mesh implant surgery to treat stress-urinary incontinence should be made permanent.
Report 'Kicks the Can Down the Road Again'
In the report, the HSCC said that while complications (including persistent pain, sexual problems, mesh exposure through vaginal tissues, and occasional injuries to bladder or bowel) had been acknowledged by NHS England, NICE, and others, "there is limited evidence collection of the long-term adverse effects following these procedures". It was, therefore, difficult to know exactly how many women had been affected prior to the procedure being paused, or the extent of their harm.
Linda Millband, head of clinical negligence at Thompsons Solicitors, which has represented hundreds of women and men with surgical mesh claims, told Medscape News UK: "Two and a half years on from the publication of the Report, we seem no closer to implementation of Baroness Cumberlege's recommendations.
"This report seems to kick the can down the road again. Given the Committee's acknowledgment of the level of distress and pain and the dysfunctional treatment offered to those suffering from mesh, you would have hoped for something more concrete.
"What our mesh-injured clients desperately need is a redress scheme, but the only commitment extracted from the Minister by the Committee is 'to look at the idea'.
"At this stage of a parliament and with unfulfilled recommendations from a Government-commissioned report, the suggestion of a pilot rather than full implementation for healthcare professionals to register interests and payments is disappointing, when they could have called for full scheme implementation.
"References to the benefits of – and the need for – non-invasive treatment to be properly considered before surgery are fine as far as they go, but to bring an end to this medical scandal there needs to be clear direction and this report sadly ducks that."
Due to ongoing litigation, the Committee was unable to take oral evidence on the pregnancy tests issue. This related to hormone tests such as Primodos, which were withdrawn from the market in the late 1970s, and which were thought to be associated with birth defects and miscarriages.
More Support Needed for Affected Women and Children
Overall, the Committee said: "More needs to be done to provide support for women and children affected by these medical interventions." It noted that, despite accepting the review recommendations, the Government had rejected its call to establish an independent redress agency to compensate women and children harmed by medical intervention. Committee Chair Steve Brine MP called on the Secretary of State Steve Barclay to explain a decision not to fund additional care and support for those eligible as a result of experiencing avoidable harm.
Other recommendations applauded included:
- Pro-actively making contact with women who had pelvic mesh procedures to enquire about their experiences and possible side effects
- A register of clinicians' interests
- A register of industry payments to clinicians to "provide transparency and reassurance"
- Allocation of sufficient resources for appointment of a Patient Safety Commissioner
- Patient input in setting up care schemes and improved engagement with patients in future
- Improved pathways to enable patients to bring claims of clinical negligence
- A review of redress for affected patients, and a possible Redress Agency