The review into the harmful side effects of medicines and medical devices was announced by the then Secretary of State for Health and Social Care, Jeremy Hunt, in 2018 following patient campaigns. Mr Hunt said that the response from the NHS and its regulators to concerns raised has “not always been good enough”. Led by Baroness Julia Cumberlege, who has conducted many reviews and enquiries over the years, the review involved two years of gathering “harrowing” testimony from women who have undergone the surgery, along with data and evidence from the healthcare system, which included the NHS, private healthcare providers, regulators and professional bodies, manufacturers, and policymakers.
Carol Simpson, partner and head of Graysons’ medical negligence team says:
“Vaginal and other pelvic mesh surgery has primarily been used to treat women’s incontinence and prolapse, usually following childbirth. Many women who’ve had the surgery have suffered severe pain, bowel and other conditions, as the mesh can become embedded in surrounding tissue and can be difficult to remove. The psychological issues following surgery can be severe.”
In her report, entitled “First Do No Harm”, Baroness Cumberlege starts by applauding the NHS for the enormous effort made in meeting the challenge posed by COVID-19, but says that the intense suffering experienced by many women was “entirely avoidable” and “caused and compounded by failings in the health system itself”. She says that the health system and its leaders “need to acknowledge what has gone so badly wrong” and recommends “wide-ranging and radical” actions for improvement, which include:
- The immediate establishment by the Government of a task force to implement recommendations within the review.
- A “fulsome” apology by the Government to those affected.
- Appointing a patient safety commissioner – sitting outside the healthcare system – to hold it to account.
- Setting up a scheme to meet the cost of providing additional care and support to those already affected.
- Setting up a redress agency for those harmed by medicines and medical devices.
- Setting up regional specialist centres providing treatment, care and advice for those affected.
- An overhaul of adverse event reporting and medical device regulation by the Medicines and Healthcare products Regulatory Agency (MHRA).
- A central database of patient details, the device implanted and the surgeon.
- An expansion of the General Medical Council’s (GMC’s) register to include information about doctors’ clinical interests and specialisms as well as their financial and non-pecuniary interests.
- Reporting of payments made to teaching hospitals, research institutions and individual clinicians by the pharmaceutical and medical device industries.
“Often, women have not been made aware of the risks when agreeing to the surgery, which means they have not been able to give informed consent to the procedure. Baroness Cumberlege’s review was “appalled” at the number of women who did not even know they’d had the mesh inserted and an improvement in the way information is conveyed to women is recommended.
Women have been campaigning for years to be listened to and believed: to find out who they should complain to and how, and to have their issues relating to the surgery acknowledged. The review accepts that there is a cultural issue of surgeons’ “dismissive and defensive attitudes” – which needs addressing.
At Graysons, we have dealt with several cases of medical negligence relating to vaginal mesh and appreciate the difficulties experienced by those affected. We welcome the findings of the review and hope that the Government will implement the suggested actions promptly.”
If you wish to speak to one of our experts about making a claim for medical negligence relating to vaginal mesh, contact us now. We can discuss your case free of charge and advise whether we can take the case on. If we can, we will offer you a no-win, no fee arrangement. You can also find out more about making a medical negligence claim for compensation on our website.
Author: Carol Simpson, partner and head of Graysons’ clinical negligence team.