Independent Medicines and Medical Devices Safety Review

Philippa Whitford Excerpts

Thursday 8th July 2021 Commons Chamber

[Dr Philippa Whitford (Central Ayrshire) (SNP) [V]]

Along with other Members here, I took part in the debates on sodium valproate in 2017 and on vaginal mesh in 2018. I welcome the fact that Baroness Cumberlege’s inquiry covered both of these issues, along with Primodos, a hormonal pregnancy test that, like valproate, contributed to congenital abnormalities. At the time of our debates, it was clear that the same underlying issues had driven all three disasters and that there were four main features: a failure of licensing and regulation in the first place, particularly regarding implantable devices such as vaginal mesh; a lack of accurate information so doctors could discuss the risks of these drugs and devices and allow patients to give genuine, informed consent; a weak and poorly publicised system for doctors or patients to report adverse events that would result in action; and finally, the failure of doctors to listen to the affected women who were raising concerns.

The report makes nine recommendations, with two main aims: the need to provide remedial support and redress for the women and children affected; and how to prevent something similar happening ever again in future. The report also captures the experiences of women who have been campaigning on these issues for years, which are well summarised on the report’s contents page:

“‘No-one is listening’—The patient voice dismissed…‘I was never told’—the failure of informed consent”.

Considering the evolution of these disasters, I would perhaps reverse those two aims, as the problems started with the failure of regulators to ensure that these drugs and devices were safe and to provide accurate information on which women and their doctors could base treatment decisions.

I will focus my remarks on vaginal mesh, as there were additional issues associated with its licensing and use. In particular, the original trials comparing mesh with traditional abdominal operations did not have a long enough follow-up. This meant that while immediate surgical complications such as bladder injury were seen to reduce from one in 10 to one in 100, the later mesh complications were not identified. This led to the original vaginal mesh tapes being defined as low-risk devices and gynaecologists switching to this approach as it actually appeared safer for patients.

The whole issue was compounded by the fact that, after that initial research, the federal drug administration in America licensed all similar tapes without further trials, despite the fact that their design and how they were inserted at surgery changed significantly. The products that it passed then largely got accepted by the European Medicines Agency and the Medicines and Healthcare Products Regulatory Agency. Because late problems such as muscle or nerve damage were not recognised, gynaecologists did not even have the accurate information to discuss benefits and risks with patients.

The Scottish Government were the first to advise against routine use of vaginal mesh in 2014 and established a registry in 2017, but there have been no vaginal meshes inserted since 2018. They have accepted all the recommendations that are under devolved control and are in the process of appointing an independent patient safety commissioner. The UK Government have brought in the Medicines and Medical Devices Act 2021 but did not take the opportunity to establish a registry of all implanted devices to allow long-term audit and patient recall in future, if necessary.

There are risks and complications with any operation and they should be presented clearly and openly to allow patients to make an informed choice of what is important for them. Dr Wael Agur, a well-known gynaecologist involved in the mesh campaigns, works in Ayrshire and Arran, my local health board, and working closely with patient groups, he developed a Scottish patient decision aid for patients with incontinence, which was praised in the report. However, there is a need to get consensus on such decision aids and to ensure they are actually used routinely.

A lack of patient information was also central to the issue of sodium valproate. While it is an excellent drug to control epilepsy, a dangerous condition that kills over 1,000 people a year, sodium valproate has caused developmental delay in thousands of babies, and birth defects ranging from cleft lip to spina bifida. While the first case reports were published many decades ago, the connection was missed due to a lack of reporting. Even now, as we have heard today, women and their children are still in danger due to not being given the right information about their medication.

All three disasters highlight the failure of the yellow card system. The MHRA plans to introduce artificial intelligence in the future to recognise common patterns and themes, but adverse events need to be reported in the first place. It is about reporting any adverse event with a possible link to a new drug or any congenital defect in a baby whose mother has received medication during pregnancy. Publicity is also needed to inform patients that they, too, can complete a yellow card and report concerns directly themselves.

A year on from the publication of the report, we need to hear from the Government how they plan to take forward Baroness Cumberlege’s recommendations, particularly on the reform of the licensing and regulation of new drugs and devices, and the system to detect and act on adverse reports. However, the Government also need to lay out how they plan to support the women affected through the provision of removal or remedial surgery and financial redress for the women who have suffered so much. Without their forceful campaigning, even more women would now be suffering. Financial compensation is also crucial for families affected by the use of Primodos or sodium valproate, so they can provide long-term support for their children.

As highlighted by the right hon. Member for Maidenhead (Mrs May), at the core of all three disasters has been the failure of doctors to listen to women, or to patronise them and dismiss them when they raise concerns. Above all, these three medical disasters should be discussed in medical schools to teach student doctors, the doctors who will look after women in the future, the importance of actually listening to all their patients.