Safety of Medicines and Medical Devices

Baroness Bryan of Partick Excerpts

Thursday 28th February 2019 Lords Chamber

[Baroness Bryan of Partick (Lab)]

My Lords, I thank the noble Lord, Lord O’Shaughnessy, for tabling this debate and for his continuing interest in the issue. As a relatively new Member, I welcome the noble Lord, Lord Carrington, and congratulate him on his maiden speech.

To confirm how important this debate is, I note that the Medicines and Healthcare products Regulatory Agency has issued three medical device alerts during February—for a pacemaker, an ophthalmic implant and an orthopaedic implant. This has to give us cause for concern. The helpful briefing paper from the Royal College of Surgeons points out:

“The vast majority of medical devices are manufactured and used to high standards”.


However, it goes on:

“Gaps within the current regulatory process … could be putting patients at risk of serious complications and harm”.


One of the examples the royal college gives is of transvaginal mesh implants. I am pleased that, over the past few years, this issue has been taken more seriously. There was a debate in the other place recently, and Members there reported the harrowing experiences of their constituents. Most importantly, the review of the noble Baroness, Lady Cumberlege, will include this issue and I am pleased to see that she will make a return visit to Glasgow later this year. Her comments today were both moving and reassuring for the future.

Last year in Scotland, a woman who died of multiple organ failure was reported to be the first Scottish woman to have had a mesh implant listed as an antecedent cause of death. For a long time, Scottish women who were experiencing debilitating symptoms following mesh implants felt they were not being listened to or even, in some cases, believed. Women made multiple visits to their GPs, taking time off work or giving up work altogether. Many were becoming more disabled and some needed wheelchairs. Women felt that the lack of treatment, continual pain and, for some, the attitude of doctors caused stress and anxiety, which often led to depression.

These women set up a campaign in Scotland, Hear Our Voice, and took the issue to the petitions committee of the Scottish Parliament. From that, a Scottish independent review was established. The review’s final report was, however, not without controversy. Two of the women who had experienced mesh implant surgery resigned before it was published, because they felt it had been watered down from the draft version. It was a real pity that women who had brought the issue to public, media and political notice then felt let down by the final publication.

The Scottish review made the following recommendations: mesh should not be offered routinely to women with prolapse; reporting of all procedures and adverse events should be mandatory; extra steps should ensure that patients have access to clear, understandable advice to help them make informed choices; all appropriate treatment should be available, subject to informed choice and assessment; there should be improved training for clinical teams; and there should be improved research into the safety and effectiveness of the products. How often do patients have to campaign, sometimes for years, to have their concerns addressed? In the meantime, they are often dismissed by so-called experts as overreacting.

We must be able to have confidence in the independence of research. Just this year, a senior medical consultant and researcher acknowledged that he failed to declare £100,000 received from the manufacturer of a type of vaginal mesh implant that he assessed. There is no evidence that his study was influenced by the support he received but it has added to concerns about the lack of transparency from the manufacturing companies.

Obviously, mesh implants are not the only area of concern; breast implants and hip replacements have also had their problems. The Royal College of Surgeons makes the point that, in contrast to drugs, many surgical innovations are introduced without clinical trials or centrally held data. This has resulted in a lack of information and often a considerable time delay in giving a diagnosis, leaving women experiencing chronic pain and sometimes inappropriate treatment.

Women were not given clear information about the risks involved, so they could not have given adequately informed consent. How could the surgeons have provided that information when they did not have the details of clinical trials? Can the Minister assure us that, for the future, will there be more effective clinical trials and faster and more effective action when adverse reactions are reported, and that the people affected will be given sufficient financial compensation, along the lines mentioned by my noble friend Lord Brennan, so as to take at least one worry off their shoulders?