Surgical Mesh

Patrick Grady Excerpts

Thursday 19th April 2018 Commons Chamber

[Patrick Grady (Glasgow North) (SNP)]

I congratulate the hon. Member for Kingston upon Hull West and Hessle (Emma Hardy) on securing the debate through the Backbench Business Committee. I took part in a powerful debate on the issue in Westminster Hall, and I am delighted that time has now been made available on the Floor of the House. I commend all those involved with the Sling the Mesh campaign and the all-party group, and I commend the hon. Member for Pontypridd (Owen Smith) for the leadership he has shown. This issue is finally getting the attention that it deserves. Like most Members, it was brought to my attention by a constituent who has been affected first hand, and I wish to reflect on some of the experiences and points that she shared with me, as well as considering broader policy issues on which I hope the Minister will respond.

Other Members have already mentioned ventral mesh rectopexy, which has not been included in the UK Government’s proposed audit. Sling the Mesh’s campaign research shows that 7% of its members have been affected by that specific procedure, and there is a certain amount of disappointment that it does not seem to have been included. As the Minister might know, I have written to the Secretary of State about that concern, and asked the Government to think again, particularly given the number of people affected and the devastating effect that this has had on their lives.

I also raised concerns about the need for a hospital episodes code to be allocated to that procedure. Without one, it is difficult to keep track of the number of people affected, and we have already heard about the problems arising from the lack of information about the exact number of people affected by the procedure and the mesh more generally.

There are also concerns that some recent National Institute for Health and Care Excellence guidelines might have been rushed through, partly in response to media attention, which only adds to the argument for a full and comprehensive audit that includes all types of mesh procedure.

The health service is devolved in Scotland, where there is a slightly different situation. In 2014, the Scottish Government requested a suspension in the use of medical mesh by the NHS in Scotland pending safety investigations, and in 2015 the Cabinet Secretary for Health, Wellbeing and Sport, Shona Robison, apologised to women who had been left in severe pain by such operations. Between 2009 and 2016, the number of women receiving mesh surgery in Scotland fell from 2,267 to just 135.

An independent review published in March last year in Scotland made eight recommendations, notably that surgical mesh implants should be used only after all other appropriate alternatives have been exhausted, and—crucially—only when women have given their fully informed consent. Scotland’s chief medical officer accepted the recommendations of that report in full, and has been clear that the requested suspension in the use of mesh implants should remain in place until she is satisfied that all recommendations have been implemented. That means that all women in Scotland who want treatment for urinary incontinence or pelvic organ prolapse should be offered the full range of options available, and they should be fully informed of the benefits and risks associated with those procedures.

Regulation of these devices is reserved, however, and operates at UK-wide level, which is why calls for a UK-wide national clinical audit and database for recording device identifiers are so important. Scottish Government officials are working with UK colleagues to consider the possibility of an automated implant registry, which would allow unique device identifiers to be entered on the patient’s electronic record. As the Minister will know, the now Cabinet Secretary for Health and Sport has written to the Health Secretary to suggest a UK-wide woman’s health summit. That would allow the NHS, and relevant decision makers across the United Kingdom, to work constructively on a range of issues.

I wish to raise other aspects of regulation, and particularly EU regulation on medical devices 2017/745. That will change mesh implants for long-term or permanent use from a class IIB to a class III device, meaning that they are generally regarded as high risk. The regulations will not take full effect until 2020, which is after the Government’s preferred date for Brexit. How will important EU regulations that monitor the use of devices across EU territories be implemented or reflected in UK law and regulation after Brexit? It is important that standards are maintained to the highest possible level.

Campaigners such as my constituent are concerned about the current process of what could be called post-market vigilance, and whether some of the devices are subject to testing that is rigorous enough before they are rolled out to the market. There is a genuine concern that device manufacturers have a profit motive to develop their devices and get them on the market as quickly as possible, although equally, they have a fear of litigation, which is why better and stronger regulation from the start is key.

The risks associated with surgical mesh implants were tragically misunderstood and underestimated by healthcare providers and professionals who provided the treatment, and by patients whose lives have been so badly affected by chronic and debilitating pain. I welcome the conclusions and recommendations of the Scottish and English reviews of this procedure, which must ensure that surgical mesh implants are used only after all other appropriate alternatives have been exhausted and—crucially—only when women have given their fully informed consent.

I hope that Ministers will be willing to work with their counterparts in the devolved Administrations and consider a UK-wide summit on the issue and women’s health more generally. I will finish as I started by paying tribute to my constituent and all campaigners for their bravery and courage in ensuring that this issue has been brought to our attention. It is them we must thank for the small and belated progress that has already been made, and for them we must continue to hope for more and faster progress in future.