John Wilkinson
@MHRAgovuk
Director of Medical Devices, Medicines & Healthcare products Regulatory Agency (MHRA), UK
The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) recognises that some women have had serious complications related to operations involving urogynaecol-ogical mesh implants and these can be very significant. We sympathise with any woman who has experienced complications, and we’re always working to raise awareness of our Yellow Card reporting scheme so we’re able to capture adverse incidents which help guide our regulatory position. We are committed to using the best sources of information to understand areas where concerns have been raised regarding medical devices, to ensure our regulatory response is pragmatic and proportionate, and our communication as proactive as possible.
In July 2018, the UK government and National Health Service (NHS) England agreed to pause the use of mesh for the treatment of incontinence, and vaginal inserted mesh for prolapse. These procedures have not been banned. During this pause, mesh implants may be used when there is no alternative or the procedure cannot be delayed. In that case, a process of high vigilance scrutiny should apply, which includes close and comprehensive consultation between patient and clinician, and adherence to the National Institute for Health and Care Excellence (NICE) interventional procedures guidance.
MHRA oversees the regulation of medical devices in the UK, and a CE mark enables a medical device to be sold throughout the European Union. A CE mark is given to devices which conform to current legislation requirements – this includes an appropriate conformity assessment by an independent third party called a Notified Body. By meeting these requirements, manufacturers demonstrate their devices are acceptably safe for use in accordance with their recommendations. While MHRA do not approve medical devices, we have a market surveillance and enforcement role, working in cooperation with healthcare and regulatory stakeholders worldwide.
The clinical decision whether to use a specific medical device is made by healthcare providers. Clinical decision making is informed by NICE, who provides guidance for healthcare professionals about how and when surgical mesh should be used. For women requiring surgical treatment for stress urinary incontinence and pelvic organ prolapse, urogynaecol-ogical mesh implants can help treat complex and often extremely debilitating conditions. Symptoms of these conditions include loss of libido, anxiety, depression and even social isolation. A substantial number of women have major improvements in their symptoms and their quality of life following successful operations.
All surgical procedures have a level of risk, and complications can occur in proce-dures which do not use mesh implants. These risks must be part of the conversations between patients and their surgeons during an informed consent process. This conversation must also include any alternatives.
Patient safety is our highest priority, and we are working in close collaboration across the health sector to address the very real concerns raised by women who have had serious complications. We have also been working internationally, championing changes to new EU legislation which places a greater level of scrutiny in pre- and post-market assessments and surveillance, particularly concerning implants such as mesh.
MHRA Yellow Card app
We engage extensively with patients, healthcare professionals, professional organisations, manufacturers and other stakeholders, including the Royal Colleges, the NHS and NICE. We have undertaken a great deal of work to assess the findings of all relevant published studies over many years, and considered feedback from all sources, including adverse events reports submitted to MHRA by patients, clinicians and industry. We have contributed to the major reviews of mesh implant procedures in Scotland and England, and support them within our regulatory role to deliver on the recommendations within those reviews.
We take our role in protecting public health extremely seriously. We are always working to make sure we are at the forefront of using the best data and clinical advice available. We continue to work closely with the NHS, NICE and professional bodies, and we are all committed to helping address the serious concerns raised by women who have experienced complications. We continue to keep this area under review, examining evidence as it becomes available, and where necessary we will take action to protect public health.
Anyone who suspects they have had a complication after having a mesh device implanted, is strongly encouraged to discuss this with their clinician and report it to us via the Yellow Card Scheme, regardless of how long ago the implant was inserted.
Be sure to read the companion piece to this article, looking at the issue from the pat perspective:
