For years, women have been given the option of surgical mesh insertion as a solution for Stress Induced Urinary Incontinence. And, for just as many years, women have found themselves in excruciating pain from mesh that has eroded, contracted and protruded into other areas of the body.
Investigations into surgical mesh
It has taken a long time for women’s concerns about the mesh they’d been implanted with to be taken seriously, and even longer for doctors and surgeons to join the dots and recognise a pattern of problems with surgical mesh.
In 2018, the government set up the Independent Medicines and Medical Devices Safety Review, chaired by Baroness Cumberlege, to look into the harm surgical mesh insertion caused to women with urinary incontinence, and what lessons could be learned to prevent similar problems occurring in the future.
The Cumberlege Review, as it became known, made a number of recommendations when it finally released its report in July 2020. One of these recommendations concerned the way medical devices in general, of which mesh is one such device, are implemented within the healthcare system and then how their use is monitored.
Process of approval
Medical devices, like medicines, have to be approved for use within the UK before patients are offered them as a treatment. Medicines go through rigorous clinical trials before being approved, but medical devices are much more patient-specific and so cannot go through the same process of clinical trials.
Authorities therefore have to ensure that a device is safe – it is not toxic, or it will not break, for example – and that it theoretically at least offers a benefit to patients before it will be approved for use. Afterwards, the device’s effectiveness can only be seen by giving it to patients and monitoring their progress once it has been implanted.
There is nothing to suggest this is inappropriate or a failing in itself as there is not an alternative way to approach this as far as medical devices are concerned.
Monitoring of effectiveness
What does need to happen though, is careful and frequent monitoring of how effective the medical device is after it’s been given to a patient, and any problems should be thoroughly recorded. That data then needs to be collated and monitored across the various NHS Trusts so any patterns of negative outcomes can be identified and reacted to quickly, ensuring patient safety and mitigating risk of further issues.
Unfortunately, this was not happening with the use of surgical mesh.
Recommendations from the Cumberlege Review
One of the Cumberlege Review’s recommendations therefore centres around this issue, and looks to implement a system so that problems with medical devices are identified much earlier, meaning fewer patients suffer the consequences of a device that is already not working as intended, or has unforeseen problems in other patients.
The idea is that in future all medical devices – which must have their own identifying number – must be recorded within a registry which also details when, how, where and why a device was implanted and who performed the surgery. Some patient data would also be included, such as their gender, date of birth and NHS number. How each patient progresses thereafter would also need to be recorded as well.
This registry would be overseen by one responsible body which would monitor the use of the device and how effective it is, while also identifying any patterns or trends in the use of that device on a national scale.
Had such a registry been in place when surgical mesh was first introduced, it would have been possible to identify that a large number of women were experiencing significant pain after mesh was implanted, and that erosion of the mesh was a common long term failure. The monitoring body could then have issued guidelines on the use of mesh, allowed for more information to be made available to patients about the risks of the treatment, or made a recommendation that the use of mesh be suspended altogether pending further investigations. This would have happened much earlier than it did in reality, and many more women would have been spared the pain and trauma of having a surgical mesh implant.
The registry would have other benefits too. If a particular batch of a medical device is determined to be defective, it will be easier to identify all those patients who have been provided with that device and so easier to contact them and get that device removed from those patients sooner.
Identifying specific patterns and problems
Also, the data would allow more specific patterns and problems to be identified.
Say for example that generally, the use of a device is having positive results for patients all over the country, but one subset of patients doesn’t seem to be benefitting at all, and in fact seems to suffer negative consequences much more frequently. It could be that a particular gender doesn’t tolerate the device well, or patients of a certain age or of a particular ethnicity.
It might be that the device works for treating certain medical ailments but not others. It could even be that patients at a certain hospital, or even under a specific surgeon, are experiencing much worse outcomes than patients elsewhere. The data would allow the monitoring body to see that pattern and take steps to prevent further issues.
The use of such a registry would sadly not have spared everyone from the negative effects of surgical mesh. Unfortunately, the nature of medical devices and the limited ways they can be trialled before use means that someone must be the first to try them, and those women who had mesh implants when mesh was first offered would not have benefitted from a registry, as their own experiences would have helped to create it in the first place.
For the thousands of women who came after however, such a registry would have informed their own treatment, and quite possibly meant they never had a surgical mesh implant at all.
Unfortunately, many women have suffered with surgical mesh implants over the last two decades, before these lessons came to light. Hopefully, now that these lessons have been learned, the Cumberlege Review’s recommendations will be heeded to ensure that the experiences of so many women with surgical mesh implants will not be repeated again in the future.
Contact our clinical negligence solicitors today
Our team of medical negligence experts have handled many surgical mesh claims, and understand the sensitivity of these cases and how stressful they can be for patients. This is why we are dedicated to advising patients every step of the way throughout their claims, helping them get the compensation they deserve.