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This is a joint blog by Patient Safety Learning and Sling the Mesh, highlighting key areas of concern included in their recent response to the Royal College of Obstetricians and Gynaecologists consultation on a new Mesh Complications Management Training Pathway.
One of the three areas of patient harm investigated by the Independent Medicines and Medical Devices Safety (IMMDS) Review (also known as the Cumberlege Review) related to implanted pelvic mesh. Complications with mesh implants can have a life-changing impact, resulting in severe and chronic pain, infections, reduced mobility, sexual difficulties, autoimmune issues and psychological strain.
The Review made a number of recommendations in regard to the shocking scale of avoidable harm experienced by mesh-injured patients, including the establishment of a network of specialist centres that could provide treatment, care and advice for mesh-injured patients. It also recommended that:
“Professional bodies should lead on ensuring surgeons only operate within their capabilities. They must provide guidance for their members and ensure that surgeons are appropriately trained, and this should be assured through the appraisal process”
In the context of this, at the start of this year the Royal College of Obstetricians and Gynaecologists (RCOG) published a consultation on a new Mesh Complications Training Pathway. It states that this has been:
“… developed to equip doctors in commissioned regional specialised centres with the clinical skills needed to manage patients presenting with a wide range of mesh implant complications originally inserted for urinary incontinence (UI), pelvic organ prolapse (POP) and rectal prolapse”.
This Training Pathway is a much-needed piece of work and should be an important tool in providing patients with confidence in the training and standard of care offered by specialists dealing with mesh complications. However, we have identified a number of key patient safety concerns that we believe need addressing.
In this blog, Patient Safety Learning and Sling the Mesh highlight some of the key issues included in our joint response to this consultation. You can find a link to our full consultation response here.
One key area of concern was the approach taken to the consultation process. This was held over a fairly short period (initially 3 weeks, subsequently extended to 4) and in our view not publicised enough with mesh-injured patients and groups. While the development of the Training Pathway did involve a focus group comprised of six women with mesh related issues, we believe that RCOG have missed an opportunity to engage much more widely.
Patient engagement is key to improving patient safety, even more so when there has been a significant loss of trust for patients in healthcare professionals, such as in the case of surgical mesh. We believe it is vital that RCOG, further to its focus group, should be engaging directly with patient groups to hear their concerns and experiences and to genuinely co-produce this type of guidance.
Patient groups with large membership bases are often well placed to provide insights, evidence, and expertise on specific areas of care. For example, in the case of this consultation, Sling the Mesh were able to highlight specific issues relating to the removal of rectopexy and sacrocolpopexy patients, which may not have been captured by a more limited focus group approach to engagement.
If effectively engaged with, patient groups can provide a vast repository of patient experience to draw on in improving patient safety and services.
To fully understand the effectiveness of mesh removal procedures, and identify any emerging patient safety concerns, it is essential that they are accompanied by universal outcome measures for capturing and monitoring patient outcomes. We are concerned that the Training Pathway currently makes no reference to this. In our view it is vital that such information is gathered and that those working in Mesh Centres are proficient at using databases to capture this evidence. This can be used to compare outcomes from procedures at different sites and subsequently feed into requirements which can inform the development of this Training Pathway.
In our consultation response we highlighted that the specific training requirements for Specialist Mesh Centres were not included in the Training Pathway. We expressed concerns that in the absence of this, there is a risk that service provision may be variable and that, without appropriate oversight, women may be at risk of inadequate services provision and an increase in avoidable harm.
The Training Pathway lists a number of surgical procedural requirements for healthcare professionals working in Mesh Centres. A specific area of concern relates to several procedures listed as ‘Mandatory’ requirements in the Pathway which involve a partial removal of vaginal prolapse mesh, taking out the vaginal section only and leaving in the arms embedded deep in the pelvis.
Sling the Mesh have members who have undergone this procedure in the UK and subsequently experienced significant disability and pain resulting from a partial removal of this type. We expressed concerns in our response about the potential for the guidance as written resulting in this becoming the default treatment option for women with vaginal prolapse mesh.
We also highlighted a specific concern relating to two procedures listed in the Training Pathway as ‘Optional’ that involve the full removal of vaginal prolapse mesh. These involve the removal the implant in its totality, including the arms embedded in the tissue of the pelvis. We set out concerns that this was misleading as in practice the UK does not currently have any surgeons who are able to perform this type of total removals of vaginal prolapse mesh, and as such is not in practice a viable option for patients.
Another area of concern highlighted in our consultation response related to the language used in parts of the Training Pathway. Certain procedures that relate to partial removals of mesh are described as removing ‘the entirety of the mesh’. However, in these cases by ‘entirety’ they refer to all the mesh only in relation to a specific part of the body.
We are concerned this could easily misunderstood as a full mesh removal when this is not what the procedure entails. Considering cases where complications may arise following surgery, where women may experience pain or disability, it would be concerning if their formal medical records referred to mesh removal in ‘entirety’ when in practice implanted mesh remains.
To ensure clarity for patients and surgeons, we have suggested that the terms such as ‘total’ or ‘complete’ should be reserved to describe only the surgical procedures where the mesh device is removed in its entirety. Any other type of removal surgery should include the word ‘partial’.
In establishing and providing the care, treatment, and advice for mesh-injured patients, we believe it is vital that a patient-centred approach is taken. When it comes to mesh removal surgery, patients also need confidence that their experiences and concerns are being listened to and acted upon. We believe that RCOG has a key part to play in this and await to see how they will respond to the issues we have highlighted.
 The IMMDS Review, First Do No Harm, 8 July 2020. https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf
 RCOG, Mesh Complications Management Training Pathway, Last Accessed 9 February 2022. https://www.rcog.org.uk/en/careers-training/specialty-training-curriculum/mesh-pathway/