Vaughan Gething, Cabinet Secretary for Health and Social Services
Following the publication of the report by the Task and Finish Group which reviewed the use of vaginal mesh for incontinence and prolapse, I have been made aware of a small number of individuals who have experienced difficulties following mesh used in hernia repairs.
Because of concerns expressed I asked the Deputy Chief Medical Officer (DCMO) to undertake a clinically-based review of hernia mesh use. I have now received that advice which includes a review of the literature, international and NICE guidelines and policy as well as data for Welsh patients with regard to procedures and complications.
There are significantly more patients who have undergone hernia mesh procedures in Welsh Local Health Boards than have undergone vaginal mesh procedures: 34,623 patients received hernia mesh over the 5 years reviewed (2011/12 to 2017/18) compared with 3,660 with vaginal mesh procedures. By way of comparison to other countries, almost 100% of patients having hernia repair have a mesh-based technique in Denmark, compared to roughly 78% of patients here undergoing surgery here in Wales.
Inguinal hernia repair is one of the most common surgical procedures performed worldwide (McCormack et al. 2003). The aim of surgery is to correct the weakness in the tissue where the hernia has occurred and to reduce the chance of hernia recurrence. The 2 options are repair using a ‘mesh’ or a suture method. A Cochrane review meta-analysis of existing evidence at the time in 2002 found that the use of mesh was superior to other techniques in view of reduced recurrence and reduced post-operative pain (EU Hernia Trialists, 2002). In 2018, a further Cochrane review of the available evidence comparing mesh procedures with non-mesh procedures was published. This review again found a statistically significant reduction in hernia recurrence when compared to non-mesh procedures (Lockhart et al. 2018). No clear conclusion regarding levels of pain was drawn in this review, due to the differences in the method of measurement of pain in different studies, but the author noted that the majority of studies reported less postoperative pain following the use of mesh than following surgery without mesh. A different meta-analysis published in 2018 found no difference in rates of chronic pain comparing mesh to non-mesh procedures in the first five years post-operatively (Oberg et al, 2018). International consensus guidelines were published in 2018 by the HerniaSurge Group and have recommended that a mesh-based technique should be performed for adults with inguinal hernias. This recommendation was made after all the available evidence was reviewed, including that on all rates of post-operative complication (HerniaSurge, 2018). I publish alongside this statement the full reference of the evidence considered as part of the DCMO’s review.
As with any procedure, a small number of patients however do experience complications with hernia mesh implants and in some of these cases removal is necessary. Available statistics reviewed from the past five years relating to mesh removal has shown that the cases where mesh removal is required are rare. For example, of the 34,385 patients who have undergone hernia repair with prosthetic materials in Wales, mostly mesh, only 238 had to have it removed, a rate of 0.7%, a figure consistent over 5 years. It is important to note that patients might have experienced pain but not sought mesh removal and that mesh removal once undertaken does not necessarily reduce pain.
The Royal College of Surgeons has also considered the use of mesh for hernia repairs and has recently issued a statement on the subject:
'It is clearly tragic if even a single patient suffers horrible complications from any type of surgery, not just hernia operations. Unfortunately the nature of surgery in general, not just mesh surgery, carries with it an inherent risk of complications which surgeons will always seek to assess, and will discuss with patients according to their individual clinical circumstances before surgery takes place…….There have already been a number of scientific studies looking at the use of different types of mesh in hernia and we should continue to review the evidence and patients’ experiences to make sure the right advice is given and the right action is taken. Along with the regulatory authorities, we will continue to listen to patients’ experiences. Patients suffering complications or pain need help, not silence. There must also be an ongoing review of the data to make sure that previous studies have not missed any serious, widespread issue. It remains vital that surgeons continue to make patients aware of all the possible side effects associated with performing a hernia repair.'
The clear opinion and advice from the Royal College of Surgeons, which is supported by the available evidence, international guidance and practice, is that we must continue to be vigilant and listen to patient feedback as well as examine any new evidence but at present, there is no indication to put a pause on the use of mesh in hernia repair. We will, of course keep the issue under review.
I do appreciate that for those patients who suffer problems, the impact can be severe. and I would urge any patient to ensure they seek ongoing advice from their GP or specialists in the usual way. In addition, if they have any concerns regarding their care, they should raise these concerns through NHS Wales’ Putting Things Right arrangements. They can be supported to do so through their local Community Health Council. Details of these contacts can be accessed via the following links: