Should hernia mesh procedures come with a larger health warning?
Gene Matthews and Charlotte Evans from the product safety and consumer law team discuss whether a review of the use of hernia mesh by the NHS is needed following reports of complications after surgery.
Posted on 15 October 2018
Recent investigation by the BBC’s Victoria Derbyshire programme has found that up to 170,000 people who have had hernia mesh operations in the past six years could be experiencing complications, yet NHS trusts in England have no consistent policy for treatment or follow-up with patients.
In that six year period, there have been approximately 570,000 operations and the complication rate is said to be in the range of 12-30%, meaning approximately 68,000 to 170,000 patients may be experiencing complications as a result of the operation. Patients told the Victoria Derbyshire programme that they have been left in constant pain, some unable to walk and some patients said they have been left suicidal yet the Medicines and Healthcare products Regulatory Agency (“MHRA”) continues to support the use of hernia mesh.
The use of mesh is the most common treatment for a hernia. The treatment involves a doctor pushing any bulging tissue back into the body and covering it with a piece of surgical mesh in order to strengthen the tissue. However alternative options are available, as confirmed by Dr Ulrike Muschaweck in the programme. Dr Muschaweck stated that she used a suture technique instead of mesh but this method was dying out due to the fact young surgeons are rarely taught it.
The investigation bears a resemblance to the ‘scandal’ of vaginal mesh. These controversial implants, used widely across Europe, the US and Australia since the early 2000s to treat stress incontinence and pelvic organ prolapse, both of which can occur after childbirth, are inserted into the vagina from the abdomen and used as an alternative for more invasive surgery with less recovery time for the patients.
However as the mesh became more widely used, women came forward suffering life-altering complications and class actions have been brought against manufacturers around the world. In 2012 the United States Food and Drug Administration reclassified transvaginal mesh as a high-risk device and in 2018 the UK government suspended the use of vaginal mesh in England to avoid further risk of life-changing injuries to women. This decision followed an independent inquiry ordered by Jeremy Hunt which concluded the surgery must be stopped until steps have been taken to mitigate the risks to patients.
Labour MP Owen Smith, who chairs the All Party Parliamentary Group on Surgical Mesh Implants, confirmed to the programme that he feared the UK could "potentially have another scandal on our hands" in relation to the use of hernia mesh. He went on to state that the MHRA, whose job it is to ensure medical devices are safe, was not doing enough to listen to the experiences of patients affected and reflects a flawed system this country has in place – neither regulators nor manufactures have to follow up on problems instead they provide devices to the NHS then walk away with the NHS carrying any liability.
In fact the mesh used for both hernia and vaginal treatment is similar and gives rise to comparable complications such as pain, infection, erosion, migration and shrinkage but in the case of hernia repair they are also associated with hernia recurrence and bowel obstruction. In these circumstances, a review (similar to that conducted in relation to the vaginal mesh) seems necessary. Questions remain as to why hernia mesh has not yet suffered the same suspension as vaginal mesh.
While a certain number of hernia meshes have already been withdrawn from the market due to concerns about their safety, including the Ethicon Physiomesh which was subject to worldwide recall in 2016 after unreported studies showed there was a higher rate of recurrence or re-operation compared to other similar meshes, the MHRA in the UK is not conducting any studies on hernia mesh use and considers them in principle to be safe.
There are well-reported issues with mesh repairs, but as with all medical devices, the decision to ban or restrict their general use will be determined by whether complication rates become unacceptable. So where does this leave patients? Will patients continue to be recommended for this procedure? Until such time that there is definitive long-term data regarding these complications, or concerted action by the regulator; complaints regarding hernia mesh procedures are likely to increase.