Just as we need to change the onus of proof on Agricultural products, we need to do the same with non drug medical products. The licensing of the mesh repair products is a case in point, and all 4 health systems should be ashamed of not reporting side effects and complications systemically (all together). The reporting of such problems is just one reason for a large mutual in health. Devolution means smaller numbers and lower standards. The commissioners and the Trust Boards are all to blame, but so is central government. Will any careers be finished? They should be.. Mesh is a foreign body, and as such the default is rejection, and possible infection.
Up to 170 000 patients 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, an investigation by the BBC’s Victoria Derbyshire programme has found.
Around 570 0000 hernia mesh operations have taken place in England over the past six years, figures from NHS Digital show. Leading surgeons think that the complication rate is between 12% and 30%, meaning that between 68 000 and 170 000 patients could have been adversely affected in this period.
Patients who had had hernia mesh operations told the programme about being in constant pain, unable to sleep, and finding it difficult to walk or even pick up a sock. Some patients said that they felt suicidal.
The Department of Health and Social Care and the Medicines and Healthcare Products Regulatory Agency (MHRA) continue to back the use of mesh for hernia repair. The use of surgical mesh for stress urinary incontinence is under ongoing review after it was suspended in July in response to pressure from campaigners and MPs.1 Campaigners are calling for a similar review into the use of hernia mesh.
Owen Smith, a Labour MP who chairs the all party parliamentary group on surgical mesh implants, said that he feared the UK could “potentially have another scandal on our hands.”
He added that the MHRA was not doing enough to listen to the experiences of patients affected. “It reflects the flawed system we have in place,” he said. “Neither the regulators nor the manufacturers have to follow-up on problems.”
Ulrike Muschaweck, a private hernia surgeon, told the programme that she used a suture technique instead of mesh for most hernia operations, but this method was dying out because young surgeons were rarely taught it. She said that she had performed 3000 mesh removals because of chronic pain—after which only two of the patients had not gone on to become “pain-free.”
Suzy Elneil, a consultant urogynaecologist who was a leading voice in the campaign to halt the use of vaginal mesh, said that the mesh used in hernia was the same product. She estimated that treating those who have had complications with hernia mesh would cost a minimum of £25 000 (€28 000; $33 000) a patient—a similar amount to that predicted for vaginal mesh complications. This includes the removal of the mesh, a further operation to treat the hernia, and follow-up care. She said that the manufacturers should be covering the cost rather than the NHS.
The Royal College of Surgeons pointed to a 2018 study, which found that both mesh and non-mesh hernia repairs were effective for patients and were not associated with different rates of chronic pain.2
A spokesperson for the college said that “complications range dramatically from minor and correctable irritations to the more serious complications highlighted [on the] programme. Complications can also occur with non-mesh hernia repairs and by not operating on a hernia at all.”
They said that the college and regulatory authorities would continue to listen to patients’ experiences. “It remains vital that surgeons continue to make patients aware of all the possible side effects associated with performing a hernia repair,” the spokesperson said.
Kath Sansom from campaign group Sling the Mesh told the programme that a lot of the studies into complications were flawed or had short follow-up times. Quality of life questionnaires, for example, asked only about whether the hernia was fixed and not about new onset pain or other complications.
In a statement, the MHRA said: “We have not had any evidence that would lead us to alter our stance on surgical mesh for hernia repairs or other surgical procedures for which they are used. The decision to use mesh should be made between patient and clinician, recognising the benefits and risks in the context of the conditions being treated and in line with NICE guidance.”
An MHRA spokesperson added, “We encourage anyone—patient, carer, or healthcare professional—who is aware of a complication after a medical device is implanted, to report to us via the yellow card scheme, regardless of how long ago the implant was inserted.”