Unlike the U.S., where industry calls the shots and regulators mostly abide with business, the Scottish government has moved to regulate transvaginal or pelvic mesh treatment options offered to women with pelvic organ prolapse and stress urinary incontinence.
The UK Daily Record reported this week that three of four mesh procedures used routinely in Scottish hospitals will no longer be recommended by doctors. Scotland seems truly interested in protecting women at the expense of mesh makers, rather than the other way around, U.S. style.
Pelvic Mesh Reform
After the Sunday Mail revealed hundreds of women had been painfully crippled after surgery with plastic mesh, the Scottish government launched complete reform of medical procedures in mesh implants. Pelvic mesh victims who joined the ‘Hear Our Voice’ campaign welcomed the review’s findings. They said the revised guidelines will save other women from enduring similar torment. Contrast Scottish response with the virtual U.S. media blackout of the tens of thousands of women who have filed lawsuits over their mesh-related injuries.
Approval removed for POP Surgery
A medical expert review group launched by the Scottish Government decided that using mesh to treat pelvic organ prolapse should not be approved for patients – ignoring advice from the UK health watchdog, the MHRA, insisting that the potential benefits outweigh any risks.
Scotland regulates Pelvic Mesh
Procedures using implants to treat bladder problems – often stress urinary incontinence – will also no longer be recommended for routine use in Scotland. The Record reports that these “changes mean doctors will not be able to use mesh implants unless authorized by a multi-disciplinary medical team.”
Adverse Events Reports Demanded
Doctors are also being warned that they must report adverse incidents or face possible sanctions, warnings which came after victims claimed the scale of the problems has been hidden by doctors failing to properly record complications. It is well known in the U.S. – by the Congressional Record and other sources – that typically just one in every ten adverse events for medical devices are reported. Additionally, studies show that the great majority of women who experience adverse events after a mesh implant do not return to their implanting doctor. In addition, at least in the U.S., many busy doctors report that they simply do not have the time it takes to report adverse events.
The Sunday Mail first reported women’s awful mesh injuries in March 2013. The paper has since “campaigned for action to ensure people are properly informed of the risks of mesh implants.”
Mesh Removal Complications
The Mail reported that patients had to have more than a dozen subsequent operations after the mesh implanted in them failed or damaged them further, and surgeons tried in vain to remove the plastic, which is actually designed – defectively so, say the women and their lawyers – to mesh with body tissues.
The Mail reported that some women were told their agony was all “in their head.” Some were sent for psychological treatment rather than given the surgery they needed.
The review states: “The independent review expressed serious concern that some women who had adverse events found they were not believed, adding to their distress and increasing the time before any remedial intervention could take place.”
Surgeons need Listening, Empathy Skills
The review further urges surgeons to improve their knowledge about mesh complications and their “listening and empathy” skills. In the U.S., many mesh surgeons have lucrative financial ties to the mesh makers. Some physicians even hold patents on the products they are implanting in women. (Conflict of interest?)
‘Hear Our Voice campaigner Elaine Holmes, of Newton Mearns, Glasgow, Scotland, said: ““We called for a total ban on mesh products as we believe time will show just how dangerous they are. But we’re happy to support the review recommendations as long as they and our petition points are put in place and actioned before any suspension is lifted. Our aim has always been to ensure women were properly educated about these devices, something we were denied, and we believe we have achieved that.
Mesh the Last, not First Option
Fellow campaigner Olive McIlroy, of Renfrew, said: “We’re also happy doctors will no longer be able turn to mesh products as a first option but rather as a last option.
“We strongly believe doctors failed their patients in the past by not reporting adverse incidents, which allowed mesh manufacturers to continue to state their products were safe when clearly they were
Despite some 400 Scottish women facing repeated surgeries and taking legal action, just a handful of doctors reported adverse incidents to the MHRA.
Scottish Health Secretary backs Review
The campaigners, who last year won an Unsung Hero gong at The Daily Mail’s Great Scot Awards, will travel to Holyrood on Tuesday to see Health Secretary Shona Robison and address the public petitions committee on the mesh report.
Robison said this week: “I welcome the interim report and the recommendations that it puts forward. . . “It is (also) clear that the whole process of treating women with these distressing conditions – the clinical governance – needs to be changed.”
Scotland suspended Mesh Implants
Last June, former health secretary Alex Neil introduced a suspension of mesh and said he was proud
Scotland was leading the way across the world.
Labour MSP Neil Findlay, who campaigned on behalf of patients, said: “These women are true heroines and I must congratulate them for their strength and determination to ensure no others suffer the injuries which have blighted their lives.”
• Scotland regulates Pelvic Mesh