Nobody knows the true scale of the pelvic mesh scandal - but new figures show it could be as high as almost 40 per cent
PUBLISHED: 17:13 27 January 2017
The true scale of the risk of surgical mesh to treat women’s incontinence and prolapse remains a mystery amid findings from America that say up to almost 40 per cent of women suffer injuries from the hooked instruments used to implant it.
In America, health watchdog body the FDA, has announced that the trocars - hooks which a surgeon uses to push mesh implants through the pelvic cavity - cause a raft of injuries leading to them being reclassified as higher risk devices.
The figures may shock patients waiting to have surgery in the UK who are told risks are as low as one to three per cent in figures published by UK watchdog body the MHRA.
Hospital episode statistics suggest TVT mesh tape complications in England are one in 11 women (8.56 per cent risk) - but that figure is woefully low as it only accounts for women who have had a removal or a further procedure to fix their mesh mess - it does not account for the women suffering problems who do not return to their surgeon for help or when they do are told their pain has nothing to do with their mesh.
A Canadian study says pelvic mesh risk is 15 per cent.
Sling The Mesh campaigner Kath Sansom said: “The grim reality is that nobody has a clue of the true scale of risk because no country has a National Register to track women throughout the lifetime of their mesh implant.
“What we see as campaigners globally is that women’s physical and mental health is being seriously compromised forever in what is sold as a simple 20 minute fix for an embarrassing problem.
“None of us were warned of the devastating risks which include nerve damage, chronic leg, groin or pelvic pain, losing a sex life and urinary tract infections.”
Scottish Mesh Survivors campaigner Elaine Holmes said: “In the last nine months, US health watchdog FDA has issued two final orders to reclassify pelvic mesh for organ prolapse to high risk Class III and heightened the risk category for surgical instrumentation.
“In addition, they issued a safety alert for urogynecologic surgical mesh implants by Boston Scientific, notifying American women of the potential for counterfeit raw material.
“The UK health watchdog MHRA chose not to issue these notifications and safety alert to inform and protect UK women - why?”
The FDA says instruments used to place pelvic mesh have been upgraded from Class I low risk to Class II higher risk which require greater controls.
In a ruling published this month FDA figures reveal that:
• Up to 39.1 per cent of women suffer nerve injuries from instruments used during prolapse repairs.
• Up to 29.4 per cent of women suffer vascular injury and bleeding during insertion of a TVT mesh sling.
• Up to 23.8 per cent of women suffer organ perforation and injury from TVT insertion.
• Up to 5.3 per cent of women suffer nerve damage and pain from TVT insertion.
Prof Tom Joyce, professor of orthopaedic engineering at Newcastle University said there is an on-going crisis with medical implants because they are approved too easily and their performance not properly monitored.
He said: “A key issue is the ‘precautionary principle’. If there is a chance of harm then its use is stopped while the potential problem is investigated.
“We see this approach in cars and aircraft with thousands of vehicles brought back to be checked and planes grounded while investigations are undertaken.
“The same precautionary approach does not appear to happen when there are concerns with medical implants.
“This should change. When major concerns exist, implantation of specific medical devices should stop and evidence be gathered and assessed so that an informed decision on benefits and risks can be made.
“Patient safety has to be prioritised.”
London-based surgeon Sohier Elneil said she is inundated by women asking for help and believes there are grounds for the procedure to be banned.
She said: “I used to see one or two a month who wanted the mesh taken out and now it’s more like five a week.
“There was a huge uptake of this therapy well before we had all the evidence and the research into it so until we have that, which is now being done in retrospect, I think it’s very difficult to keep on using them.
“For some patients, this surgery is of benefit but for some women it is a personal tragedy.”
Canadian surgeon Robert Bendavid said: “The industry has been crafty in imparting the idea that it is a simple operation and sure enough it is, but the complications are monumental, especially when alternative pure tissue repairs are available.”
A spokesman for the MHRA said: “Between January 2016 and December 2016, MHRA received 171 adverse incident reports relating to gynaecological mesh to treat incontinence.
“These figures include a range of recognised complications related to this type of surgical procedure and do not necessarily indicate a fault with any particular device and because there is no time limit on reporting, trends need to be interpreted using other data.
“Reported incidents may not necessarily represent individual patients as an individual could experience adverse incidents at different times which result in separate reports.
“Additionally, an adverse incident report could contain a number of complications being experienced by a single patient.
“Patient safety is our highest priority and we continue to monitor this issue.
“MHRA encourages anyone who suspects they have had a complication after having a mesh device implanted, to discuss with their clinician and report to us via the Yellow Card scheme regardless of how long ago the implant was inserted.”