If a car had this many faults it would be recalled - professor speaks about mesh implants, the third medical disaster in the last 10 years
PUBLISHED: 21:11 10 October 2017 | UPDATED: 14:02 12 October 2017
Mesh implants are the third major medical device disaster in the last decade, a bioengineer has warned, as campaigners wept on hearing that the growing controversy is to be debated in Parliament.
Tom Joyce, professor of orthopaedic engineering at Newcastle University, says if similar concerns existed over a car it would likely have been taken off the market and investigated by now.
Labour MPs have secured a Parliamentary debate next week on behalf of Sling The Mesh and have pledged to call for a public inquiry into the growing controversial pelvic mesh implants.
When women heard the news they took to social media to celebrate knowing campaigners have been trying for more than 10 years to have their voices heard
Professor Joyce, who was among the first to contact Scottish Parliament when Scottish Mesh Survivors called for a suspension of the polypropylene plastic devices in 2014, said: “Unlike drugs, which someone can stop taking, a medical device is usually intended to be permanent.
“It leaves patients stuck with their suffering if an implant goes wrong or having to undergo complicated and traumatic removal surgery.
“Mesh is fast becoming the biggest health controversy of our time causing life changing injuries from implants used to treat incontinence, prolapse and hernias.
“It follows on from metal on metal hips which caused chronic pain when the metal was worn away and PIP breast implants that used mattress grade instead of human grade silicone.
“In the case of mesh I find it hard to believe there’s so many patients with problems but when you go to the regulators they say they are not getting the complication numbers through,” he said.
“Therefore it appears that systems are not in place to capture what is actually happening.
“That means the failings may go on for years before regulators or Governments realise something is wrong - and often only as a result of patient campaign groups.”
Speaking on BBC Radio Four Inside Health, Professor Carl Heneghan, director of the centre for evidence-based medicine at Oxford University said: “Medical device approval system is shambolic.”
Professor Joyce called for simple measures to improve patient safety:
• All implanted medical devices to go on a registry, so that every implant is tracked.
“for artificial hips and knees, it only costs around £20 per implant. That’s a trivial amount to pay for the valuable information it brings to identify poorly performing implants.”
• Phased introduction of new medical implants undertaken at specialist centres where all patients are fully tracked.
“Only once the efficacy is shown after a certain amount of time, should the implant be introduced more widely,” he said.
• A Europe-wide implant database, like the MAUDE (Manufacturer and User Facility Device Experience) database in America, where anyone can search medical devices to see how they are performing.
• Reporting of ‘failed’ medical implants should be mandatory. “We need true and full data to ensure patient safety”
Medical device regulation “can be a complex area of legislation and lacking in transparency,” Professor Joyce added, which is why patient safety groups may struggle to prove to bodies like the MHRA that implants are failing and why.
“The priority for regulators should be patient safety. If that means regulators stop medical devices being implanted while patient concerns are investigated, then so be it,” he said.
“Look at all the women campaigning about mesh – why aren’t they being listened to?”
A spokesman for Sling The Mesh said: “When a woman’s life is ruined from a so called simple operation and you are then ignored it is devastating - many women suffer severe depression from this. To know we finally have a Parliamentary debate has been a very emotional day for many.”