All medical implants need logging on a national register to save patients a lifetime of misery, say campaigners
PUBLISHED: 15:30 26 January 2018 | UPDATED: 16:06 27 January 2018
Mesh injured women have hit out at the Government for failing to check that medical implants used in hospitals across Britain are safe.
And they warn that a watchdog body, tasked with patient safety, fails to spot problems until years later when thousands have been harmed.
Women have been forced to tell their personal stories to expose 20 years of the pelvic mesh disaster, the biggest women’s health scandal since thalidomide.
They say the MHRA is not fit to properly regulate devices because it suffers from “austerity measures” .
In addition a surgeon database fails to capture problems which means for years the NHS has said the operation is low risk when the long term picture shows the number of women suffering is at least one in ten.
Four years ago, Government watchdog body, the MHRA issued a patient safety alert, admitting nobody was properly reporting medical implant complications.
Promises were made to do better, but in 2018 campaigners say this is still not happening and the MHRA’s database, the Yellow Card, is still little used and largely unheard of.
Jackie Harvey, of Sling the Mesh, said; “Only after thousands of women were maimed from PIP breast implants and hundreds suffered irreversible pain from metal hips did the Government introduce a national register so every person is logged and their breast or hip implants tracked for life.
“This needs to happen for every new medical device launched on the market, it’s the only reliable way to pick up problems immediately.
“We believe it would add £20 per person to their treatment cost. A small price to pay to save a lifetime of unnecessary pain and suffering.”
In 2014, a worrying MHRA patient safety alert said: “Senior managers in NHS organisations are not always aware of important patient safety issues, or the quality of the reporting and learning systems that operate in their organisations.”
The alert flagged up:
• More than eight out of ten doctors were not logging the manufacturer name of a problem implant.
• Two thirds did not record the device name.
• Data was wrongly coded in up to a third of cases or used the word “other”.
• Around 40 per cent did not record outcomes because of wrong codes including death or serious harm.
A spokesman for the MHRA said: “Whilst there is no mandatory requirement, we actively encourage patients and healthcare professionals to report complications associated with implants through the Yellow Card scheme.
“As part of our regulatory role we have assessed the findings of published studies undertaken by the clinical community over many years, as well as considering the feedback from all sources in that time including adverse events.
“The publication of more data is a natural process, occurring as more experience is gained into the use and complications associated with these procedures and we will continue to review this evidence to ensure the safety of women is protected.”
Campaigners say a doctor database fails to track device performance, a weakness admitted by a spokesman for the Royal College of Obstetrics and Gynaecology (RCOG).
“As an organisation we accept that one of the weaknesses of the database is incomplete reporting which we feel can be addressed through mandating this.
“The British Society of Uro Gynaecologists is keen on this and is liaising with the RCOG to take this forward. This would have to be enforced through Government to become reality as this is outwith our control.”
The MHRA is tasked with regulating a wide range of medical devices including mesh, hips, finger joints, surgical lasers, wheelchairs, sutures, pacemakers, vascular grafts and orthopaedic pins.
• This month the MHRA announces it is streamlining its services.
• In America, a loophole was discovered in the FDA system in 2016, allowing medical device makers to hide and report problems years later, allowing a product to continue to be marketed.
• There are 6,000 surgeons working in obstetrics and gynaecology in the UK.
• RCOG has 1,835 members.
• BSUG has 493 members.
• BAUS has 1,924 members.
• There were 1,286 adverse events reported to the MHRA in a decade up to 2016. Of those less than half (533) were reported by healthcare professionals. See statistics from a House of Lords written question here.