The Sunday Times 11 January 2015
A fake report saw mesh netting on the brink of medical approval.
An Oxford scientist joined an undercover investigation to expose how the regulation of medical devices is so lax that mesh packaging for fruit could be approved as a medical device to be implanted in people’s bodies.
Carl Heneghan, professor of evidence-based medicine at Oxford, agreed to produce a fake report for Jet Schouten, a journalist with Radar, a Dutch consumer television programme, about the advantages of netting used in mesh bags for mandarin oranges as a surgical aid.
The dossier formed part of a secretly recorded presentation to TUV Austria, one of dozens of “notifying bodies” across Europe that administer safety regulations. Devices given Conformité Européenne (CE) accreditation by such bodies can be sold across the EU.
Footage shows officials from TUV Austria examining Heneghan’s report, which was ostensibly compiled for representatives of a medical equipment firm, before declaring they can foresee “no problem” with the mesh being granted a CE mark for use in surgical pelvic repair procedures.
TUV Austria has accused Radar of selectively editing the footage and insists the mesh would not have passed the CE approval process.
However, Heneghan believes there is little difference between the fruit packaging and CE-approved surgical mesh that has been used to treat an estimated 60,000 women in Britain who have had pelvic operations since 2007, usually because of earlier damage caused by childbirth.
Thousands of patients, including about 500 in Britain, are now pursuing legal action against five manufacturers of surgical mesh, which they claim can fragment into small pieces after being inserted and cut into tissue, causing intense pain. Previous scandals over substandard pacemakers, artificial hip joints and breast implants have raised questions about the regulation of medical devices as all had CE approval for sale in Europe.
Heneghan: ‘medical approval system is not safe’
The Medicines and Healthcare Products Regulatory Agency (MHRA), which oversees medical devices used in Britain, says the benefits of using surgical mesh outweigh the risks. Manufacturers say they will contest legal claims.
“We went to a notifying body in Austria with our mandarin mesh and they said it was fine,” said Heneghan. “People think approval shows a medical device is safe but it doesn’t. A teddy bear has got a CE mark on it and it is the same system that’s being used for medical devices.”
Jemima Williams, a mother of four from Barry, south Wales, who was treated with surgical mesh in 2002 and has since needed 18 operations to remove tiny fragments, is among those who are taking legal action.
“This plastic cuts through tissue and muscle. It is agony and although I keep going, it has wrecked my life,” she said.
Her GP husband, Dennis Williams, said almost a third of women receiving the mesh had experienced problems. “Most GP’s are entirely ignorant of this issue,” he said. NHS England is conducting a review into the safety of the mesh.
Glenis Willmott, the MEP for the East Midlands who is campaigning for better regulation of medical devices, said: “I want a stronger approval process for devices, especially high-risk ones such as implants.”