Shocking failings in the medical device industry
The pain is ‘unbearable’, says Angela Young. The 47-year-old hairdresser, from Stockport, describes it graphically: ‘It’s as if you have a handful of needles shoved between your legs.’
It’s more than 40 years since women first started to complain that a surgical mesh sling designed to treat post-childbirth damage was causing excruciating pain.
Their complaints were ignored, and in 1997 the mesh — a cheaper alternative to complex pelvic repair — began to be widely promoted. Since 2006, at least 126,000 meshes have been implanted to treat incontinence and prolapse.
While many have had no complaints, an estimated 15 to 40 per cent of women have suffered as the plastic mesh, sometimes known as transvaginal tape (TVT), has disintegrated into tiny shreds that slice into surrounding flesh, leaving some with injuries more consistent with a brutal sexual assault than a medical procedure.
It was a problem anticipated as long ago as the early Seventies. ‘The mesh was introduced as a treatment for female incontinence in 1968,’ says John Osborne, 75, a retired specialist consultant uro-gynaecologist who worked at University College Hospital in London.
‘A few years later the women were in pain and wanted it removed, which was extremely difficult as it was embedded in the tissue.
‘I warned there would be a similar problem when newer versions of transvaginal tape were introduced in the Nineties, and that people would need to be trained to take it out. I am very sorry to have been proved right, but I had no idea we were going to have a problem on this scale.’
Vincent Argent, a retired gynaecologist and former advisor to the National Institute for Health and Care Excellence (NICE), says he also refused to use mesh implants as long ago as 2003.
‘I strongly advised NICE that mesh procedures were risky and there was a major lack of safety and long-term outcome data,’ he said. ‘The advice was over-ruled by surgeons with a vested interest in promoting mesh procedures.’
And yet, as Good Health has highlighted, women’s complaints have been ignored or dismissed. Protests in Scotland led by two women left unable to walk because of mesh damage resulted in a review by the Scottish government. Its report, published in March, was branded a whitewash by campaigners as it failed to ban the implants.
A report by NHS England published in July merely called for greater use of the ‘yellow card’ system used by doctors to flag up problems to the Medicines and Healthcare Products Regulatory Agency (MHRA), which regulates medical devices.
Tomorrow a group of women injured by the mesh is set to descend on Westminster, to add their voices to MPs’ demands for a public inquiry into how the material was ever approved as a treatment.
But as this special three-part investigation reveals, the protest highlights shocking weaknesses in the system for regulating medical devices generally, causing disability, misery — and excruciating pain to thousands. This week more than 300 people who suffered the effects of leaking metal particles from artificial hips began a court action against one manufacturer.
A further 300 people with similar claims against different companies are waiting in the wings.
The fact is, the regulations to get a medical device approved for marketing are scarcely more stringent than the safety requirements for consumer goods such as toasters and teddy bears.
Indeed, Dutch documentary makers showed it was possible to get ‘mandarin mesh’ — the orange netting used for fruit and vegetables — approved as a pelvic implant material.
Furthermore, we’ve discovered that the MHRA does not know how many of the 60 to 70 approved varieties of surgical mesh are actually being used in the UK, let alone which patients have them. Like thousands of women, Angela Young had the mesh implanted to treat prolapse following childbirth. Soon after the surgery (in 2006, ten years after the birth of her son, now aged 21), the mesh began to fragment, causing internal bleeding, chronic infection and excruciating pain.
Angela, who runs a hairdressing business with her husband Paul McInery, says she was in pain ‘immediately afterwards’.
‘I went back to the surgeon countless times but he insisted the pain would settle down: it never has.
‘It took 20 months for the consultant to admit the mesh made a hole through the wall of the vagina.’
She says the surgeon agreed to try to remove the mesh, but without her consent, Angela says he then inserted a new, different brand of mesh which also fragmented.
‘The problems worsened,’ she says. ‘In 2009 I had five operations in a year. For the last two he wanted a bowel surgeon there as I had so much fragmented tape and scar tissue he was worried about additional damage.
‘He asked for an intensive care bed on standby. I was at my lowest ebb, I thought I was going to die.’
Angela has been told she now ‘has a mass of fragments’ that can’t be removed without causing more damage ‘but which cause tiny internal cuts every time I move’.
‘The pain goes through my stomach, my back and my legs,’ she says, adding: ‘My husband and I have tried once to have a normal relationship, but he could feel something sharp inside me and the pain for me was unbearable.’
An analysis of hospital data from more than 92,000 women implanted with the mesh in England between April 2007 and March 2015, just published in the scientific journal Nature, shows almost ten per cent had to have operations to try to remove it. Some of them have had as many as six attempts to extract the destructive fragments.
Suzy Elneil, a specialist gynaecologist in London, whose work is now focused on trying to remove the material from damaged women, says the real number injured is much higher because the statistics do not include women referred to pain clinics or otherwise not properly diagnosed.
‘This is a real problem,’ she says. ‘These women are suffering terribly. It needs urgent attention.’
Research suggests that between 15 to 40 per cent of those given a mesh suffer severe pain which destroys their sex lives and other normal functions, according to Kath Sansom, from support group Sling The Mesh. She believes it is likely that up to 25,000 of the 126,000 women who have received the mesh in operations over the past decade have been damaged by the material breaking up.
‘Some are suicidal,’ she says. ‘The health and wellbeing of thousands of women has been violated and their suffering has been ignored.
‘It has taken ten years to get this debated in Parliament. If it affected men it would have been dealt with years ago.’
Until this week’s parliamentary debate, there has been little political interest in the damage suffered by Angela and thousands like her, or in the lack of regulatory rigour governing the manufacture of pelvic mesh and the estimated 500,000 other ‘medical devices’ approved for use here.
Healthcare regulators across Europe, including the MHRA, rely on a network of 59 commercially run ‘notified bodies’ that approve the safety and efficacy of everything from contact lenses to breast implants and replacement hip joints, alongside run-of-the-mill consumer products.
The notified bodies are paid by manufacturers to approve the safety of their products — this gets them a crucial European Conformity CE mark and access to the market in all 28 EU member states, regardless of where the product was first approved.
‘The requirements for scientific validation are vague and the notified bodies have a strong incentive to help manufacturers get through the rules,’ says Carl Heneghan, professor of evidence-based medicine at Oxford University. ‘People think a CE mark shows a medical device is safe, but it doesn’t.’
He suggests there could even be a real cancer risk with mesh, but we wouldn’t know because ‘there is no register and no way of properly tracking which patients have got it’. He adds: ‘There are 50 or 60 different types of it approved for use and it’s just as likely to cause harm as to benefit a patient.
‘This system is the total opposite of the way drugs are regulated. It is a complete free-for-all. These are devices meant to be in people’s bodies for the rest of their lives, but we have no idea how the material will behave or what will happen to it.’
Three years ago Professor Heneghan helped a Dutch documentary team with their orange bag sting: to comply with European law, he said he simply filled in the forms referring to data on four other types of mesh that had previously been approved.
‘It took about a day,’ he says. ‘There is no requirement to produce any evidence from clinical trials.’ Footage shows officials declaring they can foresee ‘no problem’ with the netting being approved as a pelvic implant material.
‘We were really shocked by what we found the notified body was prepared to accept,’ said Jet Schouten, who led the TV investigation.
‘Our work did have a small effect; the number of accredited notified bodies was 69 before our report was broadcast and obviously it’s gone down, but there is still a long way to go.’
The MHRA oversees five UK companies that are approved as notified bodies for testing and approving medical devices. The others are scattered across Europe.
It says it is ‘not its remit’ to know how many types of surgical mesh are sold to British hospitals, but when pressed to give an estimate, it said reports of adverse incidents suggested that 12 types are in routine use.
Its spokesman would not say if the agency knew which products have been withdrawn.
Michael Kipping, the MHRA group manager for medical devices safety and surveillance, who is responsible for 40 managers and scientists carrying out vigilance and safety work, said the budget for monitoring medical devices, which is largely government funded, is just £10 million.
Most of the MHRA’s £157 million annual running cost income goes on drug safety surveillance. Much of the funding for the work comes from pharmaceutical companies who are obliged to contribute. ‘The onus is on the manufacturer of the device to show they’re conforming with the regulations,’ adds Mr Kipping.
Figures collected by the MHRA show they received 225 reports of mesh ‘complications’ last year compared with 381 the year before, but Mr Kipping says the agency recognises this is a ‘tiny proportion’ of the real number of women who suffer problems. ‘Patient safety is our number one priority and we are very keen to see a registry set up of all women who have the mesh in their bodies,’ he said. ‘We are looking forward to seeing what NHS Digital [the body that collects healthcare data] comes back with in terms of a recommendation about how this should be done.’
Better controls on the use of the material can’t come soon enough for women, such as Angela Young. Recently she has been told the tape has been anchored to the base of her spine and attempting to remove it could cause further nerve damage.
There is also a new collection of sharp plastic fragments protruding into her vagina. ‘I can’t have a proper relationship with my husband and I’m in permanent pain,’ she says.
The distress of so many affected women makes the indifference of the healthcare establishment hard to understand. ‘I have suffered a perforated bowel and am in constant pain but I’ve been told the mesh is now too embedded to take out and the surgery would risk my life,’ says Barbara McMahon, 58, from Aintree, Liverpool, who works in a bank call centre.
‘I had been married for 35 years but that ended last year as I can’t have a proper relationship. For a long time I was told my problems were nothing to do with the mesh.’
London solicitor David Golten represents 330 women planning to take legal action and says the number is rising steadily every week. ‘All of these women have suffered life-changing injuries and all of them have been fobbed off by the NHS,’ he says.
The All-Party Parliamentary Group on Surgical Mesh Implants, formed earlier this year, called for tomorrow’s debate on the use of the mesh.
‘I’m shocked that there isn’t greater regulation around the use of this material, as there should be for anything that’s going inside your body,’ Hull West MP Emma Hardy, who is one of its 18 members, told Good Health.
‘I have had very distressed constituents coming to see me to tell me their lives have been ruined by this material.’
Surgeons Vincent Argent and John Osborne both felt that inserting sharp plastic mesh into one of the softest and most delicate parts of a female body was bound to be a disaster.
‘The controls on implantable devices are not nearly as good as the controls on drugs,’ says Mr Osborne. ‘It’s very easy for people to get licences to market these things without adequate research to show their safety.’
The politicians and women protesters are demanding a proactive approach when things go wrong, but stricter regulations are needed to stop defective products being used in the first place, as we will reveal next week.
THE AWFUL TOLL: RUINED SEX LIVES, SUSPICION… AND EVEN SUICIDE
Fiona Wilson’s story is particularly devastating. The mother of two from Dumfries had the mesh surgery in 2011 following the birth of her second daughter a year earlier.
The damage caused destroyed her physical relationship with her husband. Convinced she was having an affair, he left her and committed suicide.
‘The hardest part is not being believed by my husband or the medical profession,’ says Fiona, 47, who finally had the mesh material removed a year ago, but has been left with bowel and nerve damage.
‘All the doctors kept saying the problems were nothing to do with the mesh.’
The pain means she can work only part-time in an office because she can’t sit for more than three hours. Her life with her daughters, aged ten and seven, has also been affected.
‘I can’t walk far with my girls, or do gardening or anything else at all physical.
‘I’ve been left with two children without a daddy and they haven’t had a true mummy either because of what’s happened to me.’
Another affected woman Denise Davis, 52, from Gorsley, Herefordshire, a mother of two adult children, says at her lowest ebb she considered suicide because of the pain which started after she had the mesh implanted in 2010 for incontinence.
‘I feel like I’ve got post-traumatic stress disorder,’ says Denise. The family building business, which she runs with husband Alan, has suffered because of her pain and fragility. And efforts to remove the mesh have made no difference.
‘I have difficulty walking and sitting down for long periods,’ she says.