Government refuses to ban scandal-hit mesh implants despite cross-party calls for suspension and public inquiry

Exclusive: Debate leader MP Emma Hardy ‘extremely disappointed’ by outcome, while Shadow minister for public health calls response ‘a load of twaddle’

Harriet Marsden
Thursday 19 October 2017 11:16 BST
The insertion of a plastic mesh device to treat hernia, prolapse and incontinence has come under increasing public scrutiny, following reports of high complication rates and accusations of an NHS cover-up
The insertion of a plastic mesh device to treat hernia, prolapse and incontinence has come under increasing public scrutiny, following reports of high complication rates and accusations of an NHS cover-up

The Government has refused to ban controversial surgical mesh implants, despite calls for suspension of the treatment and a Labour push for a full public inquiry into the scandal.

Following a debate in Westminster, minister for care and mental health, Jackie Doyle-Price, acknowledged the severity of the issues surrounding the treatment – but ruled out a public inquiry or a suspension.

She also insisted the risks were associated with clinical practice, not the mesh implants themselves, despite hearing testimony from medical device experts and gynaecological consultants to the contrary.

The issue was brought to debate by Labour’s Emma Hardy (MP for Kingston upon Hull West and Hessle), after hearing the experiences of women in her constituency who had been “suffering in silence”.

Ms Hardy told The Independent the response from the minister was “incredibly disappointing”.

“She failed to acknowledge the problems with the product; that it’s not just procedural. It was an extremely dissatisfactory reply, and I can only hope ... she might think again.”

Cross-party call to end mesh procedure ends in disappointment

The insertion of a plastic mesh device to treat hernia, prolapse and incontinence – in particular, the transvaginal mesh procedure, used on around 10,000 UK women a year – has come under increasing public scrutiny as reports have emerged of high rates of complication and inadequate data.

Campaigners and high profile surgeons have accused the NHS of “whitewashing” after the official report in July failed to address risks or lack of proper clinical trialling.

The mesh treatment is marketed as a quick, cheap and easy procedure to replace traditional, more complex surgeries. However, women have been left unable to work, walk or even sit down after complications, including chronic pain, organ erosion and perforations, nerve damage and loss of sexual function. Some have reported feeling suicidal, as their quality of life has been lost.

Ms Hardy called for a suspension of the use of mesh until a full inquiry is completed saying: “The lives of women and their families have been turned upside down ... The devastation has been appalling.

“The Government will not be able to undo suffering, but a suspension will go a long way to make sure nothing like this happens again.”

She was joined by members of the Tory party, as well as representatives from the DUP, Sinn Fein and SNP, all of whom expressed serious concern over the risks and lack of appropriate Nice guidelines surrounding the device.

Alec Shelbrooke, Conservative MP for Elmet and Rothwell, said: “I did a lot of work on the thalidomide scandal. This is the new thalidomide.”

Dr Sarah Wollaston, Conservative MP for Totness, insisted that “we cannot allow this to continue; there is cavalier practice and insufficient data, and inadequate clinical trials”.

Pointing out that the device is regulated by the EU, she asked: “How does the government propose to take this forward after Brexit? We must make sure the safety of women is prioritised at all times.”

Owen Smith, Shadow secretary of state for Northern Ireland and chair of the all-party parliamentary group on surgical mesh implants, called it one of the worst medical issues he had come across.

Mr Smith also called the response from the Government “desperately disappointing”. He addressed the women in the gallery directly: “We know there’s a problem, and we’re trying to reflect your bravery and amplify your voices in Parliament.”

Conservative MP for St Ives, Derek Thomas, said that what we know so far is clearly “just the tip of the iceberg”. He explained that, having listened to his constituents tell their “harrowing” stories, he is convinced that the scandal “could, and should, have been avoided”.

He describes a 47-year-old member of his constituency who suffered from minor prolapse, and was treated with transvaginal mesh without being told of the risks. She now has a permanent low-level infection, he said, but when she went to a doctor she was told: “Don’t worry; you truly have a designer vagina.”

She is also unable to sit or stand properly, he said; this was clearly echoed by women in the gallery, many of whom could not sit or walk easily and struggled to get from the debate hall to the conference room.

Jo Platt, Labour MP for Leigh, said: “The worrying narrative emerging is many women experiencing problems are only now finding out about the complications mesh can cause.

“Women who have had the procedure should be contacted and made aware of these issues. They deserve a full inquiry to determine how this could have happened, and steps taken to assure this will never happen again.”

While the Medicines and Healthcare products Regulatory Agency (MHRA) and NHS official statistics put the risk of side effects at 1-3 per cent, the real statistics are almost certainly much higher. Non-hospital data is not included, many symptoms only manifest themselves years after the procedure, and many women don’t come forward out of shame, embarrassment or even ignorance of even having the mesh inside them.

According to the most recent hospital independent statistics and independent studies, the risk of serious complications is actually between 10 and 12 per cent.

However, Kath Sansom, founder of the Sling the Mesh campaign, says the real risk is likely to be around 20 per cent. Many women experiencing symptoms either don’t report them, or are dismissed by their GPs, she said.

“They need to stop this myth that there are only infrequent complications,” she said. “According to the NHS, side effects for one in 100 is considered common; one in 10 is deemed ‘very common’.”

She describes the case of a 27-year-old who was implanted with mesh at 13, then again at 16, to treat birth defects; she is believed to be the youngest in the UK. Ms Sansom explains that the woman did not even know that her symptoms could be related to her mesh implant until she saw a news article about the scandal two days ago.

“She was told it would change her life. It did. She has suffered ever since but been ignored at every turn.

“This isn’t the cheap, quick fix dream. It’s the stuff of nightmares.”

Cross-party debate on mesh procedure

In the US, mesh has been considered considered a high-risk device since 2011, with medical bodies estimating that up to 40 per cent of women suffer side effects. In Scotland, former Health Secretary Alex Neil called for their suspension two years ago.

Carolyn Harris, Labour MP for Swansea East, said: “These figures are staggering, it’s like Russian roulette.

“We can’t just sit on the fence in the UK: this problem is ongoing and we can’t sit around waiting for the guidelines to be published. There has to be an immediate inquiry; we cannot wait.”

More than 800 UK women who received a mesh implant are already suing the NHS for failure to obtain proper consent and inadequate surgical technique. They are also suing device manufacturers, in particular prominent mesh providers Johnson & Johnson, who have already paid out $57m (£43m) in Philadelphia last month to a mesh sufferer.

Manufacturers have also been accused of offering grants to bias surgeons and putting pressure on medical bodies to keep the device on the market, despite safety concerns. There is even evidence that the NHS tried to keep the scandal out of the public eye.

Robert Rose, partner and head of the clinical and medical negligence team, has acted for many women who’s lives have been affected by vaginal mesh and fights for those affected to be correctly compensated.

He asks: “If the medical profession were aware of these complications, why did they not do anything to raise awareness, and if they weren’t aware then why not?”

Labour called for three things: a full public inquiry and retrospective investigation; a suspension of the use of mesh while the inquiry is carried out; and for new Nice guidelines to be published sooner than the currently predicted 2018/19, in order to raise awareness among MPs, GPs and the public.

However, all they managed to secure from Ms Doyle-Price was a commitment to bring the publication date of the updated mesh guidelines forward to before Christmas. She refused to suspend the use of mesh until then, arguing that there is not enough evidence to support suspension.

Ms Doyle-Price said: “I’m horrified to hear many women didn’t even know they were having mesh devices fitted in the first place, which indicates some arrogance in the medical world against women.

“However, the MHRA still says the device is the best product for treating incontinence. And more important than a public inquiry is that women get the treatment they need. The problem is with clinical practice, not the product.”

Ms Hardy responded to Ms Doyle-Price: “The reaction you have just given is not good enough, I completely disagree with you; it’s not just about the practice, it is about the product.”

This was echoed by Sohier “Suzy” Elneil, consultant urogynaecologist and one of the foremost mesh removal experts in the country, who treats about 15 women a week.

“It’s not just an issue with the mesh going in – most of the problem is related to the product, rather than the surgeon,” said Ms Elneil, who wants to see a ban for at least two years while the data is investigated. “And a huge amount of product is used. The inflammatory nature is so bad that it must be the device.”

It was reported that at least 83 per cent of the mesh devices were contaminated with bacteria, despite clinical requirements of sterility. Removal of the mesh is also an extremely difficult and often not fully successful procedure, as the surgery is so complex it’s been described as “trying to remove hair from chewing gum”.

Sharon Hodgson, Shadow public health minister and the front bench representative for the campaign, called the Government response today “a load of twaddle”.

“If there is not enough evidence to ban it, then there was not enough evidence to support its efficacy and safety in the first place.”

She admitted that she had not heard of the issue before becoming health minister, but sees it as a huge, global problem.

“I was horrified. When the general election was called, I had a commitment put in the manifesto to call for public inquiries into all outstanding medical scandals.”

She has now made a front-bench commitment to push for a full public inquiry.

“The Government have failed to answer big questions about the extent of this public health scandal, including how many women have been affected and why a product with such terrible risks was allowed into the market in the first place.

“As a woman, I wouldn’t have this procedure. None of us would, knowing what we do now. How many people in this chamber would agree to a mesh implant now?”

She added: “If mesh were a faulty car, it would be immediately recalled. Why does this precaution not apply to women’s safety? It’s time women’s health was taken seriously.

“We need to shout it from the rooftops: we must suspend this procedure.”

In response to the arguments about insufficient evidence to support a ban, Ms Hardy said directly to the women:

“You are the evidence. I will continue to represent you. I promise we won’t stop now. You all deserve a hell of a lot more than you’ve been given today.”

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