NHS and medical watchdog tried to suppress scandal over vaginal mesh implants

NHS bosses and the watchdog that oversees medical devices tried to limit public exposure of the scandal over vaginal mesh implants that have harmed hundreds of women.

Minutes of a meeting held in October 2016 show that NHS England and the Medicines and Healthcare Products Regulatory Agency agreed to “avoid media attention” over the implants, despite the fact they were seeking to encourage patients to report any complications.

The document, obtained by the Press Association, records an agreement to “take the press element out” of the “yellow card” campaign to record adverse reactions experienced by vaginal mesh patients, suggesting that it could be folded into a wider effort, “of which mesh is one element, to avoid media attention on mesh”.

The apparent cooperation between NHS England and the MHRA to minimise media focus on the debilitating problems increasingly associated with the implants appears to breach the NHS’s duty – reiterated regularly by health secretary Jeremy Hunt – to be open and transparent over patient safety failings.

NHS England and the Department of Health both refused to comment on the minutes of the meeting.

One possible reason for the NHS to want to limit exposure of the issuecould be to reduce the number of potential lawsuits faced by the health service.

More than 800 women are suing the NHS and the manufacturers of vaginal mesh implants after suffering serious complications, it emerged this week. Some women reported that implants had cut into their vaginas, with one woman saying she was left in so much pain that she considered suicide. Others have been left unable to walk or have sex, according to the BBC.

Vaginal mesh implants are used to treat incontinence after childbirth or pelvic organ prolapse, where the womb or bladder bulge against the walls of the vagina. Between 2006 and 2016, more than 11,000 women in England were given the implants to treat prolapse or incontinence, NHS data shows.

Around 11%-12% of users have reported problems, while lawsuits in the US have already seen around $ 2bn (£1.5bn) paid to affected women.

Campaigners say that hundreds more women have come forward after learning of the group planning to sue.

Kath Sansom, who runs the campaigning website and Facebook group Sling the Mesh, says the number of women contacting her has risen from a few people a day to more than 200 in the past 24 hours.

“It’s always the same story,” she said. “There are so many women who were told it was just them, that they were a one-off. They can’t believe there are others out there. So many people are told it’s back pain, endometriosis, gall bladder pain, scar tissue. And so many of them accept it, you trust medical professionals.”

Data from the MHRA, which has been looking at the issue since 2011 following complaints from women, shows more than 1,000 adverse incidents have been reported in the past five years.

Despite the problems that have emerged the MHRA insists that the best current evidence supports the continued use of the implants to resolve health conditions that could themselves cause serious distress to patients.

A report into the issue from a working party led by NHS England admits there is a huge lack of data on complications from the devices. Published studies on mesh implants do “not tell the whole story” and there are gaps in NHS knowledge about their safety, it added.

NHS and medical watchdog tried to suppress scandal over vaginal mesh implants

What"s your experience of vaginal mesh implants?

More than 800 women are suing the NHS and the manufacturers of vaginal mesh implants after suffering serious complications.

Some women reported that the implants – used to treat incontinence after childbirth or pelvic organ prolapse, where the womb or bladder bulge against the walls of the vagina – had cut into their vaginas. One woman said she was left in so much pain that she considered suicide. Others have been left unable to walk or have sex, according to the BBC.

The medical regulator has said that the best current evidence supports the continued use of mesh implants to resolve health conditions that could themselves cause serious distress to patients.

If you’ve received vaginal mesh implants, we’d like you to share your experiences with us. You can fill in the form – anonymously, if you prefer – and we’ll use a selection of responses in our reporting.

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What"s your experience of vaginal mesh implants?

More than 800 women sue NHS and manufacturers over vaginal mesh implants

More than 800 women are suing the NHS and the manufacturers of vaginal mesh implants after suffering serious complications.

Some women reported that implants had cut into their vaginas, with one woman saying she was left in so much pain that she considered suicide. Others have been left unable to walk or have sex, according to the BBC.

However, the medical regulator said that the best current evidence supports the continued use of mesh implants to resolve health conditions that could themselves cause serious distress to patients.

The implants are used to treat incontinence after childbirth or pelvic organ prolapse, where the womb or bladder bulge against the walls of the vagina.

Between April 2007 and March 2015, more than 92,000 women had vaginal mesh implants in England, NHS data shows. About one in 11 women suffered complications. The issue reached prominence in Scotland last year after women with painful and debilitating complications formed a support group.

Claire Cooper began to experience pain three years after her operation. Doctors initially thought the discomfort was related to the removal of her womb, a procedure she had undergone aged 39.

When the pain continued, she said a GP told her she was imagining it. This, and the severity of the pain, resulted in suicidal thoughts, which she said she only overcame because of her children. Her constant pain has forced her husband to become her carer.

Cooper said she and her husband have not had sex for more than four years. “This stuff breaks up marriages,” she told the BBC. “I wouldn’t at all be surprised if there are mesh-injured women that have taken their own lives and didn’t know what the problem was.”

Another woman, Kate Langley, described the surgery as “barbaric”. She told the BBC that a surgeon who examined her “could see the [mesh] tape had come through my vagina – protruding through”.

Data from the Medicines and Healthcare products Regulatory Agency (MHRA) for 2012 to 2017 shows there were 703 adverse incidents relating to patients who had been given the implants to treat stress urinary incontinence, where urine leaks when the bladder is under pressure. A further 346 adverse incidents were reported for patients who had been given a mesh support to prevent pelvic organ prolapse.

The MHRA said the figures did not necessarily indicate a fault with any particular device and said evidence supported the continued use of vaginal mesh surgery for certain conditions.

A spokesman said: “What we have seen, and continue to see, is that evidence supports, and the greater proportion of the clinical community and patients support, the use of these devices in the UK for treatment of the distressing conditions of incontinence and organ prolapse in appropriate circumstances.”

A study published in the Lancet in December found that women who were given mesh implants were roughly three times more likely to suffer complications and twice as likely to need follow-up surgery compared with women who had the traditional version of the surgery, where stitches are used to provide support for the organs.

Rachael Wood, a consultant in public health medicine for NHS National Services Scotland and the lead author of the Lancet study, said: “The results were quite clear that women do suffer a higher complication rate and that it is no more effective. You can make quite a clear recommendation that it shouldn’t be the first line of treatment for prolapse.”

However, Wood said that the results on incontinence surgery were less clear, and for incontinence the study found fewer short-term complications when mesh surgery had been used compared to traditional treatment, which involves major surgery.

She said: “There’s no doubt that some women have had very poor outcomes. It is worth saying that nothing is without risk. There are also bad outcomes from traditional surgery and from doing nothing.”

More than 800 women sue NHS and manufacturers over vaginal mesh implants