NHS and medical devices regulator tried to limit scandal over vaginal mesh implants
Minutes show NHS England and MHRA worked together to try to ‘avoid media attention’ of problems faced by women
Friday 21 April 2017 11.19 EDT
Last modified on Friday 21 April 2017 12.43 EDT
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 (MHRA) agreed to “avoid media attention” over the implants, despite the fact they were seeking to encourage patients to report any complications.
More than 800 women sue NHS and manufacturers over vaginal mesh implants
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 incorporated 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 the 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.
MHRA officials said the minutes were more than six months old and the conversation noted in them was one of many conversations held during one of many oversight meetings about the issue.
The campaign, when it begins, will aim to ensure that both women and healthcare professionals know that there is no time limit on reporting complications with mesh devices. It will include engagement with the media, officials stressed.
An MHRA spokeswoman said: “Patient safety is our highest priority and we are committed to help address the serious concerns raised by some patients. MHRA strongly encourages the reporting of issues related to all medical devices. When promoting reporting it is important to strike a balance between causing undue concern to patients who may benefit from a procedure and making sure they are aware of the potential complications.”
One possible reason for the NHS to want to limit exposure of the issue could 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 the 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.
About 11% to 12% of users have reported problems, while lawsuits in the US have already seen about $2bn (£1.5bn) paid to affected women.
Campaigners say that hundreds more women have come forward after learning of the group planning to sue.
What's your experience of vaginal mesh implants?
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 after 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 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.
https://www.theguardian.com/society/2017/apr/21/nhs-vaginal-mesh-implants-scandal-suppress-media
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