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NHS tried to dodge vaginal mesh implant backlash

 

The NHS tried to DODGE media attention over the agonising vaginal mesh implants that left hundreds of women in constant excruciating pain

  • Minutes from an MHRA and NHS meeting show an agreement to ‘take the press element out of’ a campaign for women suffering complications from the device
  • A report by NHS England admitted a lack of understanding over their safety
  • Kate Langley has been admitted to hospital 53 times to try and relieve the pain
  • Since 2011, the MHRA has collectedover 1,000 reports of complications
  • Over 800 women are suing the NHS and mesh implant manufacturers 

The NHS tried to dodge media attention over the vaginal mesh implants that left hundreds of women in agony.

The procedure cut into their vaginas and left many in discomfort so severe they have been left unable to work, walk or have sex.

It has now emerged the NHS actively sought to avoid courting headlines over the matter.

Minutes from an NHS meeting back in October show an agreement to ‘take the press element out of’ a campaign for women experiencing complications from the devices.

Over 800 women are suing the NHS and the implants’ manufacturers, including Johnson & Johnson.

The NHS sought to 'avoid media attention' over the agonising vaginal mesh implants

The NHS sought to ‘avoid media attention’ over the agonising vaginal mesh implants

[We should] look into taking the press element out of the mesh yellow card campaign Minutes from a October 2016 MHRA meeting

The meeting’s minutes, seen by the Press Association, outline the Medicines & Healthcare products Regulatory Agency’s (MHRA) yellow card campaign, which targets under-reporting of mesh complications.

Officials said they should’look into taking the press element out of the mesh yellow card campaign’ and ‘investigate whether there can be a general yellow card campaign, of which mesh is one element, to avoid media attention on mesh’.

Between April 2007 and March 2015, over 92,000 women had vaginal mesh implants fitted in England. Of which, around one in 11 have experienced problems, according to NHS data from the Hospital Episodes Statistics.

An investigative report from a working party led by NHS Englandadmits there is a huge lack of understanding over the devices’ complications.

Since 2011, the MHRA has collected data showing over 1,000 reports of complications after the procedure.

A December 2015 interim report from the working group in England said the NHS is unable to collect accurate data on their use.

The devices repair damaged or weakened tissue in the vagina wall.

Some women report severe and constant abdominal and vaginal pain following the surgery.

Despite criticism, the procedure is still performed if a woman’s incontinence or pelvic organ prolapse is severe.

Women should be made aware of the potential risks of the implants and agree to proceed regardless.

Around 100 types of vaginal mesh implants are available in the UK.

No model has been withdrawn to date.

If the women are successful in their legal case, the NHS compensation payout could be tens of millions of pounds.

Thousands of women have successfully sued manufacturers in the US, receiving payouts that total several billion dollars.

Yet, the report added there is an ‘under-reporting’ of complications to the MHRA

It said: ‘Despite extensive efforts, the data and information group has found it difficult to gather information on mesh-related adverse incidents other than peer-reviewed publications in the medical literature, which the group feels does not tell the whole story with regard to adverse incidents.’

In a foreword to the report, Professor Keith Willett, medical director for acute care, NHS England, said: ‘There is evidence that complications, when they do arise, can be very severe and life-altering.

‘There is a lack of comprehensive data on complications, due to issues relating to data coding and incomplete data recording.

‘This is coupled with a lack of data from safety reporting of adverse incidents and long-term population level surgical outcomes, meaning we do not currently know the true complication rates and cannot use data to gauge severity.’

Patients in England and Scotland have resigned from working groups set up to investigate the issue, describing them as a ‘whitewash’.

The vaginal mesh implants have 'eroded through' and 'destroyed' women's urethras

The vaginal mesh implants have ‘eroded through’ and ‘destroyed’ women’s urethras

Ann Bori, 61, from Lincolnshire, had a mesh implant in 2003 for incontinence but suffered debilitating pain when it ‘eroded through’ her urethra and ‘destroyed it’ eight years later.

She helps run the support group Sling The Mesh, which has 1,600 members.

Ms Bori said: ‘I resigned because the group were not tackling the safety issue around mesh and were not willing to talk about it.

‘They want to keep mesh on the market.’

Implant recipient Kate Langley has been admitted to hospital 53 times to try and relieve the pain.

Yet, the mesh is too close to her nerve to be completely removed, leaving her with nerve damage.

Ms Langley was forced to give up her childminder business because the pain left her unable to look after the children.

Kate Langley has been admitted to hospital 53 times for the pain and is unable to work

Kate Langley has been admitted to hospital 53 times for the pain and is unable to work

A spokeswoman for the MHRA said patient safety was its highest priority.

She said: ‘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.

‘The evidence we have seen and continue to see is 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 pelvic organ prolapse.

‘We encourage anyone who suspects they have had a complication after having a mesh device implanted, to discuss this with their clinician and report to us via the Yellow Card scheme regardless of how long ago the implant was inserted.’

NHS England was unable to provide a comment.

Source: http://www.dailymail.co.uk/health/article-4432344/The-NHS-tried-dodge-vaginal-mesh-implant-backlash.html