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Medical authorities wanted to 'avoid media attention' over mesh implants

The medical devices regulator and NHS England sought to "avoid media attention" on mesh implants, which have left women in debilitating pain, documents show.

Minutes from a meeting held between the Medicines and Healthcare products Regulatory Agency (MHRA) and NHS England officials in October show an agreement to "take the press element out of" a campaign for women reporting complications from the devices.

The document, seen by the Press Association, says officials should also "investigate whether there can be a general Yellow Card campaign, of which mesh is one element, to avoid media attention on mesh".

A report from a working party led by NHS England looking at the issue also admits there is a huge lack of data on complications from the devices.

It said published studies on mesh implants do "not tell the whole story" and there are NHS gaps in knowledge about their safety.

Hundreds of women are suing manufacturers and the NHS after suffering cuts, severe discomfort and inability to walk or have sex after having the implants.

Some 12% of users have reported problems, while lawsuits in the US have already seen around £2 billion paid out to affected women.

The implants are used to treat pelvic organ prolapse and incontinence after childbirth.

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.

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

It said: "The current coding does not allow the identification of the reason why the tape/mesh has been removed.

"If codes could be developed which indicate the type of removal and indicate the reason why, this would provide more information... about these procedures."

It said there was "under-reporting" of complications to the MHRA, adding: "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, NHS England's medical director for acute care, 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."

A 2016 Lancet study from UK hospitals found 12% of women with a mesh implant for prolapse suffered a complication within two years.

It concluded: "Augmentation of a vaginal repair with mesh or graft material did not improve women's outcomes in terms of effectiveness, quality of life, adverse effects, or any other outcome in the short-term, but more than one in 10 women had a mesh complication."

It said longer-term follow-up on benefits or complications was "vital".

Patients in England and Scotland have resigned from working groups set up to look at the issue, describing them as a "whitewash".

Ann Bori, 61, from Lincolnshire, resigned from the England working group.

She had a mesh implant in 2003 for incontinence but suffered debilitating pain when it "eroded through" her urethra and "destroyed it" after eight years.

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

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

"We were invited there so they were seen to be doing something but it was a lip service on their behalf for a pre-determined outcome. They want to keep mesh on the market."

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 said it was unable to provide a comment today.

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