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Hernia mesh implants used 'with no clinical evidence'

"Too many" types of hernia mesh implants are being used on NHS patients with little or no clinical evidence, the BBC has been told.

New data shows more than 100 different types of mesh were purchased by NHS Trusts from 2012 to 2018 in England and Scotland, leading to fears over safety. The meshes can cut into tissue and nerves, leaving some people unable to walk, work or care for children.

Currently, hernia mesh devices can be approved if they are similar to older products, which themselves may not have been required to undergo any rigorous testing or clinical trials in order to assess their safety or efficacy.

In England, around 100,000 such operations are performed each year, the majority using mesh. Many go well. But the Victoria Derbyshire programme has heard from nearly 300 people who have experienced complications - including chronic pain, infections and organ perforations. International guidelines estimate one in 10 patients will experience "significant chronic pain" following a mesh repair.

The director of devices at the Medicines and Healthcare products Regulatory Agency (MHRA), Graeme Tunbridge, told the BBC: "The benefits and risks of using mesh for hernia repair have been considered in detail by clinicians and the professional bodies who represent them. We continue to monitor and review evidence as it becomes available and will take any appropriate action on that basis."

Mr Tunbridge said he recognised the system "does need strengthening" and said new legislation on medical devices would take effect from May 2020.

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Source: BBC News, 15 January 2020


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