Surgical mesh used in hospitals across the region is set to be upgraded to a high risk medical device.
- Credit: Archant
Surgical mesh used in hospitals across Cambridgeshire looks set to be reclassified to a higher risk medical device under plans to improve patient safety.
The polypropylene plastic mesh material, used to fix women’s pelvic floor problems of incontinence and prolapse, and also hernia repairs, is among a list of devices that will be moved up a notch in the risk scales.
The news has been welcomed by campaigners who want to see the mesh implants taken off the market and a switch back to traditional repairs that do not carry risks of foreign body reactions where a patient rejects or has allergic reactions to the plastic material.
Campaigner Ann Boni, of Sling The Mesh, said: “As time goes on, up and coming young surgeons are gradually losing the skills needed for women’s pelvic floor reconstruction or hernia repairs using traditional methods.
“Instead they are heavily relying on plastic surgical meshes for a quick fix. Sadly as time passes we are seeing more people suffer from the painful consequences of that mesh.
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“Plastic does not have a place inside the human body where it can change under body temperature to shrink or degrade causing horrific internal injuries and crippling pain.”
Currently surgical mesh has a IIb rating.
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If reclassified it will be come a III.
This means it must undergo stricter testing before it is allowed to be unleashed on patients.
It must also be followed-up with post market studies for up to three years to make sure any problem are tracked and traced.
Other medical devices set to be upgraded, as outlined in a European medical directive document, are breast implants, devices that come into direct contact with the heart and those that are wholly or mainly absorbed .
With Brexit looming it is unclear how the document will affect the UK but an MHRA spokesperson said: “The MHRA remains wholly committed to effective regulation of drugs and devices.
“This will not change after the UK leaves the EU.
“We have been working closely with industry and other stakeholders and we have established an internal taskforce which is exploring a range of possible models for the future regulation of medicines and medical devices in the UK – this is still under negotiation.
“The European Medical Device Regulations are currently being redrafted and are due to be finalised in Spring 2017.
“Although the European Council has published the latest version of the new regulations, this text may still be subject to amendment, so we are currently not in a position to offer any formal guidance or definitive interpretation of what is meant by ‘surgical meshes’.”
• Read the draft European medical device regulations here. The section on surgical mesh can be found on page 469/70.