Surgical mesh used in hospitals across the region is set to be upgraded to a high risk medical device.

PUBLISHED: 15:10 19 March 2017 | UPDATED: 15:10 19 March 2017

A transvaginal mesh kit used to treat incontinence in women.

A transvaginal mesh kit used to treat incontinence in women.

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.

From Motorbike to mobility scooter. Lizzy Ford after a TVTO pelvic mesh surgery left her disabled. Before this she was a keen motorcyclist PHOTO: Lizzy Ford From Motorbike to mobility scooter. Lizzy Ford after a TVTO pelvic mesh surgery left her disabled. Before this she was a keen motorcyclist PHOTO: Lizzy Ford

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.

Lizzy Ford three weeks before a TVTO pelvic mesh surgery left her disabled Lizzy Ford three weeks before a TVTO pelvic mesh surgery left her disabled

“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.

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.

More news stories

Yesterday, 16:52

One of Cambridgeshire’s most influential business leaders –chamber of commerce chief executive John Bridge – claims that re-opening of the Wisbech to March rail link is a lame duck.

Yesterday, 16:54

The Light Cinema, Wisbech, closed temporarily after what bosses say was a “small fire safety related issue”. It re-opens at 6pm tonight (Saturday)

Yesterday, 14:38

Voters in March get an extra chance to go the ballot box this year following approval for a referendum on a planning document that could revolutionise decision making locally.

Yesterday, 14:34

One of Britain’s biggest trade unions - the GMB – has condemned the 30 per cent pay rise for councillors that Cambridgeshire County Council voted through this week.

Most read stories

HOT JOBS

Show Job Lists

HOT JOBS

Show Job Lists

Digital Edition

Image
Read the Cambs Times e-edition E-edition

Newsletter Sign Up

Sign up to receive our regular email newsletter