Increased pressure on regulators to ban vaginal mesh implants

Legal experts join calls for shake-up of medical devices regulations following mass legal battle over vaginal mesh implants

Christian Beadell

Legal experts are supporting widespread calls for a ban on vaginal mesh devices and a subsequent review of UK medical product regulations.

The calls come after it was revealed that more than 800 women are taking legal action against the NHS and one of the biggest manufacturers of vaginal mesh implants, US pharmaceutical giant, Johnson and Johnson.

Used to treat pelvic organ prolapse and incontinence after childbirth, some implants have been found to cut into the vagina, causing severe discomfort.

Some women have been left in permanent pain, unable to walk or work, with one calling the implants ‘barbaric’.

Other women report that their partners have been injured by the mesh during intercourse and that they have suffered severe injuries.

Made from polypropylene, the meshes are made by different companies and there are several different types.

What is clear is that the device regulation system in the UK is in dire need of overhaul

And, according to NHS data, between April 2007 and March 2015, some 92,000 women have had them fitted.

Concerns over the implants led to a review by the Medicines and Healthcare products Regulatory Agency, which ruled that, for the majority of women, the use of vaginal mesh implants is safe and effective.

They are still prescribed on the NHS across the UK, although a recent review in Scotland said they should not be routinely used for pelvic organ prolapse.

But, in the past couple of weeks, the issue has once again been debated in the House of Commons, with a number of MPs calling for an immediate ban on the use of the devices.

The subsequent debate led to an announcement by the health minister, Jackie Doyle-Price, that there would be no inquiry, but instead the publication of new guidance by the National Institute for Health and Clinical Excellence (NICE) in relation to the use of mesh in gynaecological and urogynaecological procedures.

Then, in May this year, NICE did acknowledge the well-recorded concerns around possible erosion of the device and the infections they can cause. Given the lack of clear data on safety and effectiveness, it was recommended vaginal meshes should be considered for use in the context of it being research. This would mean that there would be a greater degree of scrutiny and patient discussion when proposing the use of devices.

But the last guidance on the use of mesh to treat incontinence was issued in October 2016 and concluded the overall benefits of mesh in stress urinary incontinence procedures justified their continued use.

Now, legal experts are warning that, if the mass lawsuit is successful, it could have widespread implications for the pharmaceutical market.

Speaking to BBH, Christian Beadell, a senior solicitor at Fletchers Solicitors, one of the UK’s-leading medical negligence law firms, said: “The fact that this announcement was responded to with gasps of astonishment in the House reflects the current polarisation of views in relation to the use of these medical devices.

“If you look at the reports over the past decade, thousands of women have had mesh implants removed.”

A recent report claimed that one in 15 women who have had the most-common type of mesh device inserted, later required surgery to remove them due to complications.

Beadell said: “Some experts have questioned this study, but if the figures are correct, then this could suggest a far-higher rate of complication for both trans-vaginal tape (TVT) and trans-vaginal mesh (TVM) than previously believed.

The advancement of the NICE review is to be welcomed, but if we are to avoid this becoming a medical scandal as big as thalidomide - which has been suggested - then swift action needs to be taken

“This shows the ongoing problem for the staunch campaigners wanting a blanket ban on all mesh devices, as for many women they have provided significant relief from debilitating symptoms of incontinence.

“However, that will provide no solace to those women who have had complications from mesh devices and have been told that this is not a claim that relates to the product itself.

“What is clear is that the device regulation system in the UK is in dire need of overhaul.

“It has been playing catch-up because the devices were authorised for market use before full clinical trials had been completed regarding their safety.

“While I would not be in favour of a blanket ban, as this removes patient choice; I would be in favour of a limited restriction on the use of mesh in the procedures with the highest incidence of complications.

“The advancement of the NICE review is to be welcomed, but if we are to avoid this becoming a medical scandal as big as thalidomide - which has been suggested - then swift action needs to be taken.”

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