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MHRA launches public consultation on future of medical device regulation

helvella profile image
8 Replies

I strongly encourage you to consider replying to this invitation to submit your views.

I suspect a lot of members use one or more devices and would likely have opinions worth contributing. Although not specific to Pernicious Anaemia, I'm quite sure many use devices such as autoinjectors specifically in their management of PA.

MHRA launches public consultation on future of medical device regulation

People are being encouraged to contribute their views on changes to how medical devices will be regulated across the UK.

Launched today by the Medicines and Healthcare products Regulatory Agency (MHRA), the 10-week consultation gives everyone the opportunity to draw on their own experiences and contribute to the improvement of the regulatory framework and therefore patient safety in the future.

From hearing aids and walking sticks, to insulin pumps and thermometers, for many of us, medical devices are an essential part of our everyday lives. We all want to know that the devices we use are safe and effective, so regulation of medical devices really matters, especially where fast-developing technology has changed, and continues to influence, the landscape for medical devices, bringing new, innovative devices to the UK market, including some health apps.

The MHRA is the regulator for medical devices used in the UK. We are seeking views from across the medical devices and healthcare sectors, medical practitioners, patients and the wider public, to inform our future approach. We would like to hear from those who research, manufacture, supply and use medical devices.

More - including links on getting involved - here:

gov.uk/government/news/mhra...

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helvella
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8 Replies
pitney profile image
pitney

thank you👍

MePo profile image
MePo

Thanks for sharing this x Will investigate when I'm more awake 🥱 But, might be worth saying that Surgical Mesh is considered a Medical Device! Sadly, personal experience gives me that knowledge, and I'm waiting to re-schedule a removal operation ☹️ xx

deniseinmilden profile image
deniseinmilden in reply toMePo

I've got some, fitted in March for a sort of hernia operation, and I wish I didn't. It's incredibly painful at times.

I'm female but I had a hydrocele cyst (normally only found on men's testicles!) which they removed and patched the hole with mesh so it wouldn't rupture in future.

When I saw the Surgeon about it 5 months later he just advised me to take unbelievable amounts of painkillers, including gabapentin/pregabalin - addictive drugs that can have seriously unpleasant effects!

With some permanent neuropathy from years of B12d and chronic pancreatitis, (which can be devastatingly painful so I need maximum effect from any pain relief), I do not think he offered good advice.

MePo profile image
MePo in reply todeniseinmilden

Oh Denise I'm so sorry 😔 I paid for a 10p sized hernia under my right ribs to be repaired in 2007, thinking it would help me feel well enough to return to work, and also that surgeon would just suture it as it was so small. He slapped a mesh size of DL envelope over it with titanium screw tacks 😓 Through a mesh support group I've found lovely surgeon who will remove, repair original hernia and another hernia above my navel, with my own tissue and sutures, he is well respected among patients, and worldwide 'lurgy' stopped op last year and my B12 crash this August 😔.Due to see him in November so he can examine me properly (just telephone consults and email imaging etc for obvious reasons) If you need his details....... 😘😘😘😘

deniseinmilden profile image
deniseinmilden in reply toMePo

Oh goodness, poor you!How annoying and frustrating as well as scary and debilitating.

I'd heard that the mesh had been a problem with bladder and prolapse troubles but I didn't know how widely it is used in general surgery.

"Take pain killers" really shouldn't be the answer to the its use.

I am so sorry that you have suffered such delays in finding a possible solution and wish that you don't have to wait much longer for relief.

The very best of luck with it to you!

😘😘😘😘

helvella profile image
helvella in reply todeniseinmilden

I know this links to the USA, but various mesh products are used for hernias:

fda.gov/medical-devices/imp...

deniseinmilden profile image
deniseinmilden in reply tohelvella

Thank you for looking into it for me - very much appreciated.

While my GPs will only deal with UK research, I am much more open minded and know that some of the best advances in healthcare technology comes from the US.

Thank you!

deniseinmilden profile image
deniseinmilden

Thank you for sharing this here too!

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