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Original poster

Why aren’t binders a regulated medical device?

91 replies

everythingthelighttouches · 14/11/2021 11:34

I’m just getting my head around this and wondering if there is recourse via MHRA.

Anyone looked into this?

Definition according to government website:

www.gov.uk/guidance/medical-devices-how-to-comply-with-the-legal-requirements

“ Definition of a medical device
You need to decide if your product is a medical device before you go through the compliance process.

According to the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002), a medical device is described as any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnosis or therapeutic purposes or both and necessary for its proper application, which is intended by the manufacturer to be used for human beings for the purpose of:

diagnosis, prevention, monitoring, treatment or alleviation of disease
diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap
investigation, replacement or modification of the anatomy or of a physiological process, or
control of conception”

Email address for reporting non-compliance n the link below. What I’m not sure of is whether selling an item which should be regulated but is not is non-compliance??? e.g.Lush

www.gov.uk/government/publications/report-a-non-compliant-medical-device-enforcement-process/report-a-non-compliant-or-suspected-counterfeit-medical-device

Is there recourse through general consumer act or something?

OP posts:
ArabellaScott · 14/11/2021 13:26

Okay, I found this on the NICE site:

'Men whose breasts are causing them distress and who have a
diagnosis of gender dysphoria or have a Gender Recognition Certificate may need to have chest reconstruction around the same time as the change of gender role. Breast binders may be worn, but this can be painful and problematic. Binders restrict breathing and may have significant physical consequences. Damage to the breast tissue is also caused, so that chest surgery may be more complicated and less successful.'

ArabellaScott · 14/11/2021 13:21

I would like to see NICE/NHS guidelines and/or comment on the use of binders.

Original poster
everythingthelighttouches · 14/11/2021 13:16

“ But surely a safe binder would be one that didn't work? Compressing tissue and wrapping around the ribcage can't be done gently, can it? If manufacturers came up with "safe binders" that didn't compress enough, girls would buy them in smaller sizes or pick versions that weren't "safe", surely?”

I quite agree.

I was thinking that the process of going through medical regulations and approvals would ultimately result in these being deemed unsuitable for sale in the U.K.

In exactly the same way that many drugs are evaluated and found to be unsafe and therefore are not on sale.

OP posts:
EmbarrassingHadrosaurus · 14/11/2021 12:53

Binder seller on Amazon says:

Quality Standard
12 Years Experience
CE Marked
Class 1 Medical Device
Member of Made in Britain
NHS Supplier

www.amazon.co.uk/dp/B08SW8WXX2?tag=mumsnetforu03-21

Class 1 guidance (clear as mud to me).

www.gov.uk/government/collections/guidance-on-class-1-medical-devices

MultiStorey · 14/11/2021 12:51

This reply has been deleted

Message withdrawn at poster's request.

FlyingOink · 14/11/2021 12:47

@everythingthelighttouches

It’s not about being available on the NHS at all.

Lots of products are regulated medical devices:

Condoms, contact lenses for example.

The point us that it would have to be assessed through a rigorous process with standards far higher than that of a standard consumer product.

That's fair enough, I was thinking about it differently.

But surely a safe binder would be one that didn't work? Compressing tissue and wrapping around the ribcage can't be done gently, can it? If manufacturers came up with "safe binders" that didn't compress enough, girls would buy them in smaller sizes or pick versions that weren't "safe", surely?

Sonex · 14/11/2021 12:43

I always wonder this. And surely binding increases the chance of breast cancer further down the line due to trauma? has anyone looked at this?

EmbarrassingHadrosaurus · 14/11/2021 12:40

Medical Device regulation in the UK (and elsewhere) is a mess.

However, this is a good thought. I can't think that NICE would even take this forward as an appraisal for a medical device.

Original poster
everythingthelighttouches · 14/11/2021 12:25

It’s not about being available on the NHS at all.

Lots of products are regulated medical devices:

Condoms, contact lenses for example.

The point us that it would have to be assessed through a rigorous process with standards far higher than that of a standard consumer product.

OP posts:
FlyingOink · 14/11/2021 12:02

I'm not sure it's a good idea to get the people who made vaginal mesh and silicone implants available on the NHS to do the same for binders.

The fact there's lots of evidence to show binders are harmful may not stop them being prescribed.

2319inprogress · 14/11/2021 11:51

This is a brilliant idea Flowers

Original poster
everythingthelighttouches · 14/11/2021 11:46

Are they making a Therapeutic claim though?

Well this is very interesting isn’t it????

Either this is acknowledged to be an item of fashion or something necessary because certain individuals are suffering a great deal of distress.

If it is claimed to be necessary to alleviate symptoms (of psychological harm from having breasts), then I think it qualifies…

If a fashion accessory then why in (insert deity of choice). ‘s name is a soap shop selling an item which causes physical harm??

I refer you to a project from Loughborough

www.lboro.ac.uk/news-events/news/2019/june/student-creates-product-that-may-transform-lives/

OP posts:
Kotatsu · 14/11/2021 11:45

www.regulatory-affairs.org/en/regulatory-affairs/news-page/the-mdr-requirements-for-medical-products-also-apply-to-compression-stockings/

This is German (although in English) and about compression stockings. I can't see why binders are actually significantly different to compression stockings (of the medical grade type - eg. those you're given to wear after varicose vein surgery, that really squeeze your legs)

BloodinGutters · 14/11/2021 11:38

Because then there would be some kind of accountability surely? And the research indicates that 97% of (female) people who wear them report serious harm from wearing them.

MultiStorey · 14/11/2021 11:36

This reply has been deleted

Message withdrawn at poster's request.

MultiStorey · 14/11/2021 11:35

This reply has been deleted

Message withdrawn at poster's request.