Why aren’t binders a regulated medical device?

[everythingthelighttouches]

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?

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.

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)

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/

This is a brilliant idea

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.

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.

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.

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?

@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?

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

“ 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.

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

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.'

That's from 'Good practice guidelines for the assessment and treatment of adults with gender dysphoria'
October 2013'

Doesn't sound like a ringing endorsement. And that's for adults.

@everythingthelighttouches

“ 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.

Would that stop them being imported though?

It’s legal to import medicine that’s just for personal use from what I understand. (Which is why it’s legal to import retin a from abroad even though it should require prescription. If you look at the sites recommended for this in style & beauty etc they have a huge list of meds that can’t be prescribed here that are legal to bring in if just for personal use, adderall for example)

So while it would be great to have NHS say they can’t be prescribed safely, I think they might need further restrictions.

You may be able to buy drugs abroad and bring them home with you for your own personal use

but you certainly can’t import goods from outside U.K. for sale here if they are regulated. There is a division in MHRA which stop this.

@everythingthelighttouches

You may be able to buy drugs abroad and bring them home with you for your own personal use

but you certainly can’t import goods from outside U.K. for sale here if they are regulated. There is a division in MHRA which stop this.

Yep that’s what I mean, people might just resort to ordering them in for personal use.

It would be good if, as well as any statement made about these being unable to be licensed here because of the research showing such extreme risks, if there were also a statement to follow about how dangerous they are to import for personal use also.

It would be very difficult to get a medical product licence for a device whose sole purpose is to damage healthy tissue. At least I hope it would, but in today’s insane world, who knows?

Binders are perfectly safe as long as they are used appropriately. If binders are regulated, so should be sports bra (only to be prescribed after being measured!), all kinds of bandages and all kinds of shapewear.
I wear binders. The only time I actually did damage to myself was wearing a too tight sports bra (very popular when binders are not available) which was bought at a high street store.
High heels should definitely be banned (self mutilation - wearers are damaging their feet and legs intentionally), so should shapewear (no fitting advice given, and you can’t approve of one sort of shape wear but disapprove of another)….

@Itsanewdah

Binders are perfectly safe as long as they are used appropriately. If binders are regulated, so should be sports bra (only to be prescribed after being measured!), all kinds of bandages and all kinds of shapewear. I wear binders. The only time I actually did damage to myself was wearing a too tight sports bra (very popular when binders are not available) which was bought at a high street store. High heels should definitely be banned (self mutilation - wearers are damaging their feet and legs intentionally), so should shapewear (no fitting advice given, and you can’t approve of one sort of shape wear but disapprove of another)….

Have you seen the research? 97% of those who wear them report serious health problems including broken ribs, restricted breathing, chronic pain, damage to breast tissue and skin.

They are not perfectly safe which is why the nhs says they aren’t safe.

@everythingthelighttouches

There's different types of binders though, most work by smoothing lumps and bumps more than pure compression and are no more restrictive than corsets which are considered lingerie. Over tightening them is when damage occurs. I hate them myself, but them being medically certified legitimises them

I have a suspicion that not only would the MHRA be interested in the claims made in that Amazon advert, but so would the ISO; referenced further down as having certified the thing. Because that’s not how it works.