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?

'perfectly safe' seems an odd choice of phrase for something that the NHS says this about:

'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.''

Really sounds very far from 'perfectly safe', to me. Which is why, I presume, I can't find any guidance from NICE or the NHS on the safe use of binders.

Binders are perfectly safe as long as they are used appropriately.

So are explosives.

“ 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)….”

All those things are fashion items.

Are you saying breast binders are fashion items??

@everythingthelighttouches even worse!
But all are body modification devices. Some are mainstream fashion (and therefore damage a great number of people, especially since that damage is normalized), some help a small minority of people to live with a body they don’t feel at home in for many reasons and prevent their mental health from tanking (and come with extensive advice on wearing them responsibly).
I know which one is more damaging…
A good quality binder worn correctly is not a health risk. If at all we need more education on how to wear them correctly, not banning them.
And yes, a good one that fits properly doesn’t hinder breathing any more than shapewear designed to for more societal accepted shapes. You shouldn’t sleep in any of them, and give your body breaks, but otherwise it’s not an issue.

Looks like you're targeting binders now to get them banned or restricted. If you succeed in getting them banned or restricted we would just go back to DIY binders, so tape, scarfs, tight tops, smaller size tops, or my fave elasticated Velcro tape. You don't see the pros but heavily focus on the cons, removing safe access to binders will cause more harm than good. You can lobby parliament to outlaw any form of chest binding with a life in jail, it won't stop binding happening.

@Sonex

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?

Baroness Nicholson referenced breast cancer in her letter to LUSH: twitter.com/Baroness_Nichol/status/1458509464080846854

@ArabellaScott

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.'

Well, that's a confusing mess. I had to read it three times to work out that:

Men = transmen,
Chest reconstruction = mastectomy.

That latter is particularly egregious, because 'chest reconstruction' would normally mean just that. Reconstructing the breasts after mastectomy. It's a woeful misuse of language to use it to mean the opposite.

Whilst I share everyone's horror at the thought of teenage girls in binders, I can't fundamentally see that they're any more medical than a push up bra or a corset. I've worn all three (I used to make costumes, don't ask) and the push up bra is the least comfortable of all. Surprisingly, a well-fitting corset is the most comfortable, although don't try to do CPR in it. Digression aside, they're all three smooshing the breast tissue into a shape its owner finds cosmetically acceptable, and I think it would be difficult to legislate between them.

I don't imagine something like that has any therapeutic effect. It compressed the breast area. For no real reason other than the wearer doesn't like their breasts and wishes to compress them as much as possible so that they do not look like sexually mature (or maturing) girls and women.

I used to run in a sports bra. The cups didn't allow my breasts to move very much as that would be uncomfortable. It didn't compress them, though as I imagine that would also be uncomfortable. The sports bra wasn't too tight around my ribs/ diaphragm either; as that could affect my ability to expand and contract my diaphragm to breath effectively and without restriction. I think lung issues can occur if breathing is restricted as well.

I don't think they're even harm reduction.

I reckon, for most teenage girls, thinking they're NB or trans is roughly equivalent to how being a goth was for my generation. An sub culture which most will grow out of once they hit adulthood.

In that context, binders are a fashion item. I suspect they're no more harmful than some of the improbable platform shoes we wore - thirty years on and I still have a slightly unpredictable ankle from those.

The difference was noone sent me down a medical pathway where I was given drugs and surgery to affirm my inner gothness.

@anaily

Looks like you're targeting binders now to get them banned or restricted. If you succeed in getting them banned or restricted we would just go back to DIY binders, so tape, scarfs, tight tops, smaller size tops, or my fave elasticated Velcro tape. You don't see the pros but heavily focus on the cons, removing safe access to binders will cause more harm than good. You can lobby parliament to outlaw any form of chest binding with a life in jail, it won't stop binding happening.

Actually that large scale study showed DIY binding was less harmful than binders, iirc.

I'm sure there's a limit to DIY binding too, because of the effort to construct something. Whatever you make out of cling film and duct tape, it will have to be remade over and over. So I should imagine there would be less time spent bound up.
The thing about binding is it doesn't get rid of dysphoria around breasts, it just kicks the can down the road. At some point the binder has to be removed, and there they are. That's going to be a bigger issue psychologically than getting used to one's own body.
Using binders to avoid being looked at makes more sense, to be honest. Although there are better options than binding for that.

“ A good quality binder worn correctly is not a health risk.”

How do you know???
It hasn’t been tested.

“You don't see the pros but heavily focus on the cons”
What are the pros?? How do you know??

Pros= Changes my appearance to my preference = stupid fashion item

OR
Pros= Necessary to improve the mental health of vulnerable people, despite the physical harm = should be tested and regulated.

There is a difference between a fashion item (see high heels, corsets as someone mentioned) and something that is designed and marketed to have therapeutic benefit.

People will always find ways to do something but that doesn’t mean it should be marketed as having a benefit.

That is irresponsible, misleading and taking advantage of a vulnerable group (the group who are in need of the therapeutic benefit).

The reason that we have a medicines regulatory authority in the U.K. is to protect patients and consumers.

Don’t people who believe that a binder is offering them some therapeutic benefit deserve to have that rigorously tested ?

and proven to 1) be safe 2) actually offer the benefit it is purporting to have???

If not, then it is just a fashion item…

If no benefit then manufacturers, retailers, trans charities, institutions (including NICE and the NHS) should not be putting any misinformation out there that implies any kind of health (mental or physical) benefit whatsoever.

Oh, and generally we don’t try to sell high heels and corsets to children.

Because it is damaging to their bodies.

Here's the study on health effects of binding.

pubmed.ncbi.nlm.nih.gov/27300085/

It's subscriber only, though. Here's an article:

www.starobserver.com.au/news/international-news-news/landmark-chest-binding-study-reveals-medical-risks/155457

'Commercial binders were most commonly associated with negative health impacts. Respondents who wore commercial binders reported experiencing 20 out of the study’s 28 listed health impacts.

Materials like cling wrap and duct tape, commonly advised against for binding, were only associated with 13 of the 28 negative health impacts.

Researcher Sarah Peitzmeier said the data was surprising given that commercial binders are often considered the safest option.'

And this is what I find concerning:

'“Even medical professionals who know about binding aren’t really sure how to assess it clinically, what the potential health impact of binding could be, and what safer binding practices they should recommend to patients.”'

It's an interesting thought.

These are prescribed by our OTs working with children with autism at work.

www.southpaw.co.uk/sensory-integration/weight-resistance/bear-hugs-weighted-vests

They're a tight binder to provide calming deep pressure.

They're extremely explicit about the time limits the child can have. Eg, if works to calm when. In distress, only keep on for max 20 mins. It can go back on after a period of time if needed; but rarely needs to. They have strict max time limits too.

Similarly with weighted vests etc.

I've not explored whether they're medically licensed and I'm not sure if actually anyone could buy them. (Looks like they could.)

As an aside, my local LLL leader often talked about the benefits to breasts and backs with no bras; I'm not sure if she means generally or when breastfeeding, I actually think the former. I believe under wired bras aren't tonight to be good for breast tissue.

I would also like to see the negative effects be very clearly stated and not hidden in search engine results.

No, they are not ‘just like corsets’ or ‘sports bras’ unless you are buying corsets or sports bra that are ‘binders’.

And spreading the misinformation about them being safe is very dangerous.

How about instead of supporting their use, young females under the age of 18 are counseled about accepting their body even with gender dysphoria. After all, why are females who identify as males having to replicate a stereotyped male body? And before you tell us all about how they hate their bodies, why are trans people encouraged to hate their bodies. Why is this acceptable?

And yeah, I hated my female body as a teenager and suffer body dysmorphia even now. So, please tell us why exactly and then why gender dysphoria no longer is defined by stereotypes yet young girls are using those stereotypes to define their needs for binders.

And frankly, as on the other threads, just because people are going to do it anyway is no reason to not regulate binder usage to over 18.

If you as an adult are fully conversant with the effects and still do it, crack on. But don’t ever try to argue that under 18 females should be using them.

I work in medical device regulation.

It's an interesting thought.

It is down to the manufacturer to determine if a product classes as a medical device or not with regards the claims they make about how it should be used and what it does. However they shouldn't be disingenuous and can't advertise claims which are not supported by data. Devices are put into different categories depended how high risk they are - simple bandages are Class 1 where manufacturers can self certify to get a CE/UKCA mark with little clinical evidence. How would you differentiate a binder from a bandage? It's all down to the way it is described by the manufacturer.

Unfortunately medical device regulation in the U.K. has fallen behind that in the EU at the moment. But MHRA are keen not to be seen as a lightweight.

I haven't looked into where binders can be bought before and what the product descriptions are. I'll have a look tomorrow and feedback.

Binding is mentioned on this site about FGM, on the page about breast flattening.

'some adolescent girls and boys may choose to bind their breast using constrictive material due to gender transformation or identity, and this may also cause health problems.'

nationalfgmcentre.org.uk/breast-flattening/

Fab, Aunty. I'll be really interested to hear your thougths.

Arabella's link

Here's the study on health effects of binding.

pubmed.ncbi.nlm.nih.gov/27300085/

Peitzmeier S, Gardner I, Weinand J, Corbet A, Acevedo K. Health impact of chest binding among transgender adults: a community-engaged, cross-sectional study. Cult Health Sex. 2017 Jan;19(1):64-75. doi: 10.1080/13691058.2016.1191675. Epub 2016 Jun 14. PMID: 27300085.

is available to read free to access here:

cabinradio.ca/wp-content/uploads/2018/06/Health-impact-of-chest-binding-among-transgender-adults-a-community-engaged-cross-sectional-study.pdf

Oh, fab, thanks Embarrassing!

Actually that large scale study showed DIY binding was less harmful than binders, iirc.

Regardless of what the large scale study says, in practise this is laughable. Surely you can see that a properly fitted binder is way less harmful than duct tape or Ace bandages (which are designed to constrict, so as you breathe, they get tighter and tighter).

Auntycorruption

Brilliant, so glad you are looking into this.

what is the mechanism by which someone can report false health claims being made?

What powers, if any, does MHRA have to prevent or stop such products being on the market or claims being made?

The funny thing is that a group of people who have never seen or worn a binder are discussing them….
And at the same time normalization objectively damaging body shaping devices that they deem to be appropriate and are commonly worn by under 18 year olds.
A short reality check:
Good binders are expensive. Mine are £40 a piece. You generally need a credit card to buy one. The chance that an 11 year old manages to buy one and wear it nonstop ( as implied above) is laughable and would need some seriously unengaged parents (they are binders! Its bloody obvious if you wear one!). Good ones allow you to breath just fine - its the cheapos via amazon that can be trouble, or ace bandages etc (trans tape is fine, but you can’t get it in the uk).
Binders also don’t have and claims attached - apart from flattening your chest. Same as bras really, just that bras promise bigger chests or support while being active.
They also don’t promise or provide a completely flat chest. Depending on cup size, that’s just not possible. I have a small b cup, my binder gives my a flat chest. Anything bigger - its flatter, not but not completely flat. People on here seem to think that a binder squeezes DDcups completely flat. That’s completely unrealistic.