If you had to guess which of the two most common injectable cosmetic treatments was more tightly controlled, you would probably guess the one that is permanent or semi permanent, hard to remove, and capable of causing vascular occlusion. You would guess wrong.
Botulinum toxin, which wears off, is a prescription only medicine. Most dermal fillers, which do not necessarily wear off and which carry the risk of occlusion, are medical devices. This piece explains how that came about and what it means for you.
How the classification works
A medicine acts principally by pharmacological, immunological or metabolic means. A medical device achieves its principal intended action by physical means, even if assisted by such mechanisms. A dermal filler that works by occupying space under the skin achieves its effect physically, so it falls on the device side of the line.
That is a coherent distinction as a matter of regulatory logic. Its consequences in practice are less comfortable, because the regimes differ substantially in what has to be shown before a product can be sold.
What the two regimes require
A medicine requires a marketing authorisation. That means a dossier of quality, safety and efficacy data assessed by a regulator before the product may be placed on the market.
A medical device historically reached the UK and European market through conformity assessment, with the degree of scrutiny depending on the risk classification of the device, and with assessment carried out by notified or approved bodies rather than by a medicines regulator assessing a full efficacy dossier. Regulation of devices has been strengthened over time, and the UK is in the process of reforming its own device framework following EU exit, with the MHRA consulting on and developing new arrangements.
The important point for a patient is comparative rather than technical. The evidence pathway for a filler is not the same as the evidence pathway for a medicine, and it is reasonable to hold that in mind when a filler is described to you as clinically proven.
What you are entitled to at this stage
- To be told the exact product being used, including whether it is reversible.
- To see the packaging and to have the product name and batch number recorded.
- To a discussion of vascular complications and how they would be managed.
- To report a device related problem yourself to the MHRA through the Yellow Card scheme.
- To be told the truth about permanence, including that a permanent product may require surgery to address.
Device classification is a statement about how a product works, not a statement about how safe it is.
The three consequences that reach you
No prescription is needed. Filler may be bought without a prescription. There is no prescriber in the chain, no requirement for anyone to have assessed you before the product is obtained, and no legal barrier to a person holding stock.
Anyone may buy it. In most of the UK there is currently no restriction on who may purchase and inject dermal filler into an adult. This is the fact that surprises people most, and it is why the Botulinum Toxin and Cosmetic Fillers (Children) Act 2021 was needed to deal with under 18s specifically, and why a licensing power was created in the Health and Care Act 2022 which has not yet been commenced.
It may be advertised. The prohibition on advertising prescription only medicines to the public does not apply to devices. This is why filler is marketed openly and by name while botulinum toxin is marketed euphemistically, an asymmetry that has nothing to do with relative safety.
A treatment described as natural, biocompatible or simply sugar based, as though those words established safety. Hyaluronic acid occurs in the body. That tells you nothing about what happens when a bolus of cross linked gel is placed into an artery.
The risk that the regime does not address
The serious acute risk of filler is vascular: product entering or compressing a blood vessel, interrupting blood supply, with consequences ranging from skin necrosis to, rarely, visual loss. Managing it depends on recognition and speed, and for hyaluronic acid fillers on the availability of hyaluronidase, which is itself a prescription only medicine. The person best placed to manage the complication may therefore be legally unable to hold the treatment for it.
That is the single sharpest expression of the regulatory mismatch in this sector, and it is why the questions in our complications guide focus on it so heavily.
Permanent and semi permanent fillers
Not all fillers are hyaluronic acid. Some products are semi permanent or permanent, and those cannot be dissolved with hyaluronidase. Where a permanent product causes a problem, the options may be surgical. This is a materially different risk profile from a temporary hyaluronic acid product, and it should be discussed explicitly in a consultation.
Ask which product is being used, whether it is hyaluronic acid, and whether it can be dissolved. If the answer is that it cannot, ask what happens if you dislike the result, and get the answer before you agree. That is covered in what can be reversed.
Reporting a device problem
The MHRA's Yellow Card scheme covers medical devices as well as medicines, and patients can report directly. If you have a problem with a filler, reporting it contributes to the safety data on that product, which is one of the few mechanisms by which device regulation improves. Record the product name and batch number at the time of treatment so that a report can be made specific.
The summary
Filler is not lightly regulated because it is safe. It is lightly regulated because of how the definition of a medicine works. Knowing that lets you calibrate the marketing correctly: the absence of a prescription requirement is a fact about classification, not a reassurance about risk.