The ease with which you can buy injectable fillers online is 'absolutely shocking'

Feb 15, 2024

Journalist Ellie O'Byrne with some of the injectable cosmetics she ordered online and which were delivered to herr door. Picture: David Keane

You don’t need to be a doctor or a nurse, or indeed have any type of training at all.

Right now, you can go online and order a range of dermal fillers and other injectable cosmetics, plus other equipment including syringes and cannulas, from an Irish company and within days they will be delivered to your home.

If you wanted to, you could set up shop and start injecting fillers the very same day, with no training, no knowledge of anatomy, and no way of providing treatment if things went wrong.

And according to the Health Products Regulatory Authority (HPRA), some of these products may not even be being distributed legally.

This is what happened when I ordered a selection of fillers and other intradermal cosmetic products from an online store registered as an Irish company in 2018 and operating out of Dublin.

For €214 plus €49.99 Vat and a €9.99 postage fee, three different products were delivered to my home address within a week of me placing an order via a website.

A popular brand of filler used to plump the lips, pre-loaded into syringes, came with the warning that it should only be used “by an authorized medical practitioner".

Two other products, one promising to combat cellulite and one marketed as a “depigmentation solution,” arrived in ampules.

One had no safety information sheet or CE European safety mark on it, despite CE marking having become mandatory for dermal fillers under new EU regulations that came into effect in June, a month before the order was placed.

'Absolutely shocking'

Top consultant plastic surgeon and chairman of the Irish Association of Plastic Surgeons (IAPS), Professor Seán M Carroll, said he was shocked that I was able to order fillers online with such ease.

“It’s absolutely shocking that as a private person, without any demands as to your experience, these companies will just send these out to you,” Prof Carroll said.

He said the IAPS had been calling for regulations around fillers to be “tightened up” for a long time, and that although he doesn’t offer fillers himself, his own practice was “very frequently” contacted by people seeking treatment when things go wrong having had fillers.

“I get requests to assess clients as to what injuries occurred when they have received treatment from non-licensed people,” he said.

Many have no medical or nursing experience in any way whatsoever, which is just absolutely shocking. The whole thing needs to be seriously tightened up.

The more serious potential impacts of having fillers and other injectable cosmetics done by people without training in anatomy included necrosis and nerve damage, he said.

“Someone gets fillers on a Thursday: By Saturday, they notice their lip is turning blue. On Sunday, they have a black area of their lip. That black area is due to necrosis of the lip tissue.”

“Necrosis can be caused by too much filler being injected and that causing pressure, but injecting into an artery or vein by accident, can cause necrosis but it can also cause nerve damage.

Once a nerve is damaged, there is nothing one can do to repair it. It would be very difficult to repair a nerve with surgery and nerve injuries can be life-changing, can have an impact on the way you talk.”

Regulation

Injectable cosmetics were once the preserve of the wealthy in Ireland, and as a result were more likely to be used by middle-aged professional women with the resources to seek specialist care.

But as the cost and ease of purchase comes down, younger women with less cash to spend are seeking cheap treatments: A search through hashtags like LipFillersIreland on Instagram reveals this trend.

But Prof Carroll says this is resulting in a wave of DIY approaches: Recently he even heard of someone operating a business out of their garage. He also has serious concerns about the ever-decreasing age profile of the young people, mostly women, that he is seeing opting for fillers.

“Now that it’s cheaper, younger people can access it and I’m not even sure if anyone is checking if they are over 18 or not,” he said.

In the EU, as in the US, fillers are not regulated as medicines, so who can purchase them is not restricted. They are largely regulated as medical devices. This doesn’t apply to all intradermal cosmetics: Botox, for example, can only be administered by medically qualified people because it is a licensed medicine.

The EU Commission’s Medical Devices Regulation (MDR) was recently overhauled, with new requirements as of June 2023 that all medical devices come with CE marks and new labelling rules for manufacturers that must clearly state that dermal fillers “are not to be used in persons who are less than 18 years old” and that they should only be administered by appropriately-trained healthcare professionals.

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The Irish authority responsible for monitoring the market is the HPRA. It works with Revenue’s Customs Service and An Garda Síochána to investigate illegal supply of medicines, including online sources, and actively enforces against suspected breaches of the law.

It would not provide a representative for an interview for this article and only communicated via email through a PR firm.

The HPRA pointed out that where, how, and by whom fillers are used is not within its remit: It is responsible only for monitoring the compliance and safety of the products being sold in Ireland.

“With regards to sourcing dermal fillers, the HPRA discourages members of the public from ordering dermal fillers online for use in their own home,” it said.

Listed substances

The group of substances classed as medical devices are listed as products “without an intended medical purpose” in the MDR.

But all three of the products I ordered actually contained small quantities of active ingredients that are licensed as medicines in their own right: The lip filler, mostly consisting of hyaluronic acid, contained 3mg of the anaesthetic Lidocaine.

Another of the products, intended to improve the appearance of cellulite, contained Troxerutin, a drug licensed as a medicine for the treatment of varicose veins and haemorrhoids.

Another, marketed as a “depigmentation solution” contained tranexamic acid, which is also licensed as a medicine and use to control heavy bleeding.

Both also contained numerous other active ingredients including Melilot, a herb from the clover family that is supposed to reduce skin inflammation, vitamins, and the Alzheimer’s drug Idebenone.

Initially, the HPRA pointed to the responsibility of manufacturers when contacted by the Irish Examiner.

“With regards to devices which contain substances and are regulated under the MDR and interactions with other products or substances, manufacturers should consider risks associated with interactions with products likely to be used in conjunction with their product as part of their risk analysis,” the HPRA said through a press spokesperson.

“With regards to our market surveillance activities relating to dermal fillers, we are continuing to monitor the compliance and safety of such products and associated manufacturers.”

But the information on the products delivered to me made clear that the risks of interactions between the active ingredients in their products had not been studied. There is no way of knowing that if someone had had previous beauty treatments that there wouldn’t be an interaction between different cocktails of active ingredients in injectable cosmetics sold for different purposes.

“There is no clinical data available concerning tolerance to the injection of this product at a site that has been treated with another permanent or impermanent product,” one information sheet read, and “no forms of interaction with other medicines are known.”

Ellie O'Byrne's purchases

So I sent the HPRA photos of the packaging and products I had bought.

“Regarding the image provided, the product does not seem to be a medical device, and from the photograph of the package, appears to contain ingredients available in authorised prescription medicines, and is presented as a medicinal product,” it responded.

So the HPRA was querying the legality of the products I had purchased. How was it going to proceed? It said it could not comment on individual cases.

“The HPRA monitors for illegal supply, both in the physical and digital sphere. It has taken action in a number of cases, including in some cases prosecutions in the District Court in relation to illegal supply/administration/advertising of illicit medicines and continues to engage in enforcement of the regulations,” its statement said.

“The HPRA earlier this year released its annual enforcement data for 2022 which shows that it detained some 940,000 dosage units* of falsified and other illegal medicines. In addition, 639 websites, e-commerce listings and/or social media pages were amended or shut down.”

With regard to the products I ordered, Prof Carroll said: “The bottom line is that anything that contains a true medicine should not be delivered to someone who is not a professional.”

To Prof Carroll and other members of the IAPS, safety concerns about the current state of regulation on fillers in Ireland are going nowhere. And he has concerns over whether the HPRA has adequate resources to deal with a world where ordering products online is so easy, so cheap and so difficult to monitor and regulate.

The European Commission told me there were no plans to overhaul the MDR soon, but that there will be an evaluation report on the new MDR regulations at the end of May 2027.

In the meantime, in the absence of any action to ensure that only medical professionals can get their hands on and use fillers and other injectables, Prof Carroll said there’s another approach he’d like to see taken, and one where the Government could be pro-active.

He’d like to see a public health awareness campaign targeted to young people warning of the potentially life-altering risks of getting fillers and other injectable beauty treatments by untrained personnel.

“Right now, I think we need warnings online, specifically on channels favoured by young people such as TikTok and Instagram where the information would go to the people who are having this done,” he said.

“No-one could argue that was an unreasonable step and the IAPS would be in favour of that.”