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File image of a professional cosmetologist injecting a dermal filler into the patient lips Alamy Stock Photo

'Risky' dermal fillers will only be administered by professionals under new coalition's plans

A leading dentist warned that dermal fillers are being carried out by people who have taken a ‘one day course’ and then ‘offer high risk medical procedures completely unregulated’.

A MEMBER OF the Irish College of Aesthetic Medicine (ICAM) has welcomed a pledge within the draft programme for government to ensure dermal fillers can only be administered by trained healthcare professionals.

Leading dentist Dr Mairead Browne is a member of the newly established ICAM, which advocates for legislative reform in aesthetic medicine in Ireland.

Aesthetic medicine is distinct from plastic surgery and involves medical treatments to enhance patients’ physical appearance, such as dermal fillers.

Browne previously issued a warning about the increase in dermal fillers being carried out by people who have taken a “one day course” and then go on to “offer high risk medical procedures at bargain prices and completely unregulated”.

Dermal fillers are sometimes likened to botox.

Botox injections minimise muscle movement to soften wrinkles in the upper face, while dermal fillers aim to pump up the face in order to fill in lines and wrinkles around the lips and cheeks.

But while only a doctor, dentist or registered nurse under direction of a medical doctor can administer botox under Irish law, dermal fillers can be legally administered in Ireland without a professional qualification.

However, the next government has pledged to “ensure the administration of dermal fillers is only undertaken by trained healthcare professionals”.

‘Risky procedure’

Speaking to The Journal, Browne explained that while dermal fillers are classified as medical devices, anyone can provide them.

However, only doctors and dentists have the ability to prescribe the reversing agents should any complications arise.

“Dermal fillers, as medical devices, are very risky procedures,” said Browne.

“But these unlicensed practitioners don’t have the ability to prescribe reversing agents, and they don’t have the ability to prescribe antibiotics and steroids to manage any complications.”

She said dermal fillers carry risk from “things like bruising to blindness to stroke to disfigurement”.

“From our point of view as healthcare professionals,” said Browne, “we’re trained to spot these complications and manage them appropriately.

“Also, it’s only dentists and doctors that have the prescribing power to ensure that we can manage these complications, that we can prescribe the agent that reverses it and treat it appropriately.

“With unregulated clinics, there’s no defined training pathway and the drug that we use to reverse filler is prescription only and can’t be administered in these clinics.”

When asked why unregulated clinics can administer dermal fillers but lack access to the medicine that reverses any complications, Browne said it appears to be a legal loophole.

“Dermal fillers are a medical device, but because it’s not a prescription medication, it doesn’t fall under certain legislation.

“That’s where it’s being blurred a bit and these one-day courses are really not sufficient.

“Even the most skilled, experienced practitioner will come across a dermal filler complication, but they access the reversal drug and appropriately refer them to a specialist if further intervention is needed.

“That’s not there in these unlicensed, unregulated clinics, and it’s a massive patient safety issue.”

While Browne welcomed the government pledge, she remarked that the ICAM was “not given a heads up on this as an association”.

“Dermal fillers are sometimes compared to Botox,” said Browne, “which is a prescription only medication that does fall under strict regulatory guidelines that ensures patient safety.

“But that’s not the case with dermal fillers as it stands and it’s important to see how this pledge will play out.”

She said the Health Products Regulatory Authority (HPRA) and Department of Health should be working with organisations like the ICAM on any changes in legislation.

“It needs to involve health practitioners and a consultation process to decide who are the people that are appropriately trained and what’s the appropriate pathway.

“ICAM is exclusively dentists and doctors, and we have no problem engaging with any legislation that can be brought about on this.”

‘Buy cheap, buy twice’

Browne previously warned about an increase in dermal fillers being carried out by people who have taken a “one day course” and “offer high risk medical procedures at bargain prices and completely unregulated”.

“Buy cheap, buy twice,” Browne said when asked about the risks involved in going to such clinics.

She added that “a lot of the demographic we see that are going to these places are a lot younger and they don’t understand the complications that can occur”.

“We’ve seen it at first hand; stroke, disfigurement, blindness and even death in some cases.

“You need to see someone who’s experienced, who’s completed complications training, who can access and deal with the complication if it happens, and prescribe the agent to reverse it before it becomes a life changing outcome.”

Browne also remarked that dermal fillers are “expensive products to buy if they’ve gone through the appropriate levels of manufacturing and through the appropriate companies”.

“If it’s too cheap to be true, it generally is,” said Browne.

“These are medical treatments and they should be treated as such.”

The Journal asked the Department of Health about how it would ensure the implementation of this pledge within the draft programme for government.

A spokesperson for the Department was unable to provide detail, but noted that dermal fillers are “typically regulated under the Medical Devices Regulation as Class III medical devices – the highest risk class”.

The spokesperson also noted that in the EU, a valid medical device will bear a ‘CE’ mark – Browne told The Journal that some fillers in unregulated clinics don’t bear this mark.

The spokesperson also pointed to an existing EU regulation stating that dermal fillers should only be administered by appropriately trained healthcare professionals. 

Meanwhile, the Department spokesperson said that the HPRA has asked that individuals who experience any complications with the use of a dermal filler report these to the HPRA through its online reporting system

The HPRA also advises anyone who has health concerns relating to dermal fillers to contact their GP.  

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