THE ABSENCE OF any regulation in Ireland over who can administer popular cosmetic treatments, such as fillers, is ‘very, very dangerous’, an expert has warned.

“You need to have a lot of medical knowledge and education and upskilling all the time to ensure that you are treating patients safely – but until regulation is brought in, the public really are in danger,” said Patricia Molloy, the chair of Ireland’s association for dermatology aesthetic nurses.

In Ireland, the uptake of cosmetic procedures like fillers or anti-wrinkle injections is increasingly common – often to create a certain appearance, or sometimes, in the case of Botox, to help with a condition like migraines or bladder dysfunction.

While the materials for dermal fillers are regulated by law, there are no restrictions on who is allowed to administer them.

Experts are concerned that the absence of rules governing who can legally offer services opens patients up to injurious side-effects that can occur if something goes wrong, which can range from pain and swelling to infections and problems with vision or breathing.

A bill that would introduce new licensing requirements was scrutinised by the Oireachtas Health Committee in 2018 and sent to the Office of the Attorney General for drafting. However, nearly four years later, that legislation has still not yet come through the Dáil.

A spokesperson for the Department of Health said it is “anticipated” that the department will review the regulation of medical devices such as dermal fillers this year.

But as long as who can administer the procedures remains unregulated, patients are advised to be cautious and research their options before they decide to work with a particular provider.

‘There are non-medics doing these treatments’

Patricia Molloy, a trained nurse, is the owner of a cosmetic clinic and chairperson of the Dermatology Aesthetic Nurses Association Ireland (DANAI).

Speaking to The Journal, Molloy said: “I’ve been working in the area for 23 years. Right from the start, we’ve been asking for some regulation with it.”

“Unfortunately, there are non-medics doing these treatments.”

Dermal fillers, which are injected into the skin to temporarily soften wrinkles, are considered medical devices and must comply with European legislation to get to market in Ireland.

When they do, they fall under the remit of the Health Products Regulatory Authority (HPRA). The HPRA carries out “market surveillance and vigilance activities”, but is not involved in any regulation over how they are administered.

Meanwhile, any medicine that contains botulinum toxin A – that is, anti-wrinkle injections, or Botox, – is controlled by prescription.

Legally, it should only be administered here for medical purposes by a qualified and trained medical practitioner or dentist who is registered in Ireland, but in practice, Molloy said DANAI is aware of instances of it being acquired illegitimately.

The lack of rules on who can provide procedures like fillers means that non-medical professionals are able to offer them in Ireland without having proper training, Molloy said.

“There’s an awful lot more to this than just doing the treatments,” she explained.

“First of all, doing consultation and ensuring that the patient understands what they’re doing and also that we’re meeting their needs, and if we’re not meeting their needs, that we’re able to say that. You’ll only be able to do that if you have a medical background.”

For instance, medical professionals consulting with patients are trained to identify the signs of body dysmorphia – a disorder where someone experiences significant distress over their appearance and perceives ‘flaws’ that are minor or cannot be seen by others.

“There’s a huge amount of skill and knowledge of anatomy that it needs to be able to do carefully, but because there’s no regulation, anybody could go in the morning and buy any of these products online and start injecting, because you don’t need to be qualified in this country to do it, and that’s the danger,” Molloy said.

The danger of these treatments can go as far as cutting off blood supply to an area. The other thing that has happened, and it’s happening over the last quite a few years now, is blindness.

“If a filler is put into an artery by mistake, it can travel up into the back of the eye and cause blindness.

“You need to have a lot of medical knowledge and education and upskilling all the time to ensure that you are treating patients safely. But until regulation is brought in, the public really are in danger.”

For 23 years now, I’ve been trying to make something happen and been available to each minister for health to discuss it but unfortunately it has never been really taken up because it’s like other things – until something happens that’s really, really bad, they don’t have the time or the finance to look at it. But we have to try and push it because it’s getting to a very, very dangerous situation.”

In a statement to The Journal, a HPRA spokesperson said: “The HPRA encourages anyone who has information about dermal fillers which do not bear the CE mark or which do not appear to meet the requirements of the medical devices legislation to provide details of the device in question to the HPRA.”

On anti-wrinkle injections, “the medicine administered must be one that is authorised by the HPRA or by the European Commission”.

The HPRA asks individuals and healthcare professionals to report any adverse incidents they experience to its online system.

Patient Safety Bill

In 2017, the government approved the general scheme of the Patient Safety (Licensing) Bill, which sets out a licensing framework for hospitals and other services that are not already included in other legislation.

The scheme outlined that “designated activities are likely to initially relate to cosmetic surgery services but other services may be added over time as the licensing system becomes embedded in the health system”.

The bill went through pre-legislative scrutiny by the Oireachtas Committee on Health in 2018 and was sent to the Office of the Attorney General for drafting, where it remains.

A spokesperson for the Department of Health said the department “continues to work on the Patient Safety (Licensing) Bill which will, for the first time introduce a licensing requirement for all hospitals, public and private, and certain designated high-risk activities in the community”.

“As a precursor or interim step to the Patient Safety (Licensing) Bill, the Government approved, on 5 July 2018, the general scheme of the Patient Safety (Notifiable Patient Safety Incidents) Bill 2019 which will provide the legislative framework for the extension of the Health Information Quality Authority’s regulatory remit to private hospitals.

“This Bill is part of the current Programme for Government, was introduced into Dáil Éireann on the 12 December 2019, passed Committee Stage on 10 March 2022 and is due to go to Dáil Report Stage soon.”

The spokesperson outlined that European legislation for placing medical devices, including dermal fillers, on the market in Ireland, “does not include provisions for the regulation of matters relating to the use in practice or administration of medical devices, location of use, specific training or the qualifications of the individual administering the product”.

“It is anticipated that the Department of Health will consider and review other aspects relating to the regulation of certain medical devices such as dermal fillers in 2022.”

Advice

Anyone seeking a cosmetic procedure is advised to take some time to research providers and find a qualified professional they feel comfortable working with.

The HPRA said that it is important to understand the risks associated with procedures and to ask the service provider about their training, after-care, and ability to manage possible side effects.

“Qualified healthcare professionals are best placed to identify risks and to recognise and treat side-effects if they occur.”

When considering dermal fillers, the patient can check if the fillers have a CE mark and a four-digit number on the pack, which means they comply with medical devices legislation.

Administrators should keep up-to-date with relevant regulatory requirements to ensure they are using genuine dermal fillers, as well as reviewing their products and working with suppliers to “minimise the potential for unsafe products entering the supply chain and causing harm to the public”.

Patricia Molloy said that a reputable provider will hold a consultation with the patient prior to the treatment, and never on the same day.

She advised that prospective patients should attend the facility for a consultation, check the space is clean and professional, and ask the practitioner questions.

“They will get a good feeling for the person they’re with, whoever that healthcare provider is, and they’ve got to be able to feel comfortable with them,” Molloy said.

“Ask about their experience – how experienced are they in this area? Are they registered? Are they a member of DANAI? Are they fully insured?”

“There are people who will operate without insurance and the reason they’re doing that is because they can’t get insurance because of previous cases.

They’re the sort of questions [patients] need to ask, but particularly, go to the facility and check it out.

“Unfortunately, with social media, there’s a lot of stuff that can be airbrushed – for example, before and after photographs. That’s not what you should be judging a practitioner’s ability to do your treatment on.

“Yes, it’s good to look at it, but it’s not always the true picture that you’re seeing either, so you need to go and do your homework first.

“But in particular, ask the questions: ‘What experience [do you have]? How long have you been doing it? What training courses have you done? And are you insured?’ Because they’re the key questions to ensure that that practitioner is operating safely.”