The government’s new #CluedUpOnCosmeticProcedures campaign has turned the spotlight on dermal fillers, with the launch of a video from the Department of Health & Social Care and Grazia magazine. The video aims to educate people considering the procedure, including the potential risks and how to make safe choices. When it comes to dermal fillers “Things can and do go wrong” says Andrew Rankin, Trustee of the Joint Council for Cosmetic Practitioners (JCCP), who features in the video and goes on to express grave concerns about some of the serious risks associated with dermal fillers.
While all cosmetic procedures carry some element of risk, calls for increased regulation when it comes to dermal fillers have been gaining increased momentum. The JCCP recently launched a national petition to ‘Make Dermal Fillers prescription only and relevant insurance mandatory’. The petition notes, “Reviews of patient attitudes have exposed a gap between levels of legislation and protection expected by patients and the reality. Classification of fillers as a prescription only device would close this gap”.
Commenting on the petition, Professor David Sines, chair of the JCCP said, “By restricting fillers to be prescription devices only you would provide professional oversight for non-prescriber practitioners who can access them. As would making the insurance required mandatory in accordance with prescription riser requirements. I would encourage all practitioners in the specialty to sign the petition and advise their patients to as well.” You can find out more, and sign the petition, here.
Against this backdrop of an increased focus on the risks and regulation of dermal fillers, let’s now take a look at the types of dermal filler available and what the future holds for dermal fillers within the cosmetic industry.
The NHS defines dermal fillers as injections used to fill out wrinkles and creases in a patient’s skin. They are also often used to increase lip volume and definition, as well as to reintroduce structure and volume into the cheeks. They can even be used to correct scarring and depressions in the skin.
There are several types of dermal filler that are used by practitioners. These include:
Dermal fillers can be temporary or permanent, depending on the materials used, however many practitioners are reluctant to opt for permanent dermal fillers due to the high associated risks of carrying out the procedure.
For any practising aesthetic practitioner it is important that you have the correct cosmetic insurance in place to cover you in the event of a claim. It is important that you discuss your treatment options fully with your insurer to ensure that the treatment type you are offering is covered by your policy.
The Keogh report, released in 2013, highlighted the need for tighter regulations surrounding dermal fillers. The report noted that administering dermal fillers is a procedure that almost anyone can carry out, despite the high risk associated with the treatment, and raised questions around patient safety.
Since 2013, steps have been taken to improve patient safety in relation to dermal fillers. However, despite these inroads, it has been clear that further measures are still needed to ensure reinforced patient safety; several years on from the Keogh review, patients continue to suffer harm from fillers having been exposed to unexpected levels of risk. However, this situation is soon set to change.
Under European Regulations (EU 2017/745) all dermal fillers from May 2020 will be regulated as medical devices. The Aesthetics Journal reports that the new regulations are said to “include clearer obligation for those involved in manufacturing and supplying devices”. It is also proposed that this will place a greater emphasis on traceability through the supply chain for medical devices, with the introduction of a unique device identification (UDI) system.
A spokesperson for the Medicines and Healthcare Products Regulatory Agency (MHRA) has stated that, “Dermal fillers currently placed on the UK market with a medical purpose are classed as medical devices and require a CE mark. There are, however, dermal fillers that are marketed for aesthetic use only that are not classified as medical devices as the manufacturer is not making a medical claim. The new legislation is addressing this regulatory anomaly by making all dermal fillers medical devices, irrespective of the claims attached to the product by the manufacturer.”
The regulation of all fillers as medical devices will significantly strengthen the quality assurance and safety of dermal fillers. However, at present dermal fillers can be obtained without prescription and current information provided by the MHRA suggests that currently there are no plans to make this medical device prescription only. The Make Dermal Fillers prescription only and relevant insurance mandatory petition aims to address this.
Calls for greater regulation within the non-surgical cosmetic sector as a whole are already well underway.
Hamilton Fraser Cosmetic Insurance has over 20 years of experience within the industry, being the first ever commercial insurance provider to offer medical malpractice cover specific to the cosmetic industry. Today Hamilton Fraser Cosmetic Insurance continuously monitors the industry to adapt policies to allow for new treatments and industry changes. This helps to ensure the cover provided is comprehensive as well as being able to meet the individual needs of different cosmetic businesses and their clients.
Hamilton Fraser Cosmetic Insurance recognises the importance of continually striving to raise standards within the cosmetic industry to ensure that all patients receive a high level of quality and care when undertaking a cosmetic procedure. Hamilton Fraser is therefore proud to support initiatives that pioneer to raise these standards such as the Joint Council of Cosmetic Practitioners (JCCP).
The JCCP has campaigned tirelessly to pursue tighter industry regulations within the fast expanding cosmetic sector. The JCCP assists members of the public who are considering, or undergoing, non-surgical and hair restoration surgery treatments by providing suitable advice on patient safety. It also provides guidance on how to find approved practitioners to carry out procedures through their register of approved practitioners.
“As the UK’s leading supplier of medical indemnity insurance for cosmetic and aesthetic procedures we support fully the push for tighter regulations of dermal fillers and other elective image enhancing treatments. Ever since we launched the first aesthetics focused indemnity insurance policy in 1996 we have been staunch supporters of all initiatives to help raise standards in the sector. Our close relationship with the JCCP and the creation of the Cosmetic Redress Scheme aligns with our commitment to help professionalise the industry. The standards followed by our policyholders are already high but the industry must and can always do better.”
– Eddie Hooker, CEO of Hamilton Fraser
The Department of Health and Social Care campaign, ‘Clued up on cosmetic procedures’, is looking to raise awareness and understanding of cosmetic procedures through education. The campaign hopes to raise awareness of the risks associated with cosmetic procedures, highlights the important questions that patients should ask before undergoing a procedure and also provides prospective patients with easy access to information on cosmetic treatments in order to help them make informed decisions on whether to undergo the treatment in the first place.
It is vitally important for aesthetic practitioners to keep up to date with industry changes and government updates to ensure that you are adhering to ‘best practice’ guidelines. You can find out more information on what it means to be a responsible practitioner through Hamilton Fraser’s Content Hub including guest blogs from industry experts, as well as useful guides and ongoing support for aesthetic practitioners.