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The unscrupulous regulations surrounding non-medical professionals administering dermal fillers: A call for change

  • Writer: Serena MacMillan
    Serena MacMillan
  • Nov 30, 2024
  • 6 min read

Updated: Jan 25


Dermal fillers injected into the face and lips can result in consequential complications including: infection; [1], [2] a lumpy appearance under the skin resulting from misdistribution which might require surgery to treat; [1], [3] migrating filler to an extent where surgical intervention is required; [1], [2] scarring; [1], [3]  blocked blood vessels in the face (embolism), resulting in tissue death (necrosis) and permanent blindness; [1], [2], [3] bleeding, swelling, redness, itching, ecchymosis and pain in the injection sites; [2], [3] granulomatous inflammation or foreign body reaction; [3]  hard nodules, erythematous or not. [3]



Some early side effects are normal physiological reactions to the injection of a foreign substance such as erythema, edema, and bruising. [4]  However, some patients are not so lucky, presenting with long term serious complications.



A review of the world literature on eye complications from dermal filler injections by Beleznay et al in 2015 identified 98 cases in English-language journals. [4], [5], [6] With most cases resulting from autilogous fat (n=47), hyaluronic acid (n=23) and collagen (n=8). [4], [6]



 The most common injection sites for eye complications were the Glabella (n=38), nasal region (n=25), nasal labial fold, (n=13) and forehead (n=12). [4], [6] However 3 cases of eye complications resulted from lip injections. [4] Most cases resulted in complete unilateral vision loss (n=65) and one case resulted in death after a 4 day coma resulting from necrosis of one eye. [4], [6] Vision loss did not improve except for 2 patents, one of which had vision recovered in one eye only. No patient completely recovered. [4], [6] In a follow-up published in 2019, Katie Beleznay urges the importance of practitioners having through knowledge of complications which result in vision impairment, including prevention and management strategies. [7] 




Katie Belezney, a Dermatologist, BC Board Certified to practice in Canada warns that practitioners might not have enough knowledge on prevention and management strategies for complications. Her paper is extremely concerning for the UK as practitioners in Canada have to have extensive education in the medical field, such as physicians, dentists and nurses in order to legally train to administer dermal filler or any cosmetic injectable. [8], [9] If leading professionals in the field of dermatology are concerned over medical professionals having inadequate medical knowledge of compilations and prevention methods, the UK letting anyone who can pay for a short course to inject people is wildly irresponsible.




While most other countries, wisely, do not allow those who do not demonstrate some level of medical training to administer dermal fillers. [10] The UK does not adhere to this, resulting in untrained and undertrained practitioners whose only knowledge of preventing and managing complications is sub-par; and potentially derived from google. 




Since June 2022 Health Regulation England has recommended that anyone delivering botox and dermal fillers should be qualified to level 7. But what does this mean? Not a lot.  A ‘JCCP approved and VTCT certified clinical aesthetics diploma level 7 qualification’ requires that a three year post graduate degree has been obtained in aesthetic medicine, general medicine, dentistry or nursing before one can undertake the course. [11], [12], [13], [14] Which fluctuates in duration from 6-18 months. [12], [13] This is obviously ideal and arguably should be law given the nature of dermal fillers. However, the Health Regulation Englands recommendations are not binding and do not have to be taken into account by law makers or parliament. In other words, since there has been no update since this announcement in June 2022, it seems to have been ignored. 




Currently, courses allowing people who pay to take them to inject dermal fillers have alarmingly low entry requirements, sometimes only requiring one to be over the age of 21, with a good command of English. [15], or level 3 Beauty. [16] Some courses available last for only a day. [16], [17] One finds themselves wondering how people who undertake these courses feel qualified enough to inject patient’s faces with such a low threshold of training.




Unscrupulous, inadequate training course providers are at fault also, for potentially misleading the public and even medical professionals into believing these ‘practitioners’ are better qualified than they truly are, [10] there is a need for a level of “quality control” regarding qualifications which will only occur when the law takes notice. Allowing anyone and everyone with money for a lip filler course to become an injector is set to cause legal confusion. They are not medical professionals, yet they are in a position where a duty of care is surely required, yet the Bolam Test cannot be utilised on injectors who are not medical professionals. So what is regulating these people? 




The unregulated legal landscape of dermal filler has resulted in a breeding ground for practitioners creating their own ‘methods’ for injecting patients, since these are constantly changing, regulation cannot keep up with the often dangerous ‘methods’. A prevalent example of this is ‘russian lips’, a method of injecting hyaluronic acid-based fillers like Juvederm and Restylane [18] into the lips. The significant difference between this method and the traditional method is the placement of filler, Russian lips involves injecting small droplets of filler vertically into the lips [19] rather than horizontally. The technique was created by Dr. Evgeny Oks in Russia and is routinely advertised and carried out by injectors in the UK who are not in possession of a medical degree. The problem aside from that alarming reality? The technique employed to create Russian lips greatly increases the risk of vascular occlusion, [20] the cause of some of the most serious long term consequences of lip filler such as necrosis and complete unilateral vision loss. To put this into perspective further, Katie Belezney’s review of eye complications was published in 2015, Russian lips were created in 2015. Therefore the Russian Lips, the more dangerous version of the traditional technique, is not included in that review of medical literature.  




The Medicines and Healthcare products Regulatory Agency (MHRA) released a consultation outcome where 83% were in favour of expanding the definition of medical devices to potentially include dermal fillers, furthermore, the most common free-text response when asked what further amendments should be implemented was that ‘the regulations should provide that dermal fillers must only be administered by healthcare professionals’ followed by ‘dermal fillers should only be available on a prescription-only basis’. [21] However not all dermal fillers are classified as medical products therefore the powers of the MHRA are limited in this area. This was echoed in the government response which reminded the public that restricting the administration fo dermal fillers to practitioners is ‘outside the bounds of [the MHRA]’. [21] This response is factual but simply inadequate, strict regulation in this area is completely over-due and feasible. The U.K. is one of the last countries within the developed world which allows those who are un-educated in medicine (without at least a medical bachelors degree of any form), to administer dermal filler. 




I predict that the law will catch up with this as it often does and implement the same regulations imposed on under-trained injectors in countries such as Canada, and the U.S. No one without a medical degree (including dentistry, nursing, general medicine), should be administering dermal filler.






References


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​[3] Philippe Lafaille, Anthony Benedetto, ‘Fillers: Contraindications, Side Effects and Precautions’ (2010) 3(1) Journal of Cutaneous and Aesthetic Surgery 16-19



[4] Eckart Haneke, ’Managing Complications of Fillers: Rare and Not-So-Rare’ (2015) 8(4) Journal of Cutaneous and Aesthetic Surgery 198-210





[6] Beleznay K, Carruthers JDA, Humphrey S, Jones D. 'Avoiding an treating blindness from fillers: a review oif the world literature' (2015) 41(10) Journal of Dermatology Surgery 97–117



[7] Beleznay K, Carruthers JDA, Humphrey S, Carruthers A, Jones D. 'Update on Avoiding and Treating Blindness From Fillers: A Recent Review of the World Literature' (2019) 39(6) Journal of Aesthetic Surgery 662-674





























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