Complications associated with needle-based medical aesthetic procedures: clinical and medico-legal aspects from the Polish perspective
Abstract
Aesthetic medicine is a rapidly developing branch of modern medicine. Its main procedures include needle-based procedures such as mesotherapy, botulinum toxin injections and filler injections. Each of them may result in unwanted complications. In the case of mesotherapy, the complications are usually local, while in the case of the usage of botulinum toxin, there have been reports of deaths, whereas filler injections have been reported to cause stroke and loss of vision. It is of the highest importance for the professional to properly prepare for the procedure. In Poland, there is no such thing as a specialization in aesthetic medicine. The lack of precise regulations contributes to an increased number of complications caused by people without appropriate qualifications and offences defined in law as damage to health. It is especially important in cases when the procedure is carried out by people, who are underqualified and do not have appropriate permissions.
Keywords: needle-based proceduresaesthetic medicinebotulinum toxinhyaluronic acidcomplications
References
- Galęba A, Marcinkowski J. Aesthetic medicine ― a separate field of medicine, as a combination of many medical specialties. Open J Nurs. 2015; 5(2): 158–162.
- ltd R and M. Aesthetic Medicine Global Market Report 2023 ― research and markets. https://www.researchandmarkets.com/reports/5939158/aesthetic-medicine-global-market-report (23.11.2023).
- Smędra A, Szustowski S, Klemm J, et al. Complications of aesthetic medicine procedures: five case studies. Arch Med Sadowej Kryminol. 2015; 65(3): 158–172.
- Feng LF. Characteristics and emerging trends in modern aesthetic medicine. Chin Med J (Engl). 2020; 133(6): 741–742.
- Matthews-Kozanecka M, Baum E, Mojs E. Polemics around facial aesthetic medicine. J Face Aesthet. 2023; 5(2): 94–102.
- Prendergast PM, Shiffman MA, editors. Aesthetic medicine: art and techniques. Berlin, Heidelberg: Springer Berlin Heidelberg; 2012. https://link.springer.com/book/10.1007/978-3-642-20113-4 (21.11.2023).
- Kelso K. EU medical device regulation 2017/745 versus US food and drug administration approval of dermal filler products. J Aesthetic Nurs. 2020; 9(8): 320–324.
- Aesthetic Medicine Market Size, Share, Growth Report, 2030. https://www.grandviewresearch.com/industry-analysis/medical-aesthetics-market (22.11.2023).
- Witmanowski H, Błochowiak K. The whole truth about botulinum toxin — a review. Adv Dermatol Allergol. 2020; 37(6): 853–861.
- Michon A. Botulinum toxin for cosmetic treatments in young adults: An evidence-based review and survey on current practice among aesthetic practitioners. J Cosmet Dermatol. 2023; 22(1): 128–139.
- Hamzawi NK, Baaj SM. The abuse of dermal fillers: a clinico-epidemiological study of 35 cases. J Cosmet Dermatol Sci Appl. 2019; 9(2): 94–106.
- Aesthetics Journal. Aesthetics. https://aestheticsjournal.com/ (22.11.2023).
- Vedamurthy M. Mesotherapy in Aesthetic Medicine. In: Shiffman MA, Di Giuseppe A. ed. Cosmetic Surgery. Heidelberg: Springer, Berlin 2013: 205–218.
- Plachouri KM, Georgiou S. Mesotherapy: safety profile and management of complications. J Cosmet Dermatol. 2019; 18(6): 1601–1605.
- Sivagnanam GS. Mesotherapy - the French connection. J Pharmacol Pharmacother. 2010; 1(1): 4–8.
- Ramos-e-Silva M, Pereira AL, Ramos-e-Silva S, et al. Oleoma: rare complication of mesotherapy for cellulite. Int J Dermatol. 2012; 51(2): 162–167.
- Kandhari R, Kaur I, Sharma D. Mesococktails and mesoproducts in aesthetic dermatology. Dermatol Ther. 2020; 33(6): e14218.
- Al Faresi F, Galadari HI. Mesotherapy: myth and reality. Expert Rev Dermatol. 2014; 6(2): 157–162.
- Kato M, Watanabe T, Yamada N, et al. Mixed cell granulomatous panniculitis on the cheek due to injection of a solution containing phosphatidylcholine and deoxycholate. Dermatol Surg. 2010; 36(11): 1779–1781.
- Campos LM, Miot LD, Marques ME, et al. Case for diagnosis. Noninfectious suppurative panniculitis induced by mesotherapy with deoxycholate. An Bras Dermatol. 2019; 94(6): 754–756.
- Colón-Soto M, Peredo RA, Vilá LM. Systemic lupus erythematosus after mesotherapy with acetyl-L-carnitine. J Clin Rheumatol. 2006; 12(5): 261–262.
- Danilovic DL, Bloise W, Knobel M, et al. Factitious thyrotoxicosis induced by mesotherapy: a case report. Thyroid. 2008; 18(6): 655–657.
- Gupta AK, Polla Ravi S, Wang T, et al. Systematic review of mesotherapy: a novel avenue for the treatment of hair loss. J Dermatolog Treat. 2023; 34(1): 2245084.
- Seetharam KA. Alopecia areata: an update. Indian J Dermatol Venereol Leprol. 2013; 79(5): 563–575.
- Duque-Estrada B, Vincenzi C, Misciali C, et al. Alopecia secondary to mesotherapy. J Am Acad Dermatol. 2009; 61(4): 707–709.
- Klein AW. Complications and adverse reactions with the use of botulinum toxin. Dis Mon. 2002; 48(5): 336–356.
- Kroumpouzos G, Kassir M, Gupta M, et al. Complications of botulinum toxin A: an update review. J Cosmet Dermatol. 2021; 20(6): 1585–1590.
- Rummaneethorn P, Chalermchai T. A comparative study between intradermal botulinum toxin A and fractional microneedle radiofrequency (FMR) for the treatment of primary axillary hyperhidrosis. Lasers Med Sci. 2020; 35(5): 1179–1184.
- Borba A, Matayoshi S, Rodrigues M. Avoiding complications on the upper face treatment with botulinum toxin: a practical guide. Aesthetic Plast Surg. 2022; 46(1): 385–394.
- Carruthers J, Fagien S, Matarasso SL, et al. Consensus recommendations on the use of botulinum toxin type a in facial aesthetics. Plast Reconstr Surg. 2004; 114(6 Suppl): 1S–22S.
- Frevert J. Pharmaceutical, biological, and clinical properties of botulinum neurotoxin type A products. Drugs RD. 2015; 15(1): 1–9.
- Azzalure — Summary of Product Characteristics (SmPC) — (emc). https://www.medicines.org.uk/emc/product/6584 (15.02.2024).
- BOTOX 100 Allergan Units Powder for solution for injection — Summary of Product Characteristics (SmPC) — (emc). https://www.medicines.org.uk/emc/product/859/smpc (15.02.2024).
- BOCOUTURE 50 units powder for solution for injection — Summary of Product Characteristics (SmPC) — (emc). https://www.medicines.org.uk/emc/product/600/smpc (15.02.2024).
- Carruthers J, Carruthers A. Complications of botulinum toxin type A. Facial Plast Surg Clin North Am. 2007; 15(1): 51–54, vi.
- Naumann M, Jankovic J. Safety of botulinum toxin type A: a systematic review and meta-analysis. Curr Med Res Opin. 2004; 20(7): 981–990.
- Levy LL, Emer JJ. Complications of minimally invasive cosmetic procedures: prevention and management. J Cutan Aesthet Surg. 2012; 5(2): 121–132.
- Amer A, Amer M, Nofal H. Botulinum toxin for the face. In: Tang YB. ed. Cosmetic surgery. IntechOpen 2021.
- Vartanian AJ, Dayan SH. Complications of botulinum toxin A use in facial rejuvenation. Facial Plast Surg Clin North Am. 2005; 13(1): 1–10.
- de Maio M, Swift A, Signorini M, et al. Facial assessment and injection guide for botulinum toxin and injectable hyaluronic acid fillers: focus on the upper face. Plast Reconstr Surg. 2017; 140(2): 265e–276e.
- Bonińska K. Ophthalmic complications after needle-based medical aesthetic procedures: a narrative review. J Clin Med. 2022; 12(1): 313.
- Buono C, Mandell-Brown M. A comparison of alpha-adrenergics (anticholinesterases) in the treatment of eyelid ptosis after botulinum toxin a administration to the glabellar region: a case study. Am J Cosmet Surg. 2018; 36(3): 121–124.
- Auada Souto MP, Souto LR. An unusual adverse event of botulinum toxin injection in the lower face. J Cosmet Dermatol. 2021; 20(5): 1381–1384.
- Sugrue CM, Kelly JL, McInerney N. Botulinum toxin treatment for mild to moderate platysma bands: a systematic review of efficacy, safety, and injection technique. Aesthet Surg J. 2019; 39(2): 201–206.
- Cavallini M, Cirillo P, Fundarò SP, et al. Safety of botulinum toxin A in aesthetic treatments: a systematic review of clinical studies. Dermatol Surg. 2014; 40(5): 525–536.
- Ahsanuddin S, Roy S, Nasser W, et al. Adverse events associated with botox as reported in a food and drug administration database. Aesthetic Plast Surg. 2021; 45(3): 1201–1209.
- Lee KC, Pascal AB, Halepas S, et al. What are the most commonly reported complications with cosmetic botulinum toxin type a treatments? J Oral Maxillofac Surg. 2020; 78(7): 1190.e1–1190.e9.
- Yiannakopoulou E. Serious and long-term adverse events associated with the therapeutic and cosmetic use of botulinum toxin. Pharmacology. 2015; 95(1–2): 65–69.
- Rosenfield LK, Kardassakis DG, Tsia KA, et al. The first case report of a systemic allergy to onabotulinumtoxina (botox) in a healthy patient. Aesthet Surg J. 2014; 34(5): 766–768.
- Careta MF, Delgado L, Patriota R. Report of allergic reaction after application of botulinum toxin. Aesthet Surg J. 2015; 35(5): NP102–NP105.
- Baizabal-Carvallo JF, Jankovic J, Pappert E. Flu-like symptoms following botulinum toxin therapy. Toxicon. 2011; 58(1): 1–7.
- Tugnoli V, Eleopra R, Quatrale R, et al. Botulism-like syndrome after botulinum toxin type A injections for focal hyperhidrosis. Br J Dermatol. 2002; 147(4): 808–809.
- Mya N, Tat Y, Yeoh B, et al. Botox: the deadly beauty. Forensic Med Anat Res. 2019; 7(1): 13–17.
- Li M, Goldberger BA, Hopkins C. Fatal case of BOTOX-related anaphylaxis? J Forensic Sci. 2005; 50(1): 169–172.
- Devers KG, Nine JS. Autopsy findings in botulinum toxin poisoning. J Forensic Sci. 2010; 55(6): 1649–1651.
- Phan K, Younessi S, Dubin D, et al. Emerging off-label esthetic uses of botulinum toxin in dermatology. Dermatol Ther. 2022; 35(1): e15205.
- Sánchez-Carpintero I, Candelas D, Ruiz-Rodríguez R. [Dermal fillers: types, indications, and complications]. Actas Dermosifiliogr. 2010; 101(5): 381–393.
- Bucky LP, Kanchwala SK. The role of autologous fat and alternative fillers in the aging face. Plast Reconstr Surg. 2007; 120(6 Suppl): 89S–97S.
- Jung H. Hyaluronidase: An overview of its properties, applications, and side effects. Arch Plast Surg. 2020; 47(4): 297–300.
- Minokadeh A, Jones DH. Are you up-to-date on dermal fillers? Cutis. 2020; 106(2): 59–60.
- King M. Management of Tyndall effect. J Clin Aesthetic Dermatol. 2016; 9(11): E6–E8.
- Beauvais D, Ferneini EM. Complications and litigation associated with injectable facial fillers: a cross-sectional study. J Oral Maxillofac Surg. 2020; 78(1): 133–140.
- Beauvais D, Ferneini EM. Complications and litigation associated with injectable facial fillers: a cross-sectional study. J Oral Maxillofac Surg. 2020; 78(1): 133–140.
- Witmanowski H, Błochowiak K. Another face of dermal fillers. Adv Dermatol Allergol. 2020; 37(5): 651–659.
- Danks JJ, Dalgliesh JD, Ayton T. Cosmetic filler blindness: recovery after repeated hyaluronidase injections. Aesthet Surg J. 2022; 42(4): 411–416.
- Mehta P, Kaplan J, Zhang-Nunes S. Ischemic complications of dermal fillers. Plast Aesthetic Res. 2022; 9(10): 57.
- Beleznay K, Carruthers JDA, Humphrey S, et al. Update on avoiding and treating blindness from fillers: a recent review of the world literature. Aesthet Surg J. 2019; 39(6): 662–674.
- Yang HK, Lee Y, Woo SeJ, et al. Natural course of ophthalmoplegia after iatrogenic ophthalmic artery occlusion caused by cosmetic filler injections. Plast Reconstr Surg. 2019; 144(1): 28e–34e.
- Povolotskiy R, Oleck N, Hatzis C, et al. Adverse events associated with aesthetic dermal fillers: a 10-year retrospective study of FDA data. Am J Cosmet Surg. 2018; 35(3): 143–151.
- Yang Q, Lu B, Guo N, et al. Fatal cerebral infarction and ophthalmic artery occlusion after nasal augmentation with hyaluronic acid-a case report and review of literature. Aesthetic Plast Surg. 2020; 44(2): 543–548.
- Lee S, Jung Jh, Seo J, et al. Ischemic stroke caused by a hyaluronic acid gel embolism treated with tissue plasminogen activator. J Neurocritical Care. 2017; 10(2): 132–135.
- Urdiales-Gálvez F, Delgado NE, Figueiredo V, et al. Treatment of soft tissue filler complications: expert consensus recommendations. Aesthetic Plast Surg. 2018; 42(2): 498–510.
- Lafaille P, Benedetto A. Fillers: contraindications, side effects and precautions. J Cutan Aesthet Surg. 2010; 3(1): 16–19.
- Zambacos G, Hapsas D, Mandrekas A. Glabella impending skin necrosis: a case report. Eur J Plast Surg. 2019; 42(2): 193–196.
- Duffy DM. Complications of fillers: overview. Dermatol Surg. 2005; 31(11 Pt 2): 1626–1633.
- Ozturk CN, Li Y, Tung R, et al. Complications following injection of soft-tissue fillers. Aesthet Surg J. 2013; 33(6): 862–877.
- Woodward J, Khan T, Martin J. Facial filler complications. Facial Plast Surg Clin N Am. 2015; 23(4): 447–458.
- Snozzi P, van Loghem JAJ. Complication management following rejuvenation procedures with hyaluronic acid fillers-an algorithm-based approach. Plast Reconstr Surg Glob Open. 2018; 6(12): e2061.
- Kong J, Yang T, Yang X, et al. Death from pulmonary embolism caused by vaginal injection of hyaluronic acid: a case report and a literature review. Aesthetic Plast Surg. 2023; 47(4): 1535–1541.
- Carico R, Aspinall S, Good C. Fatalities possibly associated with hyaluronic acid injections: a review of events reported to the FDA. Drugs Ther Perspectiv. 2021; 37(3): 137–140.
- Duan Y, Zhang L, Li S, et al. Polyacrylamide hydrogel pulmonary embolism — a fatal consequence of an illegal cosmetic vaginal tightening procedure: a case report. Forensic Sci Int. 2014; 238: e6–ee10.
- Rzepczyk S, Świderski P, Sommerfeld-Klatta K, et al. Causes of death during the intravenous infusion of dimethylsulphoxide and hydrogen peroxide in the course of alternative medicine therapy. Toxics. 2023; 11(8): 652.
- Ibrahim E, Franco A, Fernandes M, et al. Ethical and legal aspects of the use of fake drugs for orofacial aesthetics — a case report. Rev Bras Odontol Leg. 2020; 7(1): 86–91.
- Pickett A, Mewies M. Serious issues relating to the clinical use of unlicensed botulinum toxin products. J Am Acad Dermatol. 2009; 61(1): 149–150.
- Dz. U. 2001 Nr 126 poz. 1381, USTAWA z dnia 6 września 2001 r. Prawo farmaceutyczne.
- Postanowienie Sądu Najwyższego RP z dnia 26 maja 2021, Sygn. akt I KK 23/21.
- Apel 1/2024 Okręgowej Rady Lekarskiej Wielkopolskiej Izby Lekarskiej z dnia 10 lutego 2024 r. do Prezesa Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Środków Biobójczych.
- Stanowisko nr 48/21/P-VIII Prezydium Naczelnej Rady Lekarskiej z dnia 15 kwietnia 2021 r. w sprawie uprawnień do wykonywania procedur wchodzących w skład zabiegów z zakresu medycyny estetycznej.
- Rayess HM, Svider PF, Hanba C, et al. A cross-sectional analysis of adverse events and litigation for injectable fillers. JAMA Facial Plast Surg. 2018; 20(3): 207–214.
- Jurek T. Opiniowanie sądowo-lekarskie w przestępstwach przeciwko zdrowiu. Wolters Kluwer Polska, Warszawa 2010: 189.
- Dobosz T, Kis-Wojciechowska M, Kołowski J, Lorkiewicz-Muszyńska D, Marcinkowski JT. In: Żaba C. ed. Wybrane zagadnienia z medycyny sądowej. Wydawnictwo Naukowe Uniwersytetu Medycznego im. Karola Marcinkowskiego, Poznań 2014.
- Jurek T. Opiniowanie sadowo-lekarskie w przypadkach narazenia na bezposrednie niebezpieczenstwo utraty zycia albo ciezkiego uszczerbku na zdrowiu. Uniwersytet Medyczny im. Piastów Śląskich, Wroclaw 2013.
- Stanowisko Nr 1/21/VIII Naczelnej Rady Lekarskiej z dnia 29 stycznia 2021 r. w sprawie przyjęcia definicji medycyny estetycznej. https://nil.org.pl/dla-lekarzy/prawo/medycyna-estetyczna/5296-propozycja-definicji-medycyny-estetycznej (23.05.2024).
- World Medical Association STATEMENT ON AESTHETIC TREATMENT, Adopted by the 65 World Medical Assembly, Durban, South Africa, Otober 2014.
- Stanowisko Nr 5/22/VIII Naczelnej Rady Lekarskiej z dnia 11 marca 2022 r. w sprawie poselskiego projektu ustawy o zawodzie kosmetologa. https://nil.org.pl/dla-lekarzy/prawo/medycyna-estetyczna/5975-stanowisko-nrl-ws-projektu-ustawy-o-zawodzie-kometologa (23.05.2024).
- Stanowisko Nr 4 Prezydium Naczelnej Rady Lekarskiej i Prezydium Naczelnej Rady Pielęgniarek i Położnych z dnia 14 lutego 2024 r. w sprawie zasadności uregulowania zasad wykonywania zabiegów medycyny estetycznej. https://nil.org.pl/uploaded_files/art_1707915905_ps-4.pdf (23.05.2024).
- Uchwała 5/21/VIII Naczelnej Rady Lekarskiej z dnia 29 stycznia 2021 r. w sprawie przyjęcia rojektu zmian w ustawie o działalności leczniczej i projekcie ustawy o wyrobach medycznych. https://nil.org.pl/uploaded_files/documents/doc_1612526524_ru005-21-viii.pdf (23.05.2024).
- Uchwała Nr 3/22/VIII Naczelnej Rady Lekarskiej z dnia 28 stycznia 2022 r. w sprawie obowiązków lekarzy i lekarzy dentystów uczestniczących w szkoleniach w roli wykładowcy. https://nil.org.pl/uploaded_files/documents/doc_1643618312_ru003-22-viii.pdf (23.05.2024).