‼️ WARNING ‼️ THIS ARTICLE CONTAINS GRAPHIC IMAGES. THEY ARE PUBLISHED WITH PATIENT CONSENT AS A WARNING TO THE PUBLIC OF HOW DIRE RESULTS CAN BE. DISCRETION IS ADVISED.
Note, the images are credited to the doctors who treated the patients after they were injected by non-medical professionals.
*This article is brought to you by AAMSSA: the Aesthetic and Anti-Ageing Medicine Society of South Africa.
Aesthetic Appointment is a proud media partner of AAMSSA*
Find an aesthetic practitioner: www.aestheticdoctors.co.za
In the world of medical aesthetics, there’s always some new trend making headlines. This invariably results in a frenzied rush for the latest treatment or product. Huge demand then gives rise to fly-by-night businesses that are unethical (even illegal) and sell products of poor quality. This combination can have dire consequences. Dr Debbie Norval reports on the dangers associated with the latest aesthetic treatment offered by unlicensed professionals: fat dissolving injections.
Fat dissolving, or lipolytic, injections are trending on social media as “miracle” fat-loss treatments. Hundreds of videos and advertisements can be found on TikTok, X, YouTube, and Instagram. While beauty enthusiasts are being lured to try Korean-made fat dissolving injections, what may seem like a low-risk beauty treatment has the potential to go seriously wrong – even resulting in death.
On 26 March 2024, the Swiss regulatory authority issued a warning about an illegal medicinal product – the “Lemon Bottle” lipolysis solution. Swissmedic expressly warns against using Lemon Bottle lipolysis solution.
The Swissmedic report highlights four important factors:
- Products for injection fall under the law on therapeutic products, regardless of how deeply they are injected into the skin. Because Lemon Bottle is administered as an injection, it cannot be marketed as cosmetics.
- No medicinal effect of Lemon Bottle has been scientifically proven.
- The quality of the ingredients has not been tested. Therefore, using the product poses a health risk.
- None on the declared ingredients could be detected by the Swissmedic laboratory in the samples of Lemon Bottle lipolysis solution obtained from various sources.
“The official Swissmedic laboratory has analysed product samples from various sources and found that the ingredients do not match the declaration and even vary greatly from one pack to another. In one sample, the only substance found was caffeine, while none of the ingredients listed on the packaging could be detected in another. These products can therefore be regarded as falsifications.”
Beauty therapists are being trained by companies to inject fat dissolving injections. AAMSSA wants the public to be aware that any fat dissolving or lipolytic injection should be administered only by medically trained doctors. In South Africa, it is illegal for beauty therapists or non-medically trained individuals to inject any lipolytic injection.
Another concern for AAMSSA is that there are currently few to no scientific studies that support the efficacy and safety of many of these products. New non-surgical treatments need to be properly assessed and scrutinised by scientific publications before safety is established.
What are lipolytics?
Injection lipolysis (“lipo” = fat, “lysis” = breakdown) is a non-surgical procedure that involves administering a series of injections under the skin to break down fat cells in the areas around the injection sites.
Lack of regulation
Lipolytic injections administered by beauty therapists, which are obtained online or from unreputable companies, are not registered with the South African Health Products Regulatory Authority (SAHPRA). In addition, they do not have US FDA approval, nor do they have the European/UK CE mark for medical devices. This lack of licensing implies insufficient safety testing, and that the technology is unproven. As a result, medical practitioners are experiencing an overwhelming number of complication referrals.
Scientifically validated and regulated lipolytic injections
The CE-marked and FDA-approved fat dissolvers that aesthetic doctors use contain ingredients like deoxycholic acid and phosphatidylcholine (PPC). While these drugs may not sound “safe and natural”, they have been scientifically researched and clinically proven to work. These important certifications mean that a product has passed stringent safety and efficacy requirements and is licensed for use only by doctors.
Cosmetic vs medical device
Fat dissolving kits are currently widely available for online purchase. The absence of deoxycholic acid and PPC means that the products are inaccurately classed as “cosmetic” rather than medical. This is a concern because non-medically trained individuals are fooled into a false sense of security, as the ingredients seem harmless and natural.
More people than ever are undertaking bogus training courses and setting up shop selling treatments that should only ever be conducted by a medically qualified practitioner. Therapists and the public are injecting fat dissolvers in salons and private homes, injecting any fatty areas, including the face. Yet even experienced doctors are extremely careful when injecting fat dissolver into the face, as people can end up with lifelong complications, including nerve and vascular damage.
Ingredients of unregulated fat dissolving injections
The ingredients of these trending injections include bromelain (a pineapple extract), B vitamins, lecithin, and peptides. These products are found in many over-the-counter oral supplements, which is why they seem familiar and “safe”.
However, it is not necessarily safe to have these products injected. While the use of the components has been noted in scientific literature for oral use, there’s little to no data to support injectable options. They have not been adequately researched to be given as a subcutaneous or intramuscular injection – and in the hands of non-medically trained individuals, they are doubly dangerous.
It is alarming that therapists are also able to order cheap, untested PPC and deoxycholate from questionable online sites. The source and quality of the ingredients are unknown and unregulated, while adverse effects and complications abound.
Why should a beauty therapist not administer lipolytic injections?
Simply put, in South Africa, it is illegal for a beauty therapist to inject. If they are administering injections, they are breaking the law. This should be a red flag regarding their ethics and standards.
A beauty therapist is neither trained nor qualified to inject. The risk of any injection – including a simple vitamin B – includes pain, swelling, rash, bleeding, bruising, infection, and allergies that can lead to anaphylaxis and death!
Fat dissolving injections must be injected in the right place, at the right dose, in the correct tissue plane, using the correct technique, and in the right patient. Even medical doctors require extra training before injecting lipolytics. This procedure falls totally outside the scope of practice of a therapist.
Non-medical individuals are not trained in aseptic technique, which entails practices and procedures to prevent contamination from pathogens (germs). It involves applying the strictest rules to minimise the risk of infection. Healthcare workers use aseptic techniques in surgery rooms, clinics, outpatient care centres, and other healthcare settings. Non-medics may not be doing this. They could be sharing vials, and needles, using the same gloves for multiple patients, not correctly cleaning their premises, or not correctly preparing the area they’re treating. Improper or unsafe injection practices by unlicensed personnel could increase the risk of scarring and skin infections, resulting in serious complications.
Lastly, therapists cannot manage the potential complications associated with lipolytic products, and it subsequently falls on doctors to treat the consequences. Complications have been so severe that patients have required admission to hospital and specialist surgical referral.
SA law regarding injections
South Africa’s law regarding injections is found in the Health Professions Act 56 of 1974. The essence of the act is that a person needs to be a medical practitioner registered with the Health Professions Council of SA to administer scheduled medicines or injections of any nature.
Simply put, if a person uses a syringe with a needle attached that physically injects a substance into a patient, they are essentially performing a medical procedure.
There is no case scenario that exists that will ever justify a therapist, somatologist, or non-medical person doing any injections whatsoever. No accredited beauty therapist or somatology course available in South Africa covers anything nearly academically or practically adequate to perform any type of intradermal or subcutaneous injection. The dermis and subcutaneous tissue are both part of an organ system, so, once a substance passes the epidermis, the potential risk of systemic complications increases.
Side effects and complications of lipolytic injections
- Infection: Infections are common and result in abscesses, tissue necrosis (cell death) and necrotising fasciitis (flesh-eating disease), especially when administered with poor aseptic practices in non-medical facilities. One of the most challenging infections to treat is atypical mycobacteria – a type of TB infection that is surprisingly common after fat dissolving injections. An infection can lead to sepsis, which is the body’s extreme response to an infection. It is a life-threatening medical emergency. Sepsis occurs when an infection triggers a chain reaction throughout the body. It can be fatal.
- Panniculitis: The subcutaneous fat layer is called the panniculus. When lipolytic agents are injected into the subcutaneous fatty tissue, they can trigger an inflammatory response in the surrounding area. This inflammation can lead to the development of panniculitis, which manifests as redness, swelling, tenderness, and the formation of painful bumps (nodules), granulomas, and cysts. In severe cases, panniculitis caused by lipolytics can lead to scarring, skin irregularities, and deformity.
- Vascular damage: Blood vessels can be destroyed if lipolytics are accidentally injected into an artery. This results in necrosis (cell death) along the path of the vessel, with subsequent tissue loss and permanent disfigurement.
- Nerve damage: If injected close to a nerve, lipolytics can dissolve the sheath of the nerve and stop it from working properly. This results in numbness or paralysis of part of the face or body.
- Muscle damage: If accidentally injected into muscles, lipolytic injections can cause swelling, severe pain, necrosis, and permanent muscle damage.
- Bromelain side effects: Bromelain is a digestive enzyme derived from pineapple. It is vital for anyone with a pineapple allergy to avoid the product. Bromelain side effects include abdominal discomfort, cramps, and diarrhoea.
- Lecithin side effects: Lecithin may cause reactions in people taking specific medications. For example, lecithin may escalate the effects of oral diclofenac, a non-steroidal anti-inflammatory drug commonly used to treat pain (e.g. muscle aches or migraine). Common side effects of lecithin include nausea, diarrhoea, stomach fullness, and stomach discomfort. Lecithin is considered safe for most people to take orally, while the likeliest side effect of lecithin injections for weight loss would be that they don’t work.
- No result: Unregulated and unproven fat dissolving injections might dissolve your budget before your waistline.
Cutting corners to make money
It is often unclear to a patient where non-medically supervised therapists get their products from. What exactly are they using? A doctor will know where to source legitimate products and which products are licensed and fit for purpose. They won’t risk using unlicensed products, as they could lose their licence!
Non-medics are buying random products over the internet and this is a recipe for disaster.
Consumer confusion
With medi-spas and beauty salons offering fat dissolving injections, the public falsely assumes that lipolysis is similar to other beauty treatments, such as facials or pedicures. What should be considered a medical treatment is therefore trivialised.
Patients are sold “home treatment” injections or “do-it-yourself packs”. This results in self-harm, with severe complications that often go untreated. Lipolytics cannot be self-administered or compared to prescription drugs like insulin, HCG, or other self-administered drugs.
Who can be trusted?
Don’t trust just anyone who says they are trained and can offer these treatments. Just because they can doesn’t mean they should.
As a rule of thumb, if the source of the lipolytic is a company or person that supplies non-medical personnel and the public directly, don’t use it. Reputable suppliers will only sell to registered medical doctors.
Ask questions, check the background of your injector, ask to see training evidence, and make sure they’re a medical professional. A list of reputable and qualified aesthetic doctors is available on the AAMSSA website.
In summary
A tidal wave of fake and unregulated fat dissolving products is flooding social media, online shopping portals, and beauty salons. These untested products are of dubious efficacy, make questionable safety claims, and have little to no scientific research behind them.
AAMSSA highlights the need for rigorous scientific research and regulatory oversight, especially regarding new and popular fads like the latest fat dissolvers. Safety and efficacy must be thoroughly evaluated through scientific studies before widespread adoption in medical practice.
AAMSSA emphasises the crucial role of qualified personnel in administering lipolytic injections. Medical professionals are trained to assess patients’ needs, consider potential risks and benefits, as well as ensure proper administration, follow-up care, and complication management.
Regulatory bodies like SAHPRA and the FDA play a pivotal role in safeguarding public health by evaluating and approving new treatments based on scientific evidence. Their oversight helps ensure that only safe and effective treatments reach the market, providing patients with confidence in the treatments they receive.
The safe and responsible dissolving of fat requires evidence-based medicine, regulatory scrutiny, and professional medical expertise.
To report any unsafe practice or if you have any queries, please feel free to contact AAMSSA at info@aestheticdoctors.co.za
Find a doctor practising aesthetic medicine in South Africa by visiting www.aestheticdoctors.co.za.
Disclaimer: This article is published solely for informational purposes and should not be considered a substitute for professional medical guidance.
References:
FDA Warning on Unauthorized Fat-Dissolving Injections
https://www.fda.gov/drugs/buying-using-medicine-safely/using-fat-dissolving-injections-are-not-fda-approved-can-be-harmful?utm_medium=email&utm_source=govdelivery
‘AAMSSA Recommendations for safe practice of lipolytic mesotherapy in South Africa’. Issued July 2021
‘AAMSSA Recommendations – Use of fat for regenerative purposes in Aesthetic Medicine’. Issued 2 September 2020
Ramirez MR, Marinaro RE, Warthan ML, Burton CS. ‘Permanent Cutaneous Adverse Events After Injection With Deoxycholic Acid’. Dermatol Surg. 2019 Nov;45(11):1432-1434. doi: 10.1097/DSS.0000000000001804. PMID: 30672855.
McKay, Cather MD; Price, Cynthia MD; Pruett, Lisa MD. ‘Vascular Injury After Deoxycholic Acid Injection’. Dermatologic Surgery. February 2019. Volume 45: Issue 2: p 306-309. doi: 10.1097/DSS.0000000000001550
Yang Y, Li S, Zhang L, Fu H, Zhou G, Chen M. ‘Skin and soft tissue infection of Nontuberculous mycobacterium after injection lipolysis’. J Cosmet Dermatol. 2023; 22: 1207-1212. doi:10.1111/jocd.15591
Córdoba S, Rojas E, Garrido-Ríos A, Borbujo J. ‘Intense Local Reaction at the Sites of Injection of Lipolytic Mesotherapy’. Actas Dermosifiliogr. 2017 Dec;108(10):958-959. English, Spanish. doi: 10.1016/j.ad.2017.02.027. Epub 2017 Jul 11. PMID: 28709616. (Photo of tummy and thigh panniculitis)
Kaur, H, C Reyes-Barron, WH Sipprell, A Cameron, T Louie, PR Tsai, and G Scott, 2022. ‘Painful Purulent Nodules Caused by Mycobacterium at Site of Lipodissolve Injections’. Am J Dermatopathol, 44(4):257–259. (FDA photo arms “knots”)
Romanova NV, Solovyova E Yu, Troitsky FE. ‘Clinical case of fatal panniculitis resulting from administration of lipolytic’. Medical Alphabet. November 2021. doi:10.33667/2078-5631-2021-27-64-69
MBBCh (Rand) Dip Pall Med (cUK) M Phil Pall Med (UCT) Adv Dip Aesthetic Med (FPD)
Dr Debbie Norval graduated as a medical doctor from the University of the Witwatersrand, in 1991. Post graduate training includes a Diploma in Palliative Medicine through the University of Wales, Masters of Philosophy from the University of Cape Town, an Advanced Diploma in Aesthetic Medicine through the Foundation for Professional Development and a City and Guilds Diploma in Adult Teaching and Training.
Dr Norval is the convenor of the Johannesburg Aesthetic Doctors Journal Club and sits on the scientific committee of the Aesthetic Medicine Congress of South Africa (AMCSA). She is the Past President of the Aesthetic and Anti-Aging Medicine Society of South Africa (AAMSSA) and serves on the International Advisory Board of CMAC (Complications in Medical Aesthetics Collaborative).
“Dr Debbie Norval Aesthetics” is a busy clinical practice in Parktown North, Johannesburg.
Please note Dr Debbie is not taking on new patients at this time.
- Dr Debbie Norvalhttps://www.aestheticappointment.co.za/author/dr-debbie-norval
- Dr Debbie Norvalhttps://www.aestheticappointment.co.za/author/dr-debbie-norval
- Dr Debbie Norvalhttps://www.aestheticappointment.co.za/author/dr-debbie-norval
- Dr Debbie Norvalhttps://www.aestheticappointment.co.za/author/dr-debbie-norval
