Plasma vs ‘Plasma’: The Dangerous Difference Between Authentic & Counterfeit Devices
Because plasma is classified as a medical device, it is imperative that it’s only used in a medical setting, and by a registered doctor. Even more important however, is that the plasma being used is a bona-fide device, as cheap counterfeits can produce major side-effects and subsequent damage. AAMSSA President, Dr Debbie Norval reports.
There are four states of matter: solid, liquid, gas and plasma. The word plasma is derived from the Greek for ‘entity’ or ‘form’, and interestingly, is the most abundant state of most elements in the universe. Plasma is an ionized gas consisting of positive ions and free electrons in proportions, which results in more or less no overall electric charge. It is formed by superheating a gas or by exerting a strong magnetic field to it. Examples of plasma include lightning and neon signs.
The use of plasma in the medical and aesthetics field
Plasma medicine is a relatively new discipline that combines physics with medicine. and has varied applications. These include sterilisation of implants and surgical equipment, disinfection, wound healing and treatment of skin cancers. In aesthetic medicine, plasma is used to treat a wide range of conditions including wrinkles, skin tightening, scarring, stretch marks, acne, warts and skin tags. One of the most popular uses for plasma is a non-surgical blepharoplasty.
The power of plasma
Plasma devices rely on ionization of the air between the tip of the device and the skin to generate plasma. The difference in potential between these two points produces an arc, which acts like a micro lightning bolt delivering energy to the epidermis (the most superficial layer of the skin).
This results in electrical changes to cell membranes and their instant sublimation. Sublimation is the process of turning a solid directly into a gas without a transitional liquid phase, thereby reducing the risk of thermal damage. Studies comparing plasma and radiofrequency found that with plasma, the basement membrane of the epidermis remained intact and there was no heat damage to the deeper dermis.
Plasma therapy results in immediate contraction of the collagen fibers, collagen reorganisation, formation of new collagen, and renewal of epidermal tissue.
Treatments and contraindications
Contraindications to the use of plasma devices include pregnancy and breast feeding, the use of Roaccutane®, systemic illness, infection at the treatment site, open wounds, body dysmorphic syndrome, immunosuppression, auto-immune disease, and in patients at risk of keloid or hypertrophic scarring.
A plasma treatment does not come without risks. Expected downtime after a plasma treatment includes swelling, redness and mild discomfort for a few days with the formation of scabs that usually shed in 7-15 days. It is not unusual after 1-3 months for there to still be some redness (in lighter Fitzpatrick skin types I-II) and transient pigmentation (particularly in patients with darker Fitzpatrick skin type IV-VI).
There should be resolution of the pigmentation over a 3-month period, and studies show that there is no reported incidence of permanent side effects from true plasma. Plasma, if used correctly, should not permanently affect the melanocytes and is safe to use in all skin types. Yet there is a risk of hyperpigmentation in darker skin types, so a patch test is recommended in Fitzpatrick skin types IV and above.
With that said, if these side effects are possible even with a true plasma device is used correctly in a medical setting, just imagine the prolonged side effects and complications from a fake device in the wrong hands! Cheap “plasma” devices can result in permanent severe pigmentation, severe burns with subsequent infection, scarring and even nerve damage. (*See photos)
The intended use of plasma technology is for medical disciplines such as dermatology, aesthetic medicine, oculoplastic surgery, dentistry and gynecology. Since plasma is classified as a medical device, it is solely intended for use in a medical context, and thus, must be performed by a medical doctor.
Reputable suppliers will only sell plasma devices to medical doctors registered with the HPCSA (or to dentists to use within the perioral area only). Reputable suppliers will also provide inhouse training with the device by a registered product trainer.
Plasma = partially ablative
Any aesthetic treatment that breaches the basement membrane of the epidermis is termed “ablative”. Ablative treatments reach the dermis and deeper tissues with potential damage and risk of scarring. It is well known that all ablative treatments fall outside of the scope of practice of a beauty therapist.
In fact, therapists may not operate any ablative lasers, ultrasound or radiofrequency. Now, while plasma is classified as “partially ablative” and is designed to be an epidermal treatment, it can easily become ablative in the wrong hands, or when it it’s a counterfeit device. Plasma devices are very operator dependent… and hence the proper qualification and training is required.
Plasma vs plasma: The dangerous difference
Plasma technology has unfortunately been taken over by a flood of dangerous counterfeit devices. Companies that market cheap “plasma pens” or “fibroblast pens” have primarily targeted medical spas and estheticians. These pens are readily available to the beauty therapy industry causing numerous issues for SAAHSP and AAMSSA who have to deal with the consequences.
These unregulated and unregistered devices are not generating true plasma. The use of nonspecific parameters, incorrect signals and electrical components in an attempt to generate plasma causes unpredictable and potentially dangerous effects; such as electric shock, loss of accuracy, unpredictable penetration and deep thermal damage. The consequences are thus ineffective results, pain, prolonged downtime and permanent complications such as post inflammatory hyperpigmentation and scarring.
In light of the above, the Canadian Department of Health has recently issued a public safety alert regarding the use of fake plasma devices. Health Canada warns that these devices have not been evaluated for safety, effectiveness or quality – and advises the public, spas and aestheticians to stop using plasma pens or fibroblasts devices.
It is very difficult to differentiate between devices that are authentic and those that are using radio frequency and other substandard technology. One of the challenges with plasma technology is that innovation moves faster than regulation. Widespread unregulated use of plasma pens has resulted in an unfair loss of credibility of the real plasma devices, loss of faith in treatments among aesthetic practitioners, and loss of faith amongst the patient population.
Ten questions to determine whether a plasma device is authentic:
- Does it have CE or FDA approval with ISO certificates?
- Does the specific device have independent scientific studies published in the medical literature?
- Is the device available for sale to non-medical doctors?If so, then it’s not a true plasma device.
- Does the distribution company have a reputable history?
- Does the distribution company offer device support and troubleshooting?
- Is comprehensive training offered by the company?
- Does the device come with documentation of its watt, output and voltage parameters as part of the safety features?
- What is the plasma beam colour? A plasma beam has an amber colour, while radiofrequency devices have a white or blue beam.
- Is there an earthing plate? A true plasma device will never require a return electrode pad.
- What did the device cost? Anything under R150 000 is a counterfeit. Believe it or not, there are “Plasma Pens” available on the South African market for R3000 (a big indicator it’s counterfeit).
- True plasma devices are effective and safe with excellent and reliable results but should only be operated by a trained medical professional. Consumers are strongly advised to avoid treatments where unauthorized plasma pens are operated by beauty therapists at salons and spas.
Be careful. Be diligent. Be safe.
- Gloustianou G, Sifaki M, Tsioumas SG, et al. Presentation of old and new histological results after plasma exercises (Plexr) application (regeneration of the skin tissue with collagen III). Pinnacle Medicine & Medical Sciences 2016;3(3):983-90
- Stamatina G, Sotiris TG, Aglaia V. Plexr in acne treatment. Pinnacle Medicine and Medical Sciences 2015;2(1):1-5.
- Sotiris TG, Nikolaos G, Irini G. Plexr: the revolution in blepharoplasty. Pinnacle Medicine and Medical Sciences 2014;1(5):423-7.
- King M, Focus on Plasma. The application of plasma devices in aesthetic medicine. PMFA news. June/July 2017. Vol 4 No 5. www.pmfanews.com
- Re: Health Canada Safety Alert on Unlicensed Plasma Pens/Fibroblast Devices https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2018/68366aeng.php
(With grateful thanks to Dr Marisa Heyns for her assistance in writing this article)
To report any unsafe practice or if you have any queries please feel free to contact Karen Nel at AAMSSA firstname.lastname@example.org
Find a doctor practicing aesthetic medicine by visiting www.aestheticdoctors.co.za
A2 Disclaimer: This article is published for information purposes only, nor should it be regarded as a replacement for sound medical advice.
This article was written by Dr Debbie Norval and edited by the A2 team EXCLUSIVELY for the A2 Aesthetic & Anti-Ageing Magazine March/Autumn 2020 Edition (Issue 33).
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