The AAMSSA Report: Not All Micro-Needling Devices Are Created Equal

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President of AAMSSA, Dr Debbie Norval guides us on how to recognise authenticity and quality in a micro-needling pen…

One of the functions of the Aesthetic and Anti-Aging Medicine Society of South Africa is to provide educational information and advice, in order to protect the public from unsafe and unsound practices.

An example of an unsafe practice is using an automated micro-needling ‘pen’ at home.  An alarming range of cheap counterfeit micro-needling devices are available for purchase online by the general public, for home use.

At home kits

Home ‘derma-rollers’ have been available for many years in South Africa. These are generally safe, with needle lengths of 0.25-0.5 mm that are designed for home use.  However, home rollers are very different to micro-needling pens, which are automated vertical needling devices.

These pens come with disposable needle cartridges, each containing multiple needles that vertically pierce the skin and create hundreds of thousands of micro-injuries.  Yet it must be noted that these types of micro-needling pens are not safe for home use, and treatments should only be performed by a professional in a medical setting.

Micro-needling unpacked

Also termed fractional mechanical resurfacing, micro-needling harnesses the body’s natural ability to repair itself, resulting in dermal remodeling with an increase in collagen and elastin. But in the wrong hands, it can cause infection, scarring and pigmentation.

Not only that, even if you do the responsible thing and have your micro-needling performed by a professional, it is important to understand that not all micro-needling pens are created equal.

And not every micro-needling procedure is the same either. Medical micro-needling performed by an aesthetic doctor is quite different from a treatment performed by a beauty therapist.  And just as the public can obtain cheap copycat pens, so can therapists and doctors. It is a scary thought!

Micro-needling pens at work

Micro-needling pens are a form of transdermal delivery system. Non-biological materials such as cosmeceuticals or pharmaceuticals, or biological materials such as bioactive peptides or PRP (platelet-rich plasma) can be infused into the skin during micro-needling.

This is important to know, as topical products and serums are not meant to be introduced past the skin barrier, as it can cause serious problems. Anything that is not designed to be used for micro-needling is basically the same as tattooing the product into the skin.

If the product hasn’t been specifically produced for injection, it introduces immunogenic particles into the dermis, increasing the risk of local and systemic hypersensitivity or allergic reactions.

Dangers of counterfeit micro-needling devices

Reports to AAMSSA on adverse effects from counterfeit micro-needling devices include infection, papules, chronic inflammation, foreign body reactions, granulomas, pigmentation, nodules and scarring – as well as keloid and hypertrophic scars.

In addition, the New Mexico Department of Health has confirmed two cases of HIV infection after micro-needling with PRP. It is therefore vitally important to be able to recognise a good quality micro-needling pen, and to differentiate it from a fake imitation.

10 questions to ask about your micro-needling treatment

1. Is the health care professional qualified to perform the procedure? 

Is the doctor or therapist registered on the manufacturer’s website as a provider for that micro-needling device? Has the doctor or therapist been trained by the company supplying the device? A reputable micro-needling company will have international trainers, while offering comprehensive and ongoing training programs. A helpful tip is to check if your aesthetic doctor is registered with AAMSSA, and if your beauty therapist or somatologist is registered with SAAHSP (South African Association of Health and Skincare Professionals).

2. Does the device come from a reputable company or over the internet?

Does the device come from a registered company with a reputable international name, or is it a cheap copycat sold on-line? Images of the quality of needles from an authentic micro-needling pen compared to a counterfeit speak volumes. The cheap needles have different lengths and angles. Under an electron microscope, the needles are blunt and chipped, resulting in trauma, scarring and other side effects.

3. Do you know the depth of the micro-needling being performed on you? 

Doctors may adjust the needle depth right until the deepest setting of 3mm, which is a scar setting. SAAHSP regulates that therapists are allowed to work to a maximum depth of 1mm.  Any deeper reaches the deep dermis falling outside their scope of practice.

4. What product is being used with the micro-needling pen?

The products used during micro-needling needs to be specifically designed for infusion with micro-needling.  A reputable micro-needling company will supply the correct products to be used during – and immediately after – micro-needling. Moreover, the products used with micro-needling require a specific molecular weight, concentration, quality and pH in order to be to be safely infused into the skin. The low molecular weight enables free movement and safe dispersion of the product in the skin without clumping (which can lead to complications like granulomas).  The product purity, aseptic packaging and preservation system are important for stability and activity.

Meanwhile, the non-cross-linked hyaluronic acid, sterile mesotherapy solutions and PRP are safe for micro-needling if correct protocols are followed.  So, ask your doctor or therapist about the molecular weight (measured in Daltons) of the product being needled in. If they can’t answer you, it’s a red flag!

5. Does the device have a built-in anti-contamination system?

Check if the pen has a built-in anti-contamination system. A good quality pen will have a guard mechanism to prevent cross contamination of fluids from other patients.  The anti-contamination system will not allow back-flow of fluid, either internally and externally on the needle cartridge.

6. Was a disposable single-use needle cartridge used?

Did you observe the disposable needle cartridge being opened from its sterile packaging – and was it thrown away in the medical sharps bin immediately afterwards? If you are told that your needle cartridge can be ‘sterilized’ and re-used for future treatments, then loud alarm bells should go off in your head! This is unsafe and unacceptable practice.

7. Is there a feeling of dragging on the skin during treatment?

Some cheap pens will result in a drag on the skin, thus creating trauma, delayed healing or even scarring. A good quality pen should have drag-free needles, with the cartridge being able to glide effortlessly over the skin without catching ‘track marks’ or red stripes on the skin afterwards. A good quality pen should have a suction release mechanism that prevents dragging and trauma.

8. Is the pen digital or mechanical?

Although there are still good quality mechanical pens available, the latest are digital with blue-tooth technology. This means that only professionals who are registered with the company can activate their pens. It also allows for automated software updates so that the calibration tables on the pen can be continuously upgraded – thus guaranteeing the correct depth of penetration every time. The digital pens have greater accuracy of depth and speed, which ultimately makes them safer, more reliable, and more precise with better results.

9. How quickly do I heal afterwards?

Modern micro-needling pens result in minimal, if any, downtime. It is normal for the skin to feel a sunburnt sensation on the day of the treatment, but within 24-48 hours, your skin should be back to normal. There should also be no scabbing, crusting, red marks, track marks or bruising. If this happens, then it is likely that the pen has poor quality cheap needles that are tearing your skin.

This is in stark contrast to the modern technology pens, as these ensure correct speed, depth and safety. The faster and more precise the oscillations of the needle cartridge, the quicker the healing time.

10. What is the cost of the treatment?

If the price of the treatment seems too good to be true, you can be assured it’s a fake pen with unsafe topical products. If an authentic pen is used, you will be paying for the quality of needles, safety, precision and rapid healing, using only the correct micro-needling products.

Take home message

You only have one, very precious skin for life. Never buy micro-needling pens online or use them at home. Be very careful who you allow to micro-needle your skin, and ask about what is being infused during treatment. Remember that not all micro-needling devices are created equal.

To report any unsafe practice or if you have any queries please feel free to contact Karen Nel at AAMSSA info@aestheticdoctors.co.za

www.aestheticdoctors.co.za

 

Written by Dr Debbie Norval 

Dr Debbie Norval

MBBCh (Rand) Dip Pall, Med (UK) M Phil Pall Med, (UCT) Adv Dip Aesthetic Med (FPD)

After graduating as a medical doctor in 1991, Dr Debbie Norval obtained a Diploma in Palliative Medicine, followed by a Masters of Philosophy in Palliative Medicine. She then obtained an Advanced Diploma in Aesthetic Medicine through the Foundation for Professional Development in 2012, and holds a City and Guilds Diploma in Adult Teaching and Training. Notably, Dr Norval is the current President of AAMSSA, serving on the Ethics and Professionalism committee of SAAHSP.

A2 Disclaimer: This article is published for information purposes only, nor should it be regarded as a replacement for sound medical advice. 

Issue 31 – September 2019 (Spring)

This article was written by Dr Debbie Norval and edited by the A2 team EXCLUSIVELY for the A2 Aesthetic & Anti-Ageing Magazine Spring 2019 Edition (Issue 31). 

A2 Magazine prints only four magazines each year – reporting seasonally on everything you need and want to know about aesthetics, anti-ageing, integrative medicine, quality and medical skin care, cosmetic dentistry and cosmetic surgery in South Africa – where to go, who to see, what to expect, something new and so much more! Never miss an edition – click here for more info about where you can buy the print and/or digital copy of A2 Magazine (including back copies).

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