| MICRONEEDLING | PEER-REVIEW
purposes, for example to increase the contrast, is classified as cosmetic micropigmentation and is part of the treatment repertoire of a qualified beauty therapist. However, an areola pigmentation after a surgical breast reconstruction with post-surgical scar tissue needling is defined as medical micropigmentation. Delegated by a physician, a qualified beauty therapist often conducts medical indicated micropigmentation. A medical areola pigmentation after a plastic surgery reconstruction of the nipple completes the cosmetic reconstruction and contributes to the physical well-being of the patient. Health insurances in Germany, tend to cover these costs9
completely. When conducting invasive microneedling procedures,
the qualified beauty therapist pierces through the epidermis into the dermis with the automated needling device using needle configurations of up to 10 combined single needles with an average frequency of 100 hertz (this means up to 1000 needle punctures per second). In Europe, the safety of the permanent implanted color
is regulated through national tattoo regulations, such as German TätoV, as well as through the European tattoo resolution (resolution ResAP(2008)1). As common cosmetic micropigmentation treatments, such as PMU, apply tiny hair drawings on the eyebrows, implants of eyeliner, and full lip drawings or the improvement of the lip contours; the invasive microneedling treatment ‘micropigmentation’ illustrates that dermal (invasive) microneedling can be performed by a non-medical professional in compliance with European regulatory laws. Of course the substance, if used in combination with the needling treatment, has to be regulated in addition. Important for the distinction between cosmetic and medical micropigmentation is not the depth of the needle penetration but the intended use of the treatment. There is no reason to proceed differently with the
Comparison of microneedling and micropigmentation Micropigmentation of the skin is an invasive microneedling treatment, which penetrates the dermis and implants pigment colors there permanently. Facial tattoos have been practiced in human society for thousands of years. In the last 20 years, PMU has been very successfully established as the modern form of facial tattooing. PMU has been a part of the initial training7 of beauty therapists for several years in Germany. In the beauty therapist bachelor directive8 issued by the German ministry of economics (BMWi) in 2015, PMU is defined as part of the examination. The distinction between medical
and cosmetic microneedling is made exclusively through the intended use of the treatment. The pigmentation of the natural areola for cosmetic
treatment of smoothing wrinkles via invasive microneedling. The qualification of the user and the absolute adherence to hygienic safety requirements are the main criteria for the safe and satisfactory control of the invasive methods used for the penetration of substances into healthy skin. Other invasive cosmetic treatments that follow this principle are ear piercings.
The distinction
Definition for cosmetic invasive microneedling An invasive microneedling treatment, such as those performed to accelerate skin renewal or rather wrinkle smoothing through PCI, are considered to be a cosmetic treatment. Similarly to the cosmetic micropigmentation (PMU), an execution of such treatments, for example to improve the skin appearance, can be performed by a qualified beauty therapist. Cosmetic products according
between medical and
cosmetic microneedling is made exclusively through the intended use of the treatment.
to the cosmetic regulation 1223/2009/EG may not be combined with invasive microneedling treatments in line with their intended use because these products are only meant for the application onto the skin.
prime-journal.com | October 2015 Figure 4
Similarities between microneedling and micropigmentation
EPIDERMIS DERMIS
Micropigmentation is an example of invasive microneedling treatment and PMU is nothing more than dermal microneedling in combination with pigment colors
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