The Unregulated Permanent Cosmetics Industry

Permanent Makeup Regulation

                  Permanent cosmetics, or micro cosmetics, is a group of procedures that focus on providing semi- permanent ‘makeup’ enhancements on areas such as the areas, lips, and eyes. Micro cosmetics can include eyebrow micro shading and microblading, permanent eye makeup such as eyeliner and lip blushing. The benefits of these procedures includes enhancing one’s features or covering any imperfections. Individuals may also choose to receive a micro cosmetic procedure because it reduces the amount of time it may take them to get ready in the mornings.

                  Microblading is a procedure that uses pigment to create hair- like strokes using stacked needles in a manner like tattooing. The needles deposit ink into the epidermis to create small incisions to create the illusion of hair. The needle used penetrates the epidermis up to 0.15 millimeters (mm), which is considerably more superficial than a tattoo needle, which can penetrate the epidermis at 1mm to 2mm (NiceBrows). This procedure relies on shaping the eyebrows and creating a fuller appearance, thus framing the face in a more flattering manner. Side effects include itching and scabbing as the skin heals after the procedure. Rarely, scarring can occur as well. Appropriate aftercare includes allowing the area to heal properly, applying A&D ointment as an occlusive, keeping the area clean and dry, and avoiding harsh products or makeup during the healing process, as well as avoiding sun exposure for up to 1 month.

Micro shading is similar to microblading; however, this technique creates a more defined brow shape by shading the full eyebrow without going as deeply into the epidermis. This technique is also known as ‘powder brows’ because it looks as though the eyebrow has been filled in with a powder product. Like microblading, a needle deposits pigment into the epidermis to create this effect. The same aftercare steps are followed as with microblading.

Tattooed eyeliner uses pigment to create a line on the superior or inferior lash line of the eyelid. This allows the lashes to have a fuller appearance. Side effects include local irritation, itching and swelling. More severe reactions include necrosis of the area, loss of eyelashes and

Lip blushing relies on depositing pigment using quick hand motions using a needle. This defines a patient’s lip shape and can make the lips appear fuller and more tinted. Individuals may prefer this procedure as an alternative to adjunct to lip fillers, with the addition of enhancing the natural color of their lips if they face discoloration in that area as well.

Side effects of these procedures are usually local and self- resolving. One can most commonly experience itching, scabbing and mild swelling of the area on which the procedure was completed. More severe side effects include allergic reactions and infections. This may be due to the equipment, or pigments used, which are unregulated by the Food and Drug Administration (FDA) (Center for Food Safety and Applied Nutrition). There are clinical reports of patients having granulomatous chronic allergic reactions for up to 3 years after receiving permanent makeup procedures with a line of ink that was recalled in September 2004. The FDA does not have the regulatory authority regarding the pigments in tattoo and permanent makeup ink due to lack of safety concerns, however, there are multiple documented hypersensitivities to pink and black pigments causing chronic dermatological allergies in patients that have received permanent makeup (Straetemans M).

Additionally, permanent makeup tools can be improperly sterilized and cause infections, such as mycobacterium. This may be a concern when individuals providing the procedure may not properly clean or replace their tools, whether in a private or business setting. It is important to consider and inquire about sterility before possibly receiving a procedure from an esthetician.

Ultimately, the lack of regulation regarding the use of the tools, pigments, and color additivies is what can make permanent cosmetic procedures more harmful than beneficial for patients. There is no overseeing entity to inspect these procedures and products. Only in retrospect after side effects are reported to the FDA, does the FDA investigate and potebntiually intervene with recalls or other measures. It is important to emphasize to patients the potential dangers of these procedures, their increased risk if they have food or contact dermatitis allergies to any dyes or color additives. Additionally, doing thorough research on the types of products, techniques, and equipment that an esthetician uses may help the patinet avoid any unwante dor unneeded side effects.

As pharmacists, we can explain to patients the dangers of unregulated products and procedures and the negative consequences. Additionally, we can provide education on preventive measures and aftercare if patienst do choose to receive permanent makeup. Lastly, as pharmacists we have the ability to lobby and advocate for increased regulation in an area of growing popularity.

Citations:

Center for Food Safety and Applied Nutrition. “Tattoos & Permanent Makeup: Fact Sheet.” U.S. Food and Drug Administration, FDA, June 2015, www.fda.gov/cosmetics/cosmetic-products/tattoos-permanent-makeup-fact-sheet#:~:text=However%2C%20because%20of%20other%20competing,pigments%20used%20in%20tattoo%20inks. 

NiceBrow. “Frequently Asked Questions (FAQ).” NiceBrow Microblading, 26 Feb. 2023, nicebrow.com/faq/#:~:text=Microblading%20penetrates%20the%20skin%20to,of%20the%20skin%20%2D%20the%20dermis. 

Straetemans M, Katz LM, Belson M. Adverse reactions after permanent-makeup procedures. N Engl J Med. 2007;356(26):2753. doi:10.1056/NEJMc063122

Permanent cosmetic makeup, also known as cosmetic tattooing or micropigmentation. This is a cosmetic technique that involves depositing pigment into the skin’s dermal layer to enhance features. It is often used to create the appearance of makeup such as eyebrows, eyeliner, lipstick, blush, and other enhancing colors to the face. Although many similarities it is not the same as a traditional design tattoo. The main difference being that traditional tattoos are made and place on the skin with permanent ink, while the cosmetic makeup is semi-permanent and will need touch ups every few years. Both procedures are puncturing of the skin that although are done for beauty purposes, they may have adverse effects that can be dangerous to people.

Permanent cosmetic makeup has become extremely popular over the years. With popular social media trends, such as “the no makeup, make up look”, people want less effort to get ready, but still look as sharp. Permanent makeup easily assists in this desire. In addition, permanent cosmetic makeup is very beneficial to people with certain skin conditions or unstable hands or vision. For instance, it can be used to cover scars, vitiligo patches, and assist people with hand dexterity. With many different permanent cosmetic procedures done, the most popular permanent makeup procedure is called microblading. Pigment is deposited to the papillary dermis, with the help of a manual device and a blade consisting of stacked needles. The result is discrete hair like incisions simulate the eyebrow hair to give a natural look of real eyebrow hair. As mentioned, the result of this procedure is semi-permanent with reapplication needed every 1-3 years. With the advancements of microblading it has seen in increase in its purpose all the way to medical assistance. Derma logically, it is helping to treat unwanted side effects of conditions like alopecia, hypothyroidism and chemotherapy induced madarosis. Understanding the side effects is important for people who are considering this cosmetic treatment.

Microblading is puncturing of the dermis which can lead to a slue of problems if not properly done. This includes the possibility of infection, allergic reactions, granulomas, sarcoidosis, and keloids. Infection can easily occur if there is malpractice. Use of dirty water or equipment can cause the spread of bacteria or even viruses like HIV or herpes. An allergic reaction is always a possibility when applying something to the skin. This can be as mild as a rash that last one or two day all the way to an anaphylactic reaction. The possibilities of granulomas may occur, this is because microblading injects a foreign substance into the skin. The skin maybe try to protect the individual by making inflammatory knots around the area. It doesn’t always happen right after the procedure but can occur months later.

The FDA does not regulate tattoo shops or cosmetic salons. They only will watch for problems once it has been reported to them. For this reason, it is essential to do research when choosing a place to get treatment done. This includes valid licenses from the artist’s performing the procedure. At home microblading is never recommended as it can damage the skin and give extremely undesirable results.

References:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7982014/

https://www.webmd.com/beauty/microblading-health-risks

https://www-ncbi-nlm-nih-gov.jerome.stjohns.edu/pmc/articles/PMC7982014/

Permanent makeup, which is also known as micro-pigmentation or cosmetic tattooing has become a growing trend over the past few decades. It is a semi-permanent cosmetic technique that enhances facial features naturally, mimicking traditional makeup. This involves the application of topical pigment beneath the skin's surface using a small needle. The pigments are formulated to harmonize with your skin, resulting in a makeup look that appears effortlessly natural. Several factors may drive individuals to explore this non-traditional form of makeup application. For example, it reduces the time required for preparation, and it proves advantageous for individuals with impairments such as vision loss or limited hand dexterity. Additionally, it can effectively conceal scars, vitiligo patches, or be utilized in nipple-areola complex reconstruction following procedures like breast reduction or breast cancer surgery.

Some examples of permanent makeup includes microblading, tattooed eyeliner, and lip blushing. Microblading falls under the umbrella of tattooing and the surgical enhancement of eyebrows. In this technique, pigment is implanted into the dermis to simulate hair-like strokes, employing a blade with stacked needles. The blade, coated with ink, makes small incisions to create the illusion of natural hair.

Following the procedure, some scabbing and itching are anticipated for the next week so it is crucial to treat the skin delicately during this period and steer clear of harsh products or makeup. Tattooing eyeliner entails the establishment of a lasting line along the upper or lower margin of the eyelid to enhance the natural lash line. Lip blushing elevates the natural lip color and outlines the shape by applying ink with a single needle and swift hand movements, resulting in a subtle enhancement.

Permanent makeup comes with adverse effects. The use of needles carries the potential for infection, particularly if the needles being used have not undergone proper sterilization. Unhygienic tools and practices can lead to Mycobacterium infections, or the reactivation of herpes simplex infection or blood-borne infections disorders. The occurrence of allergic symptoms is correlated to the use of red inks in procedures. They can present as eczematous, lymphomatoid and granulomatous reactions. Additional risks encompass bleeding, crusting, swelling, loss of eyelashes, significant eyelid injury, and ectropion, characterized by the eyelid turning away from the eyeball. The U.S. Food and Drug Administration notes that pigments may disrupt the quality of cranial MRI scans. In rare instances, MRI scans can induce swelling or a burning sensation in tattooed areas.

The FDA classifies the inks employed in intradermal tattoos, encompassing permanent makeup, as cosmetic products. Color additives present in tattoo inks are required to undergo premarket approval according to the Federal Food, Drug, and Cosmetic Act. Nevertheless, the FDA refrains from actively regulating this area, citing competing public health priorities. Instead, it investigates incidents and adverse reactions post-market release. This poses a significant health risk to consumers, and the FDA's persistence in maintaining this approach despite numerous reported cases of injuries may be deemed as irresponsible. Ensuring patient safety and satisfaction requires thorough training and strict adherence to hygiene protocols. It is also essential for individuals contemplating micropigmentation to be well-educated about potential risks, empowering them to make informed decisions regarding their beauty enhancement journey.

References:

https://www-karger-com.jerome.stjohns.edu/Article/FullText/369188

https://www.fda.gov/cosmetics/cosmetic-products/tattoos-permanent-makeup-fact-sheet

https://jameschristiancosmetics.com/permanent-makeup-is-a-growing-trend-but-is-it-worth-it/

https://health.clevelandclinic.org/want-perfect-eyeliner-every-day-permanent-makeup-pros-cons

            Tattoos are a popular form of body art, with approximately 30% of the United States population reporting at least one tattoo. Permanent cosmetics, also known as micropigmentation, refers to the aesthetic use of tattooing in dermatology. Micropigmentation has witnessed a surge in popularity, driven by a growing desire for long-lasting solutions to enhance physical features. Micropigmentation involves the deposition of pigments into the dermis using electrically driven needles. The pigments are permanently fixed within dermal cells, among collagen fibers, blood vessels, and hair follicles. The most common types of permanent cosmetics include microblading, eyeliner tattooing, and lip pigmentation. Other noteworthy applications include nipple-areola tattooing for patients undergoing breast reconstruction following mastectomy; and camouflage for patients with stable vitiligo or burns/surgical defects.

            Microblading is a form of superficial micropigmentation for eyebrow restoration. Microblading is a helpful procedure for patients seeking cosmetic enhancement, especially patients with complete alopecia, trichotillomania, and madarosis (in thyroid disorders). The technique utilizes “microblades” to form strokes resembling hair follicles, creating a defined eyebrow, or enhancing the fullness of existing brows. Eyeliner tattooing is popular among patients who want a defined eyeliner (to enhance the shape of the eyes) without daily application of makeup. Eyeliner tattooing uses a digital pen to fill gaps in the eyelash line or create a uniform line above/below the eyes. Finally, lip pigmentation is used to enhance the color and shape of the lips. Lip pigmentation is primarily used by patients with pale/uneven lip tones, and those seeking a more defined appearance. A digital pen, similar to eyeliner tattooing, is utilized to deposit the desired shade/color and, in some cases, make the lips appear fuller (extending beyond the existing margin and shape of the lips). The pigments typically last for 2 years (except microblading which requires yearly touch-ups), allowing patients freedom to change with the latest trends, etc.

            Tattooing and micropigmentation are considered safe when performed by professionals in a sterile environment, but complications can still occur. The eyebrows and lips require meticulous measurements in order to avoid an unnatural, asymmetrical appearance, while the proximity of the eyes to the site of eyeliner tattooing increases the risk of injury and infection. Permanent cosmetic removal is common and uses laser treatment, requiring expertise to avoid scarring and post-inflammatory hypo/hyperpigmentation. In the case of microblading removal, it is important to note natural hair follicles present may become depigmented or permanently damaged by the lasers used. As with any tattoo, infections are common, as punctured skin may provide a pathway for bacteria. Bacterial infections may be transmitted via contaminated tattoo needles, ink, gloves, or improper aftercare; most infections are superficial but can lead to cellulitis, bacterial endocarditis, or necrotizing fasciitis. Allergic reactions are also possible, especially in patients with a history of allergies. Tattoo reactions are considered delayed type IV hypersensitivities causing chronic itch and pain with urticaria or ulcerations. The exact cause is unknown; however, red tattoo pigments are suspected to affect a majority of allergic patients, with blue, green, and yellow to a lesser extent. Proper training and adherence to hygiene protocols are crucial to ensure patient safety and satisfaction. Additionally, patients considering micropigmentation should be well-informed about potential risks, allowing them to make informed decisions about their beauty enhancement journey.

References

Kerure AS, Marwah M, Wagh ND, Udare S. Micropigmentation. Indian Dermatol Online J. 2023 Oct;14(5):605-10. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10506827/ 

Marwah MK, Kerure AS, Marwah GS. Microblading and the science behind it. Indian Dermatol Online J. 2021 Feb;12(1):6-11. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7982014/ 

van der Bent SAS, Rauwerdink D, Oyen EMM, et al. Complications of tattoos and permanent makeup: overview and analysis of 308 cases. J Cosmet Dermatol. 2021 Nov;20(11):3630-41. https://onlinelibrary.wiley.com/doi/10.1111/jocd.14498