Traditionally injectable cosmetological procedures are divided into four main groups: Botulinum Toxin Therapy, Biorevitalization, Mesotherapy and injections of microimplants.

Botulinum Toxin Therapy is applied for the treatment of dynamic wrinkles caused by muscle contraction. Botulinum toxin exerts its effect by damaging the transmission of signal about contraction from the nerve termination to muscle fiber. As the result, muscles do not contract and wrinkles do not appear.

Mesotherapy employs multiple intradermic and hypodermic injections of pharmaceutical medications in a minimum effective dose. Among the most popular ingredients of injectable mesotherapeutic cocktails there can be marked: hyaluronic acid, vitamins A, E, K, C, B group, amino acids, organic acids, minerals, etc.

Injections of microimplants are used mostly to add extra volume to the places of its deficit. In other words, such kind of products can be called fillers.

Fillers can be divided into natural and synthetical.

-Natural fillers include gels based on bovine collagen or hyaluronic acid.

-Synthetic fillers are biopolymer gels based on the highly purified silicone or polyacrylamide.

Biorevitalization is a method of compensation of hyaluronic acid deficit in derma by means of intradermal injections of native hyaluronic acid.

It should be noted that hyaluronic acid can also be used in the composition of mesotherapeutic medications and fillers. So, why is biorevitalization a different procedure? First of all, it is connected with the characteristics of the hyaluronic acid:

1. Only native hyaluronic acid is used for this procedure (without any modifications)
2. Molecular mass of the hyaluronic acid is about 1 mln Da.
3. Concentration of hyaluronic acid is from 1 to 1,8%

Above mentioned parameters ensure the accomplishment of the objective: hyaluronic acid recreates optimal physiological environment for cells. At the same time fillers with hyaluronic acid have another objective – to fill the volume where it is needed.  That’s why the characteristics of hyaluronic acid in the composition of fillers are different. Hyaluronic acid should stay in the place of injection as long as possible and be biologically inert.  To provide hyaluronic acid with such parameters, it is combined with other materials

Medications for mesotherapy contain low-molecular hyaluronic acid (with molecular weigh less than 1 mln Da) and in less concentration. Mesotherapeutic “cocktail” can also contain vitamins and amino acids.

Russian medical device market includes only two groups of injectables – fillers and preparations for biorevitalization. It is connected with the fact that Botulinum Toxin Therapy and preparations for mesotherapy carry into effect by means of biologically active substances and are considered as pharmaceuticals in Russia.

According to the analytical organization Vademecum, currently 41 fillers and 50 preparations for biorevitalization are registered in Russian Federation. However, the proportion of  “gray market” of fillers and preparations for biorevitalization is 25,2% and 31,5% correspondingly.  And its growth is highly predictable due to the difficulties of registration of such products.

Details by link: https://beawire.com/2018/02/09/about-pharmaceutical-agents-in-the-composition-of-medical-devices-and-registration-difficulties/

It is obvious that registration difficulties and growth of “gray market” will lead to bad consequences for cosmetology and wellness industry.

References:

1. Марголина А.А., Эрнандес Е.И.. Новая косметология. Косметические средства: ингредиенты, рецептуры, применение. М.: Косметика и медицина, 2015. — 580 с.:
2. https://vademec.ru/article/golodnye_igly-_kuda_metil_i_popal_v_2017_godu_rynok_kosmetologicheskikh_inektsiy/