Hydrophilic Gel  AQUALIFTTM

Prospects for the hydrophilic gel  AQUALIFTTM

Hydrogel  AQUALIFT properties

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I. A. Zavgorodniy,

Vice-President of the International Academy
on Culture of Security, Ecology and Health,
Deputy Director of the "National Medical
Technologies Center", Ltd., Kiev, Ukraine.

 

Hydrophilic Gel "Aqualift" – Implant of a New Generation.

The article discloses problems of usage of contemporary injection implants as non-surgical alternative in the plastic surgery medicine.
Key words: injection implants, antigenic properties, biocompatibility.

Statement of problem.
Injection implants can be regarded as a self-sufficient non-surgical alternative for correction of age-specific aesthetic deficiencies. No doubt, materials of such kind must be safe and effective, and to respond to a number of requirements: biocompatibility, non-toxicity, long-term effect, absence of antigenic properties and pyrogenic reactions.
Nowadays at the market there are several hundreds of various materials for contour plastics, still not all of them respond to all the above requirements.
The preparations that are meant for injection plastic surgery can be ranked into the following three big groups:


Biological materials (Restylane, Perlane, Restylane Touch, Hylaform, Hyladerm, Juviderm, Isogel, etc.).

Combined materials (Dermalive, Dermadeep, Reviderm, etc.).

Non-biological chemical polymer materials (New-Feel, Bioplastique, Biopolymer, Bioformacryl, Argiform, Interfall, Amazing Gel, etc.).

Applying preparations of the first and second group, we can achieve apparent effect in delaying ageing process, which allows the patient to postpone in time the plastic surgeon intervention. However, the preparations of non-stabilized hyaluronic acid, though they can damp well enough the skin and increase its turgor, they appear not enough effective for correction of wrinkles. When using combined mezotherapeutic cocktails, the surgeon has to take into consideration biocompatibility of the injected preparations with the drugs the patient would take later on. Otherwise the result would not only be ineffective, but it will do a lot of harm to the patient. When applying botulinic toxin for corrections of wrinkles, very often the doctor achieves inverse effect.
Excessive augmentation of the lips can bring disharmony into the patient's general appearance and would be seen grotesque. Or, for instance, a face with deep superciliary arches will be seen even less attractive due to relaxation of its frontal muscle after injection of botulinic toxin into the forehead [1].


Chemical polymer materials, which appeared in early 90th of the last century, have become extensively used in plastic and reconstructive surgery in Ukraine, Russia and other countries [2]. Unfortunately, many of such preparations (Amazing Gel, Formacryl) did not agree with the requirements of their biocompatibility with the human organism, which brought to multiple complications in the patients and to acute polemics amidst the plastic surgeons [3].


The first generation of injectable hydrophilic implants used to suffer from their common imperfection - the physical-chemical composition: the filler in those compositions was bidistilled water, their Ph was 7 – 8,5. Some of the hydrogel producers (China, Russia) did not observe, or had no proper technology of production of such a preparation. Another drawback of that period was absence of distinctly chosen injection techniques for the doctors who applied the hydrogels. As a result, by the beginning of the year 2000 the chemical polymer preparations were almost practically excluded from the market and replaced with biological and combined preparations.
Beginning from the year 2004, an implant of a new generation was put onto the market – the chemical polymer material hydrophilic gel "Aqualift". The aim of this article is to show advantages of this hydrophilic gel "Aqualift" as compared to the other similar implants, and also to show prospects of its application in plastic, aesthetic, reconstructive surgery.
Safety of the hydrophilic gel "Aqualift" has been repeatedly confirmed by its pre-clinical tests on animals, also by its experimental clinical application within the period of 2004 – 2007, as well as by control of the European Commission through their annual inspections that regularly confirm validity of the "Aqualift" gel CE Mark Certificate.
Unlike the previous synthetic materials, the new implant – hydrophilic gel "Aqualift" – is distinct with its method of production, with the condition and technique of its polymerization, with the new technology of its washing out and refinement. Its base is 97% of physiological solution (sodium chloride 0.9%) enclosed within a 3-dimentional polymer matrix. Prepacked and tested for microbiological cleanness, as well as undergone other interim tests, the gel "Aqualift' is then sterilized in an autoclave chamber and tested for sterility.
The hydrophilic gel "Aqualift" is the most physiological and the safest implant out of the rest existing implants. Its structure and properties respond in the best way to the inner medium of the human body. Below are defined the gel "Aqualift" most important properties which distinguish it from the other polymer materials:


-it has weak-acid properties, which creates unfavorable medium against invasion and development of pathogenic microbiological flora;


-it is inert, does not react to the previously injected fillers, admits possibility of its multiple injection into the same anatomical region in the case it has been not enough injected or applied in stage-by-stage corrections;


- highly elastic, it can be injected through thin needles, hence it causes minimal traumas;


- it does not cause any irritation, nor any allergy or non-compatibility with the tissues thanks to absence in it of initiators of immune reactions;
during long-term localization within the injection zone, it does not exert any inflammatory reactions. When injected correctly, it does not migrate from the injection zone;


- when injected in big volumes (150 – 200 ml) into one anatomical zone, it does not fragment nor develop rough fibrous capsule.

Pre-clinical experiments performed on animals (white rats), to whom the gel "Aqualift" was implanted, have shown the following:


1. In microscopic research 1 month after the operation, the implanted material remained located in the subcutaneous cellular tissue in the form of grid structures of fibrous character. There was observed a round cell reaction with excess of macrophage elements.


2. Three months after the implantation, the histopathologic feature got changed. In all directions from the main conglomerate of the implanted material there had developed thin polymer taenias penetrating into the tissue. That phenomenon was explained by the fact that a conjunctive capsule began its formation. Within the connective tissue, not far from the implanted material, there were seen enlarged plethoric blood vessels.

3. After six months, around the implanted material there was revealed a connective tissue infiltrated with macrophages and other round cell elements. In some areas around the implanted material there was observed a mature connective capsule isolating the polymer from the surrounding tissues. The main components of that capsule were collagen fibers and mature fusiform fibroblasts between them. Reaction of the blood system remained expressive, some vessels were enlarged and plethoric.

 


Hence, the expounded above histological analysis testifies to the fact that around the tested samples during various periods there is observed a certain productive process. There is no forming of an alien body around the implanted material. During all this process, there is not observed any acute or pronounced cellular reaction around the material under research, and the connective tissue itself is characterized with rather insignificant macrophage infiltration. All this is indicative of non-toxicity of the material for the cells of the body.


Conclusive opinions expressed by the surgeons, who performed clinical tests of the gel "Aqualift", confirm the fact of absence of any data showing some cause-and-effect dependence between the gel injected into various parts of the human body and development of disorders within the connective tissues [5, 6].


In the scientific publications of the years 2002 – 2006, wherein various injection techniques were describes, the following side effects were considered: pain, erythema, haematomas, itching, skin infiltration, allergic reactions of slow and immediate type, necroses, granulomas, adenopathies and vessel traumas. Unfortunately, that information was rather scattered, injection material was not indicated, nor the company-producer, only slight attempts were made to classify the possible complications [8]. Side effects and complications are the subject of a special discussion. And the doctor should have complete, exhausting medical information about them.
To our view, classification of complications should schematically look like this:


1. Complications due to incomplete preoperative diagnostics, wrongly chosen medical tactics.


2. Complications due to wrong technique of corrections.


3. Complications due to wrong tactics of the patient's behavior in early period after the performed correction.


4. Complications occurred during the rehabilitation period.


5. Complications due to wrong method of anesthesia.


Unfortunately, until now there is no unified international classification of these complications, which causes ambiguity in calculations of these complications, and which does not give us objective estimation of the applied injection material.
Judging from the reports of our distributors, who distribute the gel "Aqualift" in 22 countries of the world, during the last 5 year period about 15 000 maxillofacial operations and about 2 500 operation in contour plastics of the soft tissues on the shins, thighs, buttocks, shoulders, mammary glands, serious and multiple complications were not indicated in those reports.


In the year of 2008, the staff scientists of the NMTC company, together with the leading Ukrainian specialists in the realm of plastic surgery, elaborated methodic recommendations for the doctors who are using the gel "Aqualift" in their practice. Their recommendations are based on extensive practical experience in injection techniques of applying hydrophilic gels taking into account the properties, peculiarities and characteristics of the gel "Aqualift".


Thanks to its physical-chemical properties, the gel "Aqualift" can be widely applied not only in surgery. We recommend using it as a depot of medicinal preparations for their prolonged effect, for culturing of cellular lines, also as an immune isolator in combined treatment of the patients.
There has been started testing of the gel "Aqualift" in urology, neurosurgery, oncology, which allows us to hope that it will find its wide application in these fields of medicine as well.

Literature:
1. "Aesthetic Medicine", No.1, 2008, p. 112-119.
2. "Ten-year experience in wide application of the gel "Interfall" in plastic, aesthetic and reconstructive-restoration surgery": Materials of scientific-practical conference, Kiev, 2001.
3. "Annals of Plastic, Reconstructive and Aesthetic Surgery", No. 4, p. 30-32.
4. Protocol of Testing No. 407, Kiev, Institute of Chemistry of High-Molecular Compounds, National Academy of Sciences of Ukraine.
5. S.G. Bezrukov, "Report on the results of the hydrophilic gel "Aqualift" application for elimination of deformities and defects of the facial soft tissues, during the period from 2007 to 2008".
6. "Modern Dentistry", No. 2 (42), 2008, p. 131-134.
7."Annals of Plastic, Reconstructive and Aesthetic Surgery", 2000-2003.
8. Cosmetic International Journal, No.3, 2008, p. 34-38.

The above article is published in the Scientific-Practical Almanac "Culture of Security and Health", Kiev – 20011, issued by the National Academy of Pedagogical Sciences, University of Education Management, International Academy on Culture of Security, Ecology and Health.

Chronicle of International Events:

From March 31 to April 02, there was held in Brazil the 8th Congress on Aesthetic Medicine. More than two thousand participants were taking part in it. They were doctors-cosmetologists, plastic surgeons, dermatologists of Latin and Central America, Europe and Asia. The Congress presented wide range of new medical technology, equipment, materials used in modern aesthetic medicine.
Delegation from Ukraine was headed by Mr. Ivan Zavgorodniy, Vice-President of the International Academy on Culture of Security, Ecology and Health. At the plenary session of the Congress, Doctor S.G. Bezrukov, Professor of the Crimean Medical University, was reading his report presenting to the audience a new injection technique for application of hydrophilic gel Aqualift in maxillofacial surgery.
Representatives from a number of foreign clinics, universities, laboratories were acquainted with the activity of our Academy and expressed their readiness for cooperation.