National Medical Technologies Center Ltd. Company

1

"National Medical Technologies Center" Ltd. Company

Scientific-Methodical Elaborations

recommended for doctors

applying hydrophilic gel "AQUALIFT"

in plastic, aesthetic, reconstruction

surgery and cosmetology

"National Medical Technologies Center" Ltd. Company expresses gratitude to the following doctors of medical sciences, professorswho have prepared these recommendations:

S.G. Bezrukov, V.A. Vissarionov, V.A. Galatenko, M.P. Komsky, A.L. Makarchuk, O.Ye. Malevich, N.V. Mitrofanov, D.V. Myasoyedov, A.V. Plekhanov, Yu.P. Rubizov, I.G. Terentyev, A.V. Ternov, L.V. Kharkov

President of the NMTC Co. : Ivan Zavgorodniy

Kiev 2008

During recent years, safety requirements for the injection implants and their biocompatibility have become more exacting.

Scientists of our company “National Medical Technologies Center” have accumulated fifteen-year experience while dealing with hydrophilic implants. During these years, large-scale experiments have been carried out to study and develop physical and chemical properties of the hydrophilic gels.

Now we have developed and are already producing an implant of a new generation – hydrophilic gel under the trademark "Aqualift”.

The “Aqualift” gel is authorized for application in medical practice.

Patent of Ukraine:№ 250060.

Registration Certificate of the Ukrainian Health Ministry:№ 5869/2006.

Certificate of the CE Mark:№43102/101/1/2009/CE.

ISO 13485:2003

Sphere of application: plastic and reconstructive surgery, cosmetology.

Hydrophilic Gel AQUALIFTTM – implant of a new generation.

The hydrophilic gel AqualiftTM , implant of a new generation, has now been used by a lot of plastic surgeons and cosmetologists, which has become a new stage in development of contour plastic surgery. Unique properties of the hydrophilic gel AqualiftTM allow us to attribute it to the rank of universal gels. Moreover, the implant positive charge serves to block oxidation stress, which results in favorable course of post-operative period and absence of inflammatory manifestations. Compared to the rest of analogues, the hydrogel AqualiftTM has acquired enhanced safety and efficiency in its application, greatly reduces post-operative complications.

AqualiftTM is produced out of synthetic materials of high grade purity, having no components of animal origin nor any substances of genetically modified organisms. To secure complete sterility, the AqualiftTM production process is maintained in aseptic conditions and at its final production stage it undergoes sterilization by autoclaving.

Hydrogel AQUALIFTTM properties.

• AQUALIFTTM is a highly elastic and biocompatible hydrogel, its properties and chemical structure optimally agree with the human body inner medium and with the intercellular substance of the skin dermal layer, which noticeably minimizes post operation complications and other aftereffects.
• AQUALIFTTM is most physiological and the safest implant out of those available at the market at present, because up to 98 % of its formula is physiological solution of sodium chloride (for intravenous injections) and has got the properties of universal hydrophilic filler.
• AQUALIFTTM is a soft tissues filler acting by way of creating a depot of physiological

0.9 % solution of sodium chloride put into a matrix of three-dimensional grid of a complex synthetic polymer. Long chains of the high molecular polymer are sewed together to create a stable three-dimensional grid.

• AQUALIFTTM , is a positively charged electrolyte that does not affect electric conductivity within the tissues while blocking negatively charged free radicals of the oxygen active components, which enhances the body tissues resistance to ageing processes.
• AQUALIFTTM increases electric potential of the surrounding tissues, normalizes microcirculation within the zone of its introduction, thanks to its positive charge it attracts the dissolved negatively charged molecules of the extracellular matrix – collagen, elastin, fibroectin, glucozaminglicanes.
• AQUALIFTTM is a highly elastic hydrogel, it can be injected using thin needles. When introduced in small volumes it does not require preliminary anesthetization of the injection zone. Minimum traumatic impact upon the tissues and absence of infiltration with anesthetics makes it possible to optimally estimate the gel necessary volume for injection.
• AQUALIFTTM is inert material that does not react with the previously injected fillers, which allows its multiple introduction into the same anatomic zone in cases the correction is not enough or it is to be performed by stages.
• AQUALIFTTM displays subacid properties, which creates adverse medium for entering and development of harmful microbiological flora.
• AQUALIFTTM does not cause any inflammations of the tissues, and it does not migrate from the zone of its injection.
• AQUALIFTTM does not exert any irritating impact, or any allergic reaction, or any incompatibility, since it does not contain initiators of immune reactions.
• AQUALIFTTM , when injected in big volumes up to 150-200 ml into one anatomic zone, it does not fragment and doesn’t create any rough fibrous capsules.

Composition:

• Physiological 0.9 % solution of sodium chloride - 95-98 % ;
• Synthetic polymer - 2 – 4 %.

Sphere of application:

Intertissue contour plasty of the face

During the course of its clinical approbation the biogel proved to be effective in elimination of congenital and acquired defects and deformities localized in various anatomical areas of the face and neck. Results of the patients’ observation showed that the procedure can be performed on an outpatient basis under local infiltration anesthesia.

When a standard intramuscular needle was used for the gel injection, the puncture traces on the skin were practically not left.Positive cosmetic effect of the implanted gel can be estimated both by the doctor and patient right after the manipulation is over and at request of the patient additional correction can be performed without delay.Inflammatory reaction of the tissues is rather slight and it is developed as a temporary insignificant or moderate edema, slight painful component. Borders of the hydrophilic gel implant within the cellular tissue cease to be clearly determined visually and by palpation after 1.5-3 months already, the tissues acquire their usual consistency and restore their shape, while the patient is being relieved of discomfort due to presence of a foreign body in the organism.There were not revealed any cases of the gel movement within the cellular tissue to change its location.All patients had fixation of the material in the tissues rather satisfactory.The gel Aqualift did not exert any reaction of rejection type, neither was noted any formation of fistulas or disruption of functions of the facial tissues and organs.

The last two years of wide application of the gel Aqualift in cosmetology, plastic, aesthetic and reconstruction surgery allow us to draw the following conclusions:

Relatively simple procedure of its clinical application, mostly on an outpatient basis requiring minimal number of special equipment, stable cosmetic results along with absence of functional disruptions, low percentage of early and late complications - all this stipulates for the gel Aqualift application in various regions of the human body.

Variety of the soft tissues defects and deformities appearing in maxillofacialregion,complexity of anatomicstructure, diversity of functions of the organs of this region, and also high cosmetic demands for themaximum elimination of trauma-related consequences– this list of arguments for plastic surgeons to use existing effective methods for elimination of the above conditions, and search for new applicable methods, is not complete.

Contour plasty, designed to eliminate defects and deformities,is one of the most complex trends of maxillofacial and plastic surgery. It is boundwith the necessity to involve additional plastic material within the area under reconstruction,using plastic techniques of the local tissues, auto- and allotransplant, implants and others. In the recent years, contour plasty remains the subject to constant study and keeps on being one of the most topical problems in medicine.

The hydrogel injections may remove asymmetry and change facial shape in cases of congenial and acquired deformities, and defects.

The hydrogel may correct exterior contour of the tissue in temporal, molar, cheekbone, chinregions andthe region above the relative segment of the lower jaw.

Successful contour plastywith hydrogel is possible when applied in cases of posttraumatic and postoperative facial deformities and defects.

It should be emphasized that the hydrogel Aqualift, with its property to be well-fixed in the tissueswhile preserving its volume, shape and consistency, can be well qualified for facial deformity correction in children.The formation of gel depot does not hamper growth of the organs and bones of the facial skeleton, and the opportunity to make further injections while thechild is growing enables to start correction of deformities in childhood when a child is not aware of his/her inferiority related to facial deformity.

In cosmetic facial surgery, the hydrogel Aqualift enables to eliminate glabellar wrinkles, deep nasolabial folds, age-related wrinkles on the upper and lower lips, to fill in and correct the shape of the lips, as well as to correct the nasal arch or tip.

Selection of the patients, preoperative examination and preparation

When being consulted, the patients are informed on the hydrogel properties, its harmfulness for the organism, and about the plastic surgery techniques.

When collecting the anamnesis, it is required to determine the patient’s reactions to local anesthetics and antibiotics.

The zone of hydrogel injection is examined by palpation of the soft issues and facial bones. In cases of any bone traumas or congenital deformities it is required to radiograph the patient’s skull with his/her lower jaw and closed teeth in profile and full-face.

Apparently healthy people have no contraindications for biogel prosthetics.

As relative contraindications for the surgical procedure should be considered severe general somatic diseases of thevascular and respiratory systems, blood diseases, allergic states, and endocrine’s disorders.

Preoperative examination includes:

•clinical blood analysis

•blood glucose analysis

•clinical urine analysis

•AIDs examination

•ECG

In the cases of any general diseases in the anamnesis, the patient’s examination,jointly with the therapeutist,is recommended.

Preparation for the surgery

Prior to surgical intervention, it is required to remove dental deposits and to perform complete dental sanitation of the upper and lower jaws, including removal of teeth roots and the teeth with signs of periodontitis.

Should any long lasting infections ofthe teeth roots remain, it may cause suppuration after gel injection.

Before surgical procedure the patients are required to remove all traces of make up, to shampoo and to shower.

If gel is supposed to be injected to the scalp, it is required to cuthair short and thoroughly disinfect the zone of the needle injection.Before and after surgical procedure, faces of all patients should be photographed under standard lighting conditions at the fixed shooting point by one and the same camera with focal length 50-60 mm as stipulated by the recommendations of the International Society of Plastic Surgeons. In addition, the following projections should be observed:

FACE – front (full), profile (full) from the left, right, profile (3/4) from the left and right.

Instruments to work with the gel

For hydrogel injection, the sterilized table of the instrument nurse should contain:

Reniform tray – 2,

Farabef’s hooks - 2

Tweezers - 2

Surgical spoon – 1,

Scissors – 1.

Injection needles of various size and diameter, gauze wads, solutions and anesthetics.

Hydrogel for facial corrections is preferred to be injected with 1-5 ml plastic syringes.

The ordinary needles for injections and special purpose needles of 1.2 mm diameter are required; the length of special purpose needles is 50 mm. They are chosen depending on the zone of gel injection. Large diameter needles facilitate injection, and the soft tissues increase their volume quicker, but it raises the risk of vessels and nerves damage, and the high cosmetic result is more difficult to achieve.

Dosed gel injection and accuracy of its administration into the specified zone can be facilitated by using special purpose devices, which can help move smoothly the syringe plunger. It is especially important when the gel is injected into the zones where soft tissues are in close union with bones or cartilages, for example, zygomatic, otic and nasal regions, and also when scar stretching is required. Such devices are also helpful wheninjecting the gel of average density.

For performing nerve block anesthesia, it is more preferable to use syringes with corpusculated anesthetic agents having strong analgesic action.

Gel injection techniques

Despite of apparent simplicity of contour plastyby means of gel injection without necessity ofhospitalization, this procedure should be performed under strict aseptic and antiseptic conditions same as in the operating room. The surgeon and surgical nurse should work in sterile clothes, a mask and gloves. The surgical site should be widely and thoroughly antiseptized and draped.

Most commonly, hydrogel is injected under local block anesthesia, however it should be remembered that intravascular anesthesia makes the work of a surgeon easier and facilitates accuracy of his/her actions.

For facial block anesthesia,2-4% strength anesthetics are best of all to be used, which enables achieving reliable and durable anesthetic effect in the required facial region.

Methods of block and infiltration anesthesia are well described in monograph of S.N. Voisblat “Local anesthetization in face, jaw and teeth surgery” Kiev 1962 – 265.

For infiltration anesthesia, 0.5-1% strength anesthetic of50-20 ml volume is used.

Hydrogel contour plasty of facial deformities positively differs from usage of gel in other regions.

After shaping the borders of the injection zone and defining the soft tissuesthickness, the doctor selects the needle of necessary diameter, the syringe of the required volume, and the hydrogel density needed for the purpose.

The direction of gel injection should conformtothe anatomic and topographic peculiarities of the vessels and nerves passage through the region, as well as to the state of the bone matrix at this site.

The needle puncture is preferred to be performed in the upper lateral parts,backing 0.5-1 cm from the border of the injection zone. The needle should be directed with its bevel to the bone basis and moved to the opposite border of the area.

The gel injectionshould be performed together with gradualremovalof the needle from the soft tissues. Fingers of the left hand should palpatethe tissues to feel the process of the gel being filled. As a rule, at the beginning the gel is being fed by smaller portions, then its feeding increases and then decreases again to be stopped 2 cm prior to the needle withdrawal from the soft tissues.

The needle is moved fanlike within the tissues without being withdrawn from the first puncture site, gradually filling in the marked area with the gel.

To prevent the gel escaping outside by force of moving along the surface of the needle through the skin puncture, the soft tissues over the needle should be pressed with a finger or a special hold down toolwithin the gap from the injection site to the border of the injection zone.

The skin should be punctured as little as possible. It is also strictly prohibited to make punctures through the mucous membranes of the mouth.

The higher density hydrogel is used to contour the lower border of the chin and the lateral lower jaw, the nasal arch, lower edge of the orbital cavity.

In cases of bone deformities, fractures of the edge of the orbital cavity, improperly conjoined fragments of other facial bones, irregularities of the bone surface are filled in with gel of average density, and then another layer of soft gel is applied beyond the bone deformity.

After injection of the gel second layer, it is accurately massaged with pressure increasing from the centre to the periphery of the injection zone to make the gel depot lens-shaped.

The gel must not be injected into the parotid salivary gland as it may lead to its atrophy accompanied by salivation disorder.

The patients with rough drawn-in facial posttraumatic and postoperative scars should undergo preliminary scar excision with thorough layer-by-layer wound closure. 4-6 months later, after the soft tissues become flexible, the scars may be grinded away and 3-4 months after that, the gel contour plasty may be performed.

In accordance with recommendations of the International society of plastic surgeons, the face is divided into several regions having their own peculiarities for the operations to be performed.

Apart from this, there are specified proportions characteristic to a face with regular features.

Location of the mimic muscles has its effect upon the level of hydrogel injection in the relative regions. Desire to correct deformities by increasing the gel volume above the average rates may cause its spreading beyond the injected area, which only aggravates the deformity and sometimes may lead to functional disorders.

1

1

Temporal region

Within the temporal region there arecellular tissuecavities along whichthe hydrogel, if injected excessively, can run through them going down to the subtemporal and pterygopalatine spaces. It causes hampered opening of the mouth and the gel bulging under the mucous membrane behind the upper jaw maxillary tuber. To prevent this complication gel should not be injected under the deep temporal muscle towards the squama of the frontal bone.When injecting the gel in between the superficial and deep temporal muscles, the tip of the doctor’s forefinger should be put into the patient’s oral cavity and placed between its malar arch and spinous process of the lower jaw thus preventing the gel flowing down from the temporal region. As a rule, when injecting the hydrogel into the temporal region, itis introduced fanlikeunder the external temporal muscle or its external fascia. The gel may also be injected into the subcutaneous cellular tissue. Average volumes of the injected gel vary from 20 ml to 50 ml.