"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, professors who 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
2
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: № 250 060.
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 threedimensional 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.
2
3





TM
AQUALIFT
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 maxillofacial region, complexity of
anatomic structure, diversity of functions of the organs of this region, and also high cosmetic
demands for the maximum 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 bound with the necessity to involve additional plastic
material within the area under reconstruction, using plastic techniques of the local tissues, autoand 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, chin
regions and the region above the relative segment of the lower jaw.
3
4
Successful contour plasty with 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 tissues
while 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 the child 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 the vascular 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.
4
5
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 of the 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 cut hair 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 when injecting 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 plasty by means of gel injection without necessity of
hospitalization, 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.
5
6
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 of 50-20 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 tissues thickness, 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 conform to the 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 injection should be performed together with gradual removal of the needle from the soft
tissues. Fingers of the left hand should palpate the 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 tool within 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.
Temporal region
6
7
Within the temporal region there are cellular tissue cavities along which the 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, it is introduced fanlike under 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.
Frontal region of the head
Within this region the skin is closely united with the temporal muscle aponeurosis. Most
commonly, the correction of posttraumatic retraction of the frontal bone areas is performed
here. The needle is injected from hair growth line sliding upon the bone by the bevel of the
needle point. At traumatic deformities sites the skin is usually tightly fixed to the bone, and
the gel with average density is better to be injected under aponeurosis using the feeding
device. The quantity of gel injected depends on the intensity of deformity. Direction of the
gel injection is easily regulated in this region and its spreading through the upper
edge of the orbital cavity to the upper eyelid is easily prevented.
Nasal bridge
At the nasal bridge there is expressed subcutaneous fat through which the gel may
migrate onto the nasal arch and its lateral slopes to the inner corners of the eyes. During
gel injection the needle is pricked along the middle line of the forehead 1.5-2 cm
above the eyebrows while with fingers of the left hand preventing its spreading
downwards to the nasal arch. Generally 1.5 - 3 ml dose is injected at this region.
Nasal arch
This region has small amount of cellular tissue, its skin has limited mobility. The needle is
directed from the bridge of the nose to the tip of the nose. The needle should enter
sliding with the bevel of its point along the bone and the cartilaginous septum. Most
commonly, the gel of average density is injected while attentively monitoring the tissue
filling with the left hand fingers. Average volume is 1.5 - 3 ml.
Nasal septum
The hydrogel may be used to correct skin area of the nasal septum in cases of its
congenital deformities after lip clefts, with tightened or very narrow septum especially at its
base. The needle should enter from the tip of the nose to its base, and while gradually
extracting the needle the gel is injected. Gel distribution in the soft tissues is controlled by
the first and index fingers of the left hand. Generally, the hydrogel of average density and
ordinary injection needles are used. For minor deformities of the nose and auricles, skin is
closely united with cartilages. Correction is performed by gel with average density using
ordinary injection needles. In these cases it is very important to observe exact and
dosed gel injection, while preventing its migration along the outer surface of the
needle through the skin puncture.
Intraorbital region
Intraorbital region, as a rule, has well expressed subcutaneous fatty tissue. During gel
injection the needle is directed from the zygomatic bone parallel to the lower edge of the
orbital cavity and moved to the inner corner of the eye. The edge of the orbital cavity is
formed with dense gel.
7
8
Avoid gel penetration under mucous membrane in vestibule of the oral cavity into
the area above the upper teeth. Volume is 10-15 ml.
Buccal region
This region has two muscle layers and subcutaneous fatty tissue interlayer. The needle is
directed fanlike from the zygomatic region towards the corner of the mouth. The left hand
forefinger is inserted into the mouth cavity while the thumb is placed outside the cheek
thus controlling the tissues filling with gel. Avoid gel injection into the salivary gland.
Average volume of hydrogel injected to buccal, parotid and parotid-masticatory regions is
20-50 ml.
Parotid-masticatory region
In this region, the skin is flexible, can be folded, under it is fatty cellular tissue wherein the
big salivary gland is located anteriad from the auricle. Commonly, gel is injected to this
region through the buccal region. Avoid gel penetration under mucous membrane of the
mouth and into the parotid salivary gland.
Zygomatic region
This region nearly lacks subcutaneous fatty cellular tissue and the skin is fixed to the
zygomatic bone. The gel of average density is injected from superolateral sectors. The left
hand fingers control filling of the area and prevent gel spreading in undesirable direction.
Hydrogel is usually injected at the amount of 19-20 ml.
Lips
Lips have little hypodermic cellular tissue, but there is the orbicular muscle of the mouth in
the lip depth with the artery located at its lower edge closer to mucous membrane. The
needle prick should be done 1.5 - 2 cm outwards from the corner of the mouth and then
advancing within the lower or middle one third of the lip to the medium line. Injection of the
gel is performed while sliding out the needle, initially more gel and diminishing towards the
periphery. Lip filling with gel is controlled by fingers in and outside the mouth cavity. This
procedure may be performed from the right and from the left on the upper and lower lips
depending on the specified purpose. 2-5 ml of average density gel is used per one zone.
Prevent gel spreading to the lip basis and under its mucous membrane.
Chin region
Muscles are not expressed. Sometimes there is a significant amount of subcutaneous
cellular tissue. In order to make the chin more prominent anteriad the elevation is
performed along the edge of the bone using gel of average density. Soft gel is injected into
the second layer. Avoid gel spreading towards the mucous membrane of the mouth
vestibule and under lower edge of the jaw.
Half of the lower jaw region
Its middle area has little cellular tissue and is located above the jaw m.platisma. At first, as it
is for the chin region, the elevation is formed along the lower edge of the jaw, and then the gel
of medium density is injected above it. Volumes are different and depend on the result
required. It is better to form the second layer 1.5 - 2 months after the first procedure. It is often
needed to make injection beyond this zone into the buccal region.
In conclusion it must be said, the above volumes of the gel to be injected are approximate
and may significantly vary depending on the extent of deformity, size and shape of the
face of a certain patient.
In each particular case, the surgeon has to evaluate approximately the volume of the gel
required (from 2 to 50 ml on the face). As a rule, microdoses of 0.5 - 1.5 ml are injected to
perform accurate correction of the nose and auricle.
8
9
In many cases one procedure is not enough to correct deformity even by substantial increase
of average volume of the gel injected. In such cases, it is better to divide the procedure in 2-3
sessions performed with 1.5 - 2 months interval.
Postoperative period
After the gel injection is over, the skin puncture sites are antiseptized and covered with
germicidal plaster which is to be removed after 3-5 days. Moderately compressive bandage is
applied for 1-2 days to prevent bruises and to reduce face edema. Bandaging techniques are
described in detail in the manual compiled by V.A.Kovalev “Desmurgy and drainage in surgical
dentistry” – Medicine 1985,- p.190. Starting from the 15th day after the operation,
physiotherapeutic procedures may be performed to soften soft tissues at the gel injection zone.
Since that time make-up may be used. In the cases when facial contour plasty with hydrogel is
performed under general anesthesia, the patients have to be hospitalized for one day.
Possible complications, their course and prevention
Long lasting practice of hydrogel application on hundreds of patients has revealed no
complications which might be referred to as adverse effects of the material.
However, complications can not be excluded, as it happens in any other surgical intervention.
The absolute majority of plastic-surgeons think that these complications are due to occurrence
of inflammatory processes.
Our insistent requirement for the doctors is to bear in mind that inflammatory complications
may be avoided by way of prior sanitation of the inflammatory focus at the teeth roots, strong
observation of aseptics and antiseptics during the gel injection procedure and subsequent
prescription of antibiotics for a period of 5-7 days as preventive measure.
At the stage of soft-tissue infiltration, intensive parenteral therapy with antibiotics is performed
during 5-7 days, which enables to stop inflammation.
When infection develops, it is required to open the focus, to eliminate the pus and gel and
perform drainage of the wound for 2-3 days. This surgical procedure should be performed
jointly with the experienced maxillofacial surgeon.
Upon elimination of the pus focus, the next gel injection may be performed after 5-6 months.
Complications like bruises, decrease in skin sensitivity, feeling of "spreading” at the gel
injection site do not require any specific treatment and disappear gradually and spontaneously.
In cases of expressed haematomas, parental administration of antibiotics is prescribed. Blood
is evacuated by way of puncture, and compressive bandage is applied for three days.
Another unpleasant complication is considered to be hydrogel spreading beyond the area
planned. This complication is occurred due to errors in injection techniques. Hydrogel
penetration to the orbital cavity causes double vision, hydrogel sinking to the subtemporal and
pterygopalatine fossas, and difficulty of mouth opening.
The excessive gel should be immediately evacuated by a thick needle using the puncture
technique. This complication may be prevented by thorough localization of the zone to be
injected and control over the material volume while injecting.
It should be remember, that not in all cases correction of facial deformities can be
achieved at one session. Sometimes the gel should be injected in two or three sessions with
1.5 - 2 months interval between injection procedures.
All patients having contour plasty of facial soft tissues with hydrogel should know:
1. The patient’s repeated inspection by the surgeon should take place on the 3rd and 7th days
and then after 1 and 6 months, later on the patients don't require medical care.
9
10
2. Increased physical activity, heavy sports, bodybuilding, shaping are prohibited during the
first month after the plasty.
3. On the second week after the plasty, the patient may use all types of make up and hair
dyeing.
4. To prevent frostbite, supercooling of the face should be avoided during 6-8 months.
5. Upon termination of this period the tissue reseistance to low temperatures normalizes.
6. In case of development of dental-related inflammatory diseases, facial skin diseases,
inflammatory processes in nasal (accessory) sinus, facial and maxillofacial traumas, the
doctor should be informed about hydrogel presence in the facial tissues.
7. In case of failure to achieve cosmetic result at the first hydrogel session the second
additional injection may be performed 1.5 - 2 months later.
Contour plasty of the soft breast tissues
with hydrophilic gel “AQUALIFT”
The opinion, that considerable volume of gel injected to the anatomic regions causes severe
complications, is widely spread among doctors and is originated due to:
- non-professional approach of the doctor to the surgical techniques;
- imperfect physical-chemical properties of some of those gels used previously.
The hydrogel AQUALIFT has opened new perspectives for low invasive breast
augmentation plasty. Analysis of the clinical observation results has convincingly
shown benefits of the low invasive implant surgery compared to silicone prosthesis:
 favorable behavior of the short-term postoperative period, absence of pain, maintained
ability to work, comfortable condition on the 7th day;
 absence of infiltrations within the zone of injections;
 absence of any signs of inflammation or allergic reactions within the zone of injection;
 absence of any migration from the zone of injection;
 absence of the implant fragmentation; natural consistency of the soft tissues both
within the early post operative period and during long-term follow up.
Selection of patients for contour plasty
This stage is the moment that determines success of all rehabilitation process in injection
contour plasty of the soft breast tissues with hydrophilic implant. The selection is aimed not
only at defining the possibility (local and general somatic) of breast correction for a certain
patient but rather defining the depth of the patient’s motivation for surgical intervention,
prediction of her attitude to the probable short-term and long-term result of the plasty.
General indications for intervention include:
♦ mammary aplasia;
♦ hypomastia;
♦ hypomastia accompanied by combined glandulous, skin mastoptosis 0-1 type;
♦ asymmetry of soft breast tissues;
♦ presence of deformities of the soft and bony cages at the anterior thorax (funnel
breast) with rachitic, scoliotic, traumatic genesis;
♦ presence of deformities of the soft and bony cages at the anterior thorax with
asymmetry of soft breast tissues.
Contraindications for contour plasty with hydrogel can be divided into local and general. Each
of these groups include absolute and relative contraindications of infectious and non-infectious
nature.
10
11
Local absolute contraindications of infectious nature include:
♦ acute and chronic specific and non-specific inflammatory diseases of mammary
glands;
♦ pyodermatitis of different etiology and form;
♦ eczema (more frequently of infectious-allergic genesis).
Non-infectious:
♦ tumorous diseases of the breast;
♦ tumorous diseases of skin, vasculitis, angiopathy of different etiology; dermatitis,
toxicodermia; connective tissue disease (scleroderma, systemic lupus
erythematosus, etc.);
♦ combined glandulous skin mastoptosis of type 2-3;
♦ breast hypertrophy of type 2-3;
Local relative contraindications of infectious nature include:
♦ presence of primary infected superficial defects of the skin (excoriations) in the zone of the
supposed intervention;
♦ virus dermatoses, infectious erythema.
Non-infectious etiology:
♦ neurodermatosis, psoriasis, non-infectious erythema;
♦ different forms of mastopathy;
♦ glandulus mastopatosis of type 1-2, combined skin ptosis of type 1,
breast hypertrophy of type 1;
♦ previous surgical operations on the breast that resulted in its significant cicatricial deformity;
♦ presence of premenstrual mastalgia.
General absolute contraindications include:
♦ acute infectious diseases of specific and non-specific etiology;
♦ chronic infectious diseases at acute condition;
♦ decompensation stages of the functional status of organs and systems.
General relative contraindications for plastics include:
♦ chronic inflammatory diseases at the state of stable remission;
♦ compensated stages of the course of general somatic diseases.
Patients younger 18 years, nulliparas, patients six months after delivery or breast-feeding, and
also those who would like to achieve impossible results were refused to undergo contour
plasty of soft tissues of the breast due to anatomic peculiarities of the intervention zone and
personal-psychological peculiarities.
All the above categories of patients were identified during the primary consultation.
Gynecological past medical history is collected at this stage and the patients are examined by
an independent oncologist-mammologist.
Laboratory tests include: total blood analysis, coagulogram, AIDs, Hbs, Ag, Anti HVC, RW,
total urine analysis, ECG (by indications), ultrasound, radiography (mammography).
General provisions
When admitting to the Clinic, a package of legal documents is required to perform this
surgical intervention. The patients are photo documented in four standard positions
(photos full face, full face with hands up, profile, profile with hands up).
Prior to intervention the patients with chronic inflammatory diseases at the stage of stable
remission (mono- polysinusitis, tonsillitis, otitis, adnexitis, cholecystitis, etc.) and also the
11
12
patients who previously had acute inflammations within the zone of injection
(consequences of lactational mastitis and etc.) are prescribed preventive antibiotic drug
therapies. 27 hours prior to the intervention and during 5-7 days that follow, intramuscular
injection with 1.0 Sol. Cefasoline (2 times per day No. 10-14; after tolerance test and in
case of absence of general somatic contraindications) is prescribed in complex with
fungicidal medications of Tab.Nistatini 1.000.000 units 4 times per day before meal and
medicines to stop possible events of disbacteriosis such as lactobacterin, colibacterin etc.
in average therapeutic dosages – 6-10 dosage units to be taken twice a day.
Right before the manipulation the patients are again interviewed to finally specify their
desires and to explain opportunities of the method.
Having taken hygienic shower and premedication procedure (Sol. Ketonal — 1.0
intramuscularly, Sol. Тavegili 2,0% — 1.0 ml percutaneously) the patient is taken to the
operating room.
Intervention technique
During the first period of the surgical intervention, the patient is placed lying on the
back.
The patient is located with her hands under the small of the back, the shoulders backwards
and the axillary depressions exposed.
The latter facilitates stretching and flattening of the muscle belly М. Реctoralis major, that
additionally helps to avoid traumatism of its edge during anesthesia and the implant needle
injection. Elevation of the shoulders is prohibited.
The surgical field is treated with iodopironum twice, before and after spreading sterile surgical
sheets. The patient’s face is isolated by an arc to keep the surgeon’s sterility during
manipulation.
Anesthesia
Surgical intervention is performed under local infiltration anesthesia using Vishnevsky method
- four punctures with the needle for intramuscular injections.
60—80 ml of Sol. Lidocaini hidrochloridi 0.25% with Adrenalini hidrochloridi 1:200.000 and
Cefasolini 1.0 (or any other antibiotic) is injected from each side. To avoid damage of the
breast tissue the latter is gathered into a fold and pulled upwards. To inject the aenesthetic the
needle should enter into and along the transitional fold pointed at an angle of 20,0° (after
formation of orange-peel appearance of the skin) in the direction of the chest. The bevel of the
needle should be directed strictly upwards.
The above technique enables the surgeon to inject the anesthetic solution in the
direction of the back leaf of the fascial encasement of the mammary gland, thus
pushing the mammary gland lobes anteriad and preventing their possible damage
while hydro preparing the retromammary cavity.
The first puncture is usually done at the estimated point for introducing the implant needle, on
the borderline between the superior external and upper internal quadrants of the
mammary gland. During typical contour plasty of the breast soft tissues only the implant
needle is used for injection in the majority of cases.
In other cases some surgeons apply superolateral and inferolateral access to the
retromammary cavity.
Bilateral punctures must be strictly symmetrical. To optimize choosing the skin puncture site,
the additional implant needle is used, which the surgeon locates on the skin of the patient with
its point to the areolar complex. The injection site is considered optimal when the implant
needle enters more caudal to the level of the nipple at the distal third of its length. The
anesthetic syringe needle is entered doing preceding injection of the solution during the
needle movement so that to anesthetize the forthcoming wound tract. It provides reliable
12
13
anesthesia at the zone of the forthcoming wound tract and painless pricking of the implant
needle immediately after finishing the anesthetic injection procedures. It is fundamentally
important and defines the success of the complete surgical procedure of
retromammary (i.e. the only correct) implant insertion because the outflow of the
anesthetic solution from the needle cannula shows its optimal (retromammary) position.
The needle is pierced through the transitional fold (while the surgeon’s hand is dislocating the
mammary gland anteriad), strictly parallel the tangent to the semi-circle of the chest at the
puncture punctum. In doing this, after the skin is punctured, the surgeon exerts slight
pressure with the implant needle upon the palpable edge М. Реctoralis major, thus preventing
its damage.
The implant needles should be inserted bilaterally and simultaneously irrespective of the zone
where the surgeon starts operation. Neglecting this rule often brings to the effect that by the
moment of finishing the prosthetics at one side there takes place resorption of the
hydropreparating anesthetic solution from the contralateral retromammary space and the
passage of the implant needle is difficult to control. We use implant needles № 15—16 with
the tip bevel at 60°. The needle is 180 mm long with the cannula mark on the side and
parallel to the bevel of the tip. It is required to control the position of the tip in the
retromammary space. Its positioning anteriad is considered optimal, which helps to
avoid damage of the mammary gland capsule and consequently all complications
associated with it. It is not required to prevent anesthetic flowing out of the retromammary
space as its least amount contributes to better orientation of the surgeon during the operation
in the local status and results in less apparent “shrinkage” of the implant in the nearest
postoperative period that sometimes causes negative reaction of the patients. The anesthetic
solution flowing out of the implant needle cannula is normally colorless or slightly
colored with the tissue fluid. Presence of clear blood is considered as complication of the
manipulation and the contraindication for the further prosthesis implantation because of the
threat of hematoma formation. In this case the needle should be withdrawn. Cross retaining
compression bandage is placed on the upper quadrants of the breast. The limb is immobilized
by a scarf bandage. The surgical procedure is postponed up to 10-14 days.
Implant administration technique
The hydrophilic implant is extracted from the factory packing. The injection is performed by
fractions of 1.5 - 2 ml. For symmetrical contours of the breast sequence of the material
injection into contralateral retromammary spaces has no principal meaning. In the case of
asymmetry the correction is performed starting from the smaller half. The contralateral implant
needle not involved at this stage of the operation is covered with a sterile surgical drape
wetted in the anesthetic solution.
At the first stage of the correction, each retromammary space is injected with 1/3 of the gel
implant planned to be implanted. It is important that the implant needles should not be
displaced! This requirement stipulates the formation of the primary small implant in a form of
monophyl gel formation within the retromammary space. Then, the surgeon may slightly
massage this formation with his hand to make the retromammary space more extensive due
to hydropreparation and dissection within the frontal plane of the fascial tissues in the
retromammary space. For doing this, the mammary gland is gathered into a fold and
massaged indirectly through the skin, while the implant needles remain not withdrawn.
At the second stage of the correction (injection of the remaining 2/3 of the implant) the
patient is placed sitting on the operating table. This is principally important because it
enables the surgeon to make correction at the position of the natural ptosis of the breast
tissues obtaining the best cosmetic results. General rules of the substance injection don't
differ from those described above.
Upon completing the endoprosthesis procedure the implant needles, still inserted, are
rinsed with 2.0 - 3.0 ml of the anesthetic solution simultaneously with their quick
withdrawal (to avoid possible formation of the gel fistulization). The operative field and
the surgeon’s hands are antiseptized (alcoholic solution of chlorine - hexetidine), and the
implants are slightly massaged. This method is the manual continuation of the procedure and
is exclusively important since it enables the surgeon to complete the intrusion by forming an
elastic retromammary monoimplant with the aesthetic inferolateral contour. The surgeon
gathers the mammary gland into a fold with his one hand transposing it anteriad and upwards
13
14
simultaneously exerting slight pressure onto the injection site by the ulnar edge of the hand
and pressing М. Реctoralis major belly to the chest. By doing this, the surgeon can form the
implant well-contoured occupying the inferomedial and inferolateral quadrants of the
retromammary space. The surgeon’s other hand is placed on the chest below the implant,
with its first metacarpal space resting onto the submammary fold. The massage movements
( slight by intensity ! ) are performed by the other hand which simultaneously exerts
moderate pressure with the hand support whole plane while closely grasping the medialinferolateral parts of the formed intratissular prosthesis by the fingers. By doing this, the
migration of the gel through the intratissular fistulas downwards, outside, and inside (which
would effect unsatisfactory cosmetic result) is eliminated.
The implant injection sites are then isolated by antibacterial plasters. The medical staff
observes the patient lying on the operating table during 10-15 minutes to control the
consequences of the anesthetic afteraction and to prevent possible postoperative general
somatic complications.
Peculiarities of the periosteal injection of the
correcting funnel-shaped breast
biocompatible implant when
In all cases of our practice, this surgical procedure was performed through the independent
skin punctures, after formation of the retromammary implants. The needles used where those
usually applied for the spinal (peridurial) anesthesia. The needle introduction was considered
principally important when it was directed downwards from the puncture point located at the
distance not less than 20 mm from the expected placement of the forthcoming intratissular
implant and not less than 10-15 mm from the border of the previously formed retromammary
implant. While doing this, the needle was introduced with its bevel sliding over the periosteum
along the surface of the bony cage of the frontal thorax and prefacing the movement of its tip
with the anesthetic flow (not more that 1.0 - 1.5 ml per one complete passage of the needle;
the solution formulation is given above). The implant needle was administered as caudal as
possible but not further than 5.0 - 10.0 mm from the intended lower edge of the forthcoming
periosteal implant. Then, the surgeon rotated the needle around its axis by 180° in such a way
that it would be located with the bevel of its tip directed anteriad (towards the soft tissues,
controlled by the position of the mandrel groove). The implant was injected fractionally by 0.5 1.0 ml while simultaneously doing slight massage of the injected hydrogel masses and
gradually withdrawing the needle up to the level of its point to be 5.0 - 10.0 mm more caudal to
the expected lower edge of the forthcoming periosteal implant. After that, the needle was
again inserted in the caudal direction, sliding by the bevel of the tip along the surface of the
periosteum. Such a technique consisting of one puncture of the skin is considered as most
acceptable. The implantation procedure was repeated again untill achieving sufficient
cosmetic result. At the end of the procedure the needle was withdrawn after its prior washingout with the anesthetic solution (maximum 1.0-1.5 ml!) at the level of the needle tip location
near the upper edge of the implant.
In the case of a complex flat-like deformity with distribution of the top of the funnel–shaped
breast hollow sideward to one of the retramammary spaces, step-wise implantation is
recommended with 1.5 - 2 months interval. Whereupon, primary organization of the implants
is achieved thus avoiding their potential fusion through intretissular fistulas with unsatisfactory
cosmetic outcome.
Postoperative rehabilitation
Immediately after the surgical intervention and during one month the patient is
recommended to wear clothing that tightly embraces the chest along the submammary
fold and supports the mammary glands upwards, but preserving them completely loose!
During first 72 hours, the intervention zone should be provided relative rest, only minimum
physical exercise is allowed (easy house holding, etc.). The physical inspection is performed
three days later to evaluate short-term results. The doctor answers the questions of the
patients if any and explains peculiarities of the postoperative behavior once again. The
patients are prescribed Vobenzim (starting from the 3d day after the surgical procedure: 1st
14
15
week – 10 pills three times a day, 2nd week – 7 pills three times a day 30 minutes before meal
with 0.5 - 1 glass of water).
The repeated inspection takes place in a week. It aims at detecting possible early
postoperative complications (of inflammatory character, etc.). If there are no complications
during the rehabilitation period, the patients are prescribed 10 massages of the implant zone
with Contraktubex gel, one procedure every other day in accordance with the generally
accepted technique.
The third check-up inspection is performed one month after the surgical intervention,
During it immediate cosmetic and functional results (postoperative photodocumentation) are
estimated. The patient is assigned ultrasound study. It is allowed to keep to ordinary mode of
life. Later on, check-up inspections are performed after 2, 4, 6 and 12 months, and further –
upon the client’s desire.
Errors and complications
To estimate the results, we have used the classification of possible complications occurred
during endoprosthetics with AQUALIFT gel in plastic surgery.
The complications of non-inflammatory character (postoperative hematomas, lymphorrhea,
mechanical damage of the tissue of the mammary glands by the implant needle, gel intrusion
into their tissue, gel outflowing through the puncture channel into the subcutaneous tissue due
to tight clothes, rough massage) were not observed. Also there were not recorded any
complications of the general somatic character.
Minor bleeding occurred in one case, during insertion of the implant needle into the
retromammary space. In that case further endoprosthetics was considered contraindicated.
The implant needle was withdrawn, and the superior quadrants of the mammary gland were
immobilized with the cross pressure bandage. The surgical intervention was postponed up to
14 days. Special drug therapy was not required. During the repeated surgical procedure, and
also in early and late periods after implantation, that patient had no complications.
In one case, fragmentation of the implant gel was diagnosed in the patient with old (12 years
before implantation) unilateral post lactational mastitis. That complication was caused by the
rough peritoneal process in the retromammary region, which stipulated the polifocal placement
of the implant (the latter was revealed with the help of sonography). In order to optimize the
process of internal sicatrization there was prescribed a course of massage on the implant area,
conservative therapy with Vobenzim (1 week – 10 pills 3 times per day, 2 week – 7 pills 3
times per day, 3-4 weeks – 5 pills 3 times per day 30 minutes before meal with 0.5-1 glass of
water) and 2-3 courses of local application of Contraktubex gel on the breast skin every day
during 21-28 days with 1 month interval.
In one patient there was observed migration of a part of gel to the axillary crease. The
complication was eliminated by surgical intervention (out-patient treatment under the local
anesthesia with 40 ml of Sol.Lidocaini 0.25%, from the cut of 3 cm long along Linea xillaries
aptepog in the projection of the migration zone) followed by short-term (3 days) immobilization
of the forearm by the pressure cross bandage and of the upper extremity - by the srarf
bandage. Specific treatment was not required.
Inflammatory complications were observed twice. Those were late (8 and 12 months from
the moment of the surgical procedure) unilateral retromammary abscess formation which were
terminated by means of puncture aspiration of the implant. In the first case the suppuration
was caused by odontogenic abscess, in the other case it occurred due to posttraumatic
hematoma (trauma was caused by the car safety belt).
15
16
Upon evacuation of the implant and exudates, the site of the puncture hole was bandaged
with Sol.Dimexidi 33,0% during 5-7 days. The corresponding upper extremity shoulder girdle
was immobilized by the soft bandage Desoult or a scarf bandage during the whole period of
inflammation reduction. The bandaging was applied 2 times per day. The patient was not
required to be put into hospital. It was recommended to strictly observe regime, and to have
rest. The following drugs were presribed: antibacterial midications (Сеfasolin 1.0 or its
analogues intramuscularly — 2 times per day during 5—7 days after tolerance test on Sol.
Lidocaini 0.25% in complex with fungicidal drugs Nistatine 1.000.000 units, 4 times per day
before meal, and medications stopping possible dysbacteriosis events – lactobacterin, etc. in
therapeutic average dosages – 6-10 dosage units twice a day), medicines blocking selfsensitization (Sol. Dimedroli 1% - 1 ml once a day intramuscularly during 5-7 days), improving
microcirculation (Fraksiparm in prophylactic dosages 0.3 ml a day injected to the folder of the
abdominal skin within 10—12 hours after evacuation procedure of the implant and then during
5 days after the surgical procedure, and later on 3-5 injections every other day up to complete
cancellation of the medicine by the end of antibiotical therapy). During that period nonsteroidal anti-inflammatory drugs were either not prescribed (1 patient), or, in another case
due to presence of subfever, tab. Aspyrini 0,25 was given once a day. Non-steroidal antiinflammatory drugs were prescribed in average therapeutic dosages during 10-14 days. Single
dosage of pain-relieving drugs was administered intramascularly during the evacuation of the
implant. Later on, pain relievers were not applied. Simultaneously and obligatory there was
performed termination of the primary site of the suppurative inflammation (in the case of
odontogenic infection). In early and late rehabilitation period it was recommended to undergo
an intensive outpatient course of thysiotherapy (10 procedures of UHF therapy every other
day, electrophoresis with novocain, lidaza, potassium iodid in ordinary dosages, massage,
applications with heparin, troxevasin). Starting from the 21th day after the surgical procedure
on gel elimination and terminating the inflammation, obligatory therapy with Vobensim was
prescribed (1st week — 10 pills 3 times per day, 2nd week — 7 pills 3 times per day, 3-4th
weeks — 5 pills 3 times per day 30 minutes before meal with 0.5 - 1 glass of water) and 2-3
courses with local application of Contraktubex gel on the breast skin every day during 21-28
days with 1 month interval. By the end of complication relief the asymmetry of the breast soft
tissues was formed in both cases. Correcting surgical intervention with implantation of
biocompatible prosthesis was recommended not earlier than after 12 months.
Within immediate postoperative period, having undergone the manipulation, several patients
had perifocal tissue edema accompanied by a moderately expressed pain syndrome. Those
manifestations required strict regime observation, outpatient prescription of non-steroidal antiinflammatory drugs in average therapeutic dosages and were completely eliminated by the
end of the next two weeks.
Myositis of the greater pectoral muscle was observed in 9 patients and was associated with
the trauma of the muscle belly by the implant needle during the period of mastering of the
surgical procedure technique. Clinially, the complication was developed by moderately
expressed pain syndrome during abduction, the shoulder rotation, elevation of shoulder
girdles, edema of М. Pectoralis major during palpation, subfever due to resolution of the
intramuscular hematoma. In 7 cases bilateral process was diagnosed. Two patients had
unilateral development of myositis. Myositis was uncomplicated and was completely stopped
outpatiently within the month after the intervention. The breast was bandaged with Sol.
Dimexidi 33,0% during 5-7 days. The corresponding upper extremity and shoulder girdles
were immobilized by scarf bandage. It was recommended to strictly observe regime and to
have rest. Non-steroidal anti-inflammatory drugs were prescribed in average therapeutic
dosages during 10-14 days. The outpatient course of physiotherapy was recommended (see
above) and also enzymotherapy with Vobensim (1 week — 10 pills 3 times per day, 2 week —
7 pills 3 times per day, 3-4 weeks — 5 pills 3 times per day 30 minutes before meal with 0.5-1
glass of water) and 2-3 courses with local application of Contraktubex gel on the breast skin
every day during 21-28 days with 1 month interval.
16
17
Elimination of the emerged secondary asymmetry as well as repeated procedures of
symmetrical bilateral mammary gland augmentation by injecting hydrophilic gel AQUALIFT in
technical aspect and peculiarities of the postoperative regime were similar to those described
above.
We have not observed any local and general somatic complications (early – 7 days from the
surgical interventions, and late – within 12 months) in contour plastic of funnel-shaped breast
with gel AQUALIFT. In all cases, stable functional and cosmetic effect was recorded.
CONTOUR PLASTY OF THE SHIN SOFT TISSUES WITH HYDROPHILIC GEL IMPLANT
“AQUALIFT”
Argumentation of general principles in contour plasty of the shin.
The shin differs by its high functional activity and fine anatomical constitution:
♦ big number of muscular units of statistic type with predominant isometric character of
contraction;
♦ presence of three deep (А.et V.v Tibiales anteriores N. Peronaeus profundus, А. et V.v , N.
Peronaeus posteriores, N. Tibiales; А.et V.v Tibiales anteriores N. Peronaeus superficiales)
and two superficial (V.Saphena magna, N. Saphenus; V.Saphena parva, N. Suralis)
neurovascular fascicles;
♦ relatively small anatomical volume of this segment of the lower extremity;
♦ high density and skin deficit;
♦ small solid, without inner natural boundaries, volume of subcutaneous tissue with the
branching venous network;
♦ presence of three musculofascial compartments, density of fascial tissues.
In the case of contour plasty of the shins with hydrophilic gel AQUALIFT distal sections of the
lower extremities (shins, feet) are positioned in new qualitative conditions of functioning that
are characterized by destruction of their fixed interactions. Even if a minimum volume of the
implant is injected, the shins are irreversibly traumatized, and a new locomotion stereotype will
be characterized by a long period of formation.
These circumstances enable us to state basic principles of rehabilitation of the patients with
cosmetic defects during contour plasty with hydrophilic gel AQUALIFT :
1.
Thorough selection of the patients to be operated wherein their local status is of
primary importance.
2. Rational planning of the whole rehabilitation period (the volume of the implant injected,
the number of stages, intervals between operations, postoperative regime).
3. If possible, single-stage correction and little traumatism of the intervention.
4. The sequential principle of anesthetic injections and the implant under the conditions of
isotonic and isometric contractions in the standard positions of the lower extremities
(see below).
5. Complete exclusion of the substance injection into the muscular tissue, deep into the
fascial compartments and the depth of the fascial leaves.
17
18
Selection of the patients for contour plasty:
In our practice, selection of the patients and their preoperative examination was performed in
accordance with the methodological recommendations. This stage was crucial in determining
the success of all rehabilitation process in the injection contour plasty of the shin soft tissues
with biocompatible hydrophilic implant. The selection was aimed not only at assessing the
possibility (local and general somatic) to correct aesthetic lines of the lower extremities for a
certain patient but rather at defining the depth of the patient’s motivation for surgical
intervention, prediction of her attitude to the probable short-term and long-term results of the
plastic operation.
General indications for intervention included:
♦ external abnormality of the interior esthetic line with enlarged medium aesthetic space
(superior 1/3 part of the shin);
♦ external abnormality of the interior esthetic line of the shins in 1/3 of its medium;
♦ medial abnormality of the external esthetic line of the shins in 1/3 of its upper and medium
part;
♦ abnormality of the posterior esthetic line of the shin anteriad;
♦ assymetry of the shin soft tissuess.
Contraindications for contour plasty with hydrogel were divided into local and general. Each
group included absolute and relative contraindications of infectious and non-infectious nature.
Local absolute contraindications of infectious nature included:
♦ acute and chronic specific and non-specific inflammatory diseases of lower extremities;
♦ pyodermatitis of different etiology and form;
♦ eczema (more frequently of infectious-allergic genesis).
Non-infectious:
♦ tumorous diseases of soft tissular and bony cage of the shin;
♦ varicose disease of the veins of the lower extremities;
♦ vasculitis, angiopathy of different etiology; dermatitis, toxicodermia; connective tissue
disease (scleroderma, systemic lupus erythematosus, etc.).
♦ neurogenetic deformities of the distal parts of the lower extremities.
Local relative contraindications of infectious nature included:
♦ presence of primary infected superficial defects of skin (excoriations) in the zone of the
supposed intervention;
♦ remote consequences of the hematogenic and posttraumatic osteomyelitis (the stage of
stable remission);
♦ virus dermatoses, erythema infectiosum.
Non-infectious etiology:
♦ neurodermatosis, psoriasis, non-infectious erythema;
♦ posttraumatic and post operative deformities of shin soft tissues;
♦ posttraumatic and post operative deformities of the bony cage of the shin associated with
the significant cosmetic defect;
♦ remote consequences of poliomyelitis;
18
19
General absolute contraindications included:
♦ acute infectious diseases of specific and non-specific etiology;
♦ chronic infectious diseases at the stage of exacerbation;
♦ stages of decompensation in functional status of the organs and systems.
General relative contraindications for the plasty included:
♦ Chronic inflammatory diseases at the state of stable remission;
♦ compensated stages of the course of general somatic diseases.
Patients who would like to achieve impossible results were refused contour plasty of their shin
soft tissues due to anatomic peculiarities of the intervention zone and due to their personalpsychological peculiarities.
All above categories of the patients were identified during the primary consultation.
Laboratory tests included total blood analysis, coagulogram, AIDs, Hbs, Ag, Anti HVC, RW,
total urine analysis, ECG (when indicated), radiography (when indicated).
General provisions
When admitting to the Clinic, the package of legal papers is required to perform this surgical
intervention. Patients were photodocumented in three standard positions (anterior view,
posterior view, lateral view 45° from behind).
Prior to surgical intervention, the patients with chronic inflammatory diseases at the stage of
stable remission (mono- polysinusitis, tonsillitis, otitis, adnexitis, cholecystitis, etc.) and also
patients having acute inflammatory processes at the zone of operation were prescribed
preventive antibiotic drug therapies. 24 hours prior to the intervention an during 5-7 days that
followed, Cexxxxxx 1.0 (2 times per day No 10-14; after tolerance test and in case of absence
of general somatic contraindications) was prescribed in complex with fungicidal medications
Tab.Nistatini 1.000.000 units 4 times per day before meal, and medicines to stop possible
events of disbacteriosis – lactobacterin, colibacterin and etc. in average therapeutic dosages –
6-10 dosage units taken twice a day.
Immediately before the manipulation the patients were again interviewed to finally specify their
desires and to explain opportunities of the method.
Having taken hygienic shower and pre-medication procedure (Sol. Ketonal — 1.0
intramuscularly, Sol. Тavegili 2,0% — 1.0 ml percutaneously) the patient was accompanied to
the operating room.
Preliminary marking of the zone of the forthcoming intervention was performed under unsterile
conditions in the patient’s vertical position to specify the area of the biggest gel volumes to be
injected, and also topography of the neighboring functionally important anatomic structures to
avoid their possible damage.
Intervention technique
During the surgical intervention the patient finds himself lying on the abdomen. The operation
field is treated with iodopironum twice, before and after relaying sterile surgical garb. The final
marking of the surgical intervention zone is necessarily required in horizontal position of the
patient.
Anesthesia
Surgical intervention is performed under local infiltration anesthesia.
Sol. Lidocaini hydrohloridi 0.25% with Sol. Adrenalini 1:200.000 and Cefasolini — 1.0 (or any
other antibiotic) are used.
19
20
The needle with anesthetic is inserted at an angle of 20,0° (after “orange-peel” on the skin is
formed) to the direction of the future zone of hydrogel implantation. The bevel of the needle tip
should be directed strictly into the deep tissues. This will ensure injection of the anesthetic
solution in the direction of the deep cellular tissue layer on the surface of the own fascia of the
shin, thereby pressing back the muscular mass and preventing possbile injection of the
substance under the fascial leaf of the muscle belly.
The first puncture is usually performed at the estimated spot of the future implant needle
insertion. Bilateral punctures should be strictly symmetrical. To optimize choosing the skin
puncture spot the additional implant needle is used, which the surgeon locates on the skin of
the patient with its point directed to the expected zone of the implant injection. The needle of
the syringe with anesthetic should be inserted while advancing its movement with the solution
injection, thus effecting anesthetization of the forthcoming wound tract. It provides painless
insertion of the implant needle which if to be done at the end of the anesthetic procedure.
The implant needles are inserted bilaterally and simultaneosuly irrespective of the zone where
the surgeon starts operating.
The needle is 150 mm long. The cannula mark is to be parallel to the bevel plane, which is
required to control position of the needle tip in the depth of the tissues. This position of the
bevel facing the skin surface is considered optimal, because it prevents possible implant
injection into the muscle, thus avoiding related complications. Rather big volume of the
anesthetic should be avoided as its smallest amount helps the surgeon in better orientation
during the operation as to the local status and also less expressed “shrinkage” of the implant
will be expected in the nearest postoperative period, which sometimes elicits negative
reaction of the patients. Presence of clear blood is considered as complication of the
manipulation and contraindicative to further implantation procedure because of the threat of
hematoma formation, inhibition of the implant with blood. The shin is immobilized by the
pressure bandage. The surgical procedure is postponed up to 10-14 days.
Implant injection technique
To faciliate injectiion of the implant the latter is dissolved with anesthetic solution (formulation
see above) at the amount of 10.0 ml for each 120 - 60 ml of the gel.
In all cases the surgical intervantions were aimed at the minimal number of skin punctures.
The injection is considered optimal when the needle is injected downright from the injection
spot at the distance not less than 20 mm from the expected level of the future intratissular
implant and not less than 10-15 mm from the border of the previously formed implant. In doing
this, the needle is gradually inserted with its bevel sliding above the muscle along the surface
of the fascia together with preceding injection of the anesthetic (no more than 1.0-1.5 ml for
one complete passage of the needle; the solution formula is given above). The implant
needles are inserted as distal as possible but not further than 5.0 - 10.0 mm from the expected
lower edge of the forthcoming implant placement. Then, the surgeon rotates the needle about
its axis by 180° in such a way that the bevel of the needle would locate facing the skin (in soft
tissues, controlled by the mandrin slot position). Next, the patient is asked to perform
rhythmical muscle tension of the shin. Absence of swinging movement of the implant
needle proves its over fascial (correct) position. The implant injection is performed
fractionally by 0.5 - 1.0 ml together with simultaneous slight massage of the injected hydrogel
masses by the surgeon’s hand and gradual withdrawal of the needle to the level of its tip more
proximal the expected upper level of the forthcoming implant by 5.0-10.0 mm. After that, the
needle is inserted at the distal direction again, sliding with its tip bevel along the surface of the
muscle, prefacing its movement with the anesthetic solution injection which is then followed by
injecting the required gel volume. This sequential injection technique enables performing the
correction with little traumatism and the least infiltration of the intervention zone with
anesthetic. Most acceptable is usage of the technique consisting of one-two skin punctures
20
21
done from the posterior surface of the shin but through different intratissular wound channels.
If the correcton of anterolateral parts of the shin is required, the needle is moved linearly along
the trajectory of the secant line to the semi-circle of the shin muscles to be punctured, and the
tip of the implant needle is to be inserted from the front deep into the suprafascial layers of the
subcutaneous cellular tissue. That technique was performed purely to correct internal
aesthetic lines of the shin with predominant traumatism of the inner head of the gastrocnemius
muscle and of medial edge of the salens muscle. While doing this, passage of the implant
needle tip through the anterior fascial leaf enclosing the posterior bed of the shin muscle was
controlled by palpation using “gap” symptom.
The implant procedure can be repeated until the satisfactory cosmetic result is achieved. The
sequence of the injections of the substance into the contralateral shins with assymetry of
contours of aesthetic lines had no principle meaning. In case of assymetry, the correction
starts with the smaller half. The contralateral implant needle, not involved at this stage of the
surgical procedure, is to be covered with a sterile drape wetted in the anesthetic solution.
After implantation of 5-7 ml of hydrogel into each side, the result of the procedure is controlled
in six standard positions of the extremities (with and without active tension of the shin
muscles):
1.
Internal rotation of the feet. The shin muscles are relaxed. Symmetry of the internal
and posterior aesthetic lines of the shins is evaluated.
2.
Internal rotation of the feet with active tension of the posterior group of shin muscles
(plantar flexion of feet and their adduction). By these movements isotonic muscular
contraction of the posterior group and shaping of the head contours triceps surae is achieved.
Internal and external posterior aesthetic lines of the shin are estimated in complex with
contours of the specified muscles.
3.
External rotation of feet. The shin muscles are relaxed. The external and posterior
aesthetic lines of the shins are estimated.
4.
External rotation of feet with simultaneous active tension of anterior and peroneal
group of muscles (plantar flexion of feet with their abduction). By these movements isotonic
contraction of the posterior and lateral group of muscles is achieved together with shaping the
contours of the heads triceps surae and the bellies of the peroneal muscles. The external
and posterior aesthetic lines of the shin are evaluted in complex with contours of the specified
muscles.
5.
Neutral position of the foot (no rotation of the lower extremity, angle of 90° in the ankle
joint). Shin muscles are relaxed. Internal and external aesthetic lines of the shin are
estimated.
6.
The foot is in neutral position. The surgeon asks the patient to tense the muscles of the
foot itself, while preserving its normal position with 1 finger resting on the operating table. By
this isomentric tension of all groups of shin muscles serving as stabilizers of the foot with
shaping of muscle boundaries is achieved. Internal and external aesthetic lines of the shin
are estimated in complex with the muscular contours.
The above technique is recommended to perform with special care thus observing symmetry
of the muscular contours, estimating the intermediate result and planning the zones of the
forthcoming gel implantation. Intraoperative verbal contact with the patient is decisive at
this moment. It allows to see her ability to intentionally tense the shin muscles and to
make active movements with the lower extremities. That is why local anesthesia is
essential when performing such interventions.
Upon completion of the surgical procedure the needle is withdrawn following the preliminary
washing-out of the needle with the anesthetic solution (not more than 1,0-1,5 ml!) at the
level of the needle bevel near the upper edge of the implant.
In case of significant abnormality of the aesthetic lines it is recommended to perform staged
implantation with 1.5 - 2 month interval. This approach enables to achieve primary
21
22
organisation of the implants and prevention of their possible fusion through intratissular
fistulars that could bring to unsatisfactory cosmetic outcome.
Upon completing the endoprosthetics the operative field and the surgeon’s hands are
antiseptized (alcoholic solution of chlorine hexidine), and the implant zone is slighlty
massaged. This technique is the manual continuation of the procedure and is of singular
importance because it enables to complete intervention by means of formation of regular
lines of the shin. The surgeon performs massage movements by one hand and with the other
hand by its ulnar edge slightly pressing the injection site of the implant needle. By doing this
migration of hydrogel through intratissular fisulars resulting in the unsatisfactory cosmetic
outcome is avoided.
The implant injection sites are isolated by antibacterial plasters. Immediate result of the gel
implantation is estimated in six standard positions (see above). During 10-15 minutes the
medical staff observes the patient on the operating table to control the consequences of the
anesthetic afteraction and to prevent possible postoperative general somatic complications
(collaptoid state, etc.).
Post operative rehabilitation
Immediately after the surgical intervention during a period of one month the patient is
recommended to wear shape-forming tights that tightly embrace the shins. First 72 hours the
intervention zone should be provided relative rest, minimum physical exercise is allowed (easy
house holding, etc.). Physical inspection is performed three days later to evaluate short-term
results. The doctor answers the questions of the patients if any and explains peculiarities of
the postoperative behavior once again. During this period the patients are prescribed
Vobenzim (starting from the 3d day after the surgical procedure: 1st week – 10 pilles three
times a day, 2nd week – 7 pills three times a day 30 minutes before meal with 0.5-1 glass of
water).
The second inspection takes place in a week. It aims at detecting possible early
postoperative complications (of inflammatory character, etc.). If there are no complications
during the rehabilitation period, the patients are prescribed massage of the implant zone, one
procedure every other day during No 10 according to the generally accepted technique of
using Contraktubex gel.
The third check-up inspection is performed after one month since the surgical
intervention. During it immediate cosmetic and functional results (postoperative
photodocumention) are estimated. The patient is allowed to keep to ordinary mode of life.
Then, check-up inspections are performed after 2, 4, 6 and 12 months, later on – upon the
client’s desire.
Errors and complications
Minor bleeding occurred in one case when the implant needle was inserted into the shin tissue.
Further endoprosthetics was considered contraindicated. The implant needles were withdrawn,
and the shin was immobilized by the pressure bandage. The surgical intervention was
postponed for 14 days. Special drug therapy was not required. During the second operation
and also in early and late periods after the implantation that patient had no complications.
In one patient there was observed migration of some gel to the lower 1/3 part of the shin. The
complication was eliminated by surgical intervention (out-patient treatment under the local
anesthesia with 40 ml of Sol.Lidocaini 0.25% from the puncture) followed by short-term (3
days) immobilization of the shin by the orthes bandage that was changed for a pressure
bandage during the following two weeks period. Specific treatment was not required.
22
23
In the immediate postoperative period several patients had perifocal tissue edema after the
manipulation, as well as a moderately expressed pain syndrome. That manifistation required
strict regime observation, outpatient prescription of non-steroidal anti-inflammatory drugs in
average therapeutic dosages and was stopped by the end of two weeks since the surgical
intervention.
Unilateral myositis of the shin muscles was observed in 2 patients and was associated with
trauma of the muscle belly by the implant needle during the period of training in the surgical
procedure technique. Clinically, the complication was revealed by moderately expressed pain
syndrome during active movement in the knee and ankle joints, subfever due to intramuscular
hematoma. Myositis had uncomplicated character and was stopped outpatiently within one
month after intervention. The shins were bandaged with Sol. Dimexidi 33.0% during 5-7 days.
The relative extremity was immobilized by a soft bandage. The bandaging was applied once a
day. It was recommended to strictly observe regime and to have rest. Non-steroidal antiinflammatory drugs were prescribed in average therapeutic dosages during 10-14 days. The
outpatient course of physiotherapy with Vobensim was recommended (1st week — 10 pills 3
times per day, 2nd week — 7 pills 3 times per day, 3rd - 4th weeks — 5 pills 3 times per day 30
minutes before meal with 0.5-1 glass of water) and 2-3 courses with local application of
Contraktubex gel on the skin covering of the shin on a daily basis during 21-28 days with 1
month interval.
CONCLUSIONS
Selection of the patients for intratissular endoprosthetics is the determinative moment in
achieving success of all the rehabilitation process in contour plasty of the shin soft tissues.
1. The presented above technology for the shin soft tissues contour plasty enables to achieve
stable cosmetic results without dusturbing main functions of the lower extremities distal parts
(inching, balancing and sprining).
2. Rational combination of single-stage application of the biocompatible hydrophilic implants,
by method of consequitive injections, together with staged contour plasty of the shin soft
tissues under the conditions of isometric muscular contraction, provides the optimal cosmetic
results.
3. Adequate complex of postoperative rehabilitation measures also contributes to the best
final cosmetic results of the injection contour plasty for the shin soft tissuess by the
biocompatible hydrophilic implant.
4. Postoperative early and late complications in cases of intratissular endoprosthetics of the
shin soft tissues are usually of not severe character, and can be eliminated by outpatient
treatment, if it is done timely and adequately.
5. Biomechanical method is most acceptable way of dynamic control over the outcome of the
contour plasty of the shin soft tissues with hydrogel. It can confirm the absence of funcional
disorders within the distal parts of the lower extremities in the short-term and long-term
postoperative periods. Information value of the examination increases when it already starts
at the preoperative stage.
6. Dynamics of the personal status of the patients is the integral part of the cosmetic
correction result. Efficacy of the intervention performed may be determined by correlation of
the psychological characteristics of the patients before and after implantation.
23