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Aquafilling® bodyline
Instruction for use
ComposItIon:
- has very small distance from the teat to the submammary fold; - has blood coagulation troubles, menstruation abnormalities; 0,9 % physiologic solution of sodium chloride – 98 %.
- currently takes anticoagulants or aspirin ;- has a skin infection or inflammatory disease; DesCrIptIon
Aquafilling® is a sterile synthetic biocompatible with the human - has acute contagious diseases of specific and nonspecific etiology; tissues hydrophilic gel with high safety level which structure is - has chronic contagious diseases in sustained remission stage based on multiple hydrogen H-bonds, arising between carbonyl and amine groups. The gel can be applied in plastic, aesthetic, and - has intolerability or allergy to medicines; reconstructive surgery. Information about sterilization method is - has vessels diseases of different etiology; printed on the outer package. The volume contained in each con- - has severe general somatic diseases, oncology.
tainer is stated on the outer package.
WarnIng:
InDICatIons
1. Do not inject the gel intravenously.
Hydrophilic gel is recommended for application under the following 2. Do not inject into venous plexus and cavernous bodies.
3. avoid hypercorrection.
1)contour correction of body soft tissues; Usage reqUIrements
Open the primary package, pull the package with the sterile gel out, check the cork control, take the control off.
4)removal of mammary hypomastia accompanied by glandulous, skin and combined mastoptosis of 1-2 type; treatment proCeDUre
5)removal of asymmetry of soft breast tissues; The procedure with application of Aquafilling® gel is to be per- 6)removal of deformities of the breast tissues; formed by authorized medical personnel in accordance with 7)improvement of breast volume and shape ; • Before starting the procedure the doctor should inform the
moDe of aCtIon
patient about the indications,contraindications, expected Aquafilling® is a positive charged filler, that does not damage results, warning and possible adverse events, complications. electroconductivity in tissues, blocks negatively charged free • All intervention procedures are to be performed under
radicals of active forms of oxygen, which increases the resist- strong aseptic and antiseptic conditions. Proper disinfection ance to aging process. Aquafilling® increases the electropoten- of the treatment area must be performed prior to injection. tial of surrounding tissues, normalizes microcirculation in the • Preliminary marking of the treatment area definition of its
injection area. Thanks to its positive charge it attracts nega- tively charged molecules of collagen and elastin, thus provid- • The operative intervention should be performed under local
ing long-lasting elasticity and strength of the skin.
• The G16-18 implantation needles of 45-50 mm of length and
As 98 % of its composition is made up of 0,9 % physiologic so- the G14 venous catheter needles of 80-85 mm of length lution of sodium chloride, the gel is slowly absorbed by a should be used for breast augmentation and the G14 venous human body, thus providing a long-lasting aesthetic effect. It catheter needles of 80-85 mm of length should be used for does not enter into reaction with earlier injected fillers and can be administered in the same anatomical areas in case of insuffi- • The gel should be injected in the retromammary region with
minimum alteration of the needle position during theprocedure.
Contra-InDICatIons:
• Before starting the procedure preliminary marking of the
• Do not use the product if the package is damaged or the
• Before contour plastic interventions a patient examination
• Do not perform the procedure under the following conditions,
should be done: clinical blood analysis, AIDs, Hbs, Ag, Anti HVC, RW, ECG (for course), coagulogram – start and termination points, clinical urine analysis, ultrasound, • The patients with acute inflammation diseases in sustained
remission stage and those with acute inflammation processes in their anamnesis are recommended to undergo preventive antibiotic therapy. 24 hours prior to the intervention During the intervention planning it is necessary to bear in mind all and during 5-7 days after the procedure it is recommended individual characteristics of a patient and be ready to face such to prescribe cephalosporin antibiotic therapy for such category complication. If it is necessary it is recommended to make puncture decompression of the gel, preliminary diluted with anaesthetic.
• Before and after the treatment procedure the patients are
• To prevent bruising and edema formation, cold therapy is
recommended during the initial period for one to two hours.
It is associated with trauma of the muscle belly by the implantneedle during the procedure. In this situation the breast shouldbe bandaged with sol. dimexidi diluted in 0,5% lidocaine 1:4 possIble ComplICatIons. reCommenDatIons for
with antibiotics, hydrocortisone for five to seven days.
treatment
Inflammatory complications
Non-inflammatory complications
Inflammatory process in the region of intervention It may occur due to improper aseptic and antiseptic conditions, It may occur in the process of the procedure and do not require in case of active nidus in the organism.
any special treatment. If blood is coming from implantationneedle the operation should be stopped for 5-10 minutes.
If there exist suspicion on inflammatory process, first of all it is Compression should be placed on the needle site, haemostasis recommended to place on inflammatory zone the bandages should be controlled, then the procedure may be continued.
with sol. dimexidi diluted in 0,5% lidocaine 1:4 with antibiotics,hydrocortisone for five to seven days.
In case of massive bleeding the procedure must be stopped.
In case of necessity intramuscular antibiotic pluripotential ther- Gel penetration among the segments of the mammary gland apy (cephalosporin) should be prescribed. If there is no positivechanges from the therapy indicated, decompression by punc- It is not a complication. Gel penetration may occur under the ture aspiration of exudates with injection of antibiotics in the proDUCt form
2)involution weakness of connective tissues Container 50 g, 100 g with Luer Lock cap.
3)excessive amount of the gel injected4)uneven distribution of the gel throughout the tissues storage
Store up between +5 °С and 40 °С. Protect from freezing and
During intraoperative and postoperative periods it is recom- sunlight. In case of suspicion that the package is unsealed or mended to distribute the gel evenly by massage and palpation.
damaged the gel is prohibited to for application. If it is necessary it is permitted to make puncture decompres-sion of the gel, preliminary diluted with anaesthetic.
shelflIfe
Three years from manufacturing date.
Gel penetration from puncture channel to the subcutaneous cellular layer manUfaCtUrer
Matrixcell Ltd.
It may occur under the following conditions: 3)pressure over the zone of operation in the short-term post- www.aquafilling.com
operative period4)failure to observe medical recommendations on the regimein the postoperative period (not prone to sleep etc.).
To prevent such complication appearance it is recommendedto follow the rules of the gel injections.
It may occur among the patients who had postlactational mas-titis before and it responds to commissura process.

Source: http://www.aquafilling.cz/userfiles/image/download/Bodyline%20manual.pdf