As a rule, Aquacore® hydrophilic gel application is not accompanied with any adverse events/effects. The most often body contouring procedures are fully painless and are not followed by any unfavorable senses or reactions. However, sometimes fever and weakness or mild pain can be felt. In case of general signs of posttraumatic adverse reactions, it is recommended to take analgesic and anti-inflammatory drugs. Mostly these symptoms disappear in a few days.

In addition, some transient limited local adverse events/effects caused by the procedure can appear. In some cases, the local pain, post-operative swelling (very frequently), redness, tingling, itching, bruising (frequently), skin induration, skin pigmentation, gel fragmentation (rarely), hematoma, injection related inflammations (very rarely) can be observed. Allergic intolerability to the implant can be very rarely recorded.

Typically, injection related local reactions are resolved spontaneously within few days. In case of signs of posttraumatic local edema, bruising or hematoma it is recommended to apply cold therapy on an area of injection.

If uneven gel distribution, implant displacement or any irregularities have been observed the gel drainage can be attempted. Adequate soft tissue cover and support, as well as correct gel placement and injection technique are important parameters to minimize occurrence of these events.

If there are signs of local inflammation or infection process are suspected the combination of anti-inflammatory treatment and antibiotic therapy for 5 to 7 days should be prescribed. For more severe cases of infections, removal of the gel by drainage must be used in addition to antibiotic therapy.

All adverse events/effects or complications must be reported directly to LLC Beauty Systems.

POSSIBLE COMPLICATIONS. RECOMMENDATIONS

Non-inflammatory complications

Subcutaneous haemorhage or hematoma

It may occur during the procedure and do not require any special treatment. If blood flows slowly through the small cannula or implantation needle out, implantation procedure should be stopped for 3-5 minutes. Tight compression by finger should be applied on the injection place. That way haemostasis is been controlled and then the procedure may be continued. In case of intensive continuous bleeding the procedure must be stopped completely and cannula pulled out.

Gel penetration among the segments of the mammary gland

It is not a serious complication. Gel penetration might occur due to involution weakness of mammary glands connective tissues, excessive amount of the injected gel or uneven distribution of the gel throughout the breast tissues. To manage appeared irregularities, it is recommended to redistribute them intraoperatively by light manual massage. In case of overcorrection if necessary it is possible to perform decompressive puncture and drain the gel.

Gel leakage through the skin puncture channel to outside

It might occur under the following conditions:

excessive amount of the gel injected;

failure to comply with rules during the procedure;

excessive pressure over the treated zone in early postoperative period;

breach of regime in the postoperative period (not prone to sleep etc.).

To prevent such complications, it is recommended to follow the recommendations for post-treatment period.

Gel fragmentation

It might occur with the patients who underwent lactational mastitis before and which resulted with severe cicatrical adhesions inside the breast.

In such cases during the preoperative planning the patient should be examined in detail and, if it is necessary, injection area should be investigated with an ultrasound or mammography. If such a complication happened, it is recommended to make decompressive puncture to remove the fragmented gel.

Inflammatory complications

Inflammatory complications might occur due to improper aseptic and antiseptic conditions while the treatment procedure is performed, or any violations of the techniques of implant injection.

If there is a suspicion for latent inflammatory process, preventive antibiotic therapy should be given to the patient at least for 3-5 days

besides that, it is recommended to apply bandage on the inflammatory zone with mixture of sol. dimexidi diluted in 0,5% lidocaine 1:5 with 1,0 g antibiotic from cephalosporinsand 0,1 ml 1% hydrocortisone (1 mg) for a period from five to seven days.

If conservative therapy (antibiotic + local treatment) did not stop the inflammation process, inflammation should be treated by means of decompressive puncture of inflamed area with aspiration of exudates and cleaning of the inflammation zone.

WARNINGS

To avoid aforementioned events/effects or complications:

Do not use Aquacore® hydrophilic gel if the package is damaged or the sterility of gel is compromised due to non-intendedly opened package.

Do not use the product after storage expiration date.

Do not use the product outside medical facilities.

Do not mix Aquacore® hydrophilic gel with any other non-liquid substances.

Do not inject the product into superficial layer of skin.

Do not inject the gel intravascularly. This risk can be minimized by using appropriate blunt cannulas.

Do not inject the gel into venous cavernous plexus such as zone of genitals.

Do not inject the gel into mucous and submucous layers.

The Aquacore® hydrophilic gel container is intended for single use and for one patient only, reuse is strictly prohibited.

Avoid hypercorrection while the gel is injected.

Use product Aquacore® hydrophilic gel only as it is stated in “INDICATIONS” section of this instruction.