Safety profile

A Product is not to be used in case of damage of container, disruption of the packaging integrity or suspicion of product non-sterility.

The product is not to be applied in case of contra-indications related to general diseases or local pathological processes if there is a risk of some adverse events/effects or complications.

It is prohibited to perform Aquacore® hydrophilic gel injection procedure in following conditions:

General conditions:

◉ patient is younger 18 years

◉ general poor health conditions

◉ apparent breast ptosis (stages 2-3)

◉ presence of already implanted shell implants

◉ pregnancy

◉ less than nine months after child birth,

◉ patient is breast feeding or lactating

◉ planned pregnancy within next 12 months

◉ lack of mammary gland tissue between nipple and chest muscle

◉ blood coagulation problems

◉ menstrual cycle disruptions

◉ acute inflammatory disease

◉ various autoimmune diseases

◉ intolerability or allergy to medicines

◉ any kind of coagulopathy, prescribed intake of anticoagulants or aspirin at the date of procedure

◉ vascular diseases of various origin

◉ poor mental condition


Local conditions:

◉ active skin inflammation process in injected areas

◉ active subcutaneous inflammation process in injected areas;

◉ chronic dermatitis;

◉ chronic skin contagious diseases in sustained remission stage or recrudescence;

◉ nodular type mastopathy

◉ benign mammary diseases

◉ breast cancer

◉ acute mastitis

◉ acute soft tissue inflammatory process at the buttock region

◉ benign skin diseases in injected areas

◉ malignant skin diseases of any localization

◉ mastoptosis 3d degree

◉ constricted lower pole of the breast

◉ tubular breast deformity

APPLICATION RESTRICTIONS

DO NOT INJECT PRODUCT INTRAVENOUSLY AND PREVENT INNTRAVASCULAR INJECTION
DON NOT INJECT IN THE AREAS OF VENOUS PLEXUSES AND INTO THE CAVERNOUS BODY INTRADERMALLY
AVOID TO INJECT PRODUCT INTRADERMALLY IN EXESSIVE VOLUMES
AVOID HYPERCORRECTION
AVOID PRODUCT INJECTION BELOW SITTING LINE FOR BUTTOCKS AUGMENTATION