Sculptra should only be used in the deep dermis or subcutaneous layer.
Improper injection techniques such as superficial placement, excessive amount of product or incorrect reconstitution may lead to appearance of papules or nodules at the injection site. Massaging the treatment area to ensure proper distribution of the product may minimise the appearance of such papules or nodules.
This product must not be injected intramuscularly or intravascularly. Localised superficial necrosis and scarring may occur after injection in or near vessels. It is thought to result from the injury, obstruction, or compromise of blood vessels. Special caution should be taken if the patient has undergone a prior surgical procedure in the planned treatment area. Areas with limited collateral blood flow has an increased risk of ischaemia. Aspiration prior to injection is recommended.
Unintentional introduction of soft tissue fillers into the vasculature in the face may lead to embolisation, occlusion of the vessels, ischaemia, necrosis or infarction at the implant site or in the area supplied by the blood vessels affected. Rare but serious adverse events include temporary or permanent vision impairment, blindness, cerebral ischaemia or cerebral haemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if any of the following symptoms occurs, including changes in vision, signs of a stroke, blanching of the skin, or unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and possibly evaluation by an appropriate health care practitioner specialist, should an intravascular injection occur.
Do not overcorrect (overfill) a contour deficiency, because the depression should gradually improve within several weeks as the treatment effect of Sculptra occurs. If an overcorrection occurs, the area concerned should be thoroughly massaged to ensure proper distribution of the product.
Do not inject into the red area of the lip (vermillion).
Sculptra vials are for single patient and single session use only in order to avoid contamination. Do not re-use the vial and do not re-sterilise the vial. Discard immediately after use. Do not use if package or vial is opened or damaged.
Always reconstitute the powder with sterile water for injection.