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IMPORTANT SAFETY INFORMATION1

  • Sculptra should not be used in any person who has hypersensitivity to any of the components of the product.
  • Use of Sculptra in any person with active skin inflammation or infection in or near the treatment area should be deferred until the inflammatory or infectious process has been controlled.
  • There are several precautions that are important to discuss with your healthcare practitioner prior to treatment. Inform your healthcare practitioner if you have any of the following:
    • If you are using anticoagulants as may run the risk of a hematoma or localized bleeding at the injection site.
    • If you have a known history of or susceptibility to keloid formation or hypertrophic scarring.
    • If a laser treatment, chemical peel or any other procedure based on active dermal response is performed before or after the treatment. There is a possible risk of eliciting an inflammatory reaction at the implant site.
  • Injection procedure reactions to Sculptra have been observed consisting mainly of hematoma, bruising, edema, discomfort, inflammation, erythema, transient bleeding from an area the size of the point of the needle or transient pain, localized redness at the injection site and ecchymosis. The most common device related adverse effect was the delayed occurrence of subcutaneous papules, which were confined to the injection site and were typically palpable, asymptomatic and non-visible.
  • Rare but serious adverse events associated with the intravascular injection of soft tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage, leading to stroke, skin necrosis, and damage to underlying facial structures. You should discuss the potential treatment risks with your healthcare professional so you are aware of signs and symptoms of potential complications.
  • After the treatment minimize the exposure of the treated area to excessive sun and avoid UV lamp exposure until any initial swelling and redness has resolved.
  • Product should only be administered by trained healthcare professionals.
  • This product has not been tested in pregnant or breastfeeding women.
  • Not for use in children under 18 years of age.
  • Discuss all potential risks with your healthcare practitioner prior to treatment. This is only a partial list of safety information.
  • Injection-related adverse events such as bruising, erythema, itching, swelling, pain and tenderness may occur. These side effects generally resolve spontaneously within one week after injection. Other potential side effects can occur with dermal filler injections. You should discuss the potential treatment risks with your healthcare professional.

1. Sculptra® (poly-L-lactic acid). Instructions for Use. 2016.