Information on Sculptra®

Sculptra® working naturally to restore facial volume, correct contour defects and increase dermal thickness, for longer

Why Sculptra®?

The natural ageing process causes skin to lose its full, firm, youthful appearance. Skin becomes thinner and loses its elasticity, causing wrinkles and folds to appear.¹ Fat tissue is lost and patients look older. Sculptra® can help restore lost volume to the face and smooth deep folds and wrinkles.²

Who?

For patients who want to restore volume and contour to their face or lose deep lines and folds.²

Sculptra® is injected into the deep dermis or subcutaneous layer and is ideal for³:

Upper Face

• Temple concavity

Mid Face

• Nasolabial folds
• Buccal concavity

Lower Face

• Marionette lines
• Oral rhytides³

How Sculptra® Works

Volume effects for up to 2 years

A recent European study⁴ has shown:-

• Long-lasting correction of small and large tissue defects
• Volume effects were found to persist in numerous patients for up to 2 years
• Sculptra® has potential to improve quality of life

Sculptra® a facial aesthetic treatment option:-

• Some dermal filling devices do not provide long term correction of facial lipoatrophy⁵
• Permanent implants and injectable products cannot accommodate continued changes in appearance that occur with age⁵
• Compared with fillers PLLA (Sculptra®) provides more suitable volume enhancement to correct the signs of lipoatrophy⁵

Sculptra® safety

• Contains Poly-L-lactic acid which is biocompatible and biodegradeable²
• Synthetically produced and allergy testing is unnecessary²
• Used in medicine for over 25 years and has a good safety profile¹²
• PLLA has been safely used for about 10 years in orthopaedic and facial surgery and for the correction of scars and wrinkles⁶
• Well tolerarated⁷
• Minimally invasive with a low frequency of side effects⁸

Sculptra® working naturally to restore facial volume and correct contour defects, for longer

• Replaces lost volume caused by ageing²
• Corrects deep folds, wrinkles and contour defects²
• Increases dermal thickness⁹
• Long-lasting natural appearance with results lasting for up to 2 years after your last treatment⁴
• Biocompatible and biodegradeable²
• Allergy testing is unnecessary
• Used in orthopaedic and facial surgery and for the correction of scars and wrinkles⁶
• Low frequency of side effects⁸

Important information about Sculptra®

INTENDED USE

Increase the volume of depressed areas, particularly to correct skin depressions.

OTHER USES

Large volume restoration and/or correction of the signs of facial fat loss (lipoatrophy) including HIV patients treated with antiretroviral drugs.

Contraindications

SCULPTRA® should not be used in any person who has hypersensitivity to any of the components of the product. Do not use in the case of acute or chronic skin disease (infection or inflammation) near the area to be treated. Treatment should be deferred until the inflammatory or infection has been controlled.

Warnings

SCULPTRA® should only be used subcutaneously or deep intradermally. Avoid superficial injections in order to avoid the appearance of early papules or nodules at the injection site, which could be suggestive of improper injection techniques (superficial placement, excessive amount of product, incorrect reconstitution). In addition, massaging the treatment area to ensure proper distribution of the product may also minimize the appearance of papules or nodules.

SCULPTRA® vials are for single patient use only. Do not re-use or re-sterilise the vial. Do not use if package or vial is opened or damaged.

Do not inject into a blood vessel, to avoid the risk of skin infarction or embolism of a blood vessel. The fluidity of SCULPTRA® makes it easy to aspirate with the syringe before injection, to ensure that the needle is not in a blood vessel.

Do not over-correct a contour deficiency, because the depression should gradually improve within several weeks as the treatment effect of SCULPTRA® occurs.

Caution must be taken when injecting SCULPTRA® in areas of thin skin, especially in the peri-orbital and the peri-oral areas. An increased risk of papules and nodules in the periorbital area has been reported. Refer to instructions for use for information regarding injection techniques.

Do not inject into the red area of the lip (vermillion).

Always mix the powder with sterile water for injections (sterile water for injections: in compliance with European Pharmacopoeia).

For implantation of SCULPTRA® , use 26 G needles with single-use sterile syringes.

Single patient use only: The reconstituted product is usable for 72 hours following reconstitution. Discard any material remaining after each patient use or after 72 hours following reconstitution.

PRECAUTIONS FOR USE

The injection site should be cleaned with an antiseptic and free from inflammation or infection.

As with all injections, patients treated with anti-coagulants may run the risk of a haematoma or localized bleeding at the injection site.

The safety of SCULPTRA® for use during pregnancy, in breastfeeding women or in patients under 18 years has not been established.

No studies of interactions of SCULPTRA® with drugs or other substances or implants have been made.

SCULPTRA® should only be used by health care providers with expertise in the correction of volume defects after fully familiarizing themselves with the product, the product education materials and its complete instruction leaflet.

The safety of using SCULPTRA® in patients with increased susceptibility to keloids formation and hypertrophic scarring has not been established.

The patient should be informed that exposure of the treated area to excessive sun, UV lamp exposure until any initial swelling and redness has resolved should be minimized.

Side effects

The adverse reactions considered to be possibly or probably related to the administration of poly-L-lactic acid have been obtained from clinical studies or detected from post-marketing surveillance and literature reports.

Injection site reactions

• Injection site haemorrhage
• Injection site pain
• Injection site induration
• Injection site swelling

Immune system disorders

• Hypersensitivity
• Angioedema
• Skin sarcoidosis

Infections and infestations

• Injection site infection, including cellulitis (facial), staphylococcal infection
• Injection site abscess

Skin and subcutaneous tissue disorder

• Bruising
• Hematoma
• Injection site atrophy, skin hypertrophy
• Injection site erythema
• Injection site urticaria
• Telangiectasis
• Subcutaneous papules, non visible, typically palpable, asymptomatic
• Visible nodules, including periorbital nodules, with or without inflammation or discoloration.
• Granuloma

The early occurrence of subcutaneous nodules at the injection site (within 3 to 6 weeks after the treatment) may be minimized by adhering to proper dilution and injection techniques (refer to Precautions).

Sculptra® can only be used by Healthcare Professionals who have been trained in the use of Sculptra® techniques. To become a Sculptra® practitioner, please contact us. To download product information click here.