Device Dossier
Sculptra Poly-L-lactic acid - Dermal tissue reconstructive material, synthetic polymer
Device Dossier for Sculptra Poly-L-lactic acid - Dermal tissue reconstructive material, synthetic polymer (Dermal tissue reconstructive material,…
- GMDN category: Dermal tissue reconstructive material, synthetic polymer
- Sponsor: Galderma
Intended purpose
Sculptra is suitable for increasing the volume of depressed areas of the face, particularly to correct skin depressions, such as in skin creases, wrinkles, folds, and for skin aging. Sculptra is also suitable for large volume corrections of the signs of facial fat loss (lipoatrophy).
Functional description
Sculptra consists of a suspension of solid poly-L-lactic particles of which is injected with a 25g or 26g needle into the deep dermis, subcutaneous layer or into the supraperiosteal plane, where they provide soft tissue augmentation that will improve over the course of a few weeks, as the microparticles are gradually surrounded by host connective tissue. The depth of injection and quantity of Sculptra used depend on the area to be treated and the result expected.