Sculptra, a poly-L-lactic acid (PLLA) injectable biostimulator, has received European Union Medical Device Regulation (MDR) certification for expanded aesthetic use on the body.
Previously only indicated for facial treatment in the EU, the product is now approved for four additional anatomical areas: the gluteal region, posterior thighs, décolletage, and upper arms. The certification confirms compliance with updated EU standards for safety, performance, and quality.
The expanded approval follows clinical studies showing Sculptra can be used to address skin-quality changes, including the appearance of cellulite, as well as reduced firmness, soft-tissue volume, and contour irregularities associated with ageing.
Clinical Evidence Across New Treatment Areas
Findings reported from studies in the newly authorised body zones include:
• Gluteal area: Six months after treatment, 84% of individuals were rated as “improved” or better by physicians using a global assessment scale; 96% of participants reported high satisfaction.
• Posterior thighs: Visible improvement was documented as early as one month. At 12 months, 100% showed visual improvement and 93% reported decreased sagging. 97% expressed satisfaction, and 83% indicated they would repeat treatment.
• Décolletage: Wrinkle reduction was observed in 13% of patients at one month and in 93% by month nine. More than 80% reported improvements in texture and firmness.
• Upper arms: Skin-firmness and quality improvements were noted two months after completing a three-session protocol, accompanied by positive patient-reported outcomes.
Sculptra’s mechanism of action targets extracellular-matrix decline by stimulating collagen and elastin. Progressive changes may become visible within one month and have been reported to last up to two years, depending on area and protocol.
Reflecting Shifts in Aesthetic Treatment Demand
According to survey findings referenced by the company, nine in ten women report aesthetic concerns involving the body as well as the face, with demand growing in areas such as the gluteal silhouette. The expanded Sculptra certification aligns with the trend toward integrated facial and body rejuvenation in clinical practice.
“The certification of Sculptra for body indications in the EU marks an exciting evolution in injectable aesthetics," says Galderma CEO Flemming Ørnskov. "With these new body indications extending Sculptra's trusted profile beyond the face, we are empowering practitioners to deliver natural-looking, long-lasting results across broader treatment areas, reinforcing Galderma’s commitment to innovation and holistic patient care.”
Regulatory and Market Context
Sculptra was first approved in the EU in 1999 for facial volume restoration, establishing PLLA-based injectables as a biostimulatory category. The MDR approval is part of the manufacturer’s broader regulatory transition across its portfolio of aesthetic injectables and devices.
Prior to the new EU certification, Sculptra’s use outside the face — for buttocks, thighs, décolletage, arms etc. — existed, but generally as off-label or under limited local approvals (e.g. Brazil), rather than as widely authorized, label-approved body-indication in major regulated markets.
