Galderma earns EU approval for bone-mimicking Restylane Shaype filler

Galderma secured European Union approval under the Medical Device Regulation for Restylane Shaype, a hyaluronic acid injectable designed to mimic bone for temporary chin augmentation. Utilizing the company's NASHA HD technology, the gel is engineered to shape the lower face with high lift capacity, mimicking structural bone support without surgery. The regulatory clearance expands the product's footprint, adding the EU to its existing approvals in Canada and Brazil.

In the 12-month clinical study, investigators used a specific "Shayping Technique" to inject the supraperiosteal plane. Results showed that 83% of participants had improved lower face structure at three months, and 66% maintained this correction at 12 months. Additionally, 84% of patients maintained a self-reported improvement in their chin profile through one year.

For your practice, this development highlights a shift toward highly specialized, high-lift fillers designed for deep supraperiosteal placement. While we wait to see when this formulation reaches the US market, it signals a growing international clinical focus on non-surgical jawline and chin projection, offering a viable alternative to surgical implants for patients seeking structural correction.

Source: Plastic Surgery Practice, https://www.plasticsurgerypractice.com/treatment-solutions/injectibles/dermal-fillers/eu-approves-galdermas-restylane-shaype-for-chin-augmentation/