Merz Aesthetics Receives FDA Approval for RADIESSE Treatment

The injectable dermal filler is now approved for reducing wrinkles in the décolleté area.

Apr. 8, 2026 at 5:45pm

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A ghostly, translucent X-ray photograph revealing the internal structure of a human chest, with the ribs, sternum, and soft tissue glowing against a dark background, conceptually representing a new injectable treatment for the delicate décolleté area.A new FDA-approved injectable treatment offers a non-surgical option for smoothing wrinkles and improving the appearance of the delicate décolleté area.Today in Raleigh

Merz Aesthetics, a leading pharmaceutical company, has received approval from the U.S. Food and Drug Administration (FDA) to market its RADIESSE injectable dermal filler for the treatment of wrinkles in the décolleté, or upper chest, area. RADIESSE is a calcium-based injectable that helps stimulate the body's natural collagen production to smooth and rejuvenate the skin.

Why it matters

This FDA approval expands the approved uses of RADIESSE, which was previously only cleared for facial wrinkle treatment. The décolleté area is a common concern for many women, as it can show early signs of aging and sun damage. This new approval provides an additional non-surgical option for patients seeking to improve the appearance of their chest and upper body.

The details

RADIESSE is an injectable dermal filler made of calcium-based microspheres suspended in a water-based gel. When injected, it provides immediate volume and lift to smooth wrinkles, while also stimulating the body's natural collagen production over time for long-lasting results. The FDA approval was based on clinical studies demonstrating the safety and efficacy of RADIESSE for improving the appearance of wrinkles in the décolleté area.

  • The FDA approval for using RADIESSE in the décolleté area was granted on April 8, 2026.

The players

Merz Aesthetics

A leading pharmaceutical company that develops and markets aesthetic and therapeutic solutions, including the RADIESSE injectable filler.

RADIESSE

An injectable dermal filler made of calcium-based microspheres that helps smooth wrinkles and stimulate collagen production.

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What’s next

Merz Aesthetics plans to immediately begin marketing and distributing RADIESSE for the new décolleté indication, making it available to dermatologists and plastic surgeons across the United States.

The takeaway

This FDA approval for using RADIESSE in the décolleté area provides patients with a new non-surgical option to address common signs of aging and sun damage in this often-overlooked area. It expands the versatility of this popular injectable filler and gives providers another tool to help their patients achieve a more youthful, rejuvenated appearance.