Types of FDA-Approved Dermal Fillers

Explore the most trusted FDA approved dermal fillers for smoothing wrinkles, restoring volume, and enhancing facial contours. Learn about different types, their uses, and what to expect during treatment. Get trusted information to help you make informed cosmetic enhancement choices. For more information, contact us today or schedule an appointment online. Spa Blue is located over at 7565 W Sand Lake Road, Orlando, FL 32819

Table of Contents:

How can I verify if a dermal filler is FDA-approved?
Are FDA-approved dermal fillers safe for everyone?
Can dermal fillers be used for body contouring or breast augmentation?

Dermal fillers have revolutionized the field of cosmetic dermatology, offering non-surgical solutions to address wrinkles, facial volume loss, and other signs of aging. In the United States, the Food and Drug Administration (FDA) is responsible for ensuring that these products are safe and effective for consumers. This guide provides a thorough overview of FDA-approved dermal fillers, their types, uses, safety considerations, and answers to common questions, all supported by official government references.

Understanding Dermal Fillers and FDA Approval
Dermal fillers are injectable substances used to restore lost facial volume, smooth wrinkles, and enhance facial contours. The FDA classifies these as medical devices, and only products that have undergone rigorous clinical testing for safety, efficacy, and manufacturing quality receive FDA approval. This distinction is crucial: FDA approval means a product has met high standards and is cleared for specific uses, while non-approved fillers may pose significant health risks.

To see a current list of FDA-approved dermal fillers and their intended uses, visit the official FDA Dermal Fillers page.

The FDA has approved several types of dermal fillers, each with unique properties and indications:

1. Hyaluronic Acid (HA) Fillers
Hyaluronic acid is a naturally occurring substance in the skin that helps retain moisture and volume. HA fillers are the most commonly used and approved dermal fillers in the U.S.

• Examples: Juvéderm® (Ultra, Voluma, Volbella), Restylane® (Lyft, Silk, Kysse), Belotero Balance®
• Uses: Smoothing moderate-to-severe wrinkles (like nasolabial folds), lip augmentation, cheek enhancement, and under-eye hollows.
• Duration: Results typically last 6 to 18 months, depending on the product and treatment area.
• FDA Reference: FDA Hyaluronic Acid Fillers

2. Calcium Hydroxylapatite (CaHA) Fillers
CaHA is a biocompatible mineral found in bones.

• Example: Radiesse®
• Uses: Deeper facial wrinkles and folds, such as marionette lines and chin wrinkles. Sometimes used for hand augmentation.
• Duration: Results last approximately 12 to 18 months.
• FDA Reference: The FDA has approved CaHA fillers for specific facial indications, and these are not absorbed by the body as quickly as HA fillers.

3. Poly-L-lactic Acid Fillers
This synthetic, biodegradable substance stimulates the skin’s own collagen production.

• Example: Sculptra® Aesthetic
• Uses: Gradual correction of facial volume loss, especially for hollow cheeks or temples.
• Duration: Results can last over 2 years as collagen builds in the skin.
• FDA Reference: Sculptra® FDA Information

4. Polymethylmethacrylate (PMMA) Fillers
PMMA consists of tiny microspheres suspended in a collagen gel.

• Example: Bellafill®
• Uses: Long-term correction of nasolabial folds and treatment of certain types of acne scars.
• Duration: Results are considered semi-permanent or long-lasting.
• FDA Reference: Bellafill® is the only FDA-approved filler made from a material that remains in the body and is not absorbed.

Key FDA Guidance and Safety Information

• Approved Uses Only: The FDA approves fillers for specific facial areas and purposes (e.g., smoothing wrinkles, restoring volume). It does not approve fillers for large-scale body contouring, breast augmentation, or buttocks enhancement. Using fillers outside FDA-approved indications can result in severe complications. Read FDA’s safety communication.
• Qualified Providers: Only licensed, trained healthcare professionals should administer dermal fillers. The FDA has issued warnings against self-injection and the use of needle-free devices, which are not approved for filler administration.
• Product Ingredients: Some FDA-approved fillers include lidocaine to reduce discomfort during injection. Always review the product’s ingredients and ask your provider about potential allergies.
• Risks and Side Effects: Side effects may include swelling, bruising, redness, tenderness, lumps, or rare complications like infection or vascular occlusion. The FDA recommends reviewing the product’s patient labeling and discussing risks before treatment.