Is Stylage FDA Approved?

Last Updated On: September 3, 2024

FDA approval is critical when considering cosmetic treatments, as it ensures products meet strict safety and efficacy standards. In the United States, the FDA’s rigorous approval process covers everything from clinical trials to manufacturing practices, offering patients and practitioners confidence in the treatments they choose.

Stylage, a popular brand of dermal fillers, is known for its innovative use of hyaluronic acid to provide natural-looking results. Developed by Laboratoires Vivacy, Stylage offers a range of products designed to address various aesthetic concerns, from fine lines to volume loss.

In this article, we will explore whether Stylage has received FDA approval, examining the criteria it meets and what this means for consumers seeking safe and effective cosmetic treatments.

Key Takeaways

• FDA approval is crucial for ensuring the safety and efficacy of dermal fillers. While Stylage is not FDA-approved in the U.S., it has received regulatory approvals in other regions and is widely used in Europe and various countries.
• Stylage fillers have shown high safety, efficacy, and quality standards in clinical studies. Patients have reported significant improvements in facial volume and aesthetic enhancements with good safety and tolerability.
• Experts continually monitor the performance of Stylage fillers and track any reported side effects, ensuring ongoing safety and effectiveness of the treatments.
• Patients considering Stylage fillers should be aware of potential side effects, including redness, swelling, bruising, tenderness, lumps or bumps, itching, skin discoloration, infection, delayed allergic reactions, and very rare vascular complications.

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CROSS LINKED HYALURONIC ACID

LIDOCAINE

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Understanding FDA Approval for Dermal Fillers

The FDA’s approval is a critical benchmark in the cosmetic industry, ensuring that dermal fillers meet stringent safety and efficacy standards. This approval process involves a thorough evaluation of clinical data, which helps protect consumers from potential risks associated with unregulated products. FDA-approved fillers are trusted by practitioners and patients, ensuring their quality and effectiveness.

To receive FDA approval, dermal fillers must undergo rigorous testing to demonstrate their safety, efficacy, and quality. This includes clinical trials that assess the product’s performance in real-world conditions, ensuring it delivers the intended results without significant adverse effects. The FDA also evaluates the manufacturing processes to ensure consistency and reliability, further guaranteeing that approved products meet high-quality standards.

Safety Profile of Stylage Dermal Fillers

Stylage fillers meet high safety, efficacy, and quality standards, making them a good choice for improving appearance. 

Image courtesy of Reddit

A postmarket clinical follow-up study evaluated Stylage XL Lidocaine (Laboratoires VIVACY, Paris, France) for facial volume augmentation and restoration. Participants (healthy patients aged 30-65) received subcutaneous injections in the cheekbones (essential area) and other optional areas. 

Image courtesy of Fabbylips

Results showed a significant improvement in facial volume at 6 months compared to baseline (mean FVLS score: 2.3 vs. 3.1; P < .0001). Patients remained satisfied with aesthetic improvements even at 12 and 18 months, and Stylage XL Lidocaine demonstrated good safety and tolerability. While more studies are needed, these findings highlight Stylage’s potential as a reliable dermal filler for enhancing facial features.

Regulatory Approvals in Other Regions

Stylage is widely used in Europe and other regions despite not being FDA-approved in the U.S. It is authorized in various countries to treat various aesthetic concerns, and many users report positive results from treatments like Stylage for under eyes or lips.

This indicates that Stylage remains valuable in other markets despite lacking FDA backing. Approval standards vary by country, so what’s permitted in one region may not be in another.

Post-Marketing Surveillance and Reported Side Effects

After Stylage fillers are on the market, experts monitor their performance and track any side effects. This ongoing observation ensures safety and helps identify issues early. Patient feedback and experiences guide doctors in improving care, ensuring everyone benefits from safe and effective treatments.

Like all medical treatments, Stylage fillers have possible side effects:

• Redness at the Injection Site: Redness may appear immediately after the injection and typically subsides within a few hours to a couple of days.    
• Swelling: Swelling is common, especially in delicate areas like the lips or under the eyes. It usually resolves within a few days.  
• Bruising: Bruising can occur at the injection sites, often fading within a week.  
• Tenderness or Discomfort: Some patients experience mild tenderness or discomfort in the treated area, which usually subsides within a few days.  
• Lumps or Bumps: Small lumps or uneven texture may develop, but these often resolve on their own or can be gently massaged away.  
• Itching: Mild itching around the injection site can occur but is typically short-lived.  
• Skin Discoloration: In rare cases, temporary skin discoloration may be noticed in the treated area.  
• Infection: Though rare, infections can occur if proper hygiene and injection techniques are not followed.  
• Delayed Allergic Reactions: Although uncommon, some patients may experience delayed hypersensitivity or allergic reactions to the hyaluronic acid or other components in Stylage fillers.
•   Vascular Complications: In very rare cases, improper injection techniques can lead to vascular issues, such as tissue necrosis or blindness, if the filler is accidentally injected into a blood vessel.

Making Informed Decisions about Using Stylage Fillers

When considering Stylage fillers, it’s essential to rely on evidence-based information. Clinical studies and trials provide valuable insights into their safety and efficacy. 

For instance, research has shown that Stylage fillers, which utilize hyaluronic acid, can effectively reduce wrinkles and restore facial volume with minimal side effects. Reviewing peer-reviewed journals and clinical trial results can help you understand the potential benefits and risks associated with Stylage fillers.

Several factors should be considered before opting for Stylage fillers. First, consult a qualified healthcare provider to discuss your aesthetic goals and medical history. This ensures that the treatment is tailored to your specific needs and reduces the risk of complications. 

Additionally, be aware of the potential side effects, such as swelling, redness, and bruising, and follow post-treatment care instructions to achieve the best results. Understanding these considerations can help you make an informed decision about using Stylage fillers.

Conclusion

Stylage’s lack of FDA approval in the U.S. raises valid concerns about its safety and quality. While it may deliver effective results in other regions, the rigorous FDA regulations in the U.S. are designed to ensure the highest standards of patient care.

Before considering treatments like Stylage, it’s crucial to consult a qualified medical professional who can guide you on safe and approved alternatives. Ultimately, prioritizing safety and informed decision-making is the best approach when selecting any cosmetic treatment.

FAQs

1. What is Stylage, and how does it compare to Revanesse and Revolax?

Stylage is a dermal filler that smooths wrinkles, enhances lips, and restores facial volume. It is comparable to Revanesse and Revolax, but there are differences in formulation and results, often assessed through user reviews and safety profiles.

2. Has Stylage been approved by the FDA?

No, Stylage has not received FDA approval. This means it has not undergone the rigorous testing required for FDA endorsement.

3. Is it safe to use Stylage?

Stylage is not FDA-approved, raising concerns about its safety. Consult with a healthcare provider to evaluate its suitability.

References

Center for Devices and Radiological Health. FDA-Approved Dermal fillers. U.S. Food And Drug Administration. Published November 9, 2020. https://www.fda.gov/medical-devices/aesthetic-cosmetic-devices/fda-approved-dermal-fillers

U.S. Food and Drug Administration. FDA authority over cosmetics: how cosmetics are not FDA-approved. U.S. Food and Drug Administration. Published March 2, 2022. https://www.fda.gov/cosmetics/cosmetics-laws-regulations/fda-authority-over-cosmetics-how-cosmetics-are-not-fda-approved-are-fda-regulated 

RealSelf. Experienced Injectors for Stylage: Is It Safe? RealSelf, www.realself.com/question/new-london-ct-experienced-injectors-stylage.