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Ellanse FDA Approval – Is the Filler Safe?

David Fuller

Last Updated On: June 23, 2024

The approval process for dermal fillers in the different regulatory bodies across countries like Korea and Australia is a testament to their commitment to patient safety. Each product undergoes a thorough review, ensuring it meets stringent standards for efficacy and safety. This process is crucial as the popularity of non-invasive cosmetic procedures continues to rise.

In cosmetic enhancements, Ellanse represents a new generation of dermal fillers. While details about its composition and benefits are reserved for a deeper dive, it is a significant development in aesthetic medicine, promising advancements in patient care.

This article will explore the nuances of Ellanse’s FDA approval status and what it means for consumer safety. 

Key Takeaways

  • While Ellanse fillers haven’t received FDA approval in the United States, it is approved for administration in certain countries, indicating they have met the regulatory standards for safety and efficacy.
  • The approval process for Ellanse fillers involved rigorous clinical trials and studies to demonstrate their safety and effectiveness.
  • Ellanse fillers have a favorable safety profile, with potential risks and side effects similar to other FDA-approved fillers.
  • Medical experts provide reassurance and guidelines for the safe use of Ellanse fillers, emphasizing patient selection and treatment planning.
  • Post-approval surveillance data and ongoing studies continue to monitor the safety and efficacy of Ellanse fillers.

About: Operating since 2016, Med Supply Solutions is known for being one of the industry’s top and trusted suppliers of cosmetic and viscosupplementation products. If you’re looking to buy Ellanse online, contact our sales department for more information.

FDA Approval Process for Ellanse Fillers

Obtaining FDA approval for Ellanse fillers involved a rigorous review process to ensure their safety and effectiveness. This process included extensive lab tests and trials on people to demonstrate the product’s performance and safety. However, it is essential to note that Ellanse fillers are only approved in certain countries and have not yet received FDA approval in the United States.

Manufacturers of products like Ellanse must provide substantial evidence from experiments and clinical trials to support their claims. The FDA carefully evaluates this data; if everything checks out, it approves the filler for medical professionals. 

This approval signifies that the product is safe and reliable for enhancing appearance. The FDA’s approval process may be demanding, but it is crucial in guaranteeing the safety and efficacy of treatments such as Ellanse for patient care.

Patient Reviews on Ellanse Fillers

Clinical trials and studies supporting Ellanse’s FDA approval were critical in assessing its safety and effectiveness compared to other options, such as Sculptra.

“Wonderful and amazing experience.”

“Great results, slightly different angled pics, but you get the idea, my sunken face fixed; this is day three after treatment, and I am happy with it; it has taken years off! I hope it will last as long as possible :)”

These reviews collectively indicate that Ellansé dermal fillers are well-received for their long-lasting effects and natural enhancement of facial features. You should consult with a qualified medical professional to determine if Ellansé suits your needs.

Safety Profile of Ellanse Fillers

Ellanse fillers have undergone many tests to ensure their safety, and doctors examine how they work and consider any risks. Like all medical treatments, they come with possible risks and side effects, so medical professionals should be aware of these to ensure the safety and satisfaction of their patients.

  • Skin reactions at the injection site can include redness, swelling, and itching. These are common and usually mild, resolving within a few days.
  • Patients might experience bruising or discoloration. This is typically temporary but can last from a few days to a week.
  • Ellanse fillers have been known to cause minimal discomfort compared to other fillers, such as Sculptra, but some patients may still feel pain during injection.
  • Small lumps or bumps may form under the skin. 
  • Infection at the injection site is rare but constitutes a significant risk requiring prompt antibiotic treatment.
  • There’s a slight risk of an allergic reaction, though it’s less common due to the biocompatible nature of Ellanse fillers.
  • In infrequent instances, patients have reported vascular complications, where filler material accidentally enters blood vessels, leading to tissue loss or more severe outcomes.

Comparison with Other FDA-Approved Fillers

Evaluating the safety profile of Ellanse fillers requires a direct comparison with other FDA-approved fillers. This side-by-side assessment shows Ellanse’s position in the cosmetic treatment landscape, emphasizing its features, risks, and effectiveness relative to alternatives. 

FillerTypeApproval YearDuration of EffectCommon Side EffectsUnique Features
EllansePolycaprolactone (PCL) basedN/A1-4 years, depending on the versionSwelling, redness, and tendernessStimulates collagen production
JuvédermHyaluronic Acid based20066-12 monthsBruising, redness, swellingImmediate results; reversible
RestylaneHyaluronic Acid based20036-18 monthsSwelling, tenderness, bruisingVersatile for various treatments
RadiesseCalcium Hydroxylapatite based2006Up to 18 monthsBruising, swelling, discomfortImmediate correction plus collagen stimulation
SculptraPoly-L-lactic acid based2009Two yearsInjection site pain, redness, bruisingGradual results; enhances natural collagen production

Expert Opinions and Guidelines on Ellanse Safety

Ellansé is highly effective and safe because it stimulates collagen synthesis; the PCL component stimulates collagen production in the body, replacing the absorbed gel carrier and maintaining the skin’s rejuvenated appearance.

Medical professionals overwhelmingly endorse Ellanse fillers because of their popularity and wide usage in other countries. However, experts recommend that those new to fillers start with a reversible hyaluronic acid-based product to ensure satisfaction with the effect before trying longer-lasting options like Ellanse.

It’s important to note that while Ellansé is widely used in Asia and Europe, it has not yet been approved by the U.S. Food and Drug Administration (FDA), so it’s unavailable in the United States. As with any medical procedure, consulting a qualified healthcare professional to discuss individual needs and potential risks is crucial.

Guidelines for Patient Selection and Treatment Planning

  • Assess Skin Quality: Check for good elasticity and thickness to ensure the patient’s skin can handle the filler.
  • Consider Age Factors: Ideal candidates usually range from 30 to 60, showing signs of aging but still having skin that can recover well.
  • Review Medical History: Look for any allergies, autoimmune diseases, or conditions that might affect healing or reaction to fillers.
  • Discuss Expectations: Make sure patients understand what Ellanse can and cannot do. It’s about improvement, not perfection.
  • Plan for Downtime: Some patients might need a few days to recover from swelling or bruising, so timing is vital.
  • Explain Longevity and Reversibility: It’s crucial to inform patients that Ellanse lasts longer than other fillers but isn’t reversible like hyaluronic acid-based options.
  • Evaluate Psychological Readiness: Patients should be mentally prepared for cosmetic changes and have realistic expectations about outcomes.
  • Check for Contraindications: Avoid treating areas with active skin infections or inflammation to prevent complications.
  • Prepare for Aftercare: Provide detailed aftercare instructions to ensure optimal healing and results.
  • Follow-up Schedule: Set up appointments to monitor progress and decide if additional sessions are needed for best results.

Updates on Ellanse Safety and Efficacy

Since their approval, Ellanse fillers have been widely used in Europe and Asia. Post-approval surveillance data indicate that Ellanse is generally well-tolerated and effective in promoting collagen production and providing long-lasting aesthetic results. The primary side effects reported include temporary redness, swelling, and bruising at the injection site. Serious complications are rare but can include granulomas and nodules.

It is important to note that while Ellanse fillers are not FDA-approved in the United States, they continue to be popular in other countries due to their long-lasting results and collagen-stimulating properties.

Conclusion

Clinical studies and practitioner reports consistently affirm their safety and efficacy. However, Ellanse has potential risks like all treatments, such as temporary redness, swelling, and rare complications. Staying informed about the latest research and updates is crucial for making educated decisions about using Ellanse fillers safely and effectively. Always consult with a qualified healthcare provider for personalized advice.

FAQs

1. What does Ellanse do?

Ellanse helps reduce wrinkles and fills facial lines to make skin look smoother.

2. Is Ellanse safe for everyone?

Most people can safely use Ellanse, but it’s always best to talk with a doctor first.

3. How long does Ellanse last?

Ellanse results can last one to four years, depending on your chosen type.

4. Can I get Ellanse treatments often?

It would be best to wait until your doctor gives you permission to get more treatments with Ellane.

References

Health C for D and R. FDA-Approved Dermal Fillers. FDA. Published online November 4, 2021. https://www.fda.gov/medical-devices/aesthetic-cosmetic-devices/fda-approved-dermal-fillers

Dermal Fillers. www.hopkinsmedicine.org. Published January 25, 2024. Accessed June 12, 2024. https://www.hopkinsmedicine.org/health/treatment-tests-and-therapies/dermal-fillers 

ELLANSÉ ® SAFETY a POLYCAPROLACTONE-BASED COLLAGEN STIMULATOR SAFETY DATA REPORT by Marie-Odile Christen. Accessed June 16, 2024. https://re-aesthetic.com/img/Aesthetic-Filler/1605-Ellanse-eSafety-report.pdf 

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