Did you know the first FDA-approved biostimulator was introduced back in 2004 to help treat facial lipoatrophy in HIV patients? Since then, only a few injectable collagen stimulators have met the FDA’s high standards for safety and effectiveness in aesthetic treatments. This makes regulatory status a crucial factor when choosing cosmetic procedures.
One such biostimulator that has been gaining attention is Lanluma. A poly-L-lactic acid (PLLA) treatment, Lanluma has become popular in Europe for its effectiveness in body contouring and skin rejuvenation. However, despite its CE certification, Lanluma has not yet received FDA approval for use in the United States. This difference in regulatory status can lead to some confusion for both patients and practitioners.
In this article, we’ll dive into Lanluma’s regulatory standing, compare it with other biostimulators, and break down what FDA approval means when it comes to cosmetic procedures.
Key Takeaways
- Lanluma holds a CE mark in Europe but has not received FDA approval for use in the United States. Because it lacks FDA clearance, it is not available for general use in U.S. clinics.
- FDA approval is important because it confirms that a product meets high safety, efficacy, and quality standards and ensures legal compliance. It also increases the likelihood of insurance coverage and provides peace of mind to patients.
- Until Lanluma is FDA-approved, U.S. patients should consider FDA-approved alternatives like Sculptra, Radiesse, or hyaluronic acid fillers for collagen stimulation and body contouring.
- There is currently no FDA approval timeline for Lanluma, and it is only available in the U.S. through research trials.
- Patients should ensure they are using legally approved and safe treatments by consulting with a qualified provider.
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Lanluma Regulatory Status: CE Mark vs FDA Clearance
Lanluma has made a significant impact in the world of aesthetic treatments, particularly in body contouring and skin rejuvenation. In Europe, it holds a CE mark, which means it meets the high standards of health, safety, and performance set by the European Union. This certification allows it to be sold and used across European countries, where it has become a popular choice among patients seeking collagen stimulation and fat reduction.
However, for those asking, “What is Lanluma?” and its FDA approval status, it’s important to note that FDA clearance is a separate process and is required for legal use in the United States. The FDA evaluates products like Lanluma to ensure they meet strict standards for clinical safety, efficacy, and manufacturing. Without this clearance, U.S. clinics are prohibited from offering Lanluma injections to their patients.
Lanluma Approval Timeline and Current U.S. Position
Despite Lanluma’s popularity in Europe, it has not yet been granted FDA approval for use in the United States. At this time, there is no publicly available FDA approval timeline from the manufacturer. The approval process requires thorough clinical testing, submission of safety data, and an extensive regulatory review by the FDA.
Currently, Lanluma USA’s availability is only available under research or clinical trial settings with strict medical oversight. Until it receives official FDA approval, Lanluma is not available for general use in American medical clinics.
Why FDA Approval Matters for Lanluma Use in Clinics
FDA approval isn’t just a formality; it’s crucial for ensuring that injectable products meet the highest standards of safety and quality. For clinics in the United States, using FDA-cleared injectables is not just recommended, it’s a legal requirement. Offering products that d not have FDA approval can lead to serious regulatory and legal complications. Here are some of the reasons why FDA approval matters:
- Patient Safety: FDA-approved products undergo extensive testing to confirm their safety, providing peace of mind for both patients and practitioners.
- Legal Compliance: Clinics that use FDA-approved products avoid potential legal risks, including fines and issues with licensing.
- Consumer Confidence: Patients trust treatments that meet stringent U.S. medical standards, and FDA approval assures them of quality and safety.
- Insurance Coverage: FDA-approved treatments are more likely to be covered by insurance plans, offering more financial accessibility for patients.
Until Lanluma receives FDA clearance, U.S. clinics should not offer it to patients. Patients should be aware of these considerations and seek FDA-approved alternatives for safe and effective treatments.
Alternatives to Lanluma in FDA-Cleared Markets
While Lanluma awaits FDA approval, U.S. patients have a few alternatives that are already FDA-approved for body contouring and collagen stimulation. These alternatives are legally available for use and offer similar benefits for fat reduction and volume restoration:
- Sculptra (PLLA filler): This well-established injectable is widely used for facial volume restoration and off-label body contouring. It’s a great option for patients seeking gradual, natural-looking results.
- Radiesse (Calcium Hydroxylapatite): Known for its volumizing effects, Radiesse is effective for both facial and body contouring and stimulates collagen production over time.
- Hyaluronic Acid Fillers: While temporary, these fillers can provide volumizing benefits for targeted areas of the body and are a versatile option for facial and body treatment.
These FDA-approved treatments allow patients to achieve similar cosmetic results while adhering to U.S. regulatory guidelines, ensuring that safety and legal compliance are prioritized.
Conclusion
Until Lanluma receives FDA approval, U.S. providers and patients must rely on FDA-cleared injectables for body contouring and cellulite reduction. Following regulatory guidelines ensures that treatments are both safe and effective, helping clinics avoid legal complications and offering patients the best possible outcomes.
For patients living outside the U.S., Lanluma remains a viable option in CE-marked regions. However, for those in the U.S., it’s important to stay informed about the product’s regulatory status and consult with practitioners who follow appropriate safety protocols.
By staying up-to-date with Lanluma’s FDA approval process, both clinics and patients can make well-informed decisions about their aesthetic treatments and ensure that they choose the safest, most effective options available.
FAQs
1. Is Lanluma FDA-approved?
No. Lanluma has not received FDA approval for use in the United States.
2. Where is Lanluma currently available?
Lanluma is primarily available in countries that recognize the CE mark, mainly across Europe.
3. What is the active ingredient in Lanluma?
Lanluma contains Poly-L-Lactic Acid (PLLA), a collagen-stimulating filler that gradually improves skin volume and texture.
4. Can U.S. clinics legally offer Lanluma?
No. U.S. clinics cannot administer Lanluma until the FDA officially approves it.
5. Are there FDA-approved alternatives to Lanluma?
Yes. Similar options include Sculptra, Radiesse, and various hyaluronic acid-based fillers.
6. Why is FDA approval necessary for Lanluma?
FDA approval ensures that a product meets U.S. safety, effectiveness, and quality standards for medical use.
7. How can patients access Lanluma before U.S. approval?
Patients can only receive Lanluma through international clinics or by enrolling in authorized clinical trials.
References
Klein R, Struble K. SCULPTRA for HIV facial lipoatrophy approved by FDA. NATAP. Published August 3, 2004. https://www.natap.org/2004/HIV/080404_03.htm
U.S. Food and Drug Administration. FDA-approved dermal fillers. https://www.fda.gov/medical-devices/aesthetic-cosmetic-devices/fda-approved-dermal-fillers
Amselem M, Fatsea D, Forte R, Hasenöhrl C, Haus A, Salaabian A. Safety and effectiveness results of an innovative injectable poly‐L‐lactic acid‐based collagen stimulator (Lanluma®)—Clinical outcomes at 9 months in a post‐market study. Journal of Cosmetic Dermatology. Published online September 4, 2024. doi:10.1111/jocd.16527
