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Does FDA Approve The Use of Ellanse Filler?

Aging signifies not only an increase in number but brings with it changes in physical appearance. For one, our body’s collagen production declines (in comparison to when we were younger) so wrinkles form, aging lines deepens and the skin lost its overall firmness and elasticity.  These changes can be overwhelming especially for those who are sensitive about their looks and to those who take great pains to care for their skin. One way to retain youthfulness is by adopting a healthy and active lifestyle. Lower stress and sufficient sleep will always help. Cosmetic surgery and aesthetic treatments are viable options as well. Fillers are particularly popular as an anti-aging procedure now and a current one in the lead is the Ellanse dermal filler.

But is Ellanse safe? Is it approved by the Food and Drug Administration (FDA)?

What is Ellanse Dermal Filler?

Ellansé is a branded injectable filler that is free from potentially-harmful pyrogen and latex. The active ingredient in Ellanse filler is Poly-Caprolactone (PCL) microspheres. These (PCL) microspheres; a bioresorbable soft medical polymer, is responsible to promote the production of collagen naturally in the human body. As collagen is an incredibly important protein that keeps your tissues and bones together, Ellanse works miraculously in lifting, sculpting and restoring back the elasticity of the skin due to its strong bio-stimulating properties.
Besides, collagen helps give skin structure and elasticity. Hence, boosting your skin’s collagen levels, or preventing its loss would help reduce fine lines, depth of wrinkles and sagging skin; which in turn makes you look younger.

Since Ellanse filler is able to stimulate the regeneration of collage, many patients has seen incredible results with Ellanse. Post-Ellanse, patients enjoy the glow and luminance of younger and lifted skin for between two to four years. Ongoing treatments are necessary to retain the results though. All in all, Ellanse remains as one of the best solution for both men or women who desire long-lasting effects, as compared to any other fillers.

How is it used?

When injected into the skin, Ellansé reverses skin aging with a 2-step process. The CMC gel carrier instantly volumized and fix skin imperfections. The PCL microspheres, on the other hand, will increase the restoration and production of collagen fibers to make the corrected regions appear younger, glowing and hydrated. That effect can last between two to four years. This resorption process occurs when the molecules progressively dissolve over time. The microspheres retain their original volume until almost all the molecules are dissolved completely. The longevity depends on the number of molecules that the spheres have. The more molecules there are, the longer-lasting the result will be. Hyaluronic acid can only fill in the forming wrinkles and make it fuller but PCL microspheres and CMC gel are rejuvenating the skin independently, restoring back the youth that an individual has lost due to aging. The side effect for the procedure are varied but it may include redness, swelling and bruising. Mild inflammatory reaction conjures mildly in nature as the skin slowly recovers from the minimally invasive injections.

Body areas that are treated with Ellanse dermal filler?

Ellanse can be used to treat any area that exhibits the sign of aging but it is primarily used on the face. Common areas are temples and brow, cheeks, nose, nasolabial folds, jawline, chin, and marionette lines. Other areas of treatment include hands and neck. Expected results include wrinkles reduction, added volume and contour to cheeks, chin, and lower jaw, filling under-eye hollows (tear trough), nose to mouth lines, lifted drooping mouth corners, rejuvenated the skin on the neck, cleavage, and hands, and softened appearance of acne scars.

FDA Approval Status

The approval status of the FDA regarding cosmetic treatment fillers are based on the absorbable function (temporary material). FDA approves non-absorbable (permanent) material only if the correction on the treatment area is used for the patient over 21 years old and it does not include fillers that increase breast size, size of buttocks, increase the fullness of the feet or any implant into bone, tendon, ligament, or muscle. Any kind of filler that injures patients with permanent disfigurement is not allowed. Ellanse is officially approved by MHRA in the UK and the FDA in the USA and for restoration and/or correction of the signs of facial fat loss (lipoatrophy) and is used for treating facial lines and wrinkles. Both CMC and PCL have been respectively classified by the FDA as Generally Recognized As Safe (GRAS) substances and approved by the FDA as safe to use in medical devices in humans.

Use around the globe

Ellanse is not available in the United States but it is widely used in Asia and Europe. Ellanse dermal fillers serve long-lasting effects in rejuvenating the skin and in fixing other aesthetic imperfections that are caused by aging. The result is natural and would not cause any harm to physical appearance if the correct amount is injected at suitable areas by a verified medical doctor. Is it worth it? Yes! Many past and current patients, both men and women have enjoyed turning back the clock with Ellanse, loving the result it does to their skin and had reported no negative repercussions.

Conclusion/ Final Thoughts

Ellanse dermal filler is indeed approved by the FDA to be used as one of the treatment options in rejuvenating the skin. It has since enjoyed a reputation for long-lasting results and a safe option for many.

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Dr Ong Kuok Tjun

Dr. Ong Kuok Tjun is an esteemed aesthetic physician who earned his medical degree from the University of Malaya. He holds a coveted LCP board certification from the Ministry of Health, Malaysia, and has over five years of experience. Dr. Ong's approach to facial aesthetics is unique, combining both art and science to deliver natural-looking results. He utilises a variety of techniques, including energy-based devices and injectables, to address concerns like skin aging, acne scarring, and hyperpigmentation.

Holding certifications such as the Medical Aesthetic Certification (MAC), he stays abreast of the latest advancements in the field. As an international speaker, Dr. Ong shares his expertise with fellow professionals, contributing to the global discourse on aesthetic medicine. His publication on PN-Hpt reflects his dedication to advancing medical knowledge. Dr. Ong's commitment to excellence is evident through his continuous pursuit of knowledge and skill enhancement.

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Ellanse Filler Treatment Malaysia (Collagen Stimulating Injection)

Ellansé® - the collagen stimulating filler

In recent years, many people are sorting out biostimulator injection as one of the main anti-aging treatments. One of the popular biostimulator is none other than ELLANSE.

Ellanse is made of bio resorbable microspheres called Polycaprolactone (PCL). This PCL is suspended in a gel carrier made of Carboxymethylcellulose (CMC).

The use of Ellanse designed to restore and rejuvenate the face.

These bio-stimulating dermal fillers use body’s natural response to foreign bodies and stimulate the formation of collagen around the microspheres, making a longer-lasting implant. The aim is not only to provide a smoother skin surface but also to restore the face’s individual features, providing a balance of the filler’s lifting effect on the face’s curved and hollowed areas.

Which indications can be treated using Ellanse?

  • Skin laxity and sagginess
  • Volume loss or hollowness
  • Acne scars
  • Corse or rough skin
  • Facial contouring or augmentation

(eg. Nose reshaping, Chin definition, Suncken Under eye, Laugh lines)

Ellanse - ellanse pack shot 5


Collagen is one of the important support structures found naturally in our skin, helping to maintain the appropriate tightness, elasticity and suppleness. Over time, our skin age and gradually loses its natural collagen, leading to facial laxity and the formation of wrinkles and folds.

When Ellanse is injected into the skin, Ellanse works in Two main steps.

  1. The Carboxymethlycellulose (CMC) gel works like other dermal fillers by immediately filling and replenish the volume loss. However, this effect usually lasts for about 3 months
  2. The main mechanism of Ellanse is to stimulates your collagen production via Polycaprolactone microspheres which ultimately treating the underlying causes of facial ageing. This collagen stimulation process continue for over 6-12 months.

After your new collagen has formed, it lasts for 2-4 years.

Result are immediate with the volume restore and lifting effect via CMC. PCL would continue to work on stimulating your skin to produce collagen thereafter.

Since it is a collagen stimulating filler, Ellanse creates long-lasting results by inducing natural collagen production. It could last up to 4 years depending on the subtypes of Ellanse product available.

Usually only one session required for Ellanse because this type of filler is known to last from 2 to 4 years. However different severity of the aging problem will require different amount (number of syringes) to be injected in single session.

Post-treatment reactions are usually mild and disappear after a few days. Normal activities can be resumed after the procedure. However, patient should avoid engaging in strenuous physical activities for at least a day to minimize swelling and brusing. Avoid hot bath, vigorous exercise and drinking alcohol for 24 hours. It is also recommended to avoid over-exposure to the sun’s UV rays within one week after the treatment.

They are entirely different products with different composition, hence we are unable to really compare between them. All biostimulators work toward achieving the same goal, with some similarities and some differences. The result varies not only by the products, also by different skill and experience of the doctor.

Comparing to other fillers Ellanse has fewer side effects. Allergic reactions are close to zero. Like other dermal fillers, patients who are treated with Ellanse fillers may experience mild swelling, bruising and soreness at the treatment areas, but it is temporary and will resolve with no issues over time.

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