Ellansé S 2x1ml

• Polycaprolactone (PCL) microspheres: 30 % by volume. A synthetic, biocompatible and bioresorbable polymer of the poly-α-hydroxy acid group, the same chemical group as polylactic and polyglycolic acid. It is the component responsible for the sustained effect through collagen stimulation.
• Carboxymethylcellulose (CMC) carrier gel: 70 % by volume, composed of CMC, phosphate buffered solution (PBS) as the solvent medium and glycerine, which improves the solubility of the CMC. It is the component that provides the immediate volume after implantation.
• Geometry of the microspheres: completely smooth and spherical, with a size of 25 to 50 µm. This regular morphology explains the homogeneous distribution of the collagen layer around each microsphere, forming a scaffold with minimal inflammatory reaction.
• Mechanism of the duration: the four references in the range have an identical composition. The only difference is the initial length of the polymer chain (molecular weight Mn) of the PCL, which determines the bioresorption time and, with it, the longevity of the effect.
• Final product: sterile, non-pyrogenic white gel in a ready-to-use 1 ml syringe. It does not contain lidocaine.

In the biocompatibility tests in accordance with ISO 10993 performed for CE marking, Ellansé® was assessed as non-toxic, non-mutagenic, non-pyrogenic and biocompatible.

The composition, concentration and morphology of the microspheres are identical in all four references; only the molecular weight of the PCL changes. The manufacturer states that the longevity of the L and E variants corresponds to an extrapolation from the clinical data of S and M and from the known degradation behaviour of PCL.

Injectable implant indicated for subdermal implantation in the face, for the long-lasting correction of wrinkles and facial signs associated with age.

Must not be injected into the lips, glabella or eyelids. The manufacturer likewise advises against its use in the tear trough (under-eye hollow).

• Implantation plane: subdermal. Injection that is too superficial is the technical error to which the manufacturer attributes most of the nodules and indurations reported.
• Instruments: needle, cannula or both, according to the area and the injector's technique.
• Product without incorporated anaesthetic: analgesia is planned separately from the implant.
• The manufacturer stresses the need for specific training of the injector and strict compliance with the recommendations on technique, volume per area and areas in which it must not be injected.
• Effect: immediate volumetric correction by the CMC gel, followed by the progressive stimulation of the patient's own collagen around the PCL microspheres.

• The pack contains: 2 pre-filled syringes of 1.0 ml in a sterile pouch with traceability labels (date of manufacture, batch number and expiry date).
• Storage: keep the product in its original packaging, protected from direct sunlight and from heat sources. Observe the storage temperature indicated on the packaging and in the instructions for use.
• Do not use after the expiry date shown on the packaging.
• Sterile single-use product. Do not reuse or resterilise.

Contraindications documented by the manufacturer: pregnancy and breastfeeding; active skin infection in the treatment area; concurrent infection; autoimmune diseases; diabetes; coagulation disorders; oncological disease; treatment with isotretinoin in the preceding 6 months; recent facial surgery.

Excluded areas: lips, glabella, eyelids and tear trough.

Warnings: Ellansé® is not a product reversible with hyaluronidase. The nodules and indurations reported are generally associated with technical errors, in particular with injections that are too superficial. Post-treatment oedema usually resolves spontaneously. Application requires specific training in the technique of the product.

Always consult the instructions for use included in the pack before application.