Aesplla Poly-L-Lactic Acid 1x365mg
Important Notice
Regulated medical device (EU MDR 2017/745). For sale exclusively to qualified healthcare professionals.
What this purchase includes
- Original productFrom the manufacturer or an official distributor, CE marked.
- Batch and expiry documentedRecorded per unit on the delivery note and the invoice.
- Controlled storageOur own Madrid warehouse, 12 to 18 °C under 24 h control.
- Dispatch in 24 to 48 hFrom Madrid, insured and with a tracking number.
- Reachable Monday to Friday9:00 to 17:00 by WhatsApp and email. People, not forms.
aesPlla® is a lyophilised collagen biostimulator from Oreon Life Science (South Korea) based on poly-L-lactic acid microspheres. It does not provide immediate volume: the PLLA acts as a matrix that stimulates the dermal fibroblasts to produce the patient's own collagen, with a result that develops progressively. The 365 mg vial contains 150 mg of PLLA and is reconstituted with 5 ml of sterile water for injection, with a dissolution time of 3 hours.
- PLLA 150 mg per vial
- Vial 365 mg of lyophilised powder
- Reconstitution 5 ml of sterile water
- Dissolution 3 hours
- Application cannula or 26G needle
Composition and technology
- Poly-L-lactic acid (PLLA): 150 mg per vial, in microspheres.
- Sodium carboxymethylcellulose: 90 mg — suspending agent that keeps the microspheres dispersed after reconstitution.
- Mannitol: 125 mg — bulking agent and cryoprotectant for the lyophilisation process.
- Total vial content: 365 mg of lyophilised powder.
- Mechanism: the PLLA microspheres provoke a controlled tissue remodelling response that induces collagen synthesis by the dermal fibroblasts. The polymer degrades by hydrolysis to lactic acid and is eliminated by metabolic pathways; the observed effect is that of the newly formed collagen, not of the implanted material.
- Origin: synthetic polymer. It contains no protein of animal or human origin.
Indications and treatment areas
Injectable biostimulator indicated for volume restoration and the correction of deep dermal deficits in adult patients.
- Facial wrinkles, from superficial to deep
- Nasolabial fold and marionette lines
- Temporal region and cheekbones
- Jawline and laxity of the contour (jowls)
- Deep dermal volume deficit
- Scars
Reconstitution and treatment protocol
Reconstitution determines the result and the safety profile of the product. Insufficient hydration or a non-homogeneous suspension is the principal cause of nodules with PLLA biostimulators.
- Diluent: 5 ml of sterile water for injection, introduced with an 18G needle.
- Dissolution time: 3 hours before application.
- Stability after reconstitution: the reconstituted product must be used within 72 hours.
- Loading: draw up with an 18G needle into 1 or 3 ml syringes.
- Injection plane: deep dermis, lower layers of the dermis or hypodermis.
- Application: cannula or 26G needle, with a retrograde linear threading technique.
- Post-treatment massage: massage the treated area after the session to distribute the microspheres evenly and reduce the risk of nodules.
- Onset of the result: from 4 weeks after application, progressively.
- Duration: the manufacturer states a persistence of the result of up to 36 months.
The manufacturer does not publish a fixed number of sessions or a defined interval between them. The regimen is established according to clinical assessment and the degree of correction achieved; consult the instructions for use accompanying the batch.
Technical data
| Manufacturer | Oreon Life Science Co., Ltd. — South Korea |
|---|---|
| Active substance | Poly-L-lactic acid (PLLA) 150 mg |
| Excipients | Sodium carboxymethylcellulose 90 mg, mannitol 125 mg |
| Presentation | 1 vial of 365 mg of lyophilised powder |
| Reconstitution | 5 ml of sterile water for injection (18G needle) |
| Dissolution time | 3 hours |
| Use after reconstitution | Within 72 hours |
| Injection plane | Deep dermis / hypodermis |
| Application | Cannula or 26G needle |
| Use | Exclusively qualified healthcare professionals with specific training in PLLA |
Storage and pack contents
- Storage: at room temperature. Do not refrigerate.
- Reconstituted product: use within the following 72 hours.
- Do not use after the expiry date shown on the packaging.
- Sterile single-use product. Do not reuse or resterilise.
- The pack contains: 1 vial of 365 mg of lyophilised powder and instructions for use. The diluent, syringes and needles are not included.
- Prepare the reconstitution under aseptic conditions.
Contraindications and warnings
Contraindications: known hypersensitivity to polylactic acid or to any of the excipients; active skin infection or inflammation in the treatment area; pregnancy and breastfeeding; active autoimmune disease; tendency to hypertrophic or keloid scarring; under 18 years of age.
Warnings specific to PLLA biostimulators: do not inject into the lips or into the periorbital region. Injection that is too superficial, incomplete hydration of the product, a non-homogeneous suspension or insufficient massage after the session are associated with the formation of late nodules and papules. Do not overcorrect: the effect is not immediate and is assessed after weeks, not in the same session.
Never inject intravascularly. Always consult the instructions for use included in the pack before application.
Product intended exclusively for qualified healthcare professionals with specific training in polylactic acid biostimulators. Technical information based on the documentation of the manufacturer Oreon Life Science and of its official distribution. The reconstitution and application parameters must be taken from the instructions for use accompanying each batch; this data sheet does not replace them.