FILLMED Filorga Art Filler Volume (2 x 1.2 ml)

FILLMED

Dermal filler

Cross-linked hyaluronic acid volumizing dermal filler with lidocaine

CE Marked injectable hyaluronic acid dermal filler medical device for restoration of facial volume and contouring
Manufactured under ISO 13485 Compliant quality management system for medical devices by Laboratoires FILLMED
Conforms to applicable European and UK medical device regulations governing injectable dermal fillers
Supplied with full traceability (lot number, expiry date, traceability labels) and detailed Instructions for Use

CE Marked injectable hyaluronic acid dermal filler medical device for restoration of facial volume and contouring
Manufactured under ISO 13485 Compliant quality management system for medical devices by Laboratoires FILLMED
Conforms to applicable European and UK medical device regulations governing injectable dermal fillers
Supplied with full traceability (lot number, expiry date, traceability labels) and detailed Instructions for Use

Cross-linked hyaluronic acid volumizing dermal filler with lidocaine

Description

FILLMED / Filorga Art Filler Volume is a viscoelastic, cross-linked hyaluronic acid dermal filler with lidocaine, designed to restore or create volume and sculpt facial contours. The gel is based on Tri-Hyal technology (a blend of long-chain, very long-chain and free hyaluronic acid) to provide lifting capacity, plasticity and longevity. It is slowly resorbable, colourless, transparent, sterile, non-pyrogenic and physiological, and is indicated for deep volumisation and contouring of areas such as the cheeks, midface, temples, chin and jawline. The product is supplied as two 1.2 ml pre-filled syringes for injection by qualified medical professionals.

Bnefits

Restores age-related volume loss in the midface, cheeks and other facial areas
Sculpts and enhances facial contours (cheeks, chin, jawline, temples) for a more youthful profile
Tri-Hyal technology (mix of 3 HA chain lengths) balances projection, plasticity and softness for natural-looking results
High hyaluronic acid concentration (25 mg/ml) provides strong volumizing and lifting effect with long-lasting results
Contains 0.3% lidocaine to improve patient comfort during injection
Smooth, moldable gel texture facilitates precise placement and sculpting
Gradually resorbable and biocompatible, based on non-animal-origin hyaluronic acid
Supported by clinical studies showing durable volumizing effect and good safety profile over 12–18+ months

Indications

Restoration of volume in areas affected by age-related volume loss (e.g. midface, cheeks)
Facial contouring and shaping (cheekbones, chin, jawline, temples)
Deep skin depressions and folds requiring volumetric correction
Enhancement of global facial harmony through structural support and lifting
Correction of moderate to severe volume deficiency where deep volumization is appropriate

Composition

Cross-linked hyaluronic acid (non-animal origin) 25 mg/ml
Lidocaine hydrochloride 0.3% (3 mg/ml) as a local anaesthetic
Buffered physiological saline vehicle (sodium chloride solution) with standard excipients suitable for injectable, sterile, apyrogenic gels
Tri-Hyal Technology formulation: mixture of long-chain, very long-chain and free hyaluronic acid to optimise rheology and longevity

Formulation

Viscoelastic, cross-linked hyaluronic acid gel for injection
Non-animal-origin HA gradually resorbable over time
Colourless, transparent, sterile, non-pyrogenic, physiological (saline) gel
Contains 0.3% lidocaine hydrochloride for improved comfort
Tri-Hyal Technology balancing cohesive lifting capacity with smooth injectability

Packaging

Box containing 2 pre-filled 1.2 ml single-use syringes of Art Filler Volume (total 2.4 ml)
4 sterile, single-use 27G 1/2" needles (needle configuration may vary slightly by market)
Product leaflet (Instructions for Use) with indications, contraindications and precautions
4 traceability labels (for patient record and practitioner documentation)
All components provided in sterile packaging with tamper-evident seal

Usage

For professional use only: Art Filler Volume must only be injected by legally qualified and appropriately trained medical practitioners familiar with facial anatomy and hyaluronic acid filler techniques.
Before treatment, obtain a full medical history and assess the patient’s expectations, indications and contraindications; obtain informed consent.
Cleanse and disinfect the treatment area thoroughly using appropriate antiseptic measures.
Attach a sterile needle (typically 27G 1/2") to the pre-filled syringe using aseptic technique; expel air and a small amount of product to ensure patency.
Recommended injection planes include deep dermis, subcutaneous and/or supraperiosteal/deep tissue planes depending on the area treated, following the official IFU.
Common treatment areas: midface/cheeks, temples, chin, jawline, and deep facial depressions requiring volumization.
Use suitable techniques such as bolus, linear threading/retro-tracing, fanning or a combination, as appropriate for each anatomical area and the practitioner’s expertise.
Inject slowly with minimal pressure; aspirate where appropriate to minimise risk of intravascular injection, and constantly monitor for signs of vascular compromise.
Do not overcorrect; consider a touch-up session after 2–4 weeks if required rather than excessive initial volume.
After injection, gently massage or mould the area if necessary to achieve the desired shape, avoiding excessive pressure.
Advise the patient to avoid makeup for several hours, vigorous exercise, saunas, very hot or cold environments, and alcohol on the day of treatment.
Instruct the patient to report immediately any signs of unusual pain, blanching, visual disturbance, or other symptoms suggestive of vascular occlusion.
Dispose of used syringes and needles in approved sharps containers according to local regulations.
Always follow the most recent official Art Filler Volume Instructions for Use and local clinical guidelines.

Contraindications

Known hypersensitivity to hyaluronic acid, lidocaine, or any amide-type local anaesthetics, or to any other component of the product
Patients with a history of severe allergic reactions or anaphylaxis
Presence of active inflammatory or infectious processes (acne, herpes, bacterial or fungal infections) near the intended injection site
Patients with a history of autoimmune diseases or currently receiving immunotherapy, unless specifically assessed and approved by a physician as per IFU
Uncontrolled epilepsy
Porphyria
Tendency to develop hypertrophic scars or keloids
Injection into an area where a permanent (non-resorbable) filler has already been placed
Pregnant or breastfeeding women (use is generally contraindicated due to insufficient clinical data)
Patients under 18 years of age
General contraindications to hyaluronic acid fillers and local anaesthesia as per medical judgement

Adverse Effects

Common, usually transient injection-site reactions such as redness (erythema), swelling (oedema), pain, tenderness, pruritus, bruising or induration
Temporary lumps or bumps at the injection site that usually resolve as the product integrates and swelling subsides
Local inflammatory reactions or sensitivity at the treated area, typically resolving within a few days
Rare but more significant events including infection, abscess, persistent nodules, granuloma formation or delayed inflammatory reactions
Very rare vascular complications (e.g. ischemia, necrosis, visual disturbance, blindness) associated with inadvertent intravascular injection or vascular compression; these constitute medical emergencies requiring immediate expert management
Rare hypersensitivity or allergic-type reactions to hyaluronic acid, lidocaine or excipients, potentially requiring medical treatment
Any serious, unusual or persistent adverse event should be reported to the manufacturer and relevant regulatory authorities according to medical device vigilance requirements

Storage Conditions

Store in a clean, dry place at a temperature between 2°C and 25°C.
Do not freeze; protect from extreme heat and direct sunlight.
Keep syringes in their original blister and outer carton until use to maintain sterility and protect from light.
Do not use if the blister or packaging is damaged, if the tamper-evident seal is broken, or if the gel appears cloudy or discoloured.
Do not use after the expiry date indicated on the packaging.
Keep out of reach of children and unauthorised persons.

Duration

Typically administered in a single treatment session with possible touch-up after 2\u20134 weeks. Clinical studies and manufacturer data indicate results can last around 12\u201318 months or longer, depending on treatment area, injection technique, volume used, and individual patient factors. Repeat treatments can be performed to maintain or adjust results at the clinician\u2019s discretion.

Onset

Immediate volumizing and contouring effect visible at the end of the injection session, with optimal integration and final appearance usually evident after initial post-treatment swelling subsides over several days to 2 weeks.