Fillmed Art Filler Lips 2x1ml
Important Notice
Medical device regulated by the European Medical Device Regulation (MDR), intended exclusively for authorized healthcare professionals. By purchasing, the customer declares to be authorized for their professional activity; false information may entail legal responsibilities.
FILLMED ART FILLER® LIPS is the lip reference of the ART FILLER® range: a cross-linked hyaluronic acid gel at 25 mg/g with lidocaine 3 mg/g and TRI-HYAL® technology, with a degree of cross-linking of 5.2 % that gives it the projection required for lip volume augmentation while maintaining the flexibility of the mucosa. It is injected into the mid to deep dermis and into the labial mucosa.
- Cross-linked HA 25 mg/g
- Lidocaine 3 mg/g (0.3 %)
- Contents 2 syringes × 1 ml
- Needles 4 × 27G ½"
- Cross-linking 5.2 % (BDDE)
Composition and TRI-HYAL® technology
Composition per gram of gel:
| Cross-linked sodium hyaluronate | 25 mg/g |
|---|---|
| Lidocaine hydrochloride | 3 mg/g (0.3 %) |
| Vehicle | Phosphate buffer solution, pH 6.50–7.50 |
| Degree of cross-linking | 5.2 % (modification with BDDE) |
| Residual BDDE | < 2 ppm |
TRI-HYAL® — three hyaluronic acids, three correction potentials. The gel combines three hyaluronic acid fractions of different molecular weight:
| Very long chains 3.7–4.5 × 10⁶ Da | Sculpting potential: the moulding capacity of the gel in the tissue |
|---|---|
| Long chains 1.0–1.5 × 10⁶ Da | Volumising potential: elasticity and resistance to deformation |
| Free hyaluronic acid | Smoothing potential: viscosity and tissue integration |
In the LIPS reference the balance between the three fractions is adjusted for a tissue in constant motion: it must sustain projection without compromising the flexibility of the labial mucosa.
Sterilisation: syringe contents by moist heat; needles by irradiation.
Position within the ART FILLER® range
| Fine Lines | HA 20 mg/ml · 2 × 1 ml · 4 needles 30G ½" — superficial wrinkles and fine lines |
|---|---|
| Universal | HA 25 mg/ml · 2 × 1.2 ml · 4 needles 27G ½" — moderate to deep wrinkles; deep dermis |
| Volume | HA 25 mg/ml · 2 × 1.2 ml · 4 needles 27G ½" — facial volume in the deep plane. Contraindicated in the lips |
| Lips | HA 25 mg/ml · 2 × 1 ml · 4 needles 27G ½" — lip volume and definition of the contour |
| Lips Soft | HA 25 mg/ml · 1 × 1 ml · 2 needles 30G ½" — soft lip volume and perioral wrinkles |
All the references incorporate lidocaine at 0.3 %. The range also includes ART FILLER® Eyes for the periorbital area. Within the lip segment, LIPS provides projection and a double presentation (2 ml in total); LIPS SOFT is the single-syringe option, with a finer needle, directed at soft results and at the correction of the perioral barcode lines.
This retailer does not distribute all the references in the range; the table is offered solely as technical guidance.
Indications and treatment areas
Indications according to the manufacturer:
- Augmentation of lip volume
- Definition and shaping of the lip contour
- Filling of moderate and deep nasolabial folds
Must not be injected into superficial lines, into the periocular area or into blood vessels.
Technique and treatment protocol
Injection plane: mid to deep dermis and labial mucosa.
Instruments: 27G ½" needles included in the pack; the manufacturer accepts as an alternative a cannula of 22G ½" to 25G ½".
Dose and frequency indicated by the manufacturer:
| Per lip | 1 ml |
|---|---|
| Total recommended per session | 2 ml (both lips) |
| Annual maximum | 15 ml |
| Frequency | Up to 2 sessions per year, with a minimum interval of 3 weeks between treatments |
Duration: the manufacturer estimates resorption of the product at between 6 and 12 months. The clinical study reported by FILLMED for this reference was conducted in 100 subjects.
Periprocedural precautions: avoid acetylsalicylic acid and high-dose vitamins in the preceding week; avoid sun exposure and extreme temperatures during the following two weeks.
Technical data
| Manufacturer | Laboratoires FILL-MED, Paris, France |
|---|---|
| Active substance | Cross-linked sodium hyaluronate 25 mg/g |
| Anaesthetic | Lidocaine hydrochloride 3 mg/g (0.3 %) |
| Cross-linker | BDDE — degree of cross-linking 5.2 %, residual < 2 ppm |
| Molecular weights | 1.0–1.5 × 10⁶ Da (long chain) and 3.7–4.5 × 10⁶ Da (very long chain) |
| Technology | TRI-HYAL® |
| pH | 6.50–7.50 (phosphate buffer) |
| Presentation | 2 pre-filled syringes of 1.0 ml |
| Needles | 4 × 27G ½" |
| Sterilisation | Moist heat (syringe) / irradiation (needles) |
| Injection plane | Mid to deep dermis and labial mucosa |
| Resorption | Between 6 and 12 months |
| Classification | Injectable medical device with CE marking |
| Use | Qualified healthcare professionals only |
Storage and pack contents
- Storage: between 5 °C and 25 °C, in a dry place, protected from light and from humidity.
- Single-use product. Do not reuse or resterilise.
- Do not use after the expiry date shown on the packaging.
- The pack contains: 2 pre-filled syringes of 1.0 ml, 4 needles 27G ½", instructions for use and traceability labels.
Contraindications and warnings
Contraindications: under 18 years of age; pregnancy and breastfeeding; known hypersensitivity to hyaluronic acid or to lidocaine; autoimmune disease or ongoing immunotherapy; uncontrolled epilepsy; porphyria; active inflammation or infection in the treatment area (including active labial herpes).
Excluded areas: superficial lines, periocular area and blood vessels.
Vascular warning: accidental intravascular injection may cause embolisation with a risk of visual disturbance, blindness, stroke or tissue necrosis. Apply aspiration and retrograde injection in accordance with the clinical protocol.
Always consult the instructions for use included in the pack before application.
Medical device intended exclusively for qualified healthcare professionals. Technical information based on the official documentation of Laboratoires FILL-MED (information leaflet for healthcare professionals ART FILLER® LIPS in accordance with the MDR and the technical brochure of the ART FILLER® range). This data sheet does not replace the instructions for use accompanying the product.