Description
ART FILLER FINE LINES is a viscoelastic injectable gel of cross-linked hyaluronic acid of non-animal origin, slowly resorbable over time, colourless, transparent, sterile, pyrogen-free and physiological, containing 0.3% by mass of lidocaine hydrochloride for its anaesthetic properties, from the FILLMED laboratory.
ART FILLERS products are intended for the correction of age-related changes in skin structure: filling wrinkles and skin folds, restoration of volumes.
The FINE LINES filler is an injectable implant intended for filling fine lines, superficial wrinkles and fine skin breaks (crow’s feet and peri-oral) through injection into the superficial dermis.
The presence of lidocaine is intended to reduce the patient’s pain sensation during treatment.
Indication of FILLMED ART FILLER FINE LINES
Fine lines filling, superficial wrinkles and thin skin breaks (crow’s feet and peri-oral) by injection into the superficial dermis.
Composition – FILLMED ART FILLER FINE LINES
Cross-linked hyaluronic acid gel: 20mg/ml + 3mg/ml of lidocaine
Directions for use – FILLMED ART FILLER FINE LINES
The technicality of the treatment is fundamental to its success, this device must be used by practitioners who have received specific training in volume restoration injections. A good knowledge of both the anatomy and physiology of the area to be treated is required.
Prior to starting the treatment, the patient should be informed about the indications of the device, its contraindications, incompatibilities and potential side effects.
The area to be treated must be thoroughly disinfected before injection.
Use the 30G 1/2 needle provided with the syringe. Insert the needle correctly and firmly into the tip of the pre-filled syringe, screw on gently and ensure that the needle is correctly fitted. Remove the needle cap and inject slowly into the dermis using the appropriate injection technique. The amount injected will depend on the area to be treated. After injection, it is important to massage the treated area to ensure that the product is evenly distributed. The graduations printed on the label of the syringe are an aid to the practitioner during the injection and cannot be considered as a measuring element.
Preservation – FILLMED ART FILLER FINE LINES
Store Filorga Injectable Implant in its packaging in a controlled room temperature between 2ºC and 25ºC.
Do not use the product after the expiration date. The expiration date is printed on the product labels.
Elimination – FILLMED ART FILLER FINE LINES
Used or partially used syringes and needles should be considered as potentially contaminated medical waste. They should be handled and eliminated in accordance with the medical practices of the institution and the local regulations in application.
Testimony – FILLMED ART FILLER FINE LINES
“It was with great enthusiasm that I discovered ART FILLER® Fine Lines from Laboratoires Filorga: it is a filling product with a very smooth and easy-to-inject texture, perfectly suited to superficial wrinkles.
The uniqueness of this product lies in its ability to significantly induce the synthesis of collagen and elastic fibres. This leads to a redensification and restructuring of the dermis, thus treating both the consequences and the causes of skin ageing!” Doctor Philippe Hamida Pisal
Each box contains 2 syringes, 4 sterile needles of 30G 1/2, for single use and reserved for the injection of ArtFiller Fine lines, a leaflet and 4 traceability labels. In order to guarantee the traceability of the product, one of the two labels should be placed in the patient’s file and the other should be given to the patient.
Precautions for use – FILLMED ART FILLER FINE LINES
CONTRAINDICATIONS OF FILLMED ART FILLER FINE LINES
FINE LINES must not be injected:
– For injections other than intradermal.
– Into the eyelids
– Into the blood vessels
– In a site where a non-absorbable filler implant has already been injected.
– Do not over correct.
FINE LINES must not be used:
– In patients with known hypersensitivity to hyaluronic acid, lidocaine and local anaesthetics of the amide type.
– In patients with a history of autoimmune disease or receiving immunotherapy.
– In patients with epilepsy not controlled by treatment.
– In patients with porphyria.
– In patients with a tendency to develop hypertrophic scars.
– In patients with a history of recurrent sore throat associated with acute articular rheumatism with cardiac localization.
– In pregnant or nursing women.
– In children.
– In areas with inflammatory and/or infectious skin lesions (acne, herpes, etc.).
– In immediate combination with laser treatment, deep chemical peeling or dermabrasion
– FINE LINES must only be used by doctors qualified in injection techniques.
– FINE LINES is not recommended for injections other than intradermal.
– Do not inject into blood vessels, bones, tendons, ligaments or moles.
– There is no clinical data available on the efficacy and safety of injecting FINE LINES into an area that has already been treated with another dermal filler.
– There are no clinical data available on the efficacy and safety of FINE LINES injection in patients with a history of severe multiple allergies or anaphylactic shock. The doctor will therefore have to decide on the indication on a case-by-case basis depending on the nature of the allergy and will have to ensure special monitoring of these patients at risk. In particular, it may be decided to propose a double test or an adapted preventive treatment prior to any injection.
– FINE LINES should be used with caution in patients with cardiac conduction disorders.
– FINE LINES should be used with extreme caution in patients with hepatocellular insufficiency with coagulation disorders and in patients treated with drugs that decrease or inhibit hepatic metabolism which may lead to coagulation disorders.
– Patients should be given the following recommendations:
- Avoid taking aspirin and high doses of vitamins C and/or E the week before the injection.
- Patients receiving anticoagulant therapy should be warned of the increased risk of haematoma and bleeding during injection.
- Do not apply any make-up for 12 hours after the injection.
- Avoid exposure to extreme temperatures (intense cold, sauna, steam room), as well as prolonged exposure to sunlight or ultraviolet light for 2 weeks after the injection.
– If the needle is stuck, do not increase the pressure on the plunger rod, stop the injection and replace the needle.
– The doctor’s attention is drawn to the fact that this product contains lidocaine and that they should consider it.
– The attention of athletes should be drawn to the fact that this product contains an active ingredient that can induce a positive reaction in tests carried out during anti-doping controls.
INCOMPATIBILITY
There are incompatibilities between hyaluronic acid and quaternary ammonium compounds such as benzalkonium chloride solutions. Therefore, FINE LINES must never be put in contact with medical-surgical instruments treated with this type of product.
SIDE EFFECTS – FILLMED ART FILLER FINE LINES
The doctor should inform the patient that there are potential immediate or delayed adverse effects associated with the implantation of this device.
These include (but are not limited to):
– Inflammatory reactions (redness, oedema, erythema) which may be associated with itching, superficial erosions in the crow’s feet, pain at the pressure area, may occur after the injection. These reactions may persist for a week. In a limited number of cases, 1.6% (1/61) of subjects in the clinical study, mild spontaneous or palpation pain may persist for more than a week.
– Bruises.
– Coloration or discoloration at the injection site.
– Indurations or nodules at the injection area.
– Low filling efficiency or low filling effect.
– Cases of glabellar necrosis, abscess, granuloma, and immediate or delayed hypersensitivity have been reported following injections of hyaluronic acid and/or lidocxin. These potential risks should be taken into consideration.
– The patient should inform the doctor as soon as possible if an inflammatory reaction persists beyond one week or if any other side effects occur. The doctor should treat these with appropriate treatment.
– Any other adverse effects related to the injection of FINE LINES should be reported to the distributor and/or manufacturer.
Please note that the injection of this product requires a technical medical procedure that must be carried out by a doctor (doctor specialized in dermo aesthetics, dermatologist, plastic surgeon).
The origin is certified 100% French.
THE PRODUCTS SOLD ON THIS SITE ARE PARAPHARMACEUTICAL PRODUCTS AND THEREFORE DO NOT REQUIRE A PRESCRIPTION.
THIS PRODUCT IS A MEDICAL DEVICE. THIS PRODUCT CANNOT BE RETURNED OR EXCHANGED
CAUTION: Unintentional injection of a filler into a blood vessel of the face can cause rare but serious side effects such as embolization which can lead to visual disturbances, blindness, necrosis of the skin and/or underlying tissue. These rare cases of embolization are mostly reported in the glabella, nose or peri-nasal area, forehead and peri-orbital area.
FILLMED EXPERTISE:
FILLMED laboratories are experts in hyaluronic acid. A custom-made production unit with the latest technology has been designed specifically for ART FILLER ®.
GUARANTEED QUALITY
In accordance with strict quality requirements, the factory guarantees a manufacturing process that complies with strict international standards: ISO 14644-1 and ISO 13485. All syringes are inspected individually, manually and visually, one by one, ensuring maximum quality and safety standards.
CONTINUOUS INNOVATION
FILLMED Laboratories invest in its innovative manufacturing, with 20% of turnover dedicated to R&D each year.
INNOVATIVE RESEARCH
FILLMED plans scientific studies using the latest technology to prove the performance and safety of its products.
IN VITRO sSTUDIES (BASED ON CELL CULTURE):
Fillmed tests its products on primary human skin cells adapted to real-life everyday conditions such as aged fibroblasts obtained from wrinkle depths, skin cells under UV radiation or oxidative stress, to ensure the clinical effect of the products. Skin cells would be evaluated either for their morphology or for their activities/functions.
EX VIVO STUDIES (BASED ON THE TISSUE):
In order to meet the laboratory conditions best suited to real human skin, Fillmed tests its products on pieces of living human skin: these pieces, resulting from abdominoplasty or lifting surgery, can be kept from 24 hours to 3 weeks in the laboratory. After applying the products (topical or injections), Fillmed can then evaluate skin samples (biopsies) using all available methods such as conventional microscopes, electron microscopes, marker dosage, etc.
CLINICAL TRIALS:
FILLMED plans various multi-centre, comparative, long-term studies with sufficient sample size to provide reliable data to assure practitioners and also patients about the safety and efficacy of FILLMED products. Through these studies, Fillmed has also been able to offer doctors the most accurate protocols.
