- On sale!
123,50 € tax excl.
DHL EXPRESS : Quick Expedition ! CONTACT US By e-mail: firstname.lastname@example.org
FILORGA MEDICAL Art Filler VOLUME
Hyaluronic acid gel with lidocaine
2 pre-filled syringes of 1.2ml each
4 needles TERUMO 25G1
! Limited stock !
All of your payments are secured. A doubt? Feel free to contact Us!
Shipping on the day of your order, delivery with DHL.
Via phone, Whatsapp, text, e-mail.Feel free to ask all of your questions to our team of pharmacists
ART FILLERS products are intended for the correction of changes in the structure of the skin due to ageing: filling of wrinkles and folds of the skin, restoration of volumes.
Restoration of facial volumes by subcutaneous, supra periosteal or deep dermal injection.
Cross-linked hyaluronic acid gel: 25mg/ml + 3mg/ml of lidocaine
Fillmed VOLUME is intended to be injected slowly into the deep dermis or supraperiosteally or subcutaneously by a doctor who is qualified in injection techniques. La technicité du traitement est essentielle à sa réussite.
This device should be used by practitioners specifically trained in volume restoration injections. A good knowledge of the anatomy and physiology of the area to be treated is required.
Before starting treatment, the patient must be informed of the indications of the device, its contraindications, incompatibilities and potential adverse effects.
The area to be treated must be thoroughly disinfected before injection.
Use the 27G 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.
Between 4 ºC and 25 ºC. Ambient temperature.
Do not use the product after the expiration date. The expiration date is printed on the product labels.
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.
Each box contains 2 syringes, 4 sterile needles of 27G 1/2, for single use and reserved for the injection of ArtFiller Volume, 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.
Art Filler VOLUME must not be injected:
- For the correction of superficial wrinkles.
- In the periorbital area (eye lids, crow’s feet, dark circles) and glabellar nor in the lips
- Into the blood vessels
- Into muscles
- In a site where a non-absorbable filler implant has already been injected.
- Do not over correct.
Art Filler VOLUME 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
- Art Filler VOLUME must only be used by doctors qualified in injection techniques.
- Art Filler VOLUME is not recommended for injections other than subcutaneous, supra periosteal or deep dermal. The technique and depth of injection will vary depending on the treatment site.
- Do not inject into blood vessels, bones, tendons, ligaments or moles.
- There is no clinical data available on the efficacy and safety of injecting Art Filler VOLUME into an area that has already been treated with another dermal filler.
- There are no clinical data available on the efficacy and safety of Art Filler VOLUME 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.
- Art Filler VOLUME should be used with caution in patients with cardiac conduction disorders.
- Art Filler VOLUME 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.
- Do not inject more than 2ml of ART FILLER VOLUME per treatment spot during each session.
- 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.
There are incompatibilities between hyaluronic acid and quaternary ammonium compounds such as benzalkonium chloride solutions. Therefore, Art Filler VOLUME must never be put in contact with medical-surgical instruments treated with this type of product.
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.
- 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 lidocaine. 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 Art Filler VOLUME 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).
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 laboratories are experts in hyaluronic acid. A custom-made production unit with the latest technology has been designed specifically for ART FILLER ®.
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.
FILLMED Laboratories invest in its innovative manufacturing, with 20% of turnover dedicated to R&D each year.
FILLMED plans scientific studies using the latest technology to prove the performance and safety of its products.
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.
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.
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.
Produit réservé aux professionnels de santé (médecin spécialisé en dermo esthétique, dermatologue, chirurgien plastique)
Yasser K. published the 26/08/2023 following an order made on 20/08/2023