FILLMED (FILORGA)® ART FILLER UNIVERSAL w/ Lidocaine

Product Overview: FILLMED (FILORGA)® ART FILLER UNIVERSAL w/ Lidocaine FILLMED (FILORGA)® ART FILLER UNIVERSAL w/ Lidocaine is an injectable, non-pyrogenic, transparent viscoelastic gel. It is formulated with hyaluronic acid (HA) utilizing advanced Tri-Hyal® Technology and incorporates 0.3% lidocaine hydrochloride for enhanced patient comfort. Developed by Fillmed Laboratoires (Paris, France), a specialist in aesthetic medicine, this “Universal” filler is designed for versatility in treating medium to deep facial wrinkles and can also be used for lip enhancement. It is indicated for filling various skin depressions, smoothing wrinkles, and augmenting lip volume, offering a balanced solution for multiple aesthetic concerns. Note: This medical device is intended for administration solely by licensed medical professionals trained and experienced in dermal filler injection techniques. Mechanism of Action and Properties FILLMED® ART FILLER UNIVERSAL leverages Tri-Hyal® Technology, which involves a sophisticated combination of different chain lengths of hyaluronic acid and optimized cross-linking. This technology creates a gel with balanced rheological properties, making it adaptable for various injection depths and tissue types. It aims to provide: Effective Filling: For medium to deep wrinkles and folds. Smooth Integration: Ensuring the gel blends naturally with surrounding tissues. Versatile Sculpting: Suitable for both wrinkle correction and lip augmentation. Upon injection, the HA gel provides immediate volume to the treated area. It also attracts and retains water molecules, contributing to improved skin hydration and suppleness. The 0.3% lidocaine hydrochloride provides local anesthesia, minimizing discomfort during the injection process. The gel is designed for easy injection and even distribution. Clinical effects can be long-lasting, often cited up to 18 months, but individual patient results will vary based on factors such as patient metabolism, skin type, lifestyle, area treated, volume injected, and practitioner technique. Indications and Usage FILLMED® ART FILLER UNIVERSAL w/ Lidocaine is indicated for a range of aesthetic corrections, including: Correction of medium to deep facial wrinkles and folds (e.g., nasolabial folds, marionette lines) Restoration of facial volume in moderately depressed areas Lip volume augmentation and contouring Smoothing of perioral lines Injection depth varies depending on the indication, typically into the mid to deep dermis for wrinkles, or into the lip mucosa/submucosa for lip enhancement. Administration should be performed by qualified practitioners using appropriate techniques. Expected Outcomes Professional application aims to achieve: Significant reduction of medium to deep wrinkles and folds Natural-looking enhancement of lip volume and contour (if used for lips) Improved skin texture and hydration in the treated area A versatile solution for various common aesthetic concerns Enhanced patient comfort due to the inclusion of lidocaine Potential Adverse Events Practitioners must thoroughly discuss potential side effects with patients. Common, generally temporary reactions include: Common Reactions: Swelling, bruising, redness (erythema), pain or tenderness at injection sites, temporary palpable firmness or lumps. These typically resolve within a few days to a week. If used in the lips, swelling can be more pronounced. Less Common/Rare but Serious Reactions: Prolonged swelling or firmness, significant hematoma, infection, inflammatory reactions (sometimes delayed), hypersensitivity/allergic reaction (to HA or lidocaine), nodule or granuloma formation, skin discoloration, abscess formation (pus), vascular occlusion (a rare but serious complication requiring immediate intervention), tissue necrosis (rare). Meticulous technique and a thorough understanding of facial anatomy are crucial. Patients should report any severe, prolonged, or unexpected reactions immediately. Storage Conditions Store between 2°C and 25°C, away from direct sunlight and freezing temperatures. Do not use if the package is damaged. Disclaimer: This information serves as a general guide. Healthcare professionals must consult the full instructions provided with FILLMED (FILORGA)® ART FILLER UNIVERSAL w/ Lidocaine before administration. These instructions contain essential details on indications, contraindications, warnings, precautions, injection techniques, and management of potential adverse events.