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Dermalax IMPLANT PLUS 1 x 1.1ml

Dermalax IMPLANT PLUS 1 x 1.1ml

Dermalax

Injectable dermal filler
  • CE Marked hyaluronic acid dermal filler line for use within the European Economic Area.
  • Manufactured under quality systems consistent with international medical device standards (e.g., ISO 13485) as stated by suppliers.
  • Registered as a medical device in multiple markets (e.g., prior registration with the Philippine FDA under MDR 07650 for this product configuration).
Cross-linked hyaluronic acid filler with lidocaine for deep wrinkles and facial contouring

Description

Dermalax IMPLANT PLUS is a high-density, cross-linked hyaluronic acid dermal filler with lidocaine, designed for deep tissue augmentation and correction of deep wrinkles and folds. It is intended for facial volumetry and sculpting closer to bone structures, such as the cheeks, chin, jawline, and nose. The monophasic HA gel integrates smoothly into tissues while retaining malleability shortly after injection, allowing precise shaping and contouring. Results are temporary but long-lasting, with biocompatible and biodegradable non-animal-origin HA.

Bnefits

  • Provides high-density volume suitable for deep tissue augmentation and facial contouring.
  • Specifically formulated for treating deep wrinkles and folds and restoring lost facial volume.
  • Monophasic, cohesive HA gel for smooth injection and natural tissue integration.
  • Contains lidocaine (0.3%) to improve patient comfort during and immediately after injection.
  • Maintains malleability for a short time after injection, facilitating sculpting of treated areas.
  • Non-animal-origin, highly purified hyaluronic acid for improved biocompatibility.
  • Durable effects typically lasting around 12–18 months, with some sources reporting up to 18–24 months depending on individual factors.
  • CE-certified dermal filler line meeting EU safety and quality standards.
  • Suitable for volumetric facial modeling (cheeks, chin, jawline, nose) as well as deep nasolabial folds.
  • Transparent, viscoelastic gel that supports natural-looking enhancement and facial symmetry.

Indications

  • Correction of deep wrinkles and folds (e.g., deep nasolabial folds).
  • Volumetric augmentation of midface regions such as cheeks and zygomatic areas.
  • Chin augmentation and contouring.
  • Jawline augmentation and definition.
  • Nasal bridge and tip contouring (non-surgical rhinoplasty) by qualified professionals.
  • Modeling and volumizing of the lips in selected cases where a high-density filler is appropriate and per professional judgment.
  • General facial volumetry to address deep tissue defects and age-related volume loss.
  • Facial contouring close to bone structures (e.g., jawline, cheekbones).

Composition

  • Cross-linked hyaluronic acid (non-animal origin) 24 mg/mL.
  • Lidocaine hydrochloride 3 mg/mL (0.3% w/v) as a local anaesthetic.
  • Phosphate-buffered saline, pH ~7.0, q.s. to 1.1 mL.
  • BDDE (1,4-butanediol diglycidyl ether) as a cross-linking agent (residuals within regulatory limits).

Formulation

  • Sterile, pyrogen-free, monophasic cross-linked hyaluronic acid gel with lidocaine.
  • Transparent, viscoelastic gel optimized for deep dermal and subcutaneous injection.
  • Non-animal-origin HA produced by biofermentation and highly purified.
  • Single-use, prefilled syringe system intended for professional injection only.

Packaging

  • Standard commercial box typically containing 2 prefilled syringes, each with 1.1 mL of Dermalax IMPLANT PLUS.
  • Each syringe is prefilled with cross-linked HA 24 mg/mL and lidocaine 3 mg/mL.
  • Supplied with sterile disposable needles, commonly 25G, for injection as per the instructions for use.
  • Tamper-evident sterile blister packaging for syringes.
  • Labeling includes batch/lot number and expiry date.

Usage

  • For use only by appropriately trained and qualified healthcare professionals experienced in dermal filler injections and facial anatomy.
  • Intended injection plane: deep dermis and/or subcutaneous (supraperiosteal) layer of the face, depending on indication and clinical judgment.
  • Common treatment areas include cheeks, chin, jawline, nasolabial folds, nose, and other deep facial contours as appropriate.
  • Use supplied sterile needles (often 25G) or other compatible devices as recommended in the official instructions for use.
  • Strict aseptic technique should be followed during preparation and injection.
  • Assess patient medical history, allergies (especially to hyaluronic acid, lidocaine, or related anesthetics), and contraindications before treatment.
  • Inject slowly with minimal pressure and aspirate according to professional protocols to minimize risk of intravascular injection.
  • Massage or gently mold the treated area immediately after injection if indicated, to achieve the desired contour and smooth distribution, following manufacturer and professional guidelines.
  • Do not re-sterilize or reuse syringes or needles; this is a single-use product.
  • Advise patients on post-treatment care, such as avoiding extreme temperatures, vigorous exercise, and pressure on the treated area for a specified period, and to report any unusual symptoms promptly.

Contraindications

  • Known hypersensitivity to hyaluronic acid, lidocaine, or amide-type local anesthetics, or any component of the formulation.
  • History of severe allergic reactions or anaphylaxis to injectable fillers or local anesthetics.
  • Active skin infections, inflammation, or lesions (e.g., acne, herpes, dermatitis) at or near the intended injection sites.
  • Autoimmune diseases or immunocompromised states where dermal filler use is deemed unsafe by the treating physician.
  • Uncontrolled bleeding disorders or current use of anticoagulant/antiplatelet therapy where the risk of bleeding or bruising is unacceptable.
  • Pregnancy and breastfeeding (use is generally not recommended due to lack of adequate safety data).
  • History of hypertrophic scarring or keloids in the proposed treatment area, where filler use may pose additional risk.
  • Previous permanent or incompatible implants in the intended injection area where interaction risk exists.
  • Any other condition that, in the professional judgment of the treating clinician, makes hyaluronic acid dermal filler treatment inappropriate.

Adverse Effects

  • Common, usually transient reactions at the injection site such as redness, swelling, tenderness, pain, itching, or warmth.
  • Bruising or hematoma at or near the injection site.
  • Temporary firmness, lumps, nodules, or irregularities in the treated area.
  • Transient changes in skin sensation, including numbness or tingling.
  • Mild to moderate edema in the treated region, typically resolving within days.
  • Infection at the injection site if aseptic technique is not strictly followed.
  • Delayed inflammatory reactions, including granuloma formation or persistent nodules.
  • Allergic or hypersensitivity reactions to hyaluronic acid, lidocaine, or other components.
  • Very rare but serious complications such as intravascular injection leading to tissue ischemia, necrosis, or visual disturbances, which constitute medical emergencies.
  • Other unexpected adverse effects consistent with those associated with hyaluronic acid dermal fillers in general, to be managed by qualified healthcare professionals.

Storage Conditions

  • Store at 2°C to 25°C (do not freeze or overheat).
  • Protect from direct sunlight and sources of heat.
  • Keep in original packaging until use to maintain sterility.
  • Do not use if the package or syringe is damaged, if the solution appears cloudy or discolored, or if the expiry date has passed.
  • Avoid mechanical shock, excessive pressure, or crushing of the packaging.

Duration

Typically around 12\u201318 months, with reports of longevity up to approximately 18\u201324 months depending on injection site, technique, and individual patient factors.

Onset

Immediate volumizing and contouring effect visible directly after injection, with final integration and settling over the following days to weeks.

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