HYALMASS HARD Lidocaine 1X1ML
Hyalmass
Aesthetic / Dermatology InjectableDeep dermal / contouring hyaluronic acid filler
Certifications
- CE Marked hyaluronic acid dermal filler with lidocaine for soft Tissue augmentation.
- Manufactured under medical device quality management systems with strict control of endotoxin and BDDE levels (reported below detection limit).
- Hy BRID hyper cross Linked technology provides dense, uniform HA particles for predictable rheology and long Lasting volume.
- Non Animal hyaluronic acid sourced and processed according to international safety and quality standards for injectable implants.
- CE Marked hyaluronic acid dermal filler with lidocaine for soft Tissue augmentation.
- Manufactured under medical device quality management systems with strict control of endotoxin and BDDE levels (reported below detection limit).
- Hy BRID hyper cross Linked technology provides dense, uniform HA particles for predictable rheology and long Lasting volume.
- Non Animal hyaluronic acid sourced and processed according to international safety and quality standards for injectable implants.
Deep dermal / contouring hyaluronic acid filler
Description
HYALMASS HARD Lidocaine 1X1ML is a CE-marked, hyper cross-linked hyaluronic acid dermal filler with lidocaine, designed for deep facial contouring and correction of pronounced volume loss. With a hyaluronic acid concentration of 24 mg/ml and 0.3% lidocaine, this biphasic, highly dense gel is intended to reduce the appearance of nasolabial folds, correct forehead and chin volume, and refine the facial oval. Manufactured using Hy-BRID technology to create uniform, highly dense HA particles, it offers strong volumising capacity, optimal viscoelasticity and long-lasting results with improved injection comfort.
Bnefits
- High HA concentration (24 mg/ml) provides strong and durable volumising effects.
- Hy-BRID hyper cross-linked technology creates highly dense, uniform particles for optimal viscoelasticity and shape retention.
- Formulated for deep contouring of areas such as nasolabial folds, chin, forehead and facial oval.
- Lidocaine 0.3% enhances patient comfort during and immediately after injection.
- Biphasic structure with approximately 600 µm particle size supports lift and projection for structural contouring.
- Non-animal, highly purified hyaluronic acid with controlled endotoxin and BDDE levels below detection limits.
- CE-marked medical device manufactured under strict quality and safety standards.
- Designed for long-lasting results, typically up to 12–18 months depending on treatment area and patient factors.
Indications
- Correction of moderate to severe nasolabial folds caused by volume loss.
- Deep facial contouring and volume restoration in areas such as chin and jawline (facial oval).
- Forehead volume correction and profile balancing.
- Restoration of structural support in mid and lower facial regions requiring a denser, more robust HA filler.
Composition
- Hyaluronic acid (cross-linked): 24 mg/ml
- Lidocaine hydrochloride: 0.3% (3 mg/ml)
- Hyaluronic acid of non-animal origin
- Buffer solution and water for injection (excipients as per manufacturer’s formulation)
- Biphasic HA gel with particle size approximately 600 µm
Formulation
- Cross-linked hyaluronic acid soft tissue dermal filler with lidocaine.
- Biphasic, highly dense gel based on Hy-BRID hyper cross-linked technology.
- Non-animal HA with very low residual BDDE and endotoxin (below detection limit, per manufacturer safety information).
- Intended for deep dermal and/or subcutaneous injection in indicated facial areas.
- Supplied as a 1 ml pre-filled glass syringe for single use.
Packaging
- Box containing 1 x 1 ml pre-filled sterile syringe of HYALMASS HARD with lidocaine.
- Typically supplied with one or more sterile disposable needles (contents may vary by distributor; common sizes include 25–27G for deep injection).
- Syringe and any needles are packaged in a sterile blister within an outer carton.
- Single-use medical device; contents must not be resterilised or reused.
Usage
- HYALMASS HARD must only be administered by appropriately trained and qualified healthcare professionals experienced in dermal filler injections.
- Before treatment, obtain full medical history, evaluate indications and contraindications and discuss treatment goals with the patient; obtain informed consent.
- Cleanse and disinfect the treatment area thoroughly and maintain strict aseptic technique throughout the procedure.
- Attach a suitable sterile needle or cannula to the pre-filled syringe, expel any air and verify gel flow before injection.
- Recommended injection plane is deep dermis or subcutaneous tissue depending on the indication and area (e.g. chin, jawline, nasolabial folds).
- Inject slowly using appropriate techniques (e.g. linear threading, depot, fanning) while aspirating according to clinic protocol and carefully avoiding intravascular injection.
- Do not overcorrect; build volume gradually and sculpt the contour, using the product’s high cohesiveness to maintain shape.
- After injection, gently mould the treated area if necessary to achieve a smooth and symmetrical contour, avoiding excessive pressure.
- Provide post-treatment advice, including avoiding strenuous exercise, excessive heat or cold, alcohol and manipulation of treated areas for at least 24–48 hours or as per clinic protocol.
- Schedule follow-up review to assess results, manage any adverse events and determine whether touch-up treatment is required.
- Dispose of the used syringe and needles immediately after use in approved sharps containers; any remaining product must be discarded and must not be reused.
Contraindications
- Known hypersensitivity or allergy to hyaluronic acid, lidocaine or amide-type local anaesthetics, or any component of the formulation.
- History of severe allergic reactions or anaphylaxis.
- Presence of active infection, inflammation or skin disease at or near the intended injection site.
- Autoimmune disease or significant immune compromise where the treating physician considers HA fillers inappropriate.
- Tendency to form hypertrophic scars or keloids in the proposed treatment area.
- Pregnancy or breastfeeding (use not recommended due to lack of sufficient safety data).
- Patients under 18 years of age.
- Injection into blood vessels, intramuscular injection, or injection into anatomical areas not recommended in the product information (e.g. not intended for breast or gluteal augmentation).
Adverse Effects
- Common, usually transient injection-site reactions such as redness, swelling, tenderness, pain, itching, bruising or haematoma.
- Temporary induration, nodules, palpable lumps or asymmetry that may improve spontaneously or with gentle massage and appropriate management.
- Localised inflammatory or hypersensitivity reactions, including prolonged swelling or erythema, which may require medical treatment.
- Infection at the injection site if aseptic technique or aftercare are inadequate.
- Rare but serious complications associated with inadvertent intravascular injection, including vascular occlusion, tissue ischaemia or necrosis, and in extremely rare cases visual disturbance or blindness if injected near critical vessels.
- Potential systemic effects related to lidocaine (e.g. CNS or cardiovascular symptoms) in cases of overdose, intravascular injection or hypersensitivity.
Storage Conditions
- Store in the original blister and outer carton to protect from light and maintain sterility.
- Keep in a cool, dry place within the temperature range specified by the manufacturer (typically 2–25 °C).
- Do not freeze.
- Protect from excessive heat and direct sunlight.
- Do not use after the expiry date printed on the packaging.
- Do not use if the blister, syringe or packaging is damaged, opened, or if sterility is in doubt.
Duration
Distributor and manufacturer information for the Hyalmass range indicate typical duration of effect around 12\u201324 months for deep structural fillers, depending on treatment area, injection technique, patient metabolism and lifestyle.
Onset
Results are visible immediately after injection, with final appearance stabilising over the following days to weeks as initial swelling subsides and the gel integrates into the tissue.













