HYALMASS MILD Lidocaine 1X1ML
Hyalmass
Aesthetic / Dermatology InjectableHyaluronic acid dermal filler for fine to moderate wrinkles
Certifications
- CE Marked sterile absorbable hyaluronic acid dermal filler with lidocaine for soft Tissue augmentation.
- Produced using Hy BRID hyper cross Linked HA technology with manufacturing controls that keep endotoxin and BDDE levels below detection limits.
- Manufactured under medical device quality management systems consistent with international standards for injectable implants.
- Non Animal origin hyaluronic acid, purified and processed according to regulatory requirements for safety and biocompatibility.
- CE Marked sterile absorbable hyaluronic acid dermal filler with lidocaine for soft Tissue augmentation.
- Produced using Hy BRID hyper cross Linked HA technology with manufacturing controls that keep endotoxin and BDDE levels below detection limits.
- Manufactured under medical device quality management systems consistent with international standards for injectable implants.
- Non Animal origin hyaluronic acid, purified and processed according to regulatory requirements for safety and biocompatibility.
Hyaluronic acid dermal filler for fine to moderate wrinkles
Description
HYALMASS MILD Lidocaine 1X1ML is a pure, cross-linked hyaluronic acid soft tissue dermal filler with lidocaine, designed to treat fine to moderate facial wrinkles and provide subtle volume enhancement. Using Hy-BRID hyper cross-linked technology, it features highly dense, uniform HA particles for optimal viscoelasticity, smooth injection and long-lasting results. With 24 mg/ml non-animal hyaluronic acid and 0.3% lidocaine, Hyalmass Mild targets perioral lines, cheek wrinkles, forehead lines and other volume-loss related concerns, while also being suitable for natural-looking lip contouring and soft volume. It is supplied as a 1 ml pre-filled syringe for professional use only.
Bnefits
- 24 mg/ml cross-linked hyaluronic acid provides effective correction of fine to moderate wrinkles and subtle volume restoration.
- Medium-density, soft and smooth gel designed for natural-looking results without overcorrection.
- Indicated for perioral lines, crow’s feet, forehead lines, cheek wrinkles and soft lip augmentation.
- Contains 0.3% lidocaine to improve patient comfort during and immediately after treatment.
- Hy-BRID hyper cross-linked technology creates highly dense, uniform HA particles for optimal viscoelasticity and contour retention.
- Non-animal sourced HA with tightly controlled endotoxin and BDDE levels kept below detection limits for enhanced safety.
- Ergonomic syringe design helps achieve even pressure distribution and precise product placement.
- Long-lasting effect typically around 9–12 months, depending on area treated and patient factors.
Indications
- Treatment of fine to moderate wrinkles such as perioral lines, crow’s feet and forehead lines.
- Soft volume restoration in cheeks and chin for mild contour improvements.
- Lip contouring and subtle lip volume enhancement.
- Smoothing of marionette lines, mentolabial folds and nasolabial folds.
Composition
- Cross-linked hyaluronic acid: 24 mg/ml (non-animal origin).
- Lidocaine hydrochloride: 3 mg/ml (0.3%).
- Physiological buffer solution and water for injection (excipients as per manufacturer’s formulation).
- Approximate HA particle size: 400 µm (medium-sized particles suitable for dermal injection).
Formulation
- Cross-linked hyaluronic acid dermal filler with lidocaine for soft tissue augmentation.
- Medium-density, biphasic gel based on Hy-BRID hyper cross-linked technology.
- Non-animal, highly purified HA with very low residual BDDE and endotoxin (below detection limit per manufacturer).
- Sterile, pyrogen-free gel supplied in a 1 ml pre-filled glass syringe for single use.
- Intended for injection into the dermis and/or superficial subcutaneous plane, according to indication and practitioner judgement.
Packaging
- Box containing 1 x 1 ml pre-filled sterile syringe of HYALMASS MILD with lidocaine.
- Typically supplied with 2 sterile 27G TW disposable needles (needle specification may vary by market or distributor).
- Syringe and needles packed in a sterile blister within an outer carton.
- Labelled as a CE-marked medical device for professional use only; not for self-administration.
Usage
- For use only by suitably qualified and trained healthcare professionals experienced in injectable dermal fillers.
- Take a full medical history and assess indications, expectations and contraindications prior to treatment; 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 (commonly 27G for Hyalmass Mild) to the pre-filled syringe, expel air and verify smooth gel flow.
- Inject slowly into the appropriate plane, typically mid- to deep dermis for wrinkles or subcutaneously for soft contouring, depending on area and technique.
- Use appropriate injection techniques such as linear threading, serial puncture, fanning or small depot injections, avoiding intravascular injection.
- Do not overcorrect; achieve gradual, subtle volume and smoothing, particularly in lips and delicate facial regions.
- After injection, gently mould if needed to ensure even distribution and smooth contours, avoiding excessive pressure.
- Provide post-treatment advice including avoiding makeup for several hours, refraining from alcohol, intense exercise, saunas, sunbeds and extreme temperatures for 24–48 hours, and not massaging or manipulating treated areas unless instructed.
- Schedule follow-up to assess results and determine if touch-up treatment is indicated.
- Dispose of used syringe and needles immediately after use in approved sharps containers; any remaining product must be discarded and must not be reused.
Contraindications
- Hypersensitivity or allergy to hyaluronic acid, lidocaine, amide-type local anaesthetics or any component of the product.
- History of severe allergic reactions or anaphylaxis.
- Active skin infection, inflammation or disease at or near the intended injection site (e.g. herpes simplex, dermatitis).
- Autoimmune disease, immune suppression or other systemic conditions where dermal filler use is considered inappropriate by the treating physician.
- Tendency to form hypertrophic scars or keloids in the proposed treatment area.
- Pregnancy or breastfeeding (use not recommended due to limited safety data).
- Patients under 18 years of age.
- Injection into blood vessels or intramuscular injection, and use in anatomical areas not recommended by the manufacturer (e.g. not for breast or large-volume body augmentation).
Adverse Effects
- Common transient injection-site reactions including redness, swelling, tenderness, pain, itching, bruising or haematoma.
- Temporary lumps, nodules, irregularities or asymmetry in the treated area, which may resolve spontaneously or with appropriate management.
- Local inflammatory or hypersensitivity reactions such as prolonged swelling, induration or erythema that may require medical evaluation and treatment.
- Infection at the injection site if aseptic technique is not strictly observed or if aftercare instructions are not followed.
- Rare but serious complications linked to inadvertent intravascular injection, including vascular occlusion, tissue ischaemia or necrosis, and, in rare cases, visual disturbances or blindness when injected near critical vascular territories.
- Potential systemic side effects of 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 manufacturer-specified temperature range (commonly 2–25 °C).
- Do not freeze.
- Protect from direct sunlight and excessive heat.
- Do not use after the expiry date printed on the package.
- Do not use if the blister, syringe or packaging is damaged, opened, or if sterility is in doubt.
Duration
Typical reported duration for Hyalmass Mild is approximately 9\u201312 months, varying with treatment area, injection technique, patient metabolism and lifestyle.
Onset
Visible improvement and soft volume are usually apparent immediately after injection, with final results stabilising over several days as initial swelling resolves and the filler integrates into the tissue.
