Pluryal Contour Lidocaine 1ml

Pluryal

Aesthetic / cosmetic injectable

Hyaluronic acid dermal filler with lidocaine for contouring and volume

CE Marked Class III injectable medical device within the European regulatory framework.
Manufactured under an ISO 13485 Certified quality management system for medical devices.
Gel preparation performed in cleanroom conditions compliant with ISO 14644.
Biocompatibility evaluation conducted according to ISO 10993 standards.
Compliance with Good Manufacturing Practice (GMP) standards for sterile injectable products.
Very low residual BDDE and controlled levels of proteins and endotoxins, in line with international safety specifications for hyaluronic acid fillers.

CE Marked Class III injectable medical device within the European regulatory framework.
Manufactured under an ISO 13485 Certified quality management system for medical devices.
Gel preparation performed in cleanroom conditions compliant with ISO 14644.
Biocompatibility evaluation conducted according to ISO 10993 standards.
Compliance with Good Manufacturing Practice (GMP) standards for sterile injectable products.
Very low residual BDDE and controlled levels of proteins and endotoxins, in line with international safety specifications for hyaluronic acid fillers.

Hyaluronic acid dermal filler with lidocaine for contouring and volume

Description

Pluryal Contour Lidocaine 1ml is a sterile, monophasic cross-linked hyaluronic acid dermal filler with lidocaine, developed by MD Skin Solutions for precise facial remodelling. With a hyaluronic acid concentration of 25 mg/ml (2.5%) and 0.3% lidocaine, it is designed for deep dermal, subcutaneous or supraperiosteal injection to restore facial volume, contour the midface and jawline, and correct deep volume loss. The filler targets areas such as temples, cheekbones, chin, jawline and other regions affected by age-related soft tissue deflation, providing distinguished lifting capacity, natural-looking results and long-lasting effects. The high G' factor (approximately 650,000 mPa) offers strong shaping capability while the optimised syringe design ensures smooth, low-extrusion-force injections and high patient comfort.

Bnefits

Restores facial volume and structures in areas affected by deep volume loss, including temples, cheekbones, chin and jawline.
Contours and shapes facial outlines for precise facial remodelling and improved definition.
High lifting and shaping capacity due to a high G' factor (about 650,000 mPa), providing strong volumising effect with good structural support.
Long-lasting results, with estimated in-skin duration of around 9–12 months depending on area, technique and patient factors.
Contains 0.3% lidocaine to reduce pain during injection and improve overall treatment comfort.
Monophasic, homogeneous cross-linked HA gel for predictable distribution, smooth integration and natural-looking results.
Designed for deep dermis, subcutaneous or supraperiosteal injection to address midface volume deficit and contour restoration.
Produced with very low residual BDDE and controlled protein/endotoxin levels to support safety and biocompatibility.
Manufactured in Europe as a CE-marked Class III injectable medical device under ISO 13485 and related quality standards.
Supplied in a premium, ergonomic glass syringe with thin-wall Terumo needles, offering low extrusion force, precise handling and reduced tissue trauma.

Indications

Correction of midface facial volume deficit.
Restoration of facial volume in patients with age-related soft tissue loss.
Shaping and contouring of facial outlines, including jawline and lower face.
Restoration of facial structure in areas such as temples, cheekbones, chin and mandibular contour.
Reconstructive treatments of facial lipoatrophy.
Correction of deep volume loss in facial areas where added projection and support are required.

Composition

Cross-linked sodium hyaluronate (hyaluronic acid) 25 mg/ml (2.5%), non-animal, bacterial origin.
Lidocaine hydrochloride 0.3% (3 mg/ml) as a local anaesthetic to reduce injection discomfort.
Cross-linking agent: BDDE (1,4-Butanediol Diglycidyl Ether), cross-linking grade BDDE +++++ (high degree of cross-linking).
Residual BDDE content: very low (manufacturer data; specified as within strict regulatory limits).
High G' (elastic modulus) gel, G' factor approximately 650,000 mPa, conferring strong firmness and lifting capacity.
Physiologic buffer solution (isotonic, pH balanced aqueous excipients suitable for injectable HA gels).

Formulation

Monophasic, homogeneous cross-linked hyaluronic acid gel implant intended for deep volumising and contouring.
Hyaluronic acid concentration: 25 mg/ml (2.5%).
Lidocaine concentration: 0.3% (3 mg/ml).
Non-animal HA obtained by bacterial fermentation and purified to remove proteins and contaminants.
Sterile, pyrogen-free, transparent viscoelastic gel, supplied in a pre-filled glass syringe.
Formulated for deep dermal, subcutaneous or supraperiosteal injection to provide structural support and high volumising capability.

Packaging

Box containing 1 x 1 ml pre-filled glass syringe of Pluryal Contour Lidocaine gel.
Includes 2 x 27G 1/2" ultra thin wall Terumo needles (CE 0197).
Supplied with package insert (Instructions for Use) and traceability labels.
Single-patient, single-use, sterile packaging with CE-marked labelling and batch/expiry information.

Usage

Pluryal Contour Lidocaine is a professional-use-only medical device and must be injected exclusively by appropriately trained and qualified healthcare or aesthetic practitioners experienced in deep dermal and subcutaneous filler techniques.
Before treatment, obtain a full medical history, assess facial anatomy, volume deficits and contour issues (e.g. midface, temples, cheekbones, chin, jawline), rule out contraindications and document baseline status. Obtain informed consent.
Cleanse and disinfect the treatment area thoroughly. Additional topical anaesthetic may be applied according to clinic protocol, although the product contains 0.3% lidocaine for comfort.
Attach one of the supplied 27G 1/2" Terumo ultra thin wall needles to the pre-filled 1 ml syringe under aseptic conditions and expel air bubbles before injection.
Recommended injection depth (per manufacturer brochure): deep dermis, subcutaneous or supraperiosteal plane, depending on the specific area and desired volumising effect.
Use appropriate techniques such as linear threading, fanning, depot/bolus injections or supraperiosteal boluses along the zygoma, mandibular line, chin or temple, according to the Pluryal protocol and practitioner training.
Target areas include any facial region affected by deep volume loss, with particular focus on midface, temples, cheekbones, chin and jawline; injections should be tailored to the patient’s anatomy and aesthetic goals.
Inject slowly with minimal, controlled pressure, aspirating where appropriate and observing the skin for any signs of blanching, pain or vascular compromise. Discontinue injection immediately if vascular compromise is suspected and follow standard filler complication management protocols.
After injection, gently mould or massage the treated area as needed to shape contours and optimise integration, avoiding excessive pressure that could displace product.
Typical manufacturer-stated in-skin duration is 9–12 months. Re-treatment may be scheduled within this time frame depending on clinical evolution, patient preference and practitioner judgement.
Provide post-treatment advice: avoid touching or massaging the area unnecessarily, avoid makeup for several hours, and avoid intense heat/cold, strenuous exercise and alcohol for at least 24 hours. Recommend sun protection and avoidance of tanning beds for several days.
Refer to the official Pluryal Contour Lidocaine professional brochure and Instructions for Use for full, up-to-date information on indications, injection techniques, precautions and management of adverse effects.

Contraindications

Hypersensitivity or known allergy to hyaluronic acid, lidocaine or any excipients in the formulation (including BDDE or buffer components).
History of severe allergic reactions or anaphylaxis, particularly to local anaesthetics of the amide type (e.g. lidocaine, mepivacaine, bupivacaine).
Active or chronic skin infections, inflammation or lesions at or near the intended injection sites (e.g. bacterial or viral infections such as herpes simplex, dermatitis).
Autoimmune diseases or immunodeficiency conditions in which the use of dermal fillers may be inadvisable unless carefully evaluated by a specialist.
Known tendency to hypertrophic scarring or keloid formation in the proposed treatment area.
Uncontrolled bleeding disorders or current significant anticoagulant/antiplatelet therapy that substantially increases bleeding risk, unless a medical prescriber has assessed and approved treatment.
Pregnancy and breastfeeding (commonly listed as contraindications or strong precautions for elective aesthetic injectable treatments).
Previous permanent or semi-permanent fillers in the same area where interactions or irregularities may occur, unless assessed and managed by an experienced injector.
Any additional contraindications, warnings or precautions specified in the official Pluryal Contour Lidocaine Instructions for Use and local regulatory guidance.

Adverse Effects

Common transient injection-site reactions such as redness (erythema), swelling, tenderness, pain, warmth, itching, minor bruising or slight bleeding.
Temporary lumps, nodules or contour irregularities at injection sites, which usually resolve as oedema subsides and the product integrates; persistent nodules may require medical management.
Temporary asymmetry or overcorrection, generally improving as swelling reduces or with minor corrective treatment.
Local hypersensitivity or inflammatory responses including prolonged redness, swelling or induration.
Infection at injection sites if aseptic technique is not followed; may require antibiotic or other medical treatment.
Very rare but serious complications associated with all hyaluronic acid fillers, such as inadvertent intravascular injection leading to vascular occlusion, tissue ischaemia or necrosis, and, in high-risk areas, visual disturbances or blindness; these events are medical emergencies requiring immediate appropriate intervention.
Any other adverse reactions listed in the official Pluryal Contour Lidocaine Instructions for Use, which practitioners must review prior to use.

Storage Conditions

Store at controlled room temperature as indicated on the packaging, typically between 2°C and 25°C.
Protect from direct sunlight and extreme temperatures; do not freeze.
Keep the syringe in its original blister and outer carton until use to maintain sterility and traceability.
Do not use the product if the packaging, blister or syringe is damaged, or if sterility is compromised.
Do not use after the expiry date printed on the package.
Discard any unused product after treatment; Pluryal Contour Lidocaine is intended for single-patient, single-use only.

Duration

Manufacturer data and clinical sources indicate an estimated in-skin duration of approximately 9\u201312 months, with some variability between patients and treated areas (generally within a 6\u201312 month range depending on metabolism, lifestyle, injection technique and volume).

Onset

Visible volumising and contouring results are typically immediate after injection due to the high G' hyaluronic acid gel, with final appearance stabilising over the following days as mild swelling subsides and the product integrates into surrounding tissues.