Belotero Lips Shape 1x0.6ml
Important Notice
Medical device regulated by the European Medical Device Regulation (MDR), intended exclusively for authorized healthcare professionals. By purchasing, the customer declares to be authorized for their professional activity; false information may entail legal responsibilities.
BELOTERO® Lips Shape is the reference in the Merz Aesthetics range intended specifically for the body of the lip: a cross-linked sodium hyaluronate gel at 25.5 mg/ml with 0.3 % lidocaine, formulated with CPM® technology and indicated to increase lip volume and to define the vermilion border. It is injected into the deep dermis and into the labial mucosa.
- HA 25.5 mg/ml
- Lidocaine 3 mg/ml (0.3 %)
- Contents 1 syringe × 0.6 ml
- Recommended needle 27G ½"
- Plane deep dermis and labial mucosa
Composition and technology
- Cross-linked sodium hyaluronate: 25.5 mg/ml, of non-animal origin.
- Lidocaine hydrochloride: 3.0 mg/ml (0.3 %), to reduce the local pain associated with injection of the gel.
- Phosphate buffer pH 7 q.s. to the gel volume.
- CPM® technology: cohesive polydensified matrix, a monophasic gel with variable cross-linking densities instead of suspended particles. The denser fractions provide projection and the less dense ones integrate into the surrounding tissue, which favours a homogeneous contour in a mobile area such as the lip.
Position within the BELOTERO® range
| Soft Lidocaine | HA 20 mg/ml · modification < 5 % · superficial to mid dermis · fine perioral lines |
|---|---|
| Balance Lidocaine | HA 22.5 mg/ml · modification < 8 % · superficial to mid dermis and infraorbital supraperiosteal plane · moderate wrinkles and folds, lips, infraorbital hollow |
| Intense Lidocaine | HA 25.5 mg/ml · modification < 8 % · deep dermis · deep folds, marionette lines, lip enhancement |
| Lips Shape | HA 25.5 mg/ml · deep dermis and labial mucosa · lip volume and vermilion border |
| Volume Lidocaine | HA 26 mg/ml · modification < 10 % · deep subcutaneous or supraperiosteal · cheeks, temples, chin, severe NLFs |
| Revive | HA 20 mg/ml + glycerol 17.5 mg/ml · mid and deep dermis · skin revitalisation, not volumetric filling |
Within the lip line, Lips Shape provides volume and roundness; Lips Contour, the other reference in the series, is intended for definition of the contour. Both are presented in a 0.6 ml syringe.
Indications and treatment areas
Injectable implant indicated to restore or significantly increase the volume of the cutaneous tissue, allowing the volume of the lips to be increased: the border of the red part of the lip or an increase in its roundness.
- Body of the upper and lower lip
- Vermilion border
It may be used in all skin phototypes. It may be combined with other BELOTERO products in the same session, following the instructions for use of each product.
Technique and treatment protocol
- Injection plane: deep dermis and mucosa of the lips.
- Needle: one of the supplied needles should be used; the manufacturer recommends the 27G ½" needle, since a smaller diameter would require greater injection force.
- The treatment must be carried out under appropriate aseptic conditions, on healthy, non-inflamed and rigorously disinfected skin.
- Specific training in injection techniques for soft tissue augmentation and sound knowledge of the anatomy and physiology of the area to be treated are required.
- Inject slowly and apply the minimum pressure necessary. The amount of gel depends on the area and on the desired correction. Do not overcorrect.
- Gently massage the treated area after injection to distribute the product evenly.
- If the needle becomes blocked and the injection pressure increases excessively, stop the injection and change the needle.
Technical data
| Manufacturer | Anteis SA, Plan-les-Ouates, Switzerland (Merz Aesthetics) |
|---|---|
| Active substance | Cross-linked sodium hyaluronate 25.5 mg/ml |
| Anaesthetic | Lidocaine hydrochloride 3.0 mg/ml (0.3 %) |
| Technology | CPM® (Cohesive Polydensified Matrix) |
| pH | 7 (phosphate buffer) |
| Presentation | 1 pre-filled glass syringe of 0.6 ml |
| Needles | 2 sterile CE-marked needles; the 27G ½" is recommended |
| Sterilisation | Moist heat (syringe) |
| Classification | Medical device with CE marking |
| Use | Qualified healthcare professionals only |
Storage and pack contents
- Storage: between 2 °C and 25 °C. Protect from light and from freezing. Avoid mechanical impact.
- Do not use after the expiry date shown on the packaging.
- Single-use product. Do not resterilise or reuse.
- The pack contains: 1 pre-filled syringe of 0.6 ml, 2 sterile CE-marked needles, 2 traceability labels and instructions for use.
Contraindications and warnings
Contraindications: known hypersensitivity to any of the components, in particular to sodium hyaluronate, to BDDE, to lidocaine hydrochloride or to other amide-type local anaesthetics; pregnancy and breastfeeding; under 18 years of age; general infection; active autoimmune disease.
Do not inject into blood vessels, into skin with active inflammation or infection, or into areas previously treated with a permanent dermal filler.
Warnings: rare but serious events associated with intravascular injection of facial fillers have been reported, including vascular occlusion, visual impairment, blindness, cerebral ischaemia or haemorrhage and skin necrosis. Stop the injection immediately in the event of changes in vision, signs of stroke, skin blanching or unusual pain, and refer for urgent medical care. The presence of lidocaine may cause localised redness, hypersensitivity or transient locoregional numbness, and may give a positive result in anti-doping tests.
Always consult the instructions for use included in the pack before application.
Medical device intended exclusively for qualified healthcare professionals. Technical information based on the official instructions for use of BELOTERO® Lips Shape (Anteis SA / Merz Aesthetics). Merz does not currently publish a Spanish version of the instructions for use for this reference; the data are taken from the current international version. This data sheet does not replace the instructions for use accompanying the product.