Belotero Lips Shape 1x0,6ml

Injectable filler: for medical professionals only. Belotero Lips Shape is injected submucosally or subcutaneously for lip enhancement, or into the deep dermis for perioral lines and severe oral commissures. Do not inject into blood vessels: the lip area requires particular caution and knowledge of anatomy. The pack contains 1 pre-filled 0.6 ml syringe and 2 needles.

What is Belotero Lips Shape 0.6 ml?

Belotero Lips Shape, manufactured by Anteis SA (Merz Aesthetics), is a resorbable medical device in the form of a sterile, colourless gel of cross-linked hyaluronic acid 25.5 mg/ml with lidocaine hydrochloride 3 mg/ml (0.3%), in a 0.6 ml syringe. It belongs to the Belotero range of fillers manufactured with CPM technology and is intended primarily for increasing lip volume, as well as for treating deep perioral lines and severe oral commissures. For precise lip contour, Belotero Lips Contour (22.5 mg/ml, 0.6 ml) is used. The same 25.5 mg/ml concentration, in a 1 ml syringe, is found in Belotero Intense Lidocaine. See also other products for lip enhancement and dermal fillers.

Product parameters

Composition

• Cross-linked sodium hyaluronate: 25.5 mg/ml, obtained from hyaluronic acid of non-animal origin, cross-linked with BDDE using CPM technology.
• Lidocaine hydrochloride: 3 mg/ml (0.3%), to reduce discomfort during injection.
• Phosphate buffer pH 7 (q.s. 0.6 ml).

Mechanism of action

The gel, with a variable degree of cross-linking, is placed in the tissue to supplement the extracellular matrix and support the surrounding structures. The higher-density parts of the gel fill and expand the tissue, while the lower-density parts diffuse into the fine pericellular spaces, which favours even integration with the surrounding tissue. Lidocaine reduces local pain associated with the injection. The effect is temporary: hyaluronic acid is gradually resorbed.

Indications and treatment areas

Belotero Lips Shape is indicated for:

• lip enhancement: submucosal or subcutaneous injection,
• treatment of perioral lines and severe oral commissures: injection into the deep dermis.

Both products in the Lips line can be combined in the same session, in different areas, in accordance with the instructions for each: Contour for contour and lines, Shape for volume.

Administration: injection plane and parameters

• Injection plane: submucosal or subcutaneous for lip enhancement; deep dermis for perioral lines and severe oral commissures. The final technique and dose are chosen by the specialist.
• Needles in the pack: 2 sterile single-use needles (dimensions stated on the outer box). The instructions recommend a 27G½" needle.
• Dosing: the volume depends on the area and the planned correction; do not over-correct.
• The procedure is performed under aseptic conditions, into healthy, non-inflamed skin, after disinfection of the treatment area.

Duration of effect

The duration of effect is individual and depends on the injection technique, metabolism and the patient's predisposition. Hyaluronic acid is gradually resorbed.

Contraindications and precautions

Do not use in case of hypersensitivity to sodium hyaluronate, lidocaine, BDDE or amide-type local anaesthetics, in pregnancy or breastfeeding, in persons under 18 years of age, in general infection, in active autoimmune disease, in active cutaneous inflammation or infection at the injection site, or in an area previously treated with a permanent filler. Do not inject into blood vessels or into the glabellar or nose region.

Packaging and product data

• Pack: 1 sterile pre-filled 0.6 ml syringe (single use) + 2 sterile needles (dimensions on the outer box; a 27G½" needle is recommended in the instructions).
• Manufacturer: Anteis SA, 18 Chemin des Aulx, 1228 Plan-les-Ouates, Switzerland.

Frequently asked questions

How does Belotero Lips Shape differ from the other products in the Belotero range?

The Belotero products differ in the concentration of cross-linked hyaluronic acid, the injection plane and the indications. Belotero Soft Lidocaine contains 20 mg/ml and is indicated for perioral fine lines in the superficial to mid-dermis. Belotero Balance Lidocaine contains 22.5 mg/ml: it is used for nasolabial folds, marionette lines, perioral lines and oral commissures, as well as for lip enhancement. Belotero Intense Lidocaine contains 25.5 mg/ml and is injected into the deep dermis for deep nasolabial folds and marionette lines, and submucosally or subcutaneously for lip enhancement. Belotero Lips Contour (22.5 mg/ml, 0.6 ml) is intended mainly for lip contour, perioral lines and moderate oral commissures, while Belotero Lips Shape (25.5 mg/ml, 0.6 ml) is intended for lip volume and for deep perioral lines and severe oral commissures. The choice of product is made by the specialist.

Belotero Lips Shape or Belotero Lips Contour: which one for the lips?

Shape (25.5 mg/ml, 0.6 ml) is chosen when the goal is to increase lip volume and to treat deep perioral lines and severe oral commissures. Belotero Lips Contour (22.5 mg/ml, 0.6 ml) is used for a precise contour, perioral lines and moderate commissures. Both products can be combined in the same session, in different areas, according to the physician's assessment.

At what depth is Belotero Lips Shape injected?

For lip enhancement, submucosal or subcutaneous injection is recommended. For perioral lines and severe oral commissures the product is injected into the deep dermis.

How long does the effect last?

Duration is individual and depends on the injection technique, metabolism and the patient's predisposition.

Does Belotero Lips Shape contain lidocaine?

Yes. The composition includes lidocaine hydrochloride 3 mg/ml (0.3%) and cross-linked sodium hyaluronate 25.5 mg/ml in a phosphate buffer.

Who may use this product?

Medical professionals only, in accordance with the current instructions for use and applicable regulations. By purchasing the product you confirm that you are authorised to perform procedures that break the continuity of tissues.

Information for specialists

The product is intended exclusively for use by appropriately trained healthcare professionals who are qualified or accredited under national law. Before treatment, take a medical history and assess the patient for contraindications, inform the patient about the nature of the procedure, possible risks and aftercare, and follow the current instructions for use.

Do not inject intravascularly. The lip area is highly vascular: particular caution and knowledge of the labial arteries are required. Do not inject into the glabellar or nose region. The syringe and needles are sterile and for single use; discard any leftover product and do not use if the packaging is damaged. The instructions recommend a 27G½" needle.

As after any injection, transient reactions may occur at the injection site, such as swelling, redness, tenderness, a small lump or bruising, which usually resolve spontaneously within a few days.

Table of contents

• What is Belotero Lips Shape 0.6 ml?
• Product parameters
• Composition and mechanism of action
• Indications, administration and product data
• Frequently asked questions
• Information for specialists