Genefill Contour (1x10ml)

Genefill

Aesthetic Medicine – Body Dermal Filler

Hyaluronic acid body contouring filler for small body areas (buttocks, calves, concave deformities)

CE Marked hyaluronic acid dermal/body filler within the Genefill range (medical device).
Manufactured by BioScience GmbH under quality systems consistent with ISO 13485 standards for medical devices.
Part of a Genefill / HYAcorp / Hyaprof filler portfolio that has received CE mark extension approvals for hyaluronic acid dermal fillers.
Non Animal origin hyaluronic acid produced under controlled fermentation and purification processes.
Subject to ongoing safety, quality and performance monitoring by the manufacturer and regulatory authorities.

CE Marked hyaluronic acid dermal/body filler within the Genefill range (medical device).
Manufactured by BioScience GmbH under quality systems consistent with ISO 13485 standards for medical devices.
Part of a Genefill / HYAcorp / Hyaprof filler portfolio that has received CE mark extension approvals for hyaluronic acid dermal fillers.
Non Animal origin hyaluronic acid produced under controlled fermentation and purification processes.
Subject to ongoing safety, quality and performance monitoring by the manufacturer and regulatory authorities.

Hyaluronic acid body contouring filler for small body areas (buttocks, calves, concave deformities)

Description

Genefill Contour (1x10ml) is a cross-linked, biphasic hyaluronic acid body filler from the Genefill range by BioScience GmbH, specifically designed for contouring and volumizing smaller areas of the body. It is formulated with non-animal origin hyaluronic acid of high viscosity and high particle size to provide long-lasting volume, shaping and correction. Genefill Contour is intended for restoring lost volume and contouring body surfaces such as the buttocks and calves, as well as correcting concave deformities and other localized volume deficits. The product is supplied as a sterile, ready-to-use 10 ml prefilled syringe for single use only, and is CE-marked as a medical device.

Bnefits

Body-specific hyaluronic acid filler designed for contouring and volumizing smaller body areas.
Biphasic, high-viscosity gel providing robust lifting and shaping capacity with a natural look and feel.
Non-animal origin hyaluronic acid, biocompatible and biodegradable, reducing risk of immunogenic reactions.
Endotoxin-controlled formulation to support safety during injection.
Long-lasting results, with Genefill fillers generally lasting up to approximately 18 months depending on area, technique and patient factors.
Intended for correction of concave deformities, buttocks augmentation and calves reshaping.
CE-marked body filler manufactured under strict quality controls by BioScience GmbH in Germany.
Supplied in a large 10 ml syringe to treat body areas efficiently.
Ready-to-use sterile gel requiring no reconstitution.

Indications

Restoration of lost volume and contouring of body surfaces.
Buttocks augmentation and reshaping (when used appropriately by trained professionals).
Calves reshaping and volumization.
Correction of concave deformities (localised depressions or volume defects in soft tissues).
Volume restoration and contouring of other suitable small body areas as per professional judgment and product guidelines.
Hands rejuvenation/volumization (as referenced in manufacturer materials) when appropriate technique and depth are used in line with guidance.

Composition

Non-cross-linked hyaluronic acid: 2.0 mg per ml of gel.
Cross-linked hyaluronic acid (non-animal origin): 20.0 mg per ml of gel.
Sodium chloride: approximately 6.9 mg per ml.
Water for injection (WFI) as the aqueous carrier.
Biphasic hyaluronic acid gel with particle size approximately 200–350 μm.
Sterile, pyrogen-controlled, viscoelastic gel, apyrogenic and endotoxin-controlled.

Formulation

Absorbable skin implant (medical device) based on biphasic cross-linked hyaluronic acid of non-animal origin.
Viscoelastic, transparent, sterile gel intended for subcutaneous and supraperiosteal injection in body areas.
Concentration: 20 mg/ml cross-linked hyaluronic acid plus 2 mg/ml non-cross-linked hyaluronic acid in physiological buffer.
Presentation: 1 x 10.0 ml prefilled glass syringe, ready to use.
Particle size: approximately 200–350 μm for body contouring and volumizing smaller areas.
Single-use, non-pyrogenic, latex-free formulation.

Packaging

Box containing 1 sterile prefilled syringe of Genefill Contour (10.0 ml).
Each syringe supplied in a blister pack to maintain sterility until opening.
No needles supplied in the box (NO NEEDLES COME IN THE BOX).
Package insert / instructions for use (IFU) included, detailing indications, contraindications and injection technique guidance.
Packaging labelled with batch number, expiry date, CE mark and manufacturer details.

Usage

Genefill Contour is intended for use only by trained and appropriately qualified medical professionals experienced in body filler injection techniques.
Before treatment, obtain a full medical history, assess indications, discuss expectations and obtain informed consent.
Examine the treatment area and mark planned injection points, considering volume requirements and anatomical structures.
Clean and disinfect the skin thoroughly according to aseptic technique protocols.
Select an appropriate cannula/needle (manufacturer advises 18G/22G cannula) and injection depth (subcutaneous/hypodermis or supraperiosteal depending on area and indication).
Inject slowly using retrograde or fanning techniques, depositing small threads or boluses of product to achieve the desired contour while avoiding overcorrection.
Massage gently if needed to ensure even distribution of the gel and smooth surface contour, taking care not to excessively manipulate the product.
Continuously aspirate according to clinic protocol and carefully avoid intravascular injection; if any signs of vascular compromise occur, follow local emergency protocols immediately.
Do not mix Genefill Contour with other products in the same syringe.
After the procedure, provide post-treatment instructions, including avoiding strenuous exercise, heat exposure (sauna, sunbeds) and pressure on the treated area for a specified period, and advise on signs of complications that require urgent review.
Genefill Contour syringes are single use only; discard any unused product, needles and syringes as clinical waste according to local regulations.

Contraindications

Use in the facial area is contraindicated for Genefill Contour.
Use for breast augmentation and genital augmentation is specifically contraindicated.
Known hypersensitivity or allergy to hyaluronic acid or any component of the product.
Intolerance or known allergy to gram-positive bacterial proteins (potentially present from the fermentation source).
Patients with a tendency to hypertrophic or keloid scarring.
Presence of active inflammatory or infectious processes in or near the intended treatment area (e.g. skin infections, dermatitis).
Acute or chronic skin diseases at or near the injection site.
Patients undergoing anticoagulant therapy or with coagulation disorders, due to increased risk of bruising/haematoma (risk–benefit must be assessed).
Patients with autoimmune diseases or significant immune system disorders, unless thoroughly evaluated and cleared by a specialist.
Pregnant or breastfeeding women (no clinical data available; treatment not recommended).
Adolescents under 18 years of age (lack of safety data).
Patients with multiple severe allergies or a history of anaphylactic reactions should generally be excluded from treatment.
Must not be injected into blood vessels (intravascular injection is contraindicated due to risk of vascular occlusion and embolism).

Adverse Effects

Common transient injection-site reactions including redness (erythema), swelling, itching, tenderness, pain or sensitivity.
Subcutaneous bleeding, bruising or haematoma at the injection site.
Temporary firmness, nodules, palpable irregularities or hardness in the treated area.
Hypersensitivity reactions, including local oedema or inflammatory responses.
Infection at the injection site or deeper tissues if aseptic technique is compromised.
Rare risk of granuloma formation or prolonged inflammatory reactions.
Vascular occlusion or embolism in the event of inadvertent intravascular injection, potentially leading to tissue ischaemia or necrosis (medical emergency).
Pigment changes or scarring in cases of severe inflammation or ischaemic complications.
As with all injectable fillers, unexpected adverse events may occur; patients should be monitored and treated according to standard complication management protocols.

Storage Conditions

Store in the original packaging to protect from light and contamination.
Keep at controlled room temperature as indicated on the packaging (commonly between 2°C and 25°C); do not freeze.
Do not expose the product to excessive heat, direct sunlight or strong temperature fluctuations.
Do not use after the expiry date printed on the syringe or outer box.
Do not use if the blister, syringe or packaging is opened, damaged or shows signs of compromised sterility.
Transport under conditions that avoid extreme temperatures and physical shock to the syringe.

Duration

Results are visible immediately after injection and, according to manufacturer information on Genefill fillers, can last up to approximately 18 months depending on patient metabolism, treated area, injection depth, volume used and technique. Many patients experience durable effects for several months to over a year before gradual volume reduction occurs.

Onset

Immediate volumizing and contouring effect is observed directly after injection, with final outcomes seen once transient swelling or bruising subsides over the following days.