Cross-linked hyaluronic acid filler for subcutaneous body augmentation (breast and buttock)
Certifications
Manufacturer states CE2460 certification for its hyaluronic acid dermal filler products.
Manufactured under ISO 13485 (medical devices quality management) and ISO 9001 quality systems.
Complies with relevant requirements for sterile injectable medical device Grade hyaluronic acid dermal fillers in markets where distributed.
Manufacturer states CE2460 certification for its hyaluronic acid dermal filler products.
Manufactured under ISO 13485 (medical devices quality management) and ISO 9001 quality systems.
Complies with relevant requirements for sterile injectable medical device Grade hyaluronic acid dermal fillers in markets where distributed.
Cross-linked hyaluronic acid filler for subcutaneous body augmentation (breast and buttock)
Description
Godgel Derm Sub-Skin (1x20ml) is a high-volume, body-contouring hyaluronic acid dermal filler formulated for deep subcutaneous implantation in areas such as the breasts and buttocks. Utilising the brand’s S&L intramolecular and intermolecular biphasic synchronous cross-linking technology, the product is a cross-linked sodium hyaluronate hybrid suspended gel designed to provide a more thorough cross-linking reaction, low residual BDDE and long-lasting volumising effects. With a hyaluronic acid concentration of 20mg/ml, a particle size range of 0.50–2.00mm and a swelling rate of 150–300%, Godgel Derm Sub-Skin is engineered for robust projection and contouring while maintaining a smooth gel consistency suitable for large-volume augmentation. The 1x20ml prefilled syringe presentation is intended for professional use only by suitably qualified medical practitioners in aesthetic body contouring procedures.
Bnefits
High-volume 20ml presentation designed specifically for body contouring applications such as breast enlargement and buttock enhancement.
Contains cross-linked sodium hyaluronate 20mg/ml with a particle size of 0.50–2.00mm, suitable for deep subcutaneous placement and structural volumisation.
S&L intramolecular and intermolecular biphasic synchronous cross-linking technology provides a more thorough cross-linking reaction and a hybrid suspended gel structure.
Low residual BDDE content is emphasised in marketing to support improved biocompatibility and safety profile when used appropriately.
High swelling rate (150–300%) supports pronounced volumising and shaping effects from a relatively small injected volume.
Duration of aesthetic effect is stated as approximately 6 months, depending on injection site, volume and individual patient factors.
Bacterial endotoxin level is specified as <0.5 EU/mg, in line with requirements for injectable hyaluronic acid preparations.
Manufactured by a specialist hyaluronic acid products company with CE2460, ISO 13485 and ISO 9001 certifications for its product range.
Indications
Non-surgical body contouring in adults, specifically for breast enlargements (augmentation) by deep subcutaneous or prepectoral injection performed by experienced practitioners.
Buttock enhancements and gluteal contouring where large-volume hyaluronic acid filler is deemed appropriate by the treating clinician.
Correction of large soft-tissue volume deficits and contour irregularities in body areas suitable for deep hyaluronic acid implantation, according to local regulatory allowances.
Use only in suitably selected patients after full medical assessment and informed consent, performed by licensed healthcare professionals trained in high-volume filler techniques.
Particle size: 0.50–2.00mm (large-particle, body contouring gel).
Molecular weight of hyaluronic acid: <1,200,000 Daltons.
Cross-linking agent: BDDE (1,4-butanediol diglycidyl ether), with low residual BDDE content as stated by manufacturer.
Bacterial endotoxin level: <0.5 EU/mg.
Physiological buffer and excipients to maintain gel stability and injectability (full excipient list as per official product leaflet).
Formulation
Cross-linked sodium hyaluronate hybrid suspended gel produced using S&L intramolecular and intermolecular biphasic synchronous cross-linking technology.
Highly viscoelastic, large-particle hyaluronic acid formulation targeted for deep subcutaneous implantation in body tissues rather than fine-line facial correction.
Non-animal stabilised hyaluronic acid, sterile and pyrogen-controlled injectable gel.
Prefilled syringe formulation intended for single-patient, single-use application by injection with appropriate cannula or needle (e.g. 25G cannula or 27G/30G needle as recommended by supplier protocols).
Packaging
1 x 20ml prefilled glass syringe of cross-linked sodium hyaluronate gel per box.
No needles are supplied in the box for the 20ml presentation; practitioners must use their own sterile, appropriate cannulae or needles.
Sterile blister packaging for the syringe with tamper-evident seal, enclosed in an outer carton bearing the Godgel branding and product details.
Carton labelling typically includes product name (Godgel Derm Sub-Skin), volume (1x20ml), hyaluronic acid content (20mg/ml), batch number, expiry date, CE marking (CE2460) and manufacturer details.
Usage
For professional use only by licensed medical practitioners with specific training and experience in large-volume body contouring with hyaluronic acid fillers.
Administer under strict aseptic conditions in an appropriate clinical setting, following local regulations and the official product instructions for use.
Intended for deep subcutaneous or other approved planes in body areas such as breasts and buttocks; injection depth, volume per site and technique must be tailored to the patient’s anatomy and clinical goals.
The 20ml prefilled syringe is single-use and must not be resterilised or reused.
Before injection, inspect the syringe and gel visually for particulate matter, discoloration or packaging damage; do not use if any abnormality is detected.
Use appropriate cannula/needle size and injection technique to minimise the risk of intravascular injection and other complications; aspirate and inject slowly with minimal pressure as per standard high-volume filler safety practices.
Do not mix Godgel Derm Sub-Skin in the same syringe with other injectable products; if used in combination treatments, follow all relevant product instructions and sequence protocols.
Provide patients with post-procedure care advice, including avoidance of pressure, trauma, vigorous exercise or extreme temperatures in the treated area for a specified period.
Maintain comprehensive records of product batch numbers, injection sites, volumes used and any immediate reactions for pharmacovigilance and follow-up.
Contraindications
Known hypersensitivity or allergy to hyaluronic acid, BDDE or any other component of the gel.
Presence of active skin or soft tissue infection, inflammation, or disease at or near the intended injection site.
History of severe anaphylactic reactions or multiple severe allergies where injectable fillers may pose increased risk.
Autoimmune or connective tissue disorders where the safety of large-volume hyaluronic acid implantation has not been clearly established, unless a specialist deems it appropriate.
Pregnancy and breastfeeding, as safety for these populations has not been established.
Coagulation disorders or current use of significant anticoagulant/antiplatelet therapy that may increase bleeding and bruising risk, unless carefully assessed by a physician.
Previous permanent fillers or foreign bodies in the planned injection area where interactions or unpredictable outcomes may occur.
Use in paediatric patients or individuals under the age defined by local regulations for aesthetic procedures.
Adverse Effects
Expected local reactions such as redness, swelling, tenderness, pain, bruising or itching at the injection site, usually resolving within days.
Transient lumps, irregularities or asymmetry due to gel placement or local oedema, which may require massage or further clinical management.
Infection at the injection site or deeper tissues, potentially requiring antibiotic treatment or drainage.
Inflammatory or immunological reactions including delayed nodules, granuloma formation, or prolonged induration.
Vascular complications, including intravascular injection or compression leading to tissue ischaemia or necrosis, which constitute medical emergencies and require immediate expert management.
Very rare but serious events such as embolic phenomena or systemic reactions associated with improper injection technique or inadvertent intravascular administration.
Potential need for hyaluronidase treatment or other interventions to dissolve or manage the filler in case of complication or unsatisfactory outcome.
Storage Conditions
Store in the original packaging to protect from light and physical damage.
Maintain at controlled room temperature as specified in the product leaflet (commonly between 2°C and 25°C); avoid freezing or exposing to excessive heat.
Do not use if the product has been improperly stored, frozen, or exposed to extreme temperatures.
Keep out of the sight and reach of children and unauthorised persons.
Do not use after the expiry date printed on the syringe label and outer carton.
Duration
The stated duration of effect is approximately 6 months, although longevity can vary based on treatment area, injected volume, technique, patient metabolism and lifestyle factors. Re-treatment schedules should be individualised by the practitioner.
Onset
Volumising and contouring effects are generally immediate upon injection due to the physical presence of the gel, with final results settling over days to weeks as swelling subsides and the product integrates with surrounding tissues.
