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Goldfill Volume (1 x 10ml)

Goldfill Volume (1 x 10ml)

Goldfill

Body dermal filler
  • CE Marked Class III medical device (CE 0373) for soft Tissue filling and body volume restoration within the EU/EEA regulatory framework.
  • Manufactured using European pharmaceutical Grade cross Linked hyaluronic acid under controlled processes that comply with relevant EU medical device standards and quality management requirements.
  • Complies with international quality regulations cited by the manufacturer, including microbiological and sterility standards such as ISO 11737 2.
  • Non Animal, bio Fermentative source of hyaluronic acid consistent with modern safety and biocompatibility expectations for dermal/body fillers.
  • Distribution via professional medical Aesthetic wholesalers who require professional credentials or appropriate prescriptions in many jurisdictions, reflecting regulation as a prescription device for professional use.
Cross-linked hyaluronic acid body contouring filler, 1 x 10 mL pre-filled syringe

Description

Goldfill Volume (1 x 10ml) is a high-viscosity, cross-linked hyaluronic acid body filler specifically designed for non-surgical body contouring and correction of extensive skin imperfections. The sterile, resorbable gel increases dermal–epidermal tissue volume by utilising hyaluronic acid’s natural hydrophilic ability to bind large amounts of water. This mechanism fills intradermal spaces, integrates and stimulates the intercellular matrix, and helps firm and support tissue. Formulated as a monophasic, homogeneous, transparent, colourless gel (20 mg/mL cross-linked non-animal hyaluronic acid, BDDE cross-linked), Goldfill Volume provides immediate, predictable and long-lasting volumising effects with minimal product migration. It is supplied as a single-use, pre-filled 10 mL sterile syringe with a Luer-lock fitting and is intended for use by trained medical professionals for volume restoration and remodelling of larger body areas such as the glutes, hips, calves, hands, genitals and other body depressions.

Bnefits

  • Innovative cross-linked hyaluronic acid body filler specifically developed for large-area body contouring and correction of extensive skin imperfections.
  • High-viscosity, monophasic gel provides strong volumising power for restoration and enhancement of body contours in areas such as glutes, hips, calves, hands, genitals and body depressions.
  • Increases dermal–epidermal tissue volume by binding water molecules, filling intradermal spaces and integrating the intercellular matrix, resulting in firmer, more supported tissues.
  • Immediate volume effect with low product migration, allowing the practitioner to visualise the near-final aesthetic result immediately after injection.
  • Long-lasting performance, with volumising effects typically maintained for approximately 12–18 months before gradual resorption.
  • Formulated with non-animal, bio-fermentative hyaluronic acid and a BDDE-based monophasic cross-linking technology that combines different molecular weights of HA for an optimised three-dimensional gel network.
  • Low BDDE residual content (< 2 ppm) and highly purified, non-pyrogenic gel enhance biocompatibility and reduce the risk of adverse reactions.
  • Homogeneous particle size (~600 µm) and optimised viscoelasticity support even distribution, tissue integration and a natural look and feel.
  • CE-marked Class III medical device manufactured to EU standards (including ISO 11737-2 and CE-0373), supporting quality, safety and regulatory compliance.
  • Provides a minimally invasive, reversible alternative to surgical body contouring procedures, while still offering durable and high patient-satisfaction outcomes when used appropriately.

Indications

  • Restoration and augmentation of soft tissue volume in larger body areas where volume loss, depressions or asymmetry are present (e.g., gluteal region, hips, calves, hands, genitals and other body depressions).
  • Correction of wide-spread skin imperfections affecting large volumes of the body, including contour irregularities and volume deficits.
  • Body contouring and reshaping procedures to enhance or refine body features without surgery.
  • Filling of post-surgical or post-traumatic depressions in soft tissue, where appropriate and within the product’s indication and local regulations.
  • Improvement of body asymmetry and enhancement of aesthetic proportions through targeted volumisation.
  • Hands rejuvenation through volume restoration to mask visible tendons and veins in appropriately selected patients.
  • Use in adults by trained healthcare professionals experienced in hyaluronic acid body fillers and body-contouring techniques.

Composition

  • Active substance: Cross-linked non-animal hyaluronic acid, obtained by bio-fermentation, at a concentration of 20 mg/mL.
  • Cross-linking agent: 1,4-Butanediol diglycidyl ether (BDDE), used in a monophasic cross-linking process combining HA of different molecular weights; residual BDDE content < 2 ppm.
  • Particle size: Approximately 600 µm hyaluronic acid particle size, contributing to high viscosity and volumising capacity.
  • Vehicle: Physiological, non-pyrogenic aqueous buffer (e.g., water for injections, salts and buffer components) forming a sterile, transparent, colourless gel (exact excipient profile per official IFU).
  • Presentation: Homogeneous, transparent, colourless hyaluronic acid gel in a single-use, pre-filled 10 mL sterile syringe with Luer-lock fitting, intended for body soft-tissue injection.

Formulation

  • Monophasic, cross-linked hyaluronic acid gel based on non-animal, bio-fermentative origin HA.
  • High-viscosity, viscoelastic gel developed specifically for body contouring and large-area volume restoration rather than facial microfilling.
  • Chemically unmodified hyaluronic acid chains cross-linked with BDDE to create a stable three-dimensional network, combining two HA products with different molecular weights and two cross-linking steps (“light” and “classical”).
  • Physiologically compatible and resorbable medical device, non-pyrogenic, sterile and transparent, with a low level of impurities and residual cross-linker.
  • Designed to provide immediate and durable volumising effects (12–18 months) with minimal migration and high integration into surrounding tissues.
  • Formulated to stimulate hydration and support collagen and elastin production indirectly by improving the extracellular matrix and moisture environment.

Packaging

  • Supplied as one 10 mL pre-filled sterile syringe (1 x 10ml) of Goldfill Volume per retail pack.
  • The syringe is fitted with a Luer-lock connection to allow secure attachment of compatible sterile needles or cannulas (needles/cannulas typically supplied separately unless specifically included by the distributor).
  • Each syringe is intended for single use only and is supplied sterile, in a blister or equivalent sterile barrier inside an outer carton.
  • Outer packaging includes product name (Goldfill Volume), volume (1 x 10ml), manufacturer details (Provida Paris), batch/lot number, expiry date, CE mark, classification and relevant symbols as per EU medical device regulations.
  • Packs distributed by various authorised wholesalers may include additional labelling (e.g., local language stickers, distributor information) while retaining the original manufacturer labelling for traceability.

Usage

  • Goldfill Volume is a Class III, CE-marked injectable medical device intended strictly for use by appropriately trained and qualified healthcare professionals familiar with hyaluronic acid body fillers, body-contouring techniques and complication management.
  • Before use, the practitioner should review the official instructions for use (IFU) provided by the manufacturer, including full indications, contraindications, warnings, injection techniques and recommended anatomical areas.
  • Inspect the pack and syringe before use; do not use if the sterile barrier is damaged, the syringe appears compromised, or the product is past its expiry date.
  • The product is designed for deep soft-tissue injection into indicated body areas such as glutes, hips, calves, hands, genitals and other body depressions, using suitable sterile needles or cannulas and aseptic technique, in accordance with the IFU and local guidelines.
  • Aspiration and careful injection technique should be followed in line with current best practice for injectable body fillers to minimise the risk of intravascular injection and other complications.
  • Inject slowly and gradually, assessing tissue response and contour as you proceed; Goldfill Volume’s low migration behaviour allows visualisation of the volumising effect in real time.
  • Record the batch/lot number, injection sites and volume used in the patient’s medical record to ensure traceability.
  • After treatment, provide patients with appropriate post-procedure care instructions, including information about expected transient reactions, signs of possible complications and when to seek urgent medical attention.
  • Any unused portion of the product remaining in the syringe after a session must be discarded; the syringe is single-use only and must not be resterilised or reused.
  • Use must comply with local legal and regulatory requirements; in many jurisdictions, this product may only be supplied to and used by medical professionals or under their direct responsibility.

Contraindications

  • Known hypersensitivity or allergy to hyaluronic acid, BDDE or any other component of the filler.
  • Presence of active or recent skin infection, inflammation or disease at or near the planned injection site (e.g., bacterial infection, viral lesions, dermatitis).
  • History of severe allergy or anaphylactic reaction to injectable hyaluronic acid fillers or similar products.
  • Patients with untreated bleeding disorders, significant coagulation abnormalities or those receiving high-dose anticoagulant therapy, unless the risk–benefit has been carefully evaluated by a qualified prescriber.
  • Pregnancy and breastfeeding, as safety of body fillers in these populations has not been established (use is generally not recommended).
  • Patients with severe systemic illnesses, autoimmune diseases or immunosuppression where elective aesthetic procedures may be inappropriate, unless evaluated and cleared by a qualified physician.
  • Injection into blood vessels or intravascular spaces is strictly contraindicated; the product must not be injected intramuscularly or in any anatomical area where there is a high risk of vascular compromise without appropriate expertise.
  • Use in individuals with known hypersensitivity to gram-positive bacterial proteins (given the bio-fermentative origin of the HA) if specified by the manufacturer.
  • Use in patients with unrealistic expectations, body dysmorphic disorder or where psychological assessment suggests that aesthetic treatment is not appropriate.
  • Use in any manner or anatomical location not consistent with the official instructions for use or local regulatory approvals.

Adverse Effects

  • Common, usually transient injection-site reactions such as redness (erythema), swelling, tenderness, pain, itching, bruising or mild induration at the treated area.
  • Temporary discomfort or tightness in treated body regions, especially immediately after injection and in high-tension areas (e.g., glutes, hips, calves).
  • Nodules, palpable lumps or unevenness due to product placement or localised tissue response, which may require massage, medical management or, in some cases, further intervention.
  • Delayed inflammatory reactions including swelling, induration or redness that may arise days to weeks after treatment.
  • Hypersensitivity reactions including local allergic-type responses; in rare cases, more generalised or severe allergic reactions may occur.
  • Infection at the injection site, potentially progressing to abscess formation or cellulitis if aseptic technique is not strictly followed or if post-care instructions are not observed.
  • Vascular complications (e.g., inadvertent intravascular injection, vascular compression or occlusion) potentially leading to pain, skin blanching, livedo reticularis, ischaemia, necrosis or, in very rare cases when injected near critical vasculature, serious sequelae such as embolic events; these require immediate recognition and emergency management by experienced clinicians.
  • Pigmentary changes or scarring in areas of significant inflammation, necrosis or trauma.
  • Rare granulomatous or chronic foreign-body reactions to hyaluronic acid or residual cross-linker components.
  • This list is not exhaustive; full details of potential adverse events and their management should be obtained from the official IFU and current clinical guidelines on hyaluronic acid body fillers.

Storage Conditions

  • Store the product in its original packaging, in a clean, dry place protected from direct sunlight.
  • Maintain storage within the temperature range specified on the packaging (typically controlled room temperature; avoid freezing and excessive heat).
  • Do not freeze the syringe and do not expose it to temperatures outside the recommended range, as this can alter the gel’s properties and safety.
  • Keep the product out of reach of children and unauthorised persons.
  • Do not use after the expiry date printed on the packaging and syringe label.
  • Do not use the product if the sterile barrier (blister or packaging) is damaged, opened or shows signs of tampering.
  • Transport under appropriate conditions to avoid extreme temperature fluctuations and mechanical damage.

Duration

According to manufacturer and reseller data, the volume effect of Goldfill Volume is typically maintained for approximately 12\u201318 months before gradual resorption and dissolution of the hyaluronic acid begins. The exact duration depends on factors such as treatment area, injection technique, volume used, patient metabolism and lifestyle.

Onset

Goldfill Volume provides an immediate volumising and contouring effect at the time of injection, with the treated area appearing fuller and more supported right after the procedure. Final settling of the product occurs over the following days to weeks as any transient swelling resolves and the gel integrates into the surrounding tissues.

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