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NEAUVIA INTENSE Range

NEAUVIA INTENSE Range

Neauvia Intense Rose

Medical Aesthetics
  • Class III CE Marked medical device under EU Medical Device Directive 93/42/EEC / MDR transition, for professional use only.
  • Manufactured under a certified medical device quality management system (ISO 13485) by Matex Lab S.p.A.
Intimate Area Dermal Fillers

Description

NEAUVIA INTENSE ROSE (1 x 1 ml) is a pegylated, biodegradable, crosslinked hyaluronic acid (HA) dermal filler specifically designed for female intimate rejuvenation. It is a sterile, injectable hydrogel resorbed over time and intended for intradermal injection to correct vulvar atrophy, restore volume and improve symptoms associated with tissue loss in the labia majora and surrounding vulvar area. The product contains one of the highest HA concentrations on the market (28 mg/ml) crosslinked with polyethylene glycol (PEG) using Neauvia’s Smart Cross-Linking Technology, and is enriched with the amino acids glycine and L-proline to support collagen synthesis. Intense Rose exhibits high extrusion force and high viscoelasticity, delivering strong volumising and tissue-support effects while integrating into delicate intimate tissues.

Bnefits

  • Specifically formulated for correction of vulvar atrophy and intimate area volume loss, targeting functional and aesthetic concerns of the labia majora.
  • Very high HA concentration (28 mg/ml) crosslinked with PEG provides strong volumising capacity and long-lasting results.
  • PEG-based Smart Cross-Linking Technology supports high biocompatibility, low immunogenicity and an ultra-safe profile compared with traditional BDDE-crosslinked fillers (no BDDE).
  • Includes amino acids glycine and L-proline, key building blocks of collagen, to support neocollagenesis and tissue quality improvement alongside volume restoration.
  • High viscoelasticity allows effective lifting, projection and shaping of the labia majora for improved contour, firmness and protective function.
  • Hydrates skin and mucosa, helping to rehydrate intimate tissues and improve comfort in patients with vulvar atrophy.
  • Slow, predictable degradation offers results that can last up to approximately 12 months in many patients, depending on individual factors.
  • Designed for use by trained physicians in accordance with local legislation, with clear indication and guidance for female intimate rejuvenation.

Indications

  • Intradermal injection for vulvar atrophy correction and improvement of symptoms related to tissue atrophy in the vulvar area.
  • Augmentation and restoration of volume and contour of the labia majora (correction of lipoatrophy).
  • Improvement of firmness, shape and protective function of the vulva and labia majora.
  • Rehydration of vulvar skin and mucosa and general rejuvenation of the female intimate area.

Composition

  • Hyaluronic acid 28 mg/ml, crosslinked with polyethylene glycol (PEG).
  • Glycine (amino acid).
  • L-Proline (amino acid).
  • Highly purified, non-animal origin sodium hyaluronate derived from Bacillus subtilis (as per Neauvia filler platform).
  • No BDDE crosslinking agent (BDDE-free).
  • Sterile, pyrogen-free, monophasic hydrogel formulated for intradermal injection.

Formulation

  • Pegylated crosslinked HA hydrogel (Smart Cross-Linking Technology, HA-PEG network).
  • HA concentration: 28 mg/ml (high viscoelasticity and extrusion force).
  • Intended route: intradermal / subcutaneous injection into the labia majora and selected intimate areas, as per IFU.
  • Biodegradable filler slowly resorbed over time following implantation, with long-lasting effect (up to about 12 months reported in clinical practice).
  • Sterile, single-use Class III medical device for professional use only.

Packaging

  • 1 prefilled 1 ml disposable syringe of NEAUVIA INTENSE ROSE with luer-lock connection.
  • Typically supplied with 1 x 22G cannula and 1 x 21G needle (kit contents may vary slightly by distributor).
  • Each box includes device, instruction leaflet and traceability labels.

Usage

  • For medical use only. The device must be injected exclusively by physicians or appropriately trained healthcare professionals in accordance with local legislation and Neauvia training recommendations.
  • Prior to treatment, take a full medical history, evaluate indications, rule out contraindications and obtain informed consent, specifically discussing intimate-area treatment risks and expectations.
  • Prepare the treatment area with appropriate antiseptic measures and ensure strict aseptic technique throughout the procedure.
  • Attach the recommended needle or cannula (e.g. 22G cannula) to the prefilled syringe, ensuring secure luer-lock connection and priming to expel air.
  • Inject the filler intradermally or subcutaneously into the labia majora or indicated vulvar tissue using appropriate techniques for intimate fillers (linear threading, fanning, or depot injections), avoiding intravascular injection and critical anatomical structures.
  • Massage gently if needed to shape and distribute the product evenly, respecting tissue planes and desired contour.
  • Provide post-treatment instructions including intimate hygiene, avoidance of intense pressure, friction or sexual intercourse for a recommended period, and guidance on recognising signs of complications requiring prompt review.
  • Record product batch number, injection sites and volumes in the patient’s medical record to ensure traceability.
  • Do not resterilise or reuse; dispose of syringe, needle/cannula and all sharps according to local biohazard regulations after single use.

Contraindications

  • Hypersensitivity or allergy to hyaluronic acid, PEG, glycine, L-proline or any component of the device.
  • Active local infection, inflammation, sexually transmitted infections, or dermatologic disease in the vulvar or vaginal area at the time of treatment.
  • Pregnancy and breastfeeding, as elective intimate aesthetic procedures are generally contraindicated.
  • Autoimmune diseases or severe systemic conditions that may interfere with healing, unless the risk–benefit ratio is carefully assessed by the physician.
  • Known tendency to develop keloid or hypertrophic scars or severe tissue healing disorders in the genital area.
  • Concurrent anticoagulant therapy or bleeding disorders without appropriate management, due to increased risk of haematoma.
  • Any general contraindications stated in the official instructions for use for Neauvia Intense Rose or determined by the treating clinician during assessment.

Adverse Effects

  • Common injection-related reactions such as pain, tenderness, erythema, swelling, bruising or itching at the injection site, typically mild to moderate and self-limiting.
  • Transient nodules, induration or irregularities in the treated tissue, usually resolving as the product integrates; persistent nodules may require clinical management.
  • Infection or abscess formation in the vulvar area if aseptic technique or aftercare is inadequate, which may necessitate antibiotics or drainage.
  • Hypersensitivity reactions or inflammatory responses, potentially including prolonged erythema, oedema or discomfort; very rare severe allergic reactions may occur with any HA-based filler.
  • Vascular compromise or ischaemia if inadvertent intravascular injection occurs; while rare in the labia majora, practitioners must be trained in intimate-area vascular anatomy and emergency management.
  • Long-term issues such as asymmetry, overcorrection or undercorrection may require further treatment or corrective procedures.

Storage Conditions

  • Store in the original packaging at a temperature typically between 2 °C and 25 °C, away from direct sunlight and heat sources (follow specific storage conditions on the box/IFU).
  • Do not freeze the product and protect it from extreme temperature fluctuations.
  • Do not use after the expiry date printed on the packaging or if the sterile blister or syringe is damaged or opened.

Duration

The implant is designed to degrade slowly after implantation, with clinical effects typically lasting up to approximately 12 months depending on patient factors, treatment volume and technique. Repeat treatments may be performed at intervals determined by the treating physician based on tissue response and patient expectations.

Onset

Volume restoration and contour improvement of the labia majora are generally visible immediately after injection, with further tissue integration and collagen stimulation contributing to improved firmness and hydration over the following weeks.

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