DESIRIAL PLUS (2x2ml)

Desirial

Injectable hyaluronic acid gel

Intimate gynecological filler for labia majora atrophy

Class III medical device under European medical device regulations.
CE Marked intimate hyaluronic acid device (CE 0344) specifically for gynecological indications such as labia majora atrophy/hypotrophy.
Manufactured in France by Laboratoires VIVACY under certified quality management systems (including ISO 13485 for medical devices).
Intended only for administration by appropriately trained and accredited healthcare professionals in accordance with national law and the device’s Instructions for Use.

Class III medical device under European medical device regulations.
CE Marked intimate hyaluronic acid device (CE 0344) specifically for gynecological indications such as labia majora atrophy/hypotrophy.
Manufactured in France by Laboratoires VIVACY under certified quality management systems (including ISO 13485 for medical devices).
Intended only for administration by appropriately trained and accredited healthcare professionals in accordance with national law and the device’s Instructions for Use.

Intimate gynecological filler for labia majora atrophy

Description

DESIRIAL PLUS (2x2ml) is a Class III CE-marked injectable hyaluronic acid gel medical device developed by Laboratoires VIVACY specifically for female intimate health. It is indicated for peri-menopausal, menopausal and reproductive-age women presenting with moderate to severe hypotrophy or atrophy (loss of volume) of the labia majora. Using VIVACY’s patented IPN-Like cross-linking technology, the gel combines stabilised cross-linked hyaluronic acid at 21 mg/g with antioxidant mannitol to restore volume, improve the aesthetic appearance of the labia majora and help re-establish their protective role for the labia minora and vulva. By replenishing volume and hydration directly within the labia majora tissues, DESIRIAL PLUS helps alleviate physical symptoms related to vulvar atrophy (such as discomfort and localized pain), improves vulvo-vaginal tissue quality and contributes to enhanced intimate well-being and sexual function. It is supplied as two 2 ml prefilled syringes for use exclusively by appropriately trained physicians (e.g. gynecologists, plastic surgeons, intimate-aesthetic specialists).

Bnefits

Restores volume and contour to hypotrophic or atrophic labia majora, improving intimate aesthetics.
Recreates a natural cushioning and protective effect of the labia majora, improving mechanical protection of the labia minora and vulvar vestibule.
Uses cross-linked hyaluronic acid (21 mg/g) to provide long-lasting volumising and hydrating effects in vulvar tissues.
Mannitol acts as an antioxidant, helping protect hyaluronic acid chains from free-radical degradation and supporting treatment longevity.
Improves the quality of vulvovaginal tissues by stimulating collagen and elastin production via fibroblast activation.
Helps reduce symptoms of vulvar atrophy such as discomfort, dryness-related pain and local sensitivity.
Proven efficacy and safety with clinical data showing sustained aesthetic improvement and quality-of-life benefits for up to 12 months after a single injection session.
Designed, manufactured and controlled in France according to stringent Class III medical device standards.
Specifically CE-marked (CE 0344) for gynecological indications, unlike generic dermal fillers used off-label.
Immediate visual correction with minimal downtime when injected by a trained, accredited intimate-health practitioner.

Indications

Moderate to severe hypotrophy or atrophy (loss of volume) of the labia majora.
Labia majora volume loss leading to diminished protection of the vulva and labia minora, with associated local discomfort or pain.
Peri-menopausal and menopausal women exhibiting labia majora atrophy related to aging and hormonal changes.
Women of reproductive age with either a predisposition to, or manifest signs of, moderate to severe labia majora hypotrophy.
Intimate aesthetic concerns regarding the appearance (flatness, deflation, asymmetry) of the labia majora when appropriate for medical device treatment.
Adjunctive treatment within the broader management of genitourinary syndrome of menopause where labia majora atrophy contributes to symptoms, at the discretion of a specialist physician.

Composition

Formulation

Injectable, sterile, pyrogen-free, viscoelastic, clear hyaluronic acid hydrogel.
Non-animal origin, cross-linked sodium hyaluronate (21 mg/g) stabilised using VIVACY’s proprietary IPN-Like cross-linking technology for enhanced longevity and elasticity.
Contains mannitol as an antioxidant to limit oxidative degradation of hyaluronic acid and reduce post-injection oedema.
Formulated specifically for vulvo-vaginal soft tissue with rheological characteristics suitable for labia majora volume restoration (more elastic and cohesive gel than standard DESIRIAL).

Packaging

Two 2 ml prefilled, single-use, sterile glass syringes of DESIRIAL PLUS gel (total 4 ml).
Each box includes: 2 x 27G 1/2" sterile single-use needles and 1 x 18G sterile cannula (or equivalent, depending on market), plus product instructions for use and patient traceability labels.
Supplied in a sealed blister and cardboard carton bearing CE marking (CE 0344) and full product identification details.

Usage

DESIRIAL PLUS is for intradermal/subcutaneous injection into the labia majora only and must be administered exclusively by appropriately trained and legally authorised healthcare professionals (e.g. gynecologists or doctors trained in vulvo-vaginal injection techniques).
Pre-treatment:
• Take full medical history, assess indication (labia majora atrophy/hypotrophy) and rule out contraindications such as active infection or suspicious lesions.
• Obtain informed consent and document baseline clinical and photographic assessment as appropriate.
• Perform external genital examination; disinfect the area thoroughly according to aseptic technique.
• A local anaesthetic (topical cream and/or local infiltration / pudendal block) may be used to increase comfort.
Injection technique (summary – refer to official Instructions for Use for full protocol):
• Use the supplied 18G cannula or 27G needle depending on practitioner preference and anatomy.
• Introduce the cannula/needle just under the dermis of the labia majora, staying strictly in the intended tissue plane and away from vessels and mucosa.
• Advance the cannula along the length of the labia majora, injecting small aliquots of gel in retrograde or fanning threads to achieve homogeneous volume restoration.
• Treat each side separately, adjusting volume to correct hypotrophy and respect aesthetic symmetry; do not exceed the recommended volume per session.
• After injection, gently massage the area to distribute the gel evenly and shape the labia majora without excessive pressure.
Post-treatment care:
• Advise the patient that mild swelling, tenderness or bruising at injection sites can occur and usually resolves within a few days.
• Recommend avoiding sexual intercourse, intense physical exercise, hot baths/saunas and tight clothing for several days post-procedure as per IFU.
• Instruct the patient to maintain genital hygiene and to report any unusual pain, persistent swelling, signs of infection or other adverse symptoms immediately.
• Plan follow-up visit(s) (for example 4–12 weeks post-injection) to evaluate aesthetic and functional outcomes and decide whether additional touch-up injections are necessary.
Important:
• Do not inject intravascularly; aspirate where appropriate and always use safe intimate-injection techniques.
• Do not use DESIRIAL PLUS in the presence of active infection, lesions requiring histological assessment or in patients with known contraindications to hyaluronic acid fillers.

Contraindications

Known hypersensitivity or allergy to hyaluronic acid, mannitol or any component of the device.
Skin or mucosal lesions of the vulva requiring prior histopathological verification (suspicious lesions).
Active inflammation, infection or sexually transmitted infection of the vulva, vagina or surrounding area.
Herpetic lesions (herpes simplex) or other active viral, bacterial or fungal infections of the injection area.
Systemic infection or febrile illness (e.g. cold or flu-like symptoms) at the time of treatment.
Pregnancy and generally breastfeeding (use is contraindicated or not recommended according to device labelling and standard filler precautions).
History of severe anaphylactic reactions or multiple severe allergies.
Autoimmune diseases or immune therapy where the risk–benefit ratio is considered unfavourable by the treating physician.
Coagulation disorders or ongoing anticoagulant therapy significantly increasing bleeding risk, unless carefully evaluated and managed.
Previous permanent fillers or foreign bodies in the intended injection area, unless compatibility is clearly established.
Injection into blood vessels, mucosa (vaginal canal), intramuscular or other non-approved tissue planes.

Adverse Effects

Common, usually transient reactions at the injection site: redness, swelling, tenderness, pain, bruising, itching or slight induration.
Short-term discomfort or feeling of pressure in the labia majora following volume restoration.
Nodules or palpable lumps if product distribution is uneven; often correctable by massage or, if persistent, by medical management.
Rare infectious complications (cellulitis, abscess) if aseptic technique is not rigorously followed; require prompt medical treatment.
Hypersensitivity reactions (localized or systemic) to hyaluronic acid or excipients, presenting with prolonged swelling, erythema or pruritus; may require medical management.
Very rare delayed complications associated with hyaluronic acid fillers (e.g. granulomatous reactions, delayed inflammatory nodules) which may require specific therapeutic intervention.
Vascular compromise/ischemia in the unlikely event of inadvertent intravascular injection or compression; constitutes a medical emergency requiring immediate management according to filler complication protocols.

Storage Conditions

Store in its original packaging at a controlled room temperature (typically between 2°C and 25°C) as specified on the box.
Protect from heat, direct sunlight and freezing; do not use if the product has been frozen.
Keep the syringes in the blister pack until immediately before use to maintain sterility.
Do not use after the expiry date printed on the packaging.
Keep out of the sight and reach of children.
Discard any used syringes, needles and cannulas as clinical sharps waste according to local regulations.

Duration

A single treatment session with DESIRIAL PLUS usually provides clinical benefit and volume restoration for up to approximately 12 months, depending on patient-specific factors such as metabolism, baseline atrophy severity and lifestyle. Retreatment or touch-up injections may be considered after clinical reassessment when the effect diminishes.

Onset

Immediate volumising and contouring of the labia majora is visible at the end of the injection session. Oedema and minor swelling typically subside over several days, revealing the final aesthetic result. Improvements in comfort, tissue protection and sexual function are generally reported within weeks and can persist for up to 12 months.