Intimate gynecological filler for vulvovaginal dryness and mild hypotrophy
Certifications
Class III medical device under European medical device regulations.
CE Marked (CE 0344) for gynecological indications including rehydration of vaginal and vestibular mucous membranes and mild hypotrophy of the labia majora and pubis.
Manufactured in France by Laboratoires VIVACY under certified quality Management systems (including ISO 13485 for medical devices).
Class III medical device under European medical device regulations.
CE Marked (CE 0344) for gynecological indications including rehydration of vaginal and vestibular mucous membranes and mild hypotrophy of the labia majora and pubis.
Manufactured in France by Laboratoires VIVACY under certified quality Management systems (including ISO 13485 for medical devices).
Intended exclusively for use by appropriately trained and legally authorised healthcare professionals, in accordance with the Instructions for Use and national legislation.
Intimate gynecological filler for vulvovaginal dryness and mild hypotrophy
Description
DESIRIAL (1x1ml) is a Class III CE-marked injectable hyaluronic acid gel medical device developed by Laboratoires VIVACY specifically for women’s intimate health. It is the first antioxidant hyaluronic acid–based gel formulated to restore hydration, elasticity, tone and sensitivity in the vulvovaginal region. Using VIVACY’s patented IPN-Like cross-linking technology, DESIRIAL contains stabilised cross-linked sodium hyaluronate at 19 mg/g combined with the antioxidant mannitol. It is indicated for peri-menopausal women and women of reproductive age suffering from vulvovaginal dryness and associated symptoms (discomfort, burning, irritation, itching), with or without mild hypotrophy of the labia majora and pubis. Injected directly into the tissues that require it (vaginal and vestibular mucosa and/or superficial labia majora), DESIRIAL rehydrates the mucosa, improves tissue quality, supports collagen synthesis and provides long-lasting relief of intimate dryness while enhancing overall intimate comfort and sexual well-being.
Bnefits
Restores hydration and moisture to the vulvovaginal mucosa, helping relieve intimate dryness.
Improves elasticity, tone and sensitivity of the vulvovaginal tissues.
Helps soothe symptoms such as discomfort, burning, irritation and itching associated with vulvovaginal atrophy or dryness.
Strengthens tissue quality by stimulating fibroblasts and supporting collagen and elastin production.
Antioxidant mannitol helps protect hyaluronic acid from free-radical degradation, supporting treatment durability and reducing post-injection inflammation.
Provides a non-surgical, minimally invasive solution for intimate well-being with limited downtime.
Specifically formulated and CE-marked for gynecological indications (vaginal/vestibular mucosa rehydration and mild hypotrophy of labia majora and pubis).
Immediate improvement in hydration and tissue plumpness with effects that may last many months, depending on patient factors.
Manufactured in France by a specialist aesthetic and anti-ageing medical device company using patented IPN-Like technology.
Indications
Vulvovaginal dryness (including dryness related to hormonal changes such as peri-menopause or early menopause).
Intended exclusively for use by appropriately trained and legally authorised healthcare professionals, in accordance with the Instructions for Use and national legislation.
Vaginal discomfort, burning or pain linked to vulvovaginal atrophy or decreased lubrication.
Chronic irritation and pruritus (itching) of the vulvar and vestibular mucosa that can lead to sores.
Rehydration of vaginal and vestibular mucous membranes.
Mild hypotrophy of the vulvar labia majora and pubis where improvement in hydration, tone and slight volume is desired.
Women of reproductive age or peri-menopausal women with dehydration of the vulva with or without local irritations.
Adjunctive treatment within the management of genitourinary syndrome of menopause (GSM) when mucosal dryness is a primary complaint, at the discretion of a specialist physician.
Cross-linked sodium hyaluronate at 19 mg/g using VIVACY’s IPN-Like Technology, providing cohesive, long-lasting hydration with appropriate rheology for injection into mucosa and superficial soft tissue.
Contains mannitol to reduce oxidative stress and limit post-injection oedema, improving comfort and persistence.
Non-animal origin hyaluronic acid, bioresorbable over time.
Packaging
One 1 ml prefilled, single-use, sterile glass syringe of DESIRIAL gel.
Each box includes: 1 x 1 ml syringe, 2 x 27G 1/2" needles, 2 x 30G 1/2" needles, package insert and patient traceability labels.
Supplied in a sealed blister and cardboard carton bearing CE marking (CE 0344).
Usage
DESIRIAL is a hyaluronic acid–based medical device intended exclusively for injection by legally authorised, appropriately trained healthcare professionals (e.g. gynecologists, plastic surgeons or physicians trained in reconstructive and functional gynecology and intimate injection techniques).
Pre-treatment:
• Take a full medical history and assess the patient’s symptoms (dryness, discomfort, irritation, pain during intercourse) and anatomical findings.
• Rule out contraindications such as local infection, suspicious lesions or systemic conditions that preclude treatment.
• Obtain informed consent and document baseline clinical status and, where appropriate, photographs.
• Perform a careful external and, if indicated, internal genital examination; clean and disinfect the region according to aseptic standards.
• Apply local anaesthetic (topical and/or local infiltration) as required to ensure patient comfort.
Injection technique (summary; refer to official Instructions for Use for full protocol):
• DESIRIAL is injected into the vaginal mucosa, vestibular mucosa and/or superficial tissue of the labia majora and pubis as indicated, using the supplied needles.
• Use intradermal or submucosal injection techniques with multiple micro-deposits or linear threading along the areas of dryness or mild hypotrophy.
• Inject slowly with gentle, steady pressure, avoiding intravascular injection and respecting anatomical structures.
• Distribute the gel evenly, adapting the dose to clinical needs while not exceeding recommended volumes.
• After injection, gently massage the treated areas to ensure even distribution of the gel and optimise tissue integration.
Post-treatment care:
• Inform the patient that transient swelling, redness, tenderness or bruising may occur and typically resolve within a few days.
• Advise avoidance of sexual intercourse, tampon use, intense sports, hot baths/saunas and swimming pools for several days, according to IFU and clinical judgment.
• Provide clear hygiene instructions and counsel the patient to contact the clinic immediately if they experience severe pain, signs of infection, persistent swelling or other unusual symptoms.
• Schedule follow-up (e.g. at 4–8 weeks) to assess clinical response, symptom improvement and the potential need for touch-up treatment.
Important:
• DESIRIAL must not be injected into blood vessels or outside the indicated tissue planes.
• Only use the device if the packaging is intact and the product is within its expiry date.
• Dispose of needles, syringes and other sharps in accordance with local clinical waste regulations.
Contraindications
Known hypersensitivity or allergy to hyaluronic acid, mannitol or any of the excipients.
Presence of skin or mucosal lesions requiring prior histological investigation (e.g. suspicious vulvar or vaginal lesions).
Active local or systemic infections, including sexually transmitted infections, in the treatment area.
Herpes simplex or other active viral, bacterial or fungal genital infections.
Severe inflammatory conditions or ulcerative lesions in the vulvovaginal region.
Pregnancy and generally breastfeeding (treatment is not recommended or is contraindicated as per device labelling and standard filler precautions).
History of severe anaphylactic reactions or multiple severe allergies, unless a thorough risk–benefit assessment is made by the physician.
Autoimmune diseases or immunosuppressive therapy where hyaluronic acid injection is considered high risk.
Bleeding disorders or use of anticoagulant/antiplatelet therapy that significantly increase bleeding risk, unless appropriately managed by the physician.
Previous permanent fillers or foreign bodies in the intended treatment area, unless compatibility is clearly established and risk is acceptable.
Injection into blood vessels, intramuscularly or into non-indicated anatomical sites.
Adverse Effects
Expected, usually transient local reactions at the injection site such as redness, swelling, pain, tenderness, warmth, itching and bruising.
Short-term feeling of fullness, pressure or mild discomfort in the treated area.
Palpable lumps or nodules if the gel is unevenly distributed; these are often manageable by gentle massage or may resolve with time.
Rare infectious complications (e.g. cellulitis, abscess) when aseptic technique is not adequately followed; require prompt medical treatment.
Hypersensitivity or allergic reactions, which may present as prolonged oedema, erythema, pruritus or induration; may require medical management.
Very rare delayed adverse events associated with hyaluronic acid fillers, such as granulomatous reactions or late inflammatory nodules.
Vascular compromise or tissue ischaemia in the event of inadvertent intravascular injection or significant vascular compression, which is a medical emergency requiring immediate management according to established filler complication protocols.
Storage Conditions
Store in the original packaging at a controlled room temperature as specified on the box (typically between 2°C and 25°C).
Protect from heat, direct sunlight and freezing; do not use the product if it has been frozen.
Keep the syringe in its blister packaging until immediately before use to maintain sterility.
Do not use after the expiry date indicated on the packaging.
Store out of the sight and reach of children.
Dispose of used syringes, needles and cannulas safely in accordance with local sharps and clinical waste regulations.
Duration
Symptomatic relief of vulvovaginal dryness and improvement in tissue quality typically persists for several months following a single treatment. Clinical experience and manufacturer information suggest that effects can last up to approximately 6\u201312 months, depending on individual factors such as age, hormonal status, tissue quality and lifestyle. Retreatment schedules are determined by the treating physician based on the patient\u2019s clinical evolution and comfort.
Onset
Increased hydration and local comfort often begin soon after injection, with patients commonly reporting rapid relief of dryness and irritation over the following days to weeks. Improvements in tissue tone, elasticity and sensitivity continue to develop over subsequent weeks as tissue quality and collagen synthesis are supported by the hyaluronic acid matrix.
