Desirial Plus 2x2ml

• Cross-linked hyaluronic acid (BDDE): 21 mg.
• Phosphate buffer pH 7.2 and mannitol, q.s. to 1 g of gel.
• Mannitol (antioxidant): incorporated into the formulation as an antioxidant agent. According to VIVACY's technical documentation, it protects the hyaluronic acid gel against the damage caused by the free radicals (oxidative stress) generated during the injection process, thereby slowing the degradation of the hyaluronic acid. It is the differentiating element of the VIVACY range compared with conventional HA fillers.
• Cross-linker: BDDE. Hyaluronic acid of non-animal origin.
• Bi-SOFT® syringe: patented bi-material injection system (polycarbonate and thermoplastic elastomer with a soft-touch surface), with oversized plunger and finger flanges and an optimised centre of gravity. It is a property of the syringe, not of the gel: it aims to reduce the perceived injection force and improve control of the deposit.
• Glass syringe: unlike DESIRIAL®, DESIRIAL® Plus is packaged in a 2 ml pre-filled glass syringe, sterilised by autoclave. Single-use product.
• Difference from DESIRIAL®: DESIRIAL® (19 mg/g, 1 ml syringe) is injected intradermally and into the mucosa for rehydration and mild hypotrophy. DESIRIAL® Plus (21 mg/g, 2 ml syringe) is injected exclusively by the subcutaneous route into the labia majora for moderate or severe hypotrophy and atrophy. The instructions for use of DESIRIAL® Plus expressly exclude any injection outside the subcutaneous region of the vulvar labia majora, including the vaginal and vestibular mucosa.

Injectable gel indicated in moderate hypotrophy, severe hypotrophy or atrophy of the vulvar labia majora, by means of subcutaneous injections.

Mechanism according to the manufacturer: the injection of DESIRIAL® Plus is intended to restore volume, rehydrate, retone and retighten the connective area. The instructions for use do not describe stimulation of collagen or elastin synthesis.

Expressly excluded areas: any injection outside the subcutaneous region of the vulvar labia majora; the clitoral area; the labia minora; areas close to the urethra and the ventral wall of the vagina.

• Qualification: it must be injected by legally authorised practitioners with sound anatomical knowledge of the site treated and experience in injection techniques with similar filler products.
• Anaesthesia: the instructions for use strongly recommend it, under the physician's responsibility.
• Instruments: the injections are performed with the 18G cannula or with the 27G ½″ needles. The 19G needle included is used to make the pre-hole for the cannula. The cannula and needles supplied with the product must be used.
• Technique: the injection is performed along the longitudinal axis of the labium majus, by the subcutaneous route, using a retrograde linear technique.
• Inject slowly to avoid overcorrection. If the injection is too deep, the efficacy of the correction is reduced; if it is too superficial, skin discolouration, small indurations or an irregular correction may appear.
• It is recommended not to inject more than 20 ml of cross-linked hyaluronic acid per person per year (all ranges combined).
• Sessions: depending on the type of area treated, the patient and the depth of injection, one or two sessions are required for optimal treatment. The persistence of the product depends on the patient. Regular touch-up sessions allow the correction to be maintained.
• After injection, massage the treated area thoroughly to optimise the uniformity of the correction. A follow-up visit in the following days is advisable.
• Instructions to the patient: after the injection, avoid damp places (swimming pool, gym, hammam, jacuzzi) for 10 days; avoid sexual intercourse for 5 days; avoid for a few days activities that generate pressure on the treated area (cycling, horse riding). Slight post-injection bleeding may be observed.

• Storage: in its original packaging between 2 °C and 25 °C, protected from freezing and from light. Failure to comply with the storage conditions may affect the performance of the product.
• If it has been kept in a refrigerator, allow the product to reach room temperature before injection.
• Do not use after the expiry date shown on the packaging and on the syringe. Do not use if the packaging is damaged.
• Single-use product. Do not reuse or resterilise, even if the implant has not been injected. Inject immediately after opening.
• The pack contains: according to the manufacturer's instructions for use (OPDC173 v9): 1 syringe of 2 ml, 2 sterile single-use needles of 27G ½″, 1 needle of 19G for the cannula pre-hole, 1 cannula of 18G, instructions for use and labels with the batch number — one for the patient and one for the medical record. Check the presentation format supplied against the reference ordered.

Must not be used:

• for injections other than those performed in the subcutaneous regions of the vulvar labia majora
• in the clitoral area or in the labia minora
• in areas too close to the urethra (no injection into the ventral wall of the vagina) or by the intraurethral route
• in patients with a tendency to develop hypertrophic scars
• in patients with known hypersensitivity to any of the components (hyaluronic acid, mannitol)
• in pregnant or breastfeeding women, or in children
• in areas with inflammatory and/or infectious clinical signs of bacterial, fungal (e.g. mycosis) or viral (e.g. papilloma, herpes) origin, or in patients under treatment for these conditions
• into blood vessels

Precautions specific to the genital route: a rigorous pre-injection examination must be performed to rule out any infection (fungal, viral or bacterial) and any vulvovaginal inflammation. Inject away from menstruation. Do not use quaternary ammonium derivatives for disinfection because of the risk of irritation of the genital mucosa. In patients with a history of genital herpes, the punctures may trigger a new outbreak. In patients with a history of, or with, an autoimmune-mediated disease, or who have had or have a cancer in areas close to the injection site, the practitioner must decide on a case-by-case basis, propose a prior double test and not inject if the disease is progressive.

Patients with a history of streptococcal disease (recurrent tonsillitis, rheumatic fever) must undergo a prior double test; in the case of rheumatic fever with cardiac involvement it is recommended not to inject. The intake of aspirin, NSAIDs, antiplatelet agents, anticoagulants or vitamin C should be avoided in the preceding week.

Vascular risk: do not inject into vessels or into muscles. Accidental intravascular injection may cause vascular occlusion with rare but serious complications, such as necrosis of the skin and/or of the underlying tissues.

Adverse effects described: inflammatory reactions (redness, oedema, erythema) with possible pruritus or pain at the injection site; indurations or nodules; colouration or discolouration of the area; slight bleeding at the injection site; post-injection pain; haematomas; difficulty in urinating. The patient must report to the practitioner any effect that persists for more than a week.

Always consult the instructions for use included in the pack before application. The binding contraindications are those set out in the official documentation accompanying the product.