Evaluation of the Safety and Efficacy of Hyaluronic Acid Injection in Labia Majora Augmentation

Inclusion Criteria:

• Gender: female.

• Age: more than 18 years old.

• Patient affected by labia majora atrophy/hypotrophy as per investigator's judgementand expressing the wish for volume augmentation of the labia majora.

• Patient able to understand and sign the informed consent for study enrolment.

• Patient having given freely and expressly her informed consent.

• Patient affiliated to a health social security system.

• Female of childbearing potential should use a contraceptive regimen recognized aseffective since at least 12 weeks before inclusion and during all the study.

Exclusion Criteria:

• Pregnant or breastfeeding woman or planning a pregnancy during the study

• Women who gave birth within 4 months before inclusion.

• Patient who had been deprived of their freedom by administrative or legal decisionor who is under guardianship.

• Patient in a social or sanitary establishment.

• Patient suspected to be non-compliant according to the investigator's judgment.

• Patient suffering from a severe or progressive disease.

• Patient with history of auto immune disease.

• Patient immunosuppressed.

• Patient suffering of haemostatic disorder.

• Patient presenting with acute or chronic skin diseases.

• Patient is prone to active inflammatory or infectious processes or presentingclinical signs of inflammation in or close to the labia majora.

• Patient presenting bacterial, fungal or viral infection in or close to labia majora.

• Patient with history of streptococcal disease.

• Patient with recurrent genital herpes (several times a year). A patient asymptomaticin the 6 months before inclusion is eligible.

• Patient with history of pre-cancerous condition or cancer in areas close to theinjection site (external urogenital, anal or vaginal).

• Patient with an actual cancer or presence of pre-cancerous cells (vulvar dysplasia).

• Patient with a known tendency to develop keloid or hypertrophic scars.

• Patient with known allergy or hypersensitivity to hyaluronic acid or to one ofGenefill Contour, Desirial® Plus, anesthesia (if applicable) and disinfectantcomponents.

• Patient with multiple allergies.

• Patient with a condition or receiving a medication which, in the investigator'sjudgment, put the patient at undue risk.

• Patient who started oestrogen therapies for treatment of vulvovaginal symptomatologywithin 3 months before inclusion.

• Patient under treatment for bacterial, fungal or viral infection.

• Patient under treatment with aspirin, anticoagulant, platelets aggregationinhibiting drugs, NSAIDs, immunosuppressive therapy and Vitamin C or treated withinone week before inclusion.

• Patient under local hydrating treatment within four weeks before inclusion.

• Patient with history of correction with another resorbable implants with a similarindication within 12 months before inclusion.

• Patient with history of correction with permanent implants including fat graft orsemi-permanent in the area of injection.

• Patient who underwent a surgery on labia minora within 12 months before inclusion.

• Patient who underwent a surgery on labia majora at any time.

• Patient having intolerance to gram-positive bacteria.