POST-MARKETING CLINICAL STUDY to EVALUATE the EFFICACY and SAFETY of the VAGINAL FILLER MEDICAL DEVICE in CORRECTING THINNING of the GENITAL TISSUE of the LABIA MAJORA in WOMEN, RE-PROPORTIONING the FEMALE EXTERNAL GENITAL AREA and IMPROVING SEXUAL FUNCTION.

"Vaginal Filler will be administered according to Investigator's judgment and Instruction For Use (IFU) to correct hypotrophy, improve the shape and increase the volume of the female external genital areas (labia majora). Vaginal Filler is a resorbable medical device available in packages containing 2 sterile pre-filled mono-use syringes of 1 ml with pre-assembled plunger rod and backstop, containing 25 mg/g cross-linked hyaluronic acid.~The injection is performed by medical personnel at visit V0 in one or both sides of the superficial subcutaneous layer of the labia majora, along its longitudinal axis.The dosage to be used for the individual case is at the doctor's discretion. An anesthetic may be applied (lidocaine 2% injection only in the cannula access point) to the affected area before the IP injection.~In order to maintain the results achieved, an eventual touch-up could be performed one months after the first treatment in the same areas of the first injection, at visit V2."