MMI-22-04-2019 is a dermal filler recommended for application in the intimate area. It is a sterile, injectable, colorless transparent gel, non-pyrogenic, reabsorbable medical device. Its main functional ingredient is cross-linked hyaluronic acid of non-animal origin, produced through bacterial fermentation.~The MMI-22-04-2019 is contained in pre-filled, graduated, disposable sterile syringe with Luer Lock adapter with 1 ml of net content. The sterilization of the product is achieved by moist heat.~The MMI-22-04-2019 has been classified as a Class III medical device under Annex IX of Directive MDD 93/42 EEC since it is a long-term, invasive and absorbable medical device.
The study is an open-label uncontrolled single-center study for the evaluation of the Performance characteristics (efficacy and safety) of the dermal filler MMI-22-04-2019 on the female genital area for the aesthetic, medicinal, functional and reconstructive indications.