Hyaluronic Acid and Volumetry

This information sheet has been designed under the auspices of the French Society of Plastic, Reconstructive and Aesthetic Surgery (SOF.CPRE) as a complement to your initial consultation, to address all the questions you may have if you are considering this procedure.

The purpose of this document is to provide you with all the necessary and essential information to allow you to make your decision with full knowledge of the facts. We therefore advise you to read it with the utmost care.

Hyaluronic acid injections, performed on both women and men, can correct furrows, wrinkles, depressions and increase lip volume (while also reshaping them).

Since 1996, this molecule has been developed in the field of aesthetic filling and has completely revolutionised the management of skin ageing over the past decade.

An injection session can be performed in isolation but may also complement more radical medical-surgical rejuvenation techniques.

Hyaluronic acid is today considered the reference product used in medical volumetric rejuvenation.

The fillings presented were performed using exclusively Juvederm Ultra hyaluronic acid and Voluma hyaluronic acid by Allergan, compliant with the following requirements:

Medical Devices Directive (MDD 93/42/EEC) and latest amendments 2007/47/EC

FDA Quality System Regulation 21 CFR Part 820
ISO 13485: Medical devices — Quality management system — Requirements for regulatory purposes
Materials compliant with EP/USP monographs (parenteral)
ISO 10993-1: 2009: Biological evaluation of medical devices — for active implantable medical devices
ICH Guidelines for analytical stability methods and validation
ISO 17665-1: 2006: EN 556-1: 2001 & ISO 11737-1: 2006 — Sterilisation of medical devices
ISO 14644: ISO Class 6 certification (Class 5 laminar flow), Class 6 sterilisation and Class 7 packaging

Manufacturer information

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