80 hyaluronic acids currently marketed
Currently about 80 products are marketed in France by 25 manufacturers. The AFSSAPS has classified wrinkle fillers into three categories: resorbable, slowly resorbable, non-resorbable products. “Resorbable” and “slowly resorbable” products are understood to mean products eliminated naturally by the body over time, as opposed to “non-resorbable” products which persist permanently in the skin.
The Afssaps not recommended today the use for aesthetic purposes of non-absorbable injectable products due to an uncontrolled risk of very delayed serious adverse effects. The risk of appearance of such effects, several years later, can be increased by the injection of various products or other aesthetic treatments.
Safety: mandatory CE marking
Injectable wrinkle fillers are medical devices and as such must meet the essential requirements of European Directive 93/42/EEC amended by 2007/47/EC. Manufacturers must submit their products to an assessment of their safety and performance by a so-called “notified” body, ie authorized to issue a CE certificate, necessary for the manufacturer to draw up his declaration of conformity. This allows him to affix the CE marking on his product and to ensure free circulation on the European market. This type of organization is controlled by a competent national authority (in France the Afssaps) within the EU.
The Afssaps is in the process of developing a reference system for the application of the ISO 10993 standard specific to injectable wrinkle fillers. Directive 2007/47/EC applicable on March 21, 2010 reinforces the requirements in terms of clinical evaluation and insists on the collection of additional data after the product has been placed on the market.
Traceability: stay informed
Due to their invasive nature and the great nomadism of candidates in the field of aesthetics, injectable wrinkle fillers must be traced during each injection, as are medical devices.
The patient receiving an injection must be informed of the characteristics of the injected product (trade name, manufacturer, batch number) as well as the circumstances of the injection (doctor, place, indication and injection site).
Counterfeiting and falsification: beware of online purchases
Purchased by individuals on the Internet, these products most often enter France by postal transport, which makes them difficult to detect. Their presence in illegal circuits allows them to escape the regular checks carried out by the health authorities.
Medical devices purchased on the Internet, even when they are offered under a known name already on the market, are not always those which have been the subject of medical CE marking. Under these conditions, neither the quality nor the storage conditions of medical devices purchased on the Internet can be guaranteed. The candidate for injection exposes himself to receiving counterfeit or inferior medical devices that may be outdated or altered by unsuitable storage or transport conditions. Similarly, the raw materials used in these products may also be counterfeit or of poor quality.
The Afssaps carries out an internet communication as soon as it becomes aware of the existence of counterfeit products.
Satisfactory control of French establishments
The Inspection and Establishments Department of the French Agency for Sanitary Safety of Health Products (AFSSAPS) conducted an inspection campaign in 2009 and 2010 on the French sites of the majority of establishments that market injectable products and absorbable wrinkle fillers. The panel of these establishments includes 9 manufacturers and 8 distributors. Most of the establishments inspected have made the communications for the placing on the French market of the products they place on the market. They have a generally satisfactory quality management system, with the exception of the measures taken in terms of audits, which need to be improved. They have biocompatibility data for their products, label their products correctly, have qualified their equipment, validated their production and control processes, produce under satisfactory conditions. They carry out the sterilization correctly, an operation that is all the more delicate since the injectable filling products, which are sensitive to heat, are sterilized with water vapour. The traceability of raw materials, production operations and products placed on the market is satisfactory.
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