11/04/2015

Obelis SA Obelis European Authorized Representative Center

Commission opinion on prohibiting the use of permanent dermal fillers for aesthetic purposes

On July 11, 2014, the Dutch authorities notified the European Commission of the draft decree amending the Medical Devices Decree (Besluit Medische Hulpmiddelen), which aims to prohibit the use of permanent dermal fillers for anything other than reconstructive purposes.


On July 22, 2015, the European Commission published an Opinion about this measure.


Why are the Dutch authorities maintaining this position?


The main argument is that the use of permanent dermal fillers could cause severe disfigurement. The authorities claim that there is no positive balance between the risk of such implications and the benefits of using permanent dermal fillers solely for aesthetic purposes. Moreover, a field standard published by the Dutch Association for Plastic Surgery, which stated that the use of permanent dermal fillers must be restricted and submitted to strict controls, has supported the position of the Dutch Authorities.


What is the European Commission´s point of view?


In its Opinion of July 11 the European Commission based its justification for prohibiting the use of permanent dermal fillers for aesthetic purposes on the consideration of the high risks associated with the use of these products and on the lack of any proportional benefit.


In particular, according to the Commission Opinion, the dermal fillers that should be banned are:
•Those intended for medical purposes only and which may be used “off label” for aesthetic purposes
•Those intended for both medical and aesthetic purposes


Following this Opinion, the aforementioned products should be classified as medical devices and shall be covered by the medical devices legislation.


Even though the ban only concerns the aesthetic use of permanent dermal fillers, the European Commission considers that this measure could restrict also the placing on the market of the relevant medical devices.


Further Commission proposals and reaction of the Member States


In its opinion, the Commission has invited the Dutch authorities to consider whether the ban should be extended to those products that are only intended for aesthetic purposes, as they may fall outside the medical devices scope.


As regards other Member States, even though the Netherlands´ justification was not put into question, it was not considered necessary to extend the ban throughout the EU, as the qualification of these products differs from one Member State to another.


For more information please do not hesitate to contact us.