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Accueil > Presse > Communiqué de presse ANSM du 04/05/2019 concernant le retrait de prothèses textures
Article du 04/04/2019

Communiqué de presse ANSM du 04/05/2019 concernant le retrait de prothèses textures

Mise à jour le 17/04/2019 à 18h48

A ce jour un peu plus de 600 cas de cancers sépicifiques liés au port d'implants mammaires macro texturés ont été rapportés.Dont environ 60 à ce jour en France.

Cela conduit les autorités de tutelle conformément aux recommandations de la SFCPRE  (interdire la pose de ces implants et les retirer de la vente.

Nous rappelons qu'un contrôle réguliers après la pose d'implants doit être fait auprès de votre chirurgien.

Ce contrôle est impératif au moindre changement :gonflement du sein,douleur etc..

 

Communiqué de presse ANSM du 04/05/2019

Madame , Monsieur , 

L’ANSM décide, par mesure de précaution, de retirer du marché des implants mammaires macrotexturés et des implants mammaires à surface recouverte de polyuréthane - 

L’ANSM ne recommande pas d’explantation préventive pour les femmes porteuses de ces implants -

 Communiqué du 04/04/2019 

https://ansm.sante.fr/S-informer/Actualite/L-ANSM-decide-par-mesure-de-precaution-de-retirer-du-marche-des-implants-mammaires-macrotextures-et-des-implants-mammaires-a-surface-recouverte-de-polyurethane-L-ANSM-ne-recommande-pas-d-explantation-preventive-pour-les-femmes-porteuses-de-ces-implants-Communique
 
 
 
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We emphasized the need to make options available to patients and allow them to make an informed decision. The importance of collecting long-term data through registries and other technologies was also discussed.

A few days later, the ANSM (French National Agency for Medicines and Health Products Safety) banned the sale of macrotextured and polyurethane covered breast implants in France as a cautious measure. In February of this year they had already banned Allegan Biocell implants.

 

Shortly after, Health Canada announced that Allergan had been notified of the Ministry’s intent to suspend its licenses for Biocell breast implants in Canada.

 

The NVPC (Netherlands Association for Plastic Surgery) followed the request of the Ministry of Health to recommend that its members do not use macrotextured and polyurethane implants for the timebeing in the Netherlands.

 

ISAPS has scrutinized the different approaches of France, Canada, and the Netherlands and points out the need for evidenced-based and statistically convincing studies. We are in line with the statement of the FDA and our European colleagues from the European Association of Societies of Aesthetic Plastic Surgery, EASAPS. Fortunately, the clear majority of national health ministries in other countries have endorsed this view and are awaiting reliable scientific data, so that treatment options using macrotextured and polyurethane implants will not be taken away from our patients in most countries, as this would be a huge step backwards.

 
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