Ce site n’est pas un site médical mais un site dédié aux échanges et informations entre malades de tous les types d’implants (mammaires).
La FDA renforce les exigences de sécurité des implants mammaires et met à jour les résultats de l’étude en date du 27 octobre 2021 .
Le 27 octobre 2021, la FDA a pris plusieurs nouvelles mesures pour renforcer la communication des risques liés aux implants mammaires et aider celles qui envisagent des implants mammaires à prendre des décisions éclairées.
Premièrement, la FDA a émis des ordonnances restreignant la vente et la distribution d’implants mammaires afin de garantir que les patientes envisageant des implants mammaires reçoivent des informations adéquates sur les risques afin qu’elles puissent prendre des décisions en toute connaissance de cause.
Deuxièmement, la FDA a approuvé un nouvel étiquetage pour tous les implants mammaires légalement commercialisés, qui comprend :
- Avertissement boîte noire.
- Liste de contrôle de décision du patient, qui doit être examinée avec la patiente potentielle par le fournisseur de soins de santé pour s’assurer que la patiente comprend les risques, les avantages et les autres informations concernant le dispositif d’implant mammaire. Le patient doit avoir la possibilité de parapher et de signer la liste de contrôle de décision du patient et celle-ci doit être signée par le médecin implantant le dispositif.
- Mise à jour des recommandations de dépistage des ruptures d’implants mammaires remplis de gel de silicone.
- Description de l’appareil avec une liste de matériaux spécifiques dans l’appareil.
- Carte appareil patient.
La FDA s’attend à ce que les fabricants publient l’étiquetage des appareils mis à jour sur leurs sites Web dans les 30 prochains jours.
Enfin, la FDA a publié des informations mises à jour sur l’état des études post-approbation des fabricants d’implants mammaires. Pour plus d’informations, voir FDA renforce les exigences de sécurité et met à jour les résultats de l’étude pour les implants mammaires.
Symptômes systémiques [maladie des implants mammaires ou (BII, Breast Implant Illness)] ou syndrome ASIA en Europe .
Des symptômes tels que fatigue, perte de mémoire, éruption cutanée, « brouillard cérébral » et douleurs articulaires peuvent être associés aux implants mammaires. Certaines patientes peuvent utiliser le terme « maladie des implants mammaires » (BII) pour décrire ces symptômes. Les chercheurs étudient ces symptômes pour mieux comprendre leurs origines. Ces symptômes et leurs causes sont mal compris. Dans certains cas, le retrait des implants mammaires sans remplacement est signalé pour inverser les symptômes de la maladie des implants mammaires.
Nous encourageons les patients à signaler toute blessure, événement indésirable ou symptôme lié à un dispositif médical, y compris les symptômes énumérés ci-dessus, à la FDA par téléphone au 1-800-FDA-1088 ou en ligne sur MedWatch , la FDA Safety Information and Adverse Event Programme de rapports. Veuillez inclure les informations suivantes :
- Nom de l’appareil (nom de marque)
- Nom du fabricant
- Détails de l’événement indésirable et des interventions médicales et/ou chirurgicales (le cas échéant)
Lymphome anaplasique à grandes cellules associé aux implants mammaires (LAGC-AIM)
Le lymphome anaplasique à grandes cellules associé aux implants mammaires (LAGC-AIM) est un lymphome à cellules T qui peut se développer après les implants mammaires. Pour plus d’informations, voir : Lymphome anaplasique à grandes cellules associé aux implants mammaires (ALCL-AIM)
Implants mammaires et cancer : Québec contacte des milliers de …
Le Ministère Sante canada ne peut préciser actuellement le nombre exact de femmes qui ont reçu ces implants. Des recherches sont en cours afin de retrouver toutes les patientes touchées par le LAGC , tant dans le système public que dans le privé. Québec estime qu’il pourrait y avoir jusqu’à 15 000 femmes touchées
.Après les implants mammaires, les implants fessiers peuvent-ils aussi …
D’après le communiqué publié par l’American Society for Aesthetic Plastic Surgery, il s’agit d’une femme d’âge moyen, atteinte d’un lymphome anaplasique à grandes cellules (LAGC), « une complication très rare, mais potentiellement mortelle qui a été largement associée aux implants mammaires ».
La patiente aurait subi l’opération pour la pose d’implants fessiers bilatéraux en silicone texturé seulement un an avant le diagnostic de ce lymphome.
« Les objectifs de cette étude de cas sont donc de démontrer que tous les patients subissant l’implantation d’implants en silicone texturé sont à risque de développer un lymphome anaplasique à grandes cellules, et de fournir des preuves pour un nouveau diagnostic possible associé à des implants fessiers », concluent les auteurs de cette étude publiée dans l’Aesthetic Surgery Journal.
Implants mammaires : pleins feux sur Asia ( Syndrome ASIA)
Videos des auditions de l’ANSM du 7 et 8 février 2019.
Cash investigation du mardi 27 novembre 2018 dernier à 21h sur France 2.
Elise Lucet a pénétré dans les coulisses de l’industrie de la santé, qui échappe bien souvent au contrôle des autorités sanitaires. «Cash investigation» dévoile les secrets bien cachés d’un secteur qui génère des milliards d’euros de bénéfices au détriment parfois de la santé des Français. L’enquête a été menée dans la plus grande discrétion, jusqu’aux derniers jours précédant la diffusion. Elle montre comment certains produits implantés dans le corps des patients peuvent se révéler très dangereux. Après le documentaire, Elise Lucet reçoit sur le plateau de «Cash investigation» acteurs, experts et responsables politique.
Les télévisons quebecoises et neerlandaises ont diffusé leur émission lundi 26 novembre 2018 sur le même sujet : les protheses mammaires et leur danger.
Nous assistons à une montée en puissance de femmes qui découvrent peu à peu les catastrophes que ces implants ont eu sur leur santé , sur leur vie , sur leur famille.
Plus de 80 groupes Facebook se sont ouverts dans le monde entier pour alerter les femmes sur les dangers des prothèses et une entraide mondiale s’est mise en place .
Le plus gros groupe est le groupe BII Breast Implant Illness ( les maladies des implants mammaires ) qui représente 66 000 membres en février 2019, ce groupe augmentent de 100 membres par jour .
Les autres fabricants ont ils fait une étude sérieuse sur l’innocuité et la biocomptabilité des implants mis sur le marché.
L’ANSM vient de demander ces tests , nous sommes curieux de voir les résultats et comment ont été fait ces études.
Car nous victimes des prothèses mammaires ont leur a servi de cobaye vivant.
Des victimes demandent réparations de leur préjudice et les noms des responsables ( des plaintes ont été déposées au parquet de Paris et de Marseille contre X en janvier 2019).
Prothèses mammaires: près d’une quinzaine de femmes saisissent la …
Victimes de problèmes de santé liés aux prothèses, elles portent plainte pour «mise en danger de la vie d’autrui» ou «blessures involontaires» et «tromperie aggravées»
L’affaire des implants mammaires texturés prend une tournure judiciaire. Près d’une quinzaine de femmes, porteuses de ces prothèses et ayant rencontré de graves problèmes de santé, saisissent la justice ces mercredi 6 et jeudi 7 février, rapportent nos confrères du Monde et de France Info. Dans le collimateur des plaignantes, qui souffrent pour un certain nombre d’entre elles d’un cancer: les fabricants de prothèses et l’agence nationale de sécurité du médicament et des produits de santé (ANSM). Contactés ce jeudi matin, les parquets de Paris et de Marseille n’ont pas encore donné suite à nos sollicitations.
La plupart des plaintes vont être déposées ce jeudi pour des délits de «tromperie aggravée» et de «blessures involontaires». Parmi les cas les plus emblématiques, Le Monde cite celui de Laeticia, 42 ans, aujourd’hui handicapée à 80%, qui est sous chimiothérapie. Celle-ci s’est fait poser en 2007 des implants mammaires fabriqués par le laboratoire Allergan mais en 2016, un accident de travail au cours duquel une caisse heurte son sein gauche l’oblige à consulter. À l’examen, les médecins remarquent que sa prothèse est rompue et que du silicone s’est répandu dans son corps. On lui retire en urgence ses implants mais peu de temps après on lui diagnostique un LAGC. Comprendre: un Lymphome Anaplasique à Grandes Cellules, c’est-à-dire un cancer lié aux prothèses, une tumeur très rare. En novembre dernier, l’ANSM dénombrait 53 femmes dans ce cas-là en France.
«Le produit n’a pas vocation à provoquer quelque pathologie que ce soit»
Interrogé par Le Monde, son avocat Me Emmanuel Molina assure que sa cliente n’a jamais été informée de tels risques et qu’il «est tout à fait anormal que survienne une rupture de prothèse mammaire à la suite d’un choc banal, non violent». Et même dans ce cas, «le produit n’a pas vocation à provoquer quelque pathologie que ce soit», ajoute cet avocat qui représente 11 victimes. À Paris, deux femmes ont également déposé plainte mercredi auprès du parquet pour «mise en danger d’autrui». Toujours selon le quotidien du soir, ces plaintes visent le laboratoire Allergan et l’agence du médicament.
Ces plaintes interviennent à un moment où l’agence nationale du médicament tente de réévaluer la sûreté de ces prothèses et organise deux journées consacrées à «la place et l’utilisation des implants mammaires texturés en chirurgie esthétique et reconstructrice». Un comité d’experts indépendants est chargé d’auditionner des patientes et des professionnels de santé sur ce sujet. Au cœur des débats, la texture de ces prothèses qui pourraient présenter un risque de cancer, selon 20 Minutes . À l’issue, ce comité qui retransmet ces auditions en direct sur YouTube devra émettre un avis.
85% d’implants texturés
Cette décision est très attendue, puisque 500.000 femmes portent actuellement des implants mammaires en France et que les implants texturés, mis en cause dans la survenue de cancers, représentent 85% du marché français, contre 15% pour les implants à enveloppe lisse, nous rappelait le Pr Maurice Mimoun, chef du service de chirurgie plastique de l’hôpital Saint-Louis à Paris. Dans 80% des cas, les implantations sont faites pour des raisons esthétiques et 20% pour une reconstruction après un cancer, estime un rapport de la Haute autorité de santé datant de 2015.
Les autorités sanitaires sont loin de découvrir le problème des prothèses texturées. Dès 2011, une hausse des lymphomes Anaplasiques à Grandes Cellules a été détectée chez des femmes portant ce type d’implants mammaires. L’ANSM a alors mené des investigations qui ont montré que le port de ces implants est effectivement associé à un risque supplémentaire de développer ce cancer. En novembre dernier, la ministre de la Santé interrogée à ce sujet tentait de rassurer en affirmant que les prothèses présentaient «très peu de risques». ( Article du Figaro).
Bonjour depuis septembre 2017 fuite intracapsulaire je n’ai plus de vie j’ai perdu toute autonomie j’ai des douleurs très intenses au niveau musculaire dans les deux bras,mal aux articulations des mains des maux de tête incessant, je ne dors plus je tremble comme si que j’avais la maladie de Parkinson, je suis en chaise roulante je ne peux plus me déplacer normalement j’ai des douleurs intenses dans les jambes dans les pieds, on m’a fait de nombreux examen scanner electromyogramme Irm …
tout s’est avéré négatif mais je pense qu’on ne fait pas les bons test. je fais savoir à mon chirurgien qui m’a explantaté ma prothèse de me faire faire les test du syndrome d’Asia mais c’est une lutte incessante. on veux me faire croire que je somatise et que c’est d’ordre psychologique ,c’est ahurissant!!!! je travaille plus j’ai plus de vie sociale je peux plus sortir de chez moi je tombe dans une précarité financière catastrophique, la CPAM refuse tous mes trajets de mon domicile à Paris car c’est plus de 150 km alors que le seul chirurgien qui a fait mon explantation de ma prothèse, se trouve à Paris là où ils m’ont mis une prothèse allergan suite à un cancer du sein. les autres chirurgiens à qui j’ai fait la demande de m’enlever la prothèse avec une fuite intracapsulaire ont refusés en me répondant aller voir la personne qui vous l’a posé donc j’ai pas eu trop le choix d’aller à Paris à mes propres frais en touchant 740 € par mois pour vivre. Une neurologue qui m’a fait hospitalisé pendant 5 jours n’ayant rien trouvé m’a répondu qu’il ne pouvait pas pousser les examens plus loin car ça devenait trop coûteux. La CPAM m’a téléphoné à l’hôpital sur mon lit de malade me parlant extrêmement mal et me disant qu’il fallait que je m’estime heureuse qu’on met retirer l’implant.
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