Events

Alerte De Sécurité sur SILICONE MAMMARY IMPLANTS IN GENERAL.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par N/A.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1046
  • Date
    2011-02-01
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    The US FDA agency said in an article published on 01/26/2011 that it is exploring the possible association between silicone breast implants and a very rare type of cancer, anaplastic large cell lymphoma (ALCL). On 01/31/2011 this Unit of Technovigilance requested statistical data on the incidence of ALCL cases in Brazil to the National Cancer Institute - INCA / MS. The Division of Information / Coordination of Prevention and Surveillance - Conprev stated that ALCL is an extremely rare tumor and that considering the anatomical location of the breast, the occurrence is even rarer. Data available for Brazil show that the median incidence in men was 0.3 cases per 1 million or 3 cases per 10 million and in women the median incidence was 0.15 cases per 1 million women or 1.5 cases to 10 million. Regarding the anatomical location, the cases were observed in lymph nodes (most frequent), spleen, stomach, breasts of the face and skin. There was no occurrence in the breast. At this time there are no data in the NOTIVISA system that point to this type of problem. Further details on the subject are available in Anvisa's Clarification Note: http://portal.anvisa.gov.br/wps/wcm/connect/8920ea8045a23adba87ae83de4fc28bf/nota.pdf?MOD=AJPERES
  • Cause
    Safety statement published by the food and drug administration on a possible association between silicone breast implant and anaplastic large cell lymphoma. the text published by the fda is available at http://portal.Anvisa.Gov.Br/wps/wcm/connect/0f832b0045a23c9aa8b7e83de4fc28bf/noticia.Pdf?mod=ajperes.
  • Action
    Patients who have breast implants do not need to change their routine care and follow-up care. ALCL is very rare and has occurred in only a small number of the millions of patients who have breast implants. Although not specific to ALCL, patients should follow standard medical recommendations that include: (A) Regular monitoring of breast implants as well as performing self-examination of the breasts. If any changes are noted, it is important that the physician is consulted; (B) Routine mammography, according to medical guidelines; (C) Periodic Nuclear Magnetic Resonance to detect the occurrence of ruptures, according to medical recommendation; (D) Women who wish to undergo breast implant should discuss the risks and benefits with their physician.

Device

SILICONE MAMMARY IMPLANTS IN GENERAL.
  • Modèle / numéro de série
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA