Alerte Ou Avis De Sécurité sur Silicone gel filled breast implants

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Poly Implant Prothese.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • Numéro de l'événement
    MDA/2012/011
  • Date
    2012-03-15
  • Date de publication de l'événement
    2014-12-17
  • Pays de l'événement
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
  • Notes / Alertes
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 recall data from the U.S. and the United Kingdom.
  • Notes supplémentaires dans les données
    In March 2010 the MHRA was informed by the French regulatory authorities (AFSSAPS) that most PIP silicone gel breast implants manufactured from January 2001 were filled with an unapproved silicone gel material. The MHRA’s advice for the management of women implanted with PIP silicone gel breast implants after 1 January 2001 was given in MDA/2010/078, published in October 2010.Updated information from AFSSAPS suggests that there is no guarantee that PIP silicone gel breast implants manufactured prior to 2001 contained the approved filler. Therefore, all women implanted with PIP silicone gel breast implants should be supported and managed in line with the Department of Health’s recommendations of January 2012.Information recently received from the UK supplier of PIP breast implants suggests that up to 7,000 women may have received PIP silicone gel breast implants prior to January 2001. This is in addition to the approximately 40,000 women previously believed to have received affected implants after 1 January 2001.
  • Cause
    (poly implant prothese (pip) no guarantee that silicone gel breast implants manufactured before 2001 contain approved filler. (mda/2012/011).
  • Action
    Implanting surgeonsIdentify additional women who were implanted with PIP silicone gel breast implants prior to 1 January 2001. Offer all women with these implants the support and management as set out on the Department of Health’s website .GPsFollow the advice provided by the Department of Health on its website .Note: the recommendations in this MDA update the advice given in MDA/2010/025 and MDA/2010/078.

Device

  • Modèle / numéro de série
  • Description du dispositif
    Silicone gel filled breast implants manufactured by Poly Implant Prothese (PIP).All devices implanted after 1 January 2001.
  • Manufacturer

Manufacturer