Alerte Ou Avis De Sécurité sur All models and lot numbers of 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/2010/025
  • Date
    2010-03-31
  • 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
    On Tuesday 30 March 2010 the French medical device regulatory authority (AFSSAPS) informed the MHRA that it has suspended the marketing, distribution, export and the use of silicone gel filled breast implants manufactured by PIP (a French breast implant manufacturer). It has recalled all of these devices.AFSSAPS recently carried out an inspection of the PIP manufacturing plant and established that most breast implants manufactured by the company since 2001 have been filled with a silicone gel with a composition different from that approved.The MHRA does not yet know if the use of the unapproved material affects the safety of the implants. We understand that AFSSAPS is carrying out urgent testing and has undertaken to provide further information as soon as it is available.The MHRA will provide further advice on patient management, as necessary, when more information is available.
  • Cause
    (poly implant prothese (pip)) french medical device regulatory authority (afssaps) found the composition of silicone gel for most breast implants have been different to the one approved since 2001 (mda/2010/025).
  • Action
    Implanting centresDo not implant these devices Quarantine and return all of these devices to the distributorGPsAdvise patients who are concerned about their PIP implants to consult their implanting surgeon.Implanting surgeonsAwait further advice from the MHRA regarding clinical management of patients implanted with these devices.

Device

  • Modèle / numéro de série
  • Description du dispositif
    Silicone gel filled breast implants manufactured by Poly Implant Prothese (PIP). All models and lot numbers.
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Andrew Hay (Director) Clover Leaf Products Ltd 6-10 Church Farm Courtyard High Street Chalfont St Giles HP9 4QH Tel: 01494 876 990 Fax: 01494 876 991Email: andy@cloverleafproducts.com(company name corrected August 2010)
  • Société-mère du fabricant (2017)
  • Source
    MHRA