Alerta De Seguridad O Notificaciones De Seguridad para All models and lot numbers of silicone gel filled breast implants

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Poly Implant Prothese.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • Número del evento
    MDA/2010/025
  • Fecha
    2010-03-31
  • Fecha de publicación del evento
    2014-12-17
  • País del evento
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    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.
  • Causa
    (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).
  • Acción
    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

  • Modelo / Serial
  • Descripción del producto
    Silicone gel filled breast implants manufactured by Poly Implant Prothese (PIP). All models and lot numbers.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    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)
  • Empresa matriz del fabricante (2017)
  • Source
    MHRA