Events

Notificaciones De Seguridad De Campo acerca de Silicone Gel filled Breast Implants manufactured by Poly Implant Prothese (PIP). (All models and lot numbers).

Según Health Products Regulatory Authority, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Ireland que fue producido por Poly Implant Prothese (PIP).

¿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
    Field Safety Notice
  • Número del evento
    SN2010(13)
  • Fecha
    2010-10-05
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/silicone-gel-filled-breast-implants-manufactured-by-poly-implant-prothese-(pip).-(all-models-and-lot-numbers)-05-10.2010&id=388af825-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notas adicionales en la data
  • Causa
    A recall of silicone gel filled breast implants manufactured by the french company poly implant prothese (pip) was initiated in ireland on the 30th march 2010. the recall follows a manufacturing site inspection in france which identified unauthorised silicone gel being used in the product.
  • Acción
    The IMB recommends that:  Implanting surgeons / Implanting centres  • Identify women who were implanted with PIP silicone gel filled implants after 01 January 2001.  • Reassure them that there is no current evidence of health risk associated with the implants.  • Advise them that further information about the testing is available on the IMB, Therapeutic Goods Administration in Australia, Medicines And Healthcare products Regulatory Agency in UK and French Regulatory Agency AFSSAPs websites. (web addresses provided above).  GPs  Advise patients who are concerned about their PIP implants to consult their implanting surgeon/ implanting centres.

Device

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

Manufacturer

Poly Implant Prothese (PIP)