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
    SN2011(09)
  • Fecha
    2011-05-26
  • 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)&id=0486f825-9782-6eee-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
    The latest test results confirm no evidence of genotoxicity or chemical toxicity of the filler material in breast implants manufactured by the french company poly implant prothese (pip).
  • Acción
    The IMB recommends that:  Implanting surgeons / implanting centres  1. Ensure that all patients who were implanted with PIP silicone filled implants are advised of the content of this safety notice and the previous safety notice that was issued by IMB, Safety notice SN2010(13).  2. Highlight the key findings to the patient:      • Test results show no evidence of genotoxicity or chemical toxicity of the filler material in the implants.      • Mechanical testing of the implant shell carried out by AFSSAPS confirmed that there may be      an increased risk of rupture.  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)