Events

Avis De Sécurité sur Silicone Gel filled Breast Implants manufactured by Poly Implant Prothese (PIP). (All models and lot numbers).

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland qui a été fabriqué par Poly Implant Prothese (PIP).

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
    Field Safety Notice
  • Numéro de l'événement
    SN2011(09)
  • Date
    2011-05-26
  • Pays de l'événement
    Ireland
  • Source de l'événement
    HPRA
  • URL de la source de l'événement
    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
  • Notes / Alertes
    "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."
  • Notes supplémentaires dans les données
  • Cause
    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).
  • Action
    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 ...
  • Modèle / numéro de série
  • Description du dispositif
    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)