Events

Alerte De Sécurité sur silicone-filled breast implants

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Poly Implant Prothese.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2010-03-31
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/press_20100401.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notes supplémentaires dans les données
    Press release
  • Cause
    Recall of silicone-filled breast implants the department of health (dh), through its routine surveillance today (march 31), found that a french regulatory authority has announced a recall of the silicone-filled breast implants manufactured by poly implant prothese (pip). the affected models include imghc-tx, imghc-mx and imghc-ls. there is an increase of reported adverse events concerning the problematic products in the past three years. they are mainly breakings and local complications. despite the fact that the products are not listed with dh, the department considered that there may be quality defects and safety concerns of the products after risk assessment. dh decided to inform stakeholders including hospital authority, hospitals and medical professional association about the recall. information on the recall has been posted on the dh's website. members of the public who have implanted with the affected products, or in case of doubt, should consult their doctors. the dh has not received any report of adverse events arising from the affected products. the department will closely monitor the developments of the recall. ends/wednesday, march 31, 2010.

Device

silicone-filled breast implants
  • Modèle / numéro de série
  • Description du dispositif
    Press release: Recall of silicone-filled breast implants
  • Manufacturer
    Poly Implant Prothese

Manufacturer

Poly Implant Prothese