Events

Recall of Breast implants pre-filled with silicone gel

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France that was produced by POLY IMPLANT PROTHESE.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Date
    2010-03-30
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-des-implants-mammaires-pre-remplis-de-gel-de-silicone-fabriques-par-la-societe-poly-implant-prothese
  • Notes / Alerts
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Extra notes in the data
  • Action
    Afssaps, on 30/03/2010, informed the health institutions and surgeons who implanted breast prostheses pre-filled with silicone gel manufactured by the company POLY IMPLANT PROTHESE the decision made by the Director General of the Afssaps concerning the withdrawal and suspension of the placing on the market, the distribution, the export and the use of these devices. The health facilities and surgeons concerned, in France, received the enclosed mail (30/03/2010) (48 KB). The competent European authorities have been informed of this measure by Afssaps. Read more. Animal health policy decision (30/03/2010) (65 KB) Communiqué: Poly Implant Prothes silicone gel breast implants Questions / Answers (15/04/2011) (72 kb Press morning of 30 March 2010

Device

Breast implants pre-filled with silicone gel

Manufacturer

POLY IMPLANT PROTHESE