Events

Rappel de Essure Permanent Birth Control

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Australasian Medical & Scientific Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2016-RN-00243-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-04-28
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00243-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    As part of post-market monitoring bayer healthcare has identified that women who undergo both an essure procedure and an endometrial ablation during the same surgical session may be at increased risks for events known to be associated with each procedure including damage to non-targeted tissue. performing endometrial ablation after an essure procedure may be associated with compromised ability to conduct and interpret a modified hysterosalpingogram (hsg); injury to surrounding tissue (e.G. bowel); increased risk of infection; post-ablation tubal sterilisation syndrome; stretching or removal of the essure micro-insert that could affect the patient’s ability to rely on essure for contraception. the above risks are assessed as low but should be considered in any woman having undergone both an essure procedure and an endometrial ablation.
  • Action
    The sponsor is advising the users that: - Endometrial ablation and the Essure procedure should not be performed on the same day/same surgical session. - The Essure procedure should only be performed in a woman who has undergone an endometrial ablation if visualisation and accurate localisation of the tubal ostia is possible. - Endometrial ablation should only be performed after the correct location of the Essure micro-inserts is confirmed by a satisfactory Essure Confirmation Test. The sponsor will provide updated Instructions for Use (IFU) to all customers. This action has been closed-out on 02/02/2017.

Device

Essure Permanent Birth Control

Manufacturer

Australasian Medical & Scientific Ltd