Events

Retiro De Equipo (Recall) de Essure Permanent Birth Control

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Australasian Medical & Scientific Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2016-RN-00243-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-04-28
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00243-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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