Events

Essure Permanent Birth Control 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Australasian Medical & Scientific Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2016-RN-00243-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-04-28
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00243-1
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 원인
    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.
  • 조치
    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