silicone-filled breast implants 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Poly Implant Prothese 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2010-03-31
  • 사례 국가
  • 사례 출처
    DH
  • 사례 출처 URL
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Press release
  • 원인
    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

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Press release: Recall of silicone-filled breast implants
  • Manufacturer

Manufacturer