Poly Implant Prothese breast implants 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Poly Implant Prothese (PIP) 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
    2011-12-22
  • 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
    Adverse events related to poly implant prothese breast implants a spokesman for the department of health (dh) said today (december 22) the department is aware that the french medical device regulatory authority, afssaps, is continuing to monitor adverse events reported in patients with silicone gel breast implants manufactured by a french company named poly implant prothese (pip). on december 21, dh was informed by the afssaps of their updated figures on serious adverse events related to pip breast implants. this included a fatal case of anaplastic large cell lymphoma (alcl), a rare form of cancer of the immune system, which was earlier reported in november. however, it was not possible for them to conclude whether pip implant was an additional risk. dh noted that to date, the french authority has not made any decision on the need to remove the pip implants, and that an expert meeting is expected to provide further recommendations on the management and follow-up of patients with such implants. “dh has contacted afssaps to obtain further information and sought their assistance to obtain information about distribution of the affected products in hong kong.” he said. in march 2010, the afssaps has made a decision to recall and suspend the marketing, distribution, export and the use of the silicone gel breast implants manufactured by pip, as there were increased reports of ruptures of the implants due to quality defects. a press release was also made by dh on march 31, 2010 in response to afssaps’ announcement. in hong kong, dh has so far not received any report of adverse events associated with pip breast implants. meanwhile, the department will closely follow up with the recommendations issued by afssaps and other medical device regulatory authorities. members of the public who have received breast implants, particularly those implanted with the affected products, should continue to routinely monitor their breast implants and consult their implanting surgeons if they have any concerns or doubt. “the department will closely monitor the situation,” the spokesman added. ends.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Press release: Adverse events related to Poly Implant Prothese breast implants
  • Manufacturer

Manufacturer