PIP 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
    2011-12-23
  • 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
    Recommendation by the french authority on removal of pip breast implants a spokesman for the department of health (dh) said today (december 23) the department noted the recommendation by the french ministry of health regarding the management of patients implanted with silicone gel breast implants manufactured by the french company, poly implant prothese (pip). the french ministry of health announced today its recommendation for patients to remove their pip silicone gel breast implants as a preventive measure. the decision was made after an expert meeting, which found that women with pip implants did not have a higher risk of cancer than women with implants made by other companies, but that there were well-established risks of ruptures. “since the issue came to our attention, dh has been contacting the french medical device regulatory authority, agence francaise de securite sanitaire des produits de sante (afssaps) to obtain information, and sought their assistance to ascertain the distribution of the affected products in hong kong.”the spokesman said. “according to afssaps, the french manufacturer of the products has closed down in 2010. official data on the distribution and usage of the products in hong kong are not available,” he explained. “however, based on the information at hand, the product is not popular in hong kong,” he said. dh noted that while individual health authorities may recommend the removal of pip implants as a precautionary measure, other health authorities have not recommended their removal. the spokesman reiterated that members of the public who have received breast implants, particularly those implanted with the affected products, should consult their implanting surgeons or surgeons experienced in this field if they have any concerns or doubt. so far, the department has not received any adverse events in relation to the pip breast implants. "the department will continue to closely monitor the situation," the spokesman added. end.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Press release: Recommendation by the French authority on removal of PIP breast implants
  • Manufacturer

Manufacturer