Macrolane™ Volume Restoration Factor (VRF) dermal filler for breast augmentation 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Q-Med AB - a Galderma division 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert / Field Safety Notice
  • 사례 연번
    MDA/2012/022
  • 날짜
    2012-04-25
  • 사례 출판 날짜
    2014-12-17
  • 사례 국가
  • 사례 출처
    MHRA
  • 사례 출처 URL
  • 비고 / 경고
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • 데이터 추가 비고
    Use of Macrolane VRF20 and Macrolane VRF30 for breast augmentation can make diagnosis of breast cancer more difficult, particularly with the use of mammography.The MHRA has been made aware of a Dear Doctor Letter (160Kb) issued in April 2012 to clinicians by Q-Med about the use of Macrolane recommending that it is not used for injection into breasts because it can make diagnosis of breast cancer more difficult, particularly during mammography.The manufacturer has stated:
    ‘Macrolane is detectable in mammography, ultrasound examination and MRI examination of the breasts.Mammograms
    A clinical study indicates that the presence of Macrolane may significantly reduce the diagnostic quality of mammograms, since Macrolane will appear as a gray/white shadow in the mammogram. In this case ultrasound can be used as a complementary examination.Ultrasound
    Ultrasound can be used to diagnose lumps in the breast after a Macrolane treatment. Ultrasound may also be a complement to mammography at breast screening and diagnosing. Some radiologists explain that Macrolane has a typical appearance in an ultrasound, similar to that of water, but with a snowstorm appearance.’Breast diagnostics and MarolaneThere is no association with cancer and no safety concerns have been identified for this product. The product remains on the market for use elsewhere in the body.  The manufacturer plans to issue updated instructions for use in due course with updated indications for Macrolane use.
  • 원인
    (q-med ab - a galderma division) problem with use of macrolane vrf20 and macrolane vrf30 for breast augmentation which can make diagnosis of breast cancer more difficult. (mda/2012/022).
  • 조치
    Do not use Macrolane for breast augmentation.Have procedures in place for radiographers to check with patients presenting for breast examination for any history of breast injection.  Staff should request the card (appendix 1) that the patient was given at the time of injection, identifying Macrolane as the product used, and pass it on to the examining radiologist.Women may present with concerns that the injected Macrolane has affected mammogram results. GPs may wish to consider referral for repeat imaging.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Dermal filler for breast augmentation.Macrolane™ Volume Restoration Factor (VRF).Manufactured by Q-Med AB (a Galderma division).Macrolane VRF20 and VRF30 is an injectable filler for volume restoration and body contouring in a range of indications including breast augmentation.
  • Manufacturer

Manufacturer

  • 제조사 주소
    David Wall Director of Sales & Marketing, Q-Med, OTC & Ireland Galderma UK & Ireland Meridien House 69-71 Clarendon Road Watford WD17 1DS Tel: 01923 208 950 Fax: 01923 208 998Email: David.wall@galderma.com
  • 제조사 모회사 (2017)
  • Source
    MHRA