BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 14471191 · Received May 23, 2022

    Report

    Report Number
    9617229-2022-08536
    Event Type
    Injury
    Date Received
    May 23, 2022
    Date of Event
    April 20, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). (B)(4). ARTICLE CITATION: DAVID HOPKINS, DEAN SMYTH, MIKE LEACH, BARBARA J. BAIN. BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA. AMERICAN JOURNAL OF HEMATOLOGY, DOI: 10.1002/AJH.26574. 20APRIL2022. INITIAL CORRESPONDENCE CONTACT: BARBARA J. BAIN - EMAIL: [email protected], BLOOD SCIENCES, ST. MARY'S HOSPITAL, PRAED STREET, LONDON, W2 1NY, UK. BARBARA BAIN ADDITIONAL CONTACT: CENTRE FOR HAEMATOLOGY, ST. MARY'S HOSPITAL CAMPUS OF IMPERIAL COLLEGE, FACULTY OF MEDICINE ST. MARY'S HOSPITAL, LONDON W2 1NY, UK ADDITIONAL PHYSICIANS CONTACT: DAVID HOPKINS - EMAIL: [email protected], BEATSON WEST OF SCOTLAND CANCER CENTRE, GLASGOW G12 0YN, UK. DEAN SMYTH - EMAIL: [email protected], BEATSON WEST OF SCOTLAND CANCER CENTRE, GLASGOW G12 0YN, UK. MIKE LEACH - EMAIL: [email protected], BEATSON WEST OF SCOTLAND CANCER CENTRE, GLASGOW G12 0YN, UK. THE EVENT OF LYMPHOMA-ALCL AND SEROMA-LATE ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE REASON FOR REOPERATION: LYMPHOMA-ALCL, SEROMA-LATE.

    Description of Event or Problem · 0

    LITERATURE REVIEW: DAVID HOPKINS, DEAN SMYTH, MIKE LEACH, BARBARA J. BAIN. BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA. AMERICAN JOURNAL OF HEMATOLOGY, DOI: 10.1002/AJH.26574. 20APRIL2022. PATIENT PRESENTED WITH A SHORT HISTORY OF RIGHT BREAST SWELLING WITH ERYTHEMA AND AXILLARY PAIN. MRI DEMONSTRATED A LARGE SEROMA AROUND THE IMPLANT. NO BREAST OR SOFT TISSUE MASS LESION AND NO LYMPHADENOPATHY. FLUID SAMPLING SHOWED THESE CELLS TO EXPRESS CD30. ALK WAS NOT EXPRESSED. BIA-ALCL DIAGNOSED. NO INDICATION OF TREATMENT OR PATIENT OUTCOME HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563792 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Life Threatening