BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 8948004 · Received August 29, 2019

    Report

    Report Number
    9617229-2019-11067
    Event Type
    Injury
    Date Received
    August 29, 2019
    Date of Event
    May 6, 2019
    Report Date
    November 19, 2020
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    ALTHOUGH HISTOPATHOLOGICAL MARKERS WERE NOT REPORTED, THE DIAGNOSIS WAS CERTIFIED BY THE LYMPHOPATH NETWORK. THEREFORE, THIS EVENT WILL BE CAPTURED AS LYMPHOMA-ALCL.

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: "THIRTY-SIX (36) FRENCH CASES OF BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL): WHAT DO WE KNOW ABOUT THEIR PROSTHETIC HISTORIES, AND WHAT CONCLUSIONS MAY BE DRAWN?" L. RUFFENACH, C. BRUANT-RODIER, F. GOLDAMMER, E. RAMELLI, F. BODIN, C. DISSAUX; ANN CHIR PLAST ESTHET (2019), HTTPS://DOI.ORG/10.1016/J.ANPLAS.2019.05.002¿. THE EVENT IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. THE REASON FOR REOPERATION: LYMPHOMA ALCL FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING. (B)(4).

    Description of Event or Problem · 1

    JOURNAL ARTICLE "THIRTY-SIX (36) FRENCH CASES OF BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL): WHAT DO WE KNOW ABOUT THEIR PROSTHETIC HISTORIES, AND WHAT CONCLUSIONS MAY BE DRAWN?¿ REPORTED "A RETROSPECTIVE STUDY WAS CONDUCTED ON THE FRENCH BIA-ALCL CASES DIAGNOSED BY THE LYMPHOPATH NETWORK AND REPORTED TO THE (B)(6). WISHING TO OBTAIN SUPPLEMENTARY DATA ON THE PROSTHETIC HISTORY OF IMPLANTS, WE SENT THE REFERENT SURGEONS A QUESTIONNAIRE." "BY COMBINING THE RELEVANT (B)(6) DATA AND QUESTIONNAIRE DATA, WE STUDIED THE HISTORIES OF 32 UNILATERAL CASES OF BIA-ALCL AND 2 BILATERAL CASES OF BIA-ALCL. MEAN PATIENT AGE ON DIAGNOSIS WAS 59 (29; 83). TWELVE BIA-ALCL CASES OCCURRED AFTER BREAST AUGMENTATION FOR ESTHETIC PURPOSES, 22 FOLLOWING MASTECTOMY FOR NEOPLASIA AND 2 AFTER SYMMETRIZATION OF THE CONTRALATERAL BREAST IN RECONSTRUCTION. FIFTEEN BIA-ALCL CASES WERE DIAGNOSED ON SINGLE PROSTHESES, ALL OF THEM MACRO TEXTURED WITH MACRO TEXTURING OBTAINED BY PROJECTION OF BIOCELL SALT CRYSTALS, ALSO KNOWN AS THE BIOCELL ¿¿SALT LOSS¿¿ TECHNIQUE. THE OTHER 21 BIA-ALCL CASES WERE DIAGNOSED ON MULTIPLE PROSTHESES (2 TO 5), AND ALL OF THEM HAD AT LEAST ONE CONTACT WITH A BIOCELL IMPLANT. MEAN DURATION OF EXPOSURE TO IMPLANTS WAS 11 YEARS (4; 31). MEAN DURATION OF EXPOSURE TO THE MACRO TEXTURED SHELL SURFACES OBTAINED BY THE SALT LOSS TECHNIQUE WAS 9 YEARS (2; 23). SIX PATIENTS WERE EXPOSED TO A TEMPORARY MACRO TEXTURED EXPANDER IMPLANT OBTAINED WITH THE AFOREMENTIONED SALT LOSS TECHNIQUE. NO PATIENT WAS EXPOSED TO THE MACRO TEXTURED EXPANDER IMPLANT ALONE." "SALT LOSS MACRO TEXTURED IMPLANTS, PARTICULARLY THOSE OF THE BIOCELL-TYPE, WERE FOUND IN THE PROSTHETIC HISTORY OF ALL 36 BIA-ALCL CASES IN THIS SERIES.¿ AS PATHOLOGICAL MARKERS CONFIRMING ALCL HAVE NOT BEEN PROVIDED, THE EVENT WILL BE CAPTURED AS LYMPHOMA. IT IS UNKNOWN IF THE DEVICES HAVE BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740086 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention