BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 18992250 · Received March 28, 2024

    Report

    Report Number
    9617229-2024-05322
    Event Type
    Injury
    Date Received
    March 28, 2024
    Date of Event
    January 26, 2024
    Report Date
    March 27, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IN RESPONSE TO FDA REPORT NUMBER: MW5152278 AND MW 5152279. THE EVENT OF LYMPHOMA - ALCL - SUSPECTED IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN/WILL BE REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: LYMPHOMA - ALCL - SUSPECTED.

    Description of Event or Problem · 0

    PATIENT REPORTED VIA VOLUNTARY MW5152278 AND MW 5152279 "I HAD ALLERGAN NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS PLACED AS RECONSTRUCTION FROM A BILATERAL MASTECTOMY FOR BREAST CANCER. I HAVE SINCE DEVELOPED BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL) FROM THESE IMPLANTS WHICH WERE RECALLED. I WILL BE HAVING THE IMPLANTS REMOVED AND WILL FIND OUT ABOUT FURTHER TREATMENT AFTER PATHOLOGY COMES BACK. I AM BELIEVED TO BE STAGE I." BIOMARKERS OF CD30 POSITIVE AND ALK NEGATIVE HAVE BEEN REPORTED, BUT HAVE NOT BEEN CONFIRMED VIA PATHOLOGY. THIS RECORD REPRESENTS THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724597 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention