BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS

    MDR report key: 18828180 · Received March 4, 2024

    Report

    Report Number
    MW5152278
    Event Type
    Injury
    Date Received
    March 4, 2024
    Date of Event
    January 26, 2024
    Report Date
    February 29, 2024
    Manufacturer
    ALLERGAN SALES, LLC.
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAD ALLERGAN NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS PLACED ON (B)(6) 2017 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 IN 2019 AFTER THE FDA RECOMMENDED TO ALLERGAN THAT THEY BE RECALLED. I WILL BE HAVING THE IMPLANTS REMOVED ON (B)(6) 2024, AND WILL FIND OUT ABOUT FURTHER TREATMENT AFTER PATHOLOGY COMES BACK. I AM BELIEVED TO BE STAGE 1. REF REPORT: MW5152279.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710647 NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN SALES, LLC. MF-410470

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Other| L| R