BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOCELL TEXTURED BREAST IMPLANTS AND TISSUE EXPANDERS

    MDR report key: 9379557 · Received November 26, 2019

    Report

    Report Number
    9617229-2019-20473
    Event Type
    Malfunction
    Date Received
    November 26, 2019
    Date of Event
    July 22, 2019
    Report Date
    November 26, 2019
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Removal / Correction Number
    2011068-7/2/19-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS APPLICABLE TO ALL BIOCELL TEXTURED BREAST IMPLANTS AND TISSUE EXPANDERS WHICH INCLUDES PROCODES FTR, FWM, AND LCJ. ALLERGAN IS SUBMITTING THIS 5-DAY MDR IN ACCORDANCE WITH 21 CFR 803 FOLLOWING THE CLASS I RECALL OF BIOCELL® TEXTURED BREAST IMPLANTS AND TISSUE EXPANDERS DUE TO THE UNCOMMON INCIDENCE OF BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL). ALLERGAN DID NOT SUBMIT THIS MDR WITHIN 5 WORK DAYS OF THE DECISION TO INITIATE THE REMEDIAL ACTION. ALLERGAN HAS INITIATED NC # (B)(4) TO INVESTIGATE THE LATE 5-DAY MDR RELATED TO 2011068-7/2/19-001-R.

    Description of Event or Problem · 1

    FDA NOTIFIED ALLERGAN OF RECENTLY UPDATED GLOBAL SAFETY INFORMATION CONCERNING THE UNCOMMON INCIDENCE OF BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL). BASED ON THE CURRENTLY AVAILABLE INFORMATION, INCLUDING THE NEWLY SUBMITTED DATA, FDA ANALYSIS DEMONSTRATES THAT THE RISK OF BIA-ALCL WITH ALLERGAN BIOCELL TEXTURED IMPLANTS IS APPROXIMATELY 6 TIMES THE RISK OF BIA-ALCL WITH TEXTURED IMPLANTS FROM OTHER MANUFACTURERS MARKETING IN THE U.S. AND CONTINUED DISTRIBUTION OF ALLERGAN'S BIOCELL TEXTURED BREAST IMPLANTS WOULD LIKELY CAUSE SERIOUS, ADVERSE HEALTH CONSEQUENCES AND POTENTIALLY DEATH FROM BIA-ALCL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1174063 BIOCELL TEXTURED BREAST IMPLANTS AND TISSUE EXPANDERS PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O| R