BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 468 SALINE FILLED BREAST IMPLANT

    MDR report key: 2100509 · Received May 16, 2011

    Report

    Report Number
    2024601-2011-00456
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    March 31, 2010
    Report Date
    April 29, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    MED WATCH SUBMITTED VIA FED-EX (B)(4) 2011. FILE EXTENSION GRANTED ON (B)(4) 2011. DEVICE LABELING: THERE WERE NO REPORTED EVENTS OF LYMPHOMA/ALCL FOR PTS IN THE (B)(4) STUDY INCLUDED IN THE LABELING FOR SALINE BREAST IMPLANTS. THE FOLLOWING IS A LIST OF POTENTIAL ADVERSE EVENTS THAT MAY OCCUR WITH BREAST IMPLANT SURGERY. THE RISKS INCLUDE: IMPLANT DEFLATION/LEAKAGE, ADD'L SURGERY, CAPSULAR CONTRACTURE, INFECTION, TOXIC SHOCK SYNDROME, NECROSIS, HEMATOMA, SEROMA, EXTRUSION, BREAST PAIN, CHANGES IN NIPPLE SENSATION, CHANGES IN BREAST SENSATION, DISSATISFACTION WITH COSMETIC RESULTS (WRINKLING, FOLDING, DISPLACEMENT, ASYMMETRY, PALPABILITY, VISIBILITY, PTOSIS, SLOSHING), CALCIFIC DEPOSITS, IRRITATION/INFLAMMATION, DELAYED WOUND HEALING, HYPERTROPHIC SCARRING, BREAST TISSUE ATROPHY/CHEST WALL DEFORMITY, DIFFICULTY/INABILITY IN BREAST FEEDING, AND INABILITY TO ADEQUATELY VISUALIZE BREAST LESIONS WITH MAMMOGRAPHY. IN ADDITION TO THESE POTENTIAL ADVERSE EVENTS, THERE HAVE BEEN CONCERNS WITH CERTAIN SYSTEMIC DISEASES.

    Description of Event or Problem · 1

    PT REPORTED ON VOLUNTARY MW FORM THAT IN 2010 SHE WAS DIAGNOSED WITH ALCL. ALK NEGATIVE. POSSIBLY RELATED OR CAUSED BY BREAST IMPLANTS RECEIVED IN 2002 FOR AUGMENTATION. LEFT BREAST CAPSULAR CONTRACTURE WAS NOTED. PT HAD LEFT IMPLANT REPLACED IN 2008. STILL EXPERIENCING CAPSULAR CONTRACTURE AFTER REPLACEMENT. IN 2010 A NEEDLE BIOPSY WAS PERFORMED AND THE DIAGNOSIS LYMPHOMA WAS MADE. ALSO IN 2010 SURGICAL BIOPSY WAS PERFORMED AND A DIAGNOSIS OF ALCL WAS MADE. THE PT IS PREPARING FOR STEM-CELL TRANSPLANT SCHEDULED IN 2011. WITHIN THE VOLUNTARY FORM THE IMPLANTING NOR EXPLANTING SURGEON INFO WAS NOT GIVEN AND THERE IS NO FURTHER INFO TO BE GATHERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STYLE 468 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NA 1650955

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Female Required Intervention