BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK SALINE IMPLANT

    MDR report key: 2210610 · Received August 10, 2011

    Report

    Report Number
    2024601-2011-00674
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    November 11, 2010
    Report Date
    November 22, 2010
    Manufacturer
    UNKNOWN MANUFACTURER
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SUBMITTED ON (B)(6) 2011. DEVICE LABELING ADDRESSES THE EVENT OF SEROMA AS: FOR PRIMARY AUGMENTATION PTS, SEROMA RATE = 1.6%. PRIMARY RECONSTRUCTION PTS = 1.0%. (OTHER COMPLICATIONS.) SWELLING = 7.1%. "AFTER BREAST IMPLANT SURGERY THE FOLLOWING MAY OCCUR AND/OR PERSIST, WITH VARYING INTENSITY AND/OR FOR A VARYING LENGTH OF TIME: HEMATOMA/SEROMA..." (ALLERGAN SILICONE LABELING). DEVICE LABELING REVIEWED: THERE WERE NO REPORTED EVENTS OF LYMPHOMA/ALCL, FOR PTS IN THE CORE STUDY, IN THE LABELING FOR SILICONE IMPLANTS. THERE WERE NO REPORTED EVENTS OF LYMPHOMA/ALCL FOR PTS IN THE (B)(4) STUDY INCLUDED IN THE LABELING FOR SALINE BREAST IMPLANTS.

    Description of Event or Problem · 1

    RECEIVED AN ABSTRACT ENTITLED, "PRIMARY ANAPLASTIC LARGE CELL LYMPHOMA OF THE BREAST OCCURRING IN PTS WITH SILICONE BREAST IMPLANTS", WAS REPORTED AND WILL BE PUBLISHED IN THE FINAL ARTICLE ENTITLED LEUKEMIA AND LYMPHOMA, AUG 2011;52(8):1481-1487. WITHIN THE ARTICLE THIS PT IS IDENTIFIED AS PT 7. THIS IS A COSMETIC PT (AUGMENTATION). SHE WAS DIAGNOSED BY EXCISIONAL BIOPSY OF A NODULE FROM THE LEFT BREAST ADJACENT TO THE IMPLANT. SHE WAS IMMEDIATELY TREATED WITH SIX CYCLES OF CHOP AFTER WHICH SHE ACHIEVED WENT INTO REMISSION. SHE THEN HAD HER IMPLANTS REMOVED, FOLLOWED BY RADIATION TO THE LEFT BREAST. PET SCAN AT 6 MONTHS AFTER COMPLETION OF RADIATION SHOWED RELAPSE IN THE RIGHT BREAST, AXILLA AND ABDOMEN. SHE WAS THEN GIVEN ESHAP (ETOPSIDE, METHYLPREDNISOLONE, HIGH-DOSE ARA-C, AND CISPLATIN) SALVAGE, FOLLOWED BY STEM CELL COLLECTION. FOLLOWING AN AUTOLOGUS TRANSPLANT, THE PT HAS BEEN IN REMISSION FOR 6 YEARS. THIS MW IS FOR THE RIGHT SIDE. REFER TO MEDWATCH MFR REPORT 2024601-2011-00663 FOR THE LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK SALINE IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM UNKNOWN MANUFACTURER NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention