BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 3133486 · Received May 24, 2013

    Report

    Report Number
    2024601-2013-00506
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 16, 2013
    Manufacturer
    ALLERGAN
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE LABELING REVIEWED: THERE WERE NO REPORTED EVENTS OF LYMPHOMA/ALCL, FOR PT 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. THERE WERE NO REPORTED EVENTS OF LUMP/NODULES (LYMPHADENOPATHY) FOR PTS IN THE CORE STUDY, IN THE LABELING FOR SILICONE BREAST IMPLANTS. THERE WERE NO REPORTED EVENTS OF LUMP/NODULES (LYMPHADENOPATHY) FOR PTS IN THE (B)(4) STUDY, IN THE LABELING FOR SALINE BREAST IMPLANTS.

    Additional Manufacturer Narrative · 1

    MEDWATCH SUBMITTED TO THE FDA ON 07/24/2015. LITERATURE REPORTS HAVE ALSO BEEN MADE ASSOCIATING SILICONE BREAST IMPLANTS WITH VARIOUS RHEUMATOLOGICAL SIGNS AND SYMPTOMS SUCH AS FATIGUE, EXHAUSTION, JOINT PAIN AND SWELLING, MUSCLE PAIN AND CRAMPING, TINGLING, NUMBNESS, WEAKNESS, AND SKIN RASHES. IN THE CORE STUDY, SELF-REPORTED SIGNS AND SYMPTOMS WERE COLLECTED IN THE CATEGORIES OF GENERAL, GASTROINTESTINAL, NEUROLOGICAL, URINARY, GLOBAL, PAIN, FATIGUE, FIBROMYALGIA, JOINT, MUSCULAR, SKIN, AND OTHER. FOR PRIMARY AUGMENTATION PATIENTS AT 10 YEARS, STATISTICALLY SIGNIFICANT INCREASES AFTER ACCOUNTING FOR AGE WERE FOUND FOR THE SYMPTOM CATEGORIES OF SKIN, URINARY, AND OTHER FOR PRIMARY RECONSTRUCTION PATIENTS AT 10 YEARS, STATISTICALLY SIGNIFICANT INCREASES AFTER ACCOUNTING FOR AGE WERE FOUND IN THE SYMPTOM CATEGORY OF SKIN. FOR REVISION-AUGMENTATION AND REVISION-RECONSTRUCTION PATIENTS, NO SIGNIFICANT INCREASES WERE FOUND.

    Description of Event or Problem · 1

    ADDITIONAL EVENTS NOTED OF SIDE UNSPECIFIED "FATIGUE" AND "ENLARGED LYMPH NODES" IN JOURNAL ARTICLE: "SILICONE IMPLANT INCOMPATIBILITY SYNDROME (SIIS) A FREQUENT CAUSE OF ASIA (SHOENFELD'S SYNDROME)" IMMUNOLOGIC RESEARCH, (2013 APRIL 11) ELECTRONIC PUBLICATION DATE- 11 APRIL 2013. THIS

    Description of Event or Problem · 1

    DOCTOR REPORTED EVENT OF LYMPHOMA AND LUMP SYNDROME FROM JOURNAL ARTICLE "SILICONE IMPLANT INCOMPATIBILITY SYNDROME (SIIS): A FREQUENT CAUSE OF ASIA (SHOENFELD'S SYNDROME)", IMMUNOLOGIC RESEARCH, (04/11/2013). ELECTRONIC PUBLICATION DATE: 04/11/2013. THE MFR OF THE DEVICE IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232114 UNK MAMMARY IMPLANT FWM ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention NO INFO