BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 3031001 · Received November 29, 2012

    Report

    Report Number
    2024601-2012-01267
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    August 5, 2008
    Report Date
    August 5, 2008
    Manufacturer
    ALLERGAN
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SUBMITTED ON: (B)(4) 2012. THESE EVENTS WERE INITIALLY SUBMITTED VIA (B)(6) Q4 (B)(6) 2011. DEVICE LABELING ADDRESSES: CAPSULAR CONTRACTURE WITH THE FOLLOWING INFORMATION: PATIENTS SHOULD BE ADVISED THAT CAPSULAR CONTRACTURE MAY BE COMMON FOLLOWING INFECTION, HEMATOMA AND SEROMA AND THE CHANCE OF IT HAPPENING MAY INCREASE OVER TIME. THE SEVEN YEAR CORE STUDY NOTES FOR PRIMARY AUGMENTATION: CAPSULAR CONTRACTURE III/IV (B)(4) THE SEVEN YEAR CORE STUDY NOTES FOR PRIMARY RECONSTRUCTION (B)(4) (SILICONE DFU). THE LABELING NOTES FOR PATIENTS IN THE (B)(4) STUDY INCLUDED CAPSULAR CONTRACTURE RATE OF (B)(4) FOR AUGMENTATION AND (B)(4) FOR RECONSTRUCTION (SALINE DFU). DEVICE LABELING REVIEWED: THERE WERE NO REPORTED EVENTS OF LYMPHOMA/ALCL FOR PATIENTS IN THE (B)(4) STUDY INCLUDED IN THE LABELING FOR SALINE BREAST IMPLANTS. DEVICE LABELING REVIEWED: THERE WERE NO REPORTED EVENTS OF LYMPHOMA/ALCL, FOR PATIENTS IN THE (B)(6) STUDY, IN THE LABELING FOR SILICONE IMPLANTS.

    Description of Event or Problem · 1

    REPORTED AS ANAPLASTIC LARGE CELL LYMPHOMA, FROM RESEARCH ARTICLE PUBLISHED 2008 AMERICAN JOURNAL OF SURGICAL PATHOLOGY ENTITLED 'ANAPLASTIC LARGE CELL LYMPHOMA ASSOCIATED WITH A BREAST IMPLANT CAPSULE: A CASE REPORT AND REVIEW OF THE LITERATURE.' FOLLOW-UP FINDINGS: DOCTOR STATES IN ALLERGAN DEVICE BUT IS UNABLE TO EXONERATE DEVICE AS INSUFFICIENT STUDY EVIDENCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention NO INFORMATION