BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 110 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 3031018 · Received November 15, 2012

    Report

    Report Number
    2024601-2012-01224
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 15, 1991
    Report Date
    January 27, 2020
    Manufacturer
    ALLERGAN
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Removal / Correction Number
    2011068-7/2/19-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALLERGAN IS SUBMITTING THIS FOLLOW-UP MDR IN ACCORDANCE WITH 21 CFR 803 FOLLOWING THE RECALL OF BIOCELL® TEXTURED BREAST IMPLANTS AND TISSUE EXPANDERS IN RELATION TO THE UNCOMMON INCIDENCE OF BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL). ALLERGAN DID NOT SUBMIT THIS MDR WITHIN 30 DAYS OF ALLERGAN¿S DECISION TO INITIATE THE REMEDIAL ACTION. ALLERGAN HAS INITIATED AN INVESTIGATION TO ADDRESS LATE MDRS SUBMITTED RELATED TO 2011068-7/2/19-001-R.

    Additional Manufacturer Narrative · 1

    MED WATCH SUBMITTED ON: (B)(4) 2012. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF SEROMA AS FOLLOWS: THE (B)(4) STUDY: 7 YEAR ADVERSE EVENT RATES: FOR PRIMARY AUGMENTATION PATIENTS. SEROMA RATE = (B)(4). PRIMARY RECONSTRUCTION PATIENTS = (B)(4). (OTHER COMPLICATIONS). SWELLING = (B)(4). THERE WERE NO REPORTED EVENTS OF LYMPHOMA/ALCL, FOR PATIENTS IN THE (B)(4) STUDY, IN THE LABELING FOR SILICONE IMPLANTS.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED TO AN ALLERGAN EMPLOYEE ALCL AND SEROMA. ALLERGAN WAS ABLE TO GATHER INFORMATION REGARDING THE DEVICE ALONG WITH PATIENT NOTES. THIS MEDWATCH HAD BEEN SUBMITTED VIA (B)(6) 2011.

    Description of Event or Problem · 1

    ALLERGAN IS SUBMITTING THIS FOLLOW-UP MDR IN ACCORDANCE WITH 21 CFR 803 FOLLOWING THE RECALL OF BIOCELL® TEXTURED BREAST IMPLANTS AND TISSUE EXPANDERS IN RELATION TO THE UNCOMMON INCIDENCE OF BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STYLE 110 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN 2-143391

    Patients

    Seq Age Sex Outcome Treatment
    1 68 DA Required Intervention HYPOTHYROID| HYPERTENSION| JOINT DISEASE| HYSTERECTOMY