BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 110 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 4180236 · Received October 10, 2014

    Report

    Report Number
    2024601-2014-00581
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    June 5, 2013
    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
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABELING ADDRESS 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.

    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.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED: PT DEVELOPED SEROMA IN LEFT CHEST. THE IMPLANTS WERE REMOVED, WHICH IS ENTIRELY INTACT BUT BIG SEROMA ON THE LEFT SIDE. NUMEROUS TISSUE BIOPSIES COLLECTED. LYMPHOMA SHOWING FOCAL INFLAMMATION WITH FIBROSIS, BUT NO MALIGNANT. MAMMOGRAPHY AND ULTRASOUND BEFORE SURGERY, INDICATED THAT THERE WAS NO TUMOR, BUT SEROMA. PT FEELS A LUMP IN HER LEFT BREAST. THE BIOPSY SHOWS THE T-CELL LYMPHOMA (ALCL). THE MEDICAL SAFETY TEAM HAS DETERMINED THAT COMBINED RESULTS OF IMMUNE-CHEMICAL, HISTOLOGICAL AND CYTOLOGICAL ANALYSIS OF SPECIMENS ARE SCIENTIFICALLY ACCEPTABLE CRITERIA WITH WHICH TO DIAGNOSE ALCL. AS A RESULT OF THIS INCREASED SPECIFICITY THE TERM CODE "LYMPHOMA-ALCL" HAS BEEN CHANGED TO "LYMPHOMA..." THERE IS LIMITED INFO AVAILABLE FOR THIS CASE AFTER THE INITIAL INVESTIGATION AND THERE IS AN UNLIKELY CHANCE THAT THIS INFO WILL BE OBTAINED. HOWEVER, IF THERE IS ADDITIONAL INFO, SUCH AS DEVICE INFO, IMPLANTING/EXPLANTING PHYSICIAN OR ANY LABS RELATED TO, BUT NOT LIMITED TO ANY COMBINED RESULTS OF IMMUNE-CHEMICAL, HISTOLOGICAL AND CYTOLOGICAL ANALYSIS OF SPECIMENS ARE SCIENTIFICALLY ACCEPTABLE CRITERIA WITH WHICH TO DIAGNOSE ALCL THE FILE WILL BE REVIEWED AND UPDATED.

    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
    642747 STYLE 110 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN NA 78225

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention