BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 168 SALINE FILLED BREAST IMPLANT

    MDR report key: 3993362 · Received July 24, 2014

    Report

    Report Number
    2024601-2014-00425
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    June 15, 2013
    Report Date
    January 27, 2020
    Manufacturer
    ALLERGAN
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Removal / Correction Number
    2011068-7/2/19-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 RECONSTRUCTIONS PTS = 1.0%. (OTHER COMPLICATIONS). SWELLING = 7.1%. THERE WERE NO REPORTED EVENTS OF LYMPHOMA/ALCL FOR PTS IN THE (B)(4) STUDY INCLUDED IN THE LABELING FOR SALINE BREAST IMPLANTS. THE EXACT DEVICE INFO IS UNK, HOWEVER, IT DOES SPEAK TO A 168-330. AN ONGOING INVESTIGATION WILL BE CARRIED OUT ON THIS CASE. 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. 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 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.

    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

    (B)(4).

    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
    435497 STYLE 168 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN NA 1716755

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention