BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 14112254 · Received April 14, 2022

    Report

    Report Number
    9617229-2022-05854
    Event Type
    Injury
    Date Received
    April 14, 2022
    Date of Event
    July 7, 2021
    Report Date
    October 11, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    05060191601108
    PMA / PMN Number
    P040046
    Removal / Correction Number
    2011068-7/2/19-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A DEVICE HISTORY RECORD IS NOT AVAILABLE DUE TO INSUFFICIENT DEVICE DATA. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE REASON FOR REOPERATION IS: "A DIAGNOSIS OF BIA-ALCL," "INTRA AND EXTRACAPSULAR RUPTURE," ¿SIGNIFICANT EFFUSION,¿ AND "A MASS 40 MM TUMOR.¿

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    PHYSICIAN REPORTED RIGHT SIDE VIA REGULATORY AGENCY A DIAGNOSIS OF BIA-ALCL. THE PATIENT UNDERWENT AN ULTRASOUND WHICH OBSERVED A INTRA AND EXTRACAPSULAR RUPTURE OF THE DEVICE WITH SIGNIFICANT EFFUSION WITH "THICK PERIPROSTHETIC". A "PUNCTURE" OF THE EFFUSION WAS CARRIED OUT AND TESTED WHICH SHOWED "ABUNDANT PNN, ABSENCE OF ATYPICAL ELEMENT." THE DEVICE WAS REMOVED WITH TOTAL CAPSULECTOMY. A MASS WAS OBSERVED WITHIN THE CAPSULE OF 40MM. A SAMPLE OF THE CAPSULE WAS TESTED AND HISTOPATHOLOGICAL MARKERS CD30 + ALK- WERE CONFIRMED.

    Description of Event or Problem · 0

    PHYSICIAN REPORTED RIGHT SIDE VIA REGULATORY AGENCY A DIAGNOSIS OF BIA-ALCL. THE PATIENT UNDERWENT AN ULTRASOUND WHICH OBSERVED A INTRA AND EXTRACAPSULAR RUPTURE OF THE DEVICE WITH SIGNIFICANT EFFUSION WITH "THICK PERIPROSTHETIC". A "PUNCTURE" OF THE EFFUSION WAS CARRIED OUT AND TESTED WHICH SHOWED "ABUNDANT PNN, ABSENCE OF ATYPICAL ELEMENT." A MASS WAS OBSERVED WITHIN THE CAPSULE OF 40MM. A SAMPLE OF THE CAPSULE WAS TESTED AND HISTOPATHOLOGICAL MARKERS CD30 + ALK- WERE CONFIRMED. THE DEVICE HAS BEEN EXPLANTED. TREATMENT: TOTAL CAPSULECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1278896 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1364018 05060191601108

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Life Threatening| R