BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK GEL BREAST IMPLANT

    MDR report key: 8181289 · Received December 19, 2018

    Report

    Report Number
    9617229-2018-09510
    Event Type
    Injury
    Date Received
    December 19, 2018
    Date of Event
    November 16, 2018
    Report Date
    December 19, 2018
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: ¿BREAST IMPLANT TEXTURIZATION DOES NOT AFFECT THE CROSSTALK BETWEEN MSC AND ALCL CELLS¿, BY ORCIANI, MONIA; CAFFARINI, MIRIAM; DI PRIMIO, ROBERTO; TORRESETTI, MATTEO; DI BENEDETTO, GIOVANNI; CAMPANATI, ANNA; AND PARODI, PIERCAMILLO, NOVEMBER 16 2018, DOI:10.1007/S10753-018-0930-4. THE EVENT OF CAPSULAR CONTRACTURE IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    THROUGH JOURNAL ARTICLE 'BREAST IMPLANT TEXTURIZATION DOES NOT AFFECT THE CROSSTALK BETWEEN MSC AND ALCL CELLS' IT WAS REPORTED THAT A PATIENT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III. TREATMENT: IMPLANT REPLACEMENT AND CAPSULECTOMY. THE AFFECTED SIDE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020766 UNK GEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention