BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 12024966 · Received June 18, 2021

    Report

    Report Number
    9617229-2021-07577
    Event Type
    Injury
    Date Received
    June 18, 2021
    Date of Event
    March 29, 2021
    Report Date
    June 18, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITED ARTICLE : IMPLANT-BASED MULTIPLANE BREAST AUGMENTATION¿A PERSONAL SURGICAL CONCEPT FOR DYNAMIC IMPLANT¿TISSUE INTERACTION PROVIDING SUSTAINABLE SHAPE STABILITY. VOGT, PETER M.; DASTAGIR, KHALED; MACKOWSKI, MARIAN S. EUROPEAN JOURNAL OF PLASTIC SURGERY HTTPS://DOI.ORG/10.1007/S00238-021-01816-2. THE EVENT OF SEROMA 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. REASON FOR REOPERATION: PAINFUL LATE SEROMA.

    Description of Event or Problem · 1

    JOURNAL ARTICLE "IMPLANT-BASED MULTIPLANE BREAST AUGMENTATION¿A PERSONAL SURGICAL CONCEPT FOR DYNAMIC IMPLANT¿TISSUE INTERACTION PROVIDING SUSTAINABLE SHAPE STABILITY." REPORT "IN 2 PATIENTS CARRYING ALLERGAN IMPLANTS (0.2%), A PAINFUL LATE SEROMA WAS TREATED BY IMPLANT EXCHANGE AFTER CAPSULECTOMY AND IRRIGATION. NO ALCL WAS DIAGNOSED.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919459 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention