BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK GEL BREAST IMPLANT

    MDR report key: 22376465 · Received July 1, 2025

    Report

    Report Number
    9617229-2025-10969
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    December 21, 2024
    Report Date
    July 1, 2025
    Manufacturer
    MANUFACTURER UNKNOWN
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN/WILL BE REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE REASON(S) FOR REOPERATION IS/ARE: "AXILLARY ADENOPATHY FOLLOWED BY NODE EXCISION THAT PROVIDED THE DIAGNOSIS OF ALCL" SUSPECTED (HISTOPATHOLOGICAL MARKERS ARE NOT REPORTED, AND ALCL CANNOT BE CONFIRMED.), "RAPID-ONSET BREAST SWELLING", AND "SMALL RIGHT PERI-IMPLANT EFFUSION WITH FAINT UNIFORM THIN PERI-IMPLANT ENHANCEMENT" DIAGNOSED VIA MRI. THE REPORTED EVENTS ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. ARTICLE CITATION: MAIMONE, SANTO ET AL. ¿PERI-IMPLANT ENHANCEMENT OF THE BREAST: IMAGING FEATURES, SIGNIFICANCE, AND MANAGEMENT STRATEGIES.¿ JOURNAL OF BREAST IMAGING VOL. 7,3 (2025): 301-310. DOI:10.1093/JBI/WBAE084.

    Description of Event or Problem · 0

    THROUGH JOURNAL ARTICLE "PERI-IMPLANT ENHANCEMENT OF THE BREAST: IMAGING FEATURES, SIGNIFICANCE, AND MANAGEMENT STRATEGIES", "A 57-YEAR-OLD WOMAN WITH TEXTURED SILICONE IMPLANTS IN PLACE FOR 29 YEARS PRESENTED WITH NEW RIGHT AXILLARY ADENOPATHY FOLLOWED BY NODE EXCISION THAT PROVIDED THE DIAGNOSIS OF ALCL. BREAST MRI AT THE TIME OF DIAGNOSIS SHOWED A SMALL RIGHT PERI-IMPLANT EFFUSION WITH FAINT UNIFORM THIN PERI-IMPLANT ENHANCEMENT" WAS REPORTED. HISTOPATHOLOGICAL MARKERS ARE NOT REPORTED, AND ALCL CANNOT BE CONFIRMED. CAPSULECTOMY WAS PERFORMED. THE DEVICE STATUS IS UNKNOWN. THIS RELATES TO THE RIGHT-SIDE DEVICE. MANUFACTURER OF DEVICE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1194176 UNK GEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MANUFACTURER UNKNOWN NI

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention| L