BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 23223422 · Received October 6, 2025

    Report

    Report Number
    9617229-2025-16961
    Event Type
    Injury
    Date Received
    October 6, 2025
    Date of Event
    April 18, 2025
    Report Date
    October 6, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: ELIJAH BURTON, LINDSAY MINER, OSTEOMYELITIS MIMICKER: EXPANDING THE KNOWN PRESENTATIONS OF BREAST IMPLANT¿ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA, JOURNAL OF BREAST IMAGING, VOLUME 7, ISSUE 4, JULY/AUGUST 2025, PAGES 510¿512, HTTPS://DOI.ORG/10.1093/JBI/WBAF017. ADDITIONAL CONTACT: (B)(6). THE EVENTS OF LYMPHOMA-ALCL-SUSPECTED, BREAST MASS AND NECROSIS ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. 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: LYMPHOMA-ALCL-SUSPECTED, BREAST MASS, NECROSIS.

    Description of Event or Problem · 0

    LITERATURE ARTICLE TITLED "OSTEOMYELITIS MIMICKER: EXPANDING THE KNOWN PRESENTATIONS OF BREAST IMPLANT¿ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA" REPORTED "CHEST PAIN AND RIGHT BREAST ERYTHEMA". EVENTS REPORTED INCLUDE "CONTRAST-ENHANCED CT OF THE CHEST WAS PERFORMED AND DEMONSTRATED A SOFT TISSUE COLLECTION IN THE MEDIAL RIGHT BREAST", "THERE WAS ALSO DIRECT INVASION OF THE STERNUM WITH ASSOCIATED BONY DESTRUCTION", "US DEMONSTRATED A HETEROGENEOUS COMPLEX CYSTIC AND SOLID MASS IN THE INNER RIGHT BREAST, CORRESPONDING TO THE CT FINDING", "MILD SKIN THICKENING AND INCREASED VASCULARITY ON COLOR DOPPLER IMAGING". "14-GAUGE CORE BIOPSY SAMPLES WERE OBTAINED", "PATHOLOGIC ANALYSIS DEMONSTRATED FIBROADIPOSE TISSUE AND SKELETAL MUSCLE WITH INFLAMMATORY AND SUPPURATIVE CHANGE AND NECROSIS, WHICH IS MOST SUGGESTIVE OF AN ABSCESS", "SURGICAL PATHOLOGY DEMONSTRATED NO BACTERIAL GROWTH", "MILD LEUKOCYTOSIS AND ELEVATED C-REACTIVE PROTEIN", MRI DEMONSTRATED "A HETEROGENEOUSLY ENHANCING MASS WITHOUT A DRAINABLE FLUID COLLECTION. BONY DESTRUCTION AND ENHANCEMENT OF THE STERNUM WAS NOTED". IMPLANTS WERE REMOVED WITH "CAPSULECTOMY AND DEBRIDEMENT OF THE RIGHT BREAST MASS", "CYTOLOGIC ANALYSIS OF THE RIGHT BREAST MASS AND IMPLANT CAPSULE DEMONSTRATING ABNORMAL CD30+ T-CELL LYMPHOCYTES, COMPATIBLE WITH BREAST IMPLANT¿ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL).", " STAGE II DISEASE EXTENDS BEYOND THE CAPSULE AS IN THIS CASE". THIS RECORD IS FOR THE RIGHT SIDE. HISTOPATHOLOGY PROVIDED CD30+, BUT ALK- WAS NOT PROVIDED. DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2574853 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Life Threatening| R