BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK GEL BREAST IMPLANT

    MDR report key: 17935885 · Received October 13, 2023

    Report

    Report Number
    9617229-2023-17032
    Event Type
    Injury
    Date Received
    October 13, 2023
    Date of Event
    August 11, 2023
    Report Date
    October 13, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Removal / Correction Number
    2011068-7/2/19-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: AL-SHAIKHLI S A, MAUTNER S, NASSERI-NIK N, ET AL. (AUGUST 11, 2023) BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA PRESENTING IN A POSTPARTUM PATIENT: A CASE REPORT. CUREUS 15(8): E43334. DOI 10.7759/CUREUS.4333. CONTINUED E1 (FACILITY NAME): RADIOLOGY, (B)(6) COLLEGE OF MEDICINE AT (B)(6) UNIVERSITY, (B)(6) USA CONTINUED HEALTH EFFECT - IMPACT CODES: F2201, F2203. THE EVENTS OF LYMPHOMA-ALCL ,SEROMA, LYMPHADENOPATHY 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. REASON FOR REOPERATION: LYMPHOMA-ALCL, SEROMA, LYMPHADENOPATHY.

    Description of Event or Problem · 0

    THROUGH JOURNAL ARTICLE "BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA PRESENTING IN A POSTPARTUM PATIENT: A CASE REPORT" A PATIENT WAS REPORTED WITH LEFT SIDE "BREAST SWELLING, SHOOTING PAINS IN THE BREAST, NIGHT SWEATS, LEFT BREAST ENLARGEMENT AND TENDERNESS WITH A LARGE PERICAPSULAR FLUID COLLECTION AND A SOFT, MOBILE LEFT AXILLARY LYMPH NODULE, AND WAS DIAGNOSED WITH BIA-ALCL, FLUID COLLECTION WITH INTERNAL SEPTATIONS SURROUNDING THE LEFT IMPLANT DISPLACING THE IMPLANT ANTERIORLY". HISTOPATHOLOGICAL MARKERS CD30+ AND ALK- HAVE BEEN RECEIVED. THE DEVICE HAS BEEN EXPLANTED. TREATMENT PROVIDED IN THE FORM OF DEVICE EXPLANT, CAPSULECTOMY, LEFT AXILLARY LYMPH NODE EXCISIONAL BIOPSY. THE EVENT OF "NIGHT SWEATS" IS NOT RELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631087 UNK GEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Life Threatening