BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NON-ALLERGAN BREAST IMPLANT

    MDR report key: 18823196 · Received March 2, 2024

    Report

    Report Number
    9617229-2024-03566
    Event Type
    Injury
    Date Received
    March 2, 2024
    Date of Event
    January 10, 2023
    Report Date
    August 13, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    -
    Removal / Correction Number
    2011068-7/2/19-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: CAPPELLI, SONIA, ET AL. ¿REVERSE STRATEGY TO LOCALLY ADVANCED BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA: A CASE REPORT.¿ FRONTIERS IN ONCOLOGY, VOL. 12, 10 JAN. 2023, HTTPS://DOI.ORG/10.3389/FONC.2022.1062389. THE EVENTS OF "LYMPHOMA-ALCL, NECROSIS, 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, RUPTURE, NECROSIS, SEROMA, LYMPHADENOPATHY.

    Description of Event or Problem · 0

    JOURNAL ARTICLE ¿REVERSE STRATEGY TO LOCALLY ADVANCED BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA: A CASE REPORT¿ DISCUSSES A PATIENT PRESENTING WITH SWELLING, ERYTHEMA, PALPABLE MASS, AND PEAU D¿ORANGE ON THE LEFT BREAST...SIGNS OF INTRACAPSULAR RUPTURES. ON THE SAME SIDE, IT HAD MORBID TISSUE WITH A NECROTIC COMPONENT LOCALIZED IN THE EXTERNAL QUADRANT EXTENDING FROM THE SKIN TO THE MUSCLE LAYER (4 × 8 CM); THE LOCAL SWELLING AND THE INCREASE IN SKIN THICKNESS AFFECT ALL THE BREAST TISSUE. IN ADDITION, SUSPICIOUS AXILLARY LYMPH NODES HAVE BEEN REPORTED IN THE SAME SIDE." THE FOLLOWING PERCUTANEOUS BIOPSY OF THE MASS DEMONSTRATED A PROLIFERATION OF PHENOTYPICALLY ABERRANT POPULATION OF LARGE CELLS THAT EXPRESSED CD30 AND CD45, NEGATIVE FOR CD3, CD20, AND ALK1, DIAGNOSTIC FOR ANAPLASTIC LARGE CELL LYMPHOMA, ALK NEGATIVE (ALK-ALCL). THE HISTOLOGY REVEALED A COMPLETE PATHOLOGIC RESPONSE WITH CD30 IMMUNOHISTOCHEMISTRY NEGATIVE. THIS CONFIRMED THE DIAGNOSIS ALCL. TREATMENT THE PATIENT WAS TREATED WITH ¿SEQUENTIAL CHEMOTHERAPEUTIC APPROACH CONSISTING OF INDUCTION CHEMOTHERAPY, HEMATOPOIETIC STEM CELL MOBILIZATION, AND HARVEST FOLLOWED BY AUTOLOGOUS STEM CELL TRANSPLANT (ASCT), ACCORDING TO OUR INSTITUTIONAL POLICY AND INTERNATIONAL GUIDELINES ABOUT TREATMENT OF ADVANCED-STAGE ALK-NEGATIVE PERIPHERAL T- CELL LYMPHOID MALIGNANCIES. ONE HUNDRED DAYS AFTER THE STEM CELL TRANSPLANT, THEY UNDERWENT REMOVAL OF BOTH IMPLANTS WITH TOTAL EN BLOC CAPSULECTOMY. THE SITE OF THE PERIPROSTHETIC MASS WAS ALSO REMOVED." IN PARTICULAR, INDUCTION CHEMOTHERAPY CONSISTED OF SIX COURSES OF ALTERNATING CHOEP (CYCLOPHOSPHAMIDE, VINCRISTINE, DOXORUBICIN, ETOPOSIDE, AND PREDNISONE; THREE CYCLES) AND DHAP (CISPLATIN, CYTARABIN, AND DEXAMETHASONE; THREE CYCLES). AFTERWARDS, A CONSOLIDATION TREATMENT WITH ASCT AFTER BEAM CONDITIONING REGIMEN (BCNU, ETOPOSIDE, CYTARABINE, AND MELPHALAN) WAS FINALLY PERFORMED. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

    Description of Event or Problem · 0

    IT HAS BEEN DETERMINED THAT THE DEVICE ASSOCIATED WITH THIS COMPLAINT IS NON-ALLERGAN. THIS RECORD IS NO LONGER REPORTABLE TO THE FDA AND WILL BE UN-REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212909 NON-ALLERGAN BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Life Threatening| R