BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK SALINE IMPLANT

    MDR report key: 3031014 · Received November 15, 2012

    Report

    Report Number
    2024601-2012-01204
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 27, 2012
    Report Date
    October 27, 2012
    Manufacturer
    UNKNOWN MANUFACTURER
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NO INFORMATION
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE LABELING ADDRESSES SEROMA: DEVICE LABELING ADDRESSES THE REPORTED EVENT OF SEROMA AS FOLLOWS: (B)(4). "IF UNUSUAL SYMPTOMS OCCUR AFTER SURGERY, SUCH AS FEVER OR NOTICEABLE SWELLING OR REDNESS IN ONE BREAST, YOU SHOULD CONTACT YOUR SURGEON IMMEDIATELY." (ALLERGAN SALINE BREAST IMPLANT LABELING). THERE WERE NO REPORTED EVENTS OF (B)(4) INCLUDED IN THE LABELING FOR SALINE BREAST IMPLANTS.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS IN AN ARTICLE A CASE OF SEROMA AND ALCL (THE LANCET 2012; 380: 1530.) WITHIN THE ARTICLE THE AUTHOR REPORTS "IN (B)(4) 2010, A PREVIOUSLY HEALTHY (B)(6) WOMAN WITH TEXTURED SALINE BREAST IMPLANTS PLACED SUBPECTORALLY 8 YEARS AGO (FOR AESTHETIC PURPOSES), PRESENTED WITH 2-MONTH HISTORY OF A PAINLESS MASS UNDERNEATH HER LEFT ARM. PHYSICAL EXAMINATION SHOWED A SYMMETRICAL BREASTS WITH NO OVERLYING SKIN OR NIPPLE CHANGES. THERE WERE TWO LARGE MOBILE NODES PALPABLE IN THE LEFT AXILLA. INITIAL BREAST MAMMOGRAPHY AND ULTRASONOGRAPHY CONFIRMED LEFT AXILLARY LYMPHADENOPATHY BUT DID NOT SHOW ANY PERI-IMPLANT FLUID COLLECTION. BIOPSY OF THE LEFT AXILLARY MASS SHOWED FINDINGS CONSISTENT WITH CLASSIC HODGKIN'S LYMPHOMA, NODULAR SCLEROSING TYPE. IT LACKED TWO TYPICAL STAINS-CD15 AND PAX5. PET-CT SHOWED A 5-CM AREA OF PET-AVID LEFT AXILLARY LYMPHADENOPATHY. HODGKIN'S LYMPHOMA STAGE IA WAS DIAGNOSED. THE PT THEN HAD TWO CYCLES OF ADRIAMYCIN, BLEOMYCIN, VINBLASTINE, AND DACARBAZINE (ABVD) AND 2000 GY OF FIELD RADIATION TO THE LEFT AXILLA. HER INITIAL TREATMENT WAS COMPLETED IN (B)(6) 2011. F/U CT SCAN IN (B)(6) 2011, SHOWED A DECREASE IN THE SIZE OF THE LEFT AXILLARY LYMPHADENOPATHY. UNILATERAL FLUID COLLECTION, HOWEVER, WAS NOTED AROUND THE LEFT BREAST IMPLANT (FIGURE). THE FLUID INCREASED IN SIZE AND SHE PRESENTED 6 MONTHS ALTER WITH LEAKAGE OF SEROUS FLUID FROM HER LEFT BREAST. CYTOLOGY OF THE PERI-IMPLANT FLUID SHOWED CD30+ LYMPHOMA CELLS OF INDETERMINATE LINEAGE. DIFFERENT DIAGNOSIS INCLUDED RECURRENT HODGKIN'S LYMPHOMA OR IMPLANT-ASSOCIATED ANAPLASTIC LARGE-CELL LYMPHOMA. REPEAT PET-CT SHOWED PET-AVID AREAS ON BILATERAL AXILLARY LYMPH NODES. BOTH IMPLANTS WERE REMOVED WITH CAPSULECTOMIES. IN (B)(6) 2011, SHE REPEAT PET-CT SHOWED PET-AVID AREAS IN BILATERAL AXILLARY LYMPH NODES. BOTH IMPLANTS WERE REMOVED WITH CAPSULECTOMIES. IN (B)(6) 2011, SHE WAS TREATED WITH FOUR CYCLES OF SALVAGE CHEMOTHERAPY WITH GEMCITABINE AND CISPLATIN FOR ASSUMED RECURRENT HODGKIN'S LYMPHOMA. F/U SONOGRAPHY OF THE LEFT BREAST 1 MONTH LATER SHOWED A HYPOECHOIC MASS. BIOPSY OF THE MASS SHOWED SIMILAR CELLS FROM THE PERI-IMPLANT FLUID, WHICH WERE CD30+ LYMPHOMA CELLS OF INDETERMINATE ORIGIN. THE MASS WAS RESECTED IN (B)(6) 2012, AND PATHOLOGICAL TESTS SHOWED (B)(6), SEROMA-ASSOCIATED (LARGE-CELL LYMPHOMA (ALK-NEGATIVE ALCL). A RETROSPECTIVE REVIEW OF ALL SIDES SHOWED LARGE CELLS CHARACTERISTIC OF ALK-NEGATIVE ALCL. SUBSTANTIAL OVERLAP IN MORPHOLOGY AND IMMUNOPHENOTYPE OF CELLS FROM THE INITIAL AXILLARY LYMPH NODE BIOPSY, THE PERI-IMPLANT FLUID AND THE FINAL LEFT BREAST MASS BIOPSY SUGGESTED THE SAME MANIFESTATIONS OF THE ALCL. THE PRESENTATION IS UNIQUE BECAUSE ALK-NEGATIVE ALCL PRESENTED WITH A PATHOLOGICAL AXILLARY LYMPH NODE INSTEAD OF THE TYPICAL PERI-IMPLANT SEROMA. OUR PT COMPLETED BRENTUXIMAB THERAPY FOR TREATMENT OF ALK-NEGATIVE ALCL. THE PT WAS LAST SEEN ON (B)(6) 2012 AND IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK SALINE IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM UNKNOWN MANUFACTURER NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention