BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 6958857 · Received October 18, 2017

    Report

    Report Number
    9617229-2017-03248
    Event Type
    Death
    Date Received
    October 18, 2017
    Report Date
    October 18, 2017
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: "BREAST IMPLANT ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA IN AUSTRALIA AND NEW ZEALAND ¿ HIGH SURFACE AREA TEXTURED IMPLANTS ARE ASSOCIATED WITH INCREASED RISK", ANNA LOCH-WILKINSON, KENNETH BEATH, ROBERT JOHN WILLIAM KNIGHT, WILLIAM LOUIS FICK WESSELS, MARK MAGNUSSON, TIM PAPADOPOULOS, TONY CONNELL, JULIAN LOFTS, MICHELLE LOCKE, INGRID HOPPER, RODNEY COOTER, KAREN VICKERY, PREETI AVINASH JOSHI, H. MILES PRINCE & ANAND K. DEVA, PLASTIC AND RECONSTRUCTIVE SURGERY ADVANCE ONLINE ARTICLE THE EVENTS ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. (B)(4). DEVICE LABELING: POTENTIAL ADVERSE EVENTS THAT MAY OCCUR WITH SALINE-FILLED BREAST IMPLANT SURGERY INCLUDE: REOPERATION, PAIN, WRINKLING, ASYMMETRY, IMPLANT PALPABILITY/VISIBILITY, IMPLANT REMOVAL, CAPSULAR CONTRACTURE, CHANGES IN NIPPLE AND BREAST SENSATION, IMPLANT DISPLACEMENT/MIGRATION, IMPLANT DEFLATION, SCARRING, INFECTION, HEMATOMA/SEROMA, BREASTFEEDING COMPLICATIONS, IMPLANT EXTRUSION, NECROSIS, DELAYED WOUND HEALING, BREAST TISSUE ATROPHY/CHEST WALL DEFORMITY, CALCIUM DEPOSITS, AND LYMPHADENOPATHY. INFECTION ¿ IN RARE INSTANCES, ACUTE INFECTION MAY OCCUR IN A BREAST WITH IMPLANTS. THE SIGNS OF ACUTE INFECTION INCLUDE ERYTHEMA, TENDERNESS, FLUID ACCUMULATION, PAIN, AND FEVER. VERY RARELY, TOXIC SHOCK SYNDROME, A POTENTIALLY LIFE-THREATENING CONDITION, HAS BEEN REPORTED IN WOMEN AFTER BREAST IMPLANT SURGERY. IT IS CHARACTERIZED BY SYMPTOMS THAT OCCUR SUDDENLY AND INCLUDE HIGH FEVER (102°F, 38.8°C OR HIGHER), VOMITING, DIARRHEA, A SUNBURN-LIKE RASH, RED EYES, DIZZINESS, LIGHTHEADEDNESS, MUSCLE ACHES, AND DROPS IN BLOOD PRESSURE, WHICH MAY CAUSE FAINTING. PATIENTS SHOULD BE ADVISED TO CONTACT A PHYSICIAN IMMEDIATELY FOR DIAGNOSIS AND TREATMENT FOR ANY OF THESE SYMPTOMS. ADDITIONAL COMPLICATIONS ¿ AFTER BREAST IMPLANT SURGERY THE FOLLOWING MAY OCCUR AND/OR PERSIST, WITH VARYING INTENSITY AND/OR FOR A VARYING LENGTH OF TIME: HEMATOMA/SEROMA, IMPLANT EXTRUSION, NECROSIS, DELAYED WOUND HEALING, AND BREAST TISSUE ATROPHY/CHEST WALL DEFORMITY. CALCIUM DEPOSITS CAN FORM IN THE TISSUE CAPSULE SURROUNDING THE IMPLANT WITH SYMPTOMS THAT MAY INCLUDE PAIN AND FIRMNESS. LYMPHADENOPATHY HAS ALSO BEEN REPORTED IN SOME WOMEN WITH IMPLANTS. CANCER - PUBLISHED STUDIES INDICATE THAT BREAST CANCER IS NO MORE COMMON IN WOMEN WITH IMPLANTS THAN THOSE WITHOUT IMPLANTS. A LARGE, LONG-TERM FOLLOW-UP FOUND NO SIGNIFICANT INCREASES IN THE RISK RATES FOR A WIDE VARIETY OF CANCERS, INCLUDING STOMACH CANCER AND LEUKEMIA. BASED ON INFORMATION REPORTED TO GLOBAL REGULATORY AGENCIES AND FOUND IN MEDICAL LITERATURE, AN ASSOCIATION HAS BEEN IDENTIFIED BETWEEN BREAST IMPLANTS AND THE DEVELOPMENT OF ANAPLASTIC LARGE CELL LYMPHOMA (ALCL), A TYPE OF NON-HODGKIN¿S LYMPHOMA. WOMEN WITH BREAST IMPLANTS MAY HAVE A VERY SMALL BUT INCREASED RISK OF DEVELOPING BREAST IMPLANT ASSOCIATED ALCL (BIA-ALCL) IN THE FLUID OR SCAR CAPSULE ADJACENT TO THE IMPLANT, WITH DOCUMENTED POTENTIAL FOR LOCAL, REGIONAL, AND DISTANT SPREAD OF THE CANCER WITH MORTALITY REPORTED IN RARE CASES. BIA-ALCL HAS BEEN REPORTED GLOBALLY IN PATIENTS WITH AN IMPLANT HISTORY THAT INCLUDES ALLERGAN¿S AND OTHER MANUFACTURERS¿ BREAST IMPLANTS WITH VARIOUS SURFACE PROPERTIES, STYLES, AND SHAPES. MOST OF THE CASES IN THE LITERATURE REPORTS DESCRIBE A HISTORY OF THE USE OF TEXTURED IMPLANTS. YOU SHOULD CONSIDER THE POSSIBILITY OF BIA-ALCL WHEN YOU HAVE A PATIENT WITH LATE ONSET, PERSISTENT PERI-IMPLANT SEROMA. IN SOME CASES, PATIENTS PRESENTED WITH CAPSULAR CONTRACTURE OR MASSES ADJACENT TO THE BREAST IMPLANT. WHEN TESTING FOR BIA-ALCL, COLLECT FRESH SEROMA FLUID AND REPRESENTATIVE PORTIONS OF THE CAPSULE, AND SEND TO A LABORATORY WITH APPROPRIATE EXPERTISE FOR PATHOLOGY TESTS TO RULE OUT ALCL, INCLUDING IMMUNOHISTOCHEMISTRY TESTING FOR CD30 AND ALK (ANAPLASTIC LYMPHOMA KINASE). IF YOUR PATIENT IS DIAGNOSED WITH PERI-IMPLANT BIA-ALCL, DEVELOP AN INDIVIDUALIZED TREATMENT PLAN IN COORDINATION WITH A MULTI-DISCIPLINARY CARE TEAM. BECAUSE OF THE SMALL NUMBER OF CASES WORLDWIDE, THERE IS NO WORLDWIDE CONSENSUS ON THE TREATMENT REGIMEN FOR PERI-IMPLANT BIA-ALCL. (B)(4).

    Description of Event or Problem · 1

    THROUGH JOURNAL ARTICLE "BREAST IMPLANT ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA IN AUSTRALIA AND NEW ZEALAND ¿ HIGH SURFACE AREA TEXTURED IMPLANTS ARE ASSOCIATED WITH INCREASED RISK¿ HEALTHCARE PROFESSIONAL REPORTED ¿THERE WERE 4 PATIENT DEATHS IN THIS SERIES. ONE PATIENT PRESENTED WITH A CLINICAL SEROMA AND THREE OTHERS PRESENTED WITH MASS AND/OR METASTATIC DISEASE. TWO CASES FOLLOWED COSMETIC AUGMENTATION AND 2 FOLLOWED CANCER RECONSTRUCTION. THEIR MEAN AGE WAS 49.7 (RANGE 44.5-58.0) AND 3 WERE FOLLOWING SINGLE IMPLANTS WITH ALLERGAN BIOCELL IMPLANTS AND 1 HAD MULTIPLE IMPLANTS (SMOOTH THEN ALLERGAN BIOCELL X 2). THE MEAN TIME TO DEVELOPING THIS DISEASE WAS 7.35 YEARS. ALL PATIENTS HAD MASS DISEASE EXTENDING BEYOND THE CAPSULE ON HISTOLOGICAL STAGING. TWO OF THESE PATIENTS HAD SPREAD TO LYMPH NODES (IPSILATERAL AXILLA/AXILLA AND MEDIASTINUM) AT THE TIME OF PRESENTATION. TWO PATIENTS HAD RECURRENCE (1 HAD INCOMPLETE RESECTION ON HISTOLOGY) FOLLOWING TREATMENT (SURGERY/ADJUVANT THERAPY) WITH SUBSEQUENT SPREAD TO MEDIASTINUM AND DISTANT METASTASES. THEY DIED FROM OBSTRUCTIVE RESPIRATORY FAILURE. TWO OTHER PATIENT DEATHS WERE RELATED TO COMPLICATIONS OF ADJUVANT THERAPY (SEPSIS POST CHEMOTHERAPY/BONE MARROW TRANSPLANTATION). A MULTI-CENTER ANALYSIS OF POOR OUTCOMES FOLLOWING BIA-ALCL PRESENTATION AND TREATMENT IS CURRENTLY IN PROGRESS AND WILL REPORT THESE CASES IN MORE DETAIL.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739167 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death