BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 168 SALINE FILLED BREAST IMPLANT

    MDR report key: 12173875 · Received July 15, 2021

    Report

    Report Number
    9617229-2021-47373
    Event Type
    Injury
    Date Received
    July 15, 2021
    Report Date
    November 18, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. DEVICE EVALUATION: VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: FLAT CREASES, BROWN PARTICLES ON THE SHELL, BROKEN ON PLUG STRAP, A CURVED OPENING ON RADIUS, AND WHITE CALCIFICATION ON THE SHELL. LEAK TEST AND MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED: A STRIATED OPENING ON RADIUS AND A SHARP BROKEN ON PLUG STRAP. THE FILL TEST INSPECTION WAS PERFORMED, THE RESULT IS NO BLOCKAGE. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: A SHARP BROKEN ON PLUG STRAP ASSESSED AS AN UNIDENTIFIED (TEAR) OPENING. A STRIATED OPENING ON RADIUS ASSESSED AS SURGICAL DAMAGE. THE EVENT OF LYMPHOMA - ALCL - SUSPECTED IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT.

    Additional Manufacturer Narrative · 0

    FURTHER INVESTIGATION RESULTS: WITH THE INFORMATION COLLECTED DURING THE INVESTIGATION, THERE IS ENOUGH EVIDENCE TO SUPPORT THAT DEVICE WORK ORDER 1090488 WAS MANUFACTURED UNDER CONTROLLED CONDITIONS IN ACCORDANCE WITH ALLERGAN PROCEDURES. SEAL STRENGTH RESULTS WERE ACCEPTABLE. ENVIRONMENTAL MONITORING RESULTS WERE FOUND TO BE ACCEPTABLE, AND THEY CONFIRMED THAT THERE WAS NOT AN ADVERSE IMPACT ON ENVIRONMENTAL CONDITIONS, DEVICE QUALITY OR PERFORMANCE. THE STERILIZATION RUN 101171 NOT RELATED TO ANY ADDITIONAL COMPLAINT INFECTION RECORD REPORTED AS OF TODAY. DURING THE TREND REVIEW OF ALL INFECTION COMPLAINTS FOR SALINE BREAST IMPLANTS FOR THE PERIOD OF (B)(6)2019 THROUGH (B)(6)2021, WAS NOTED AN OUTLIER IN (B)(6)2020. AN ADDITIONAL ANALYSIS WAS PERFORMED TO DETERMINE ANY PATTERN OR ANY SIMILARITIES RELATION BETWEEN PR¿S INVOLVED. IT WAS FOUND THAT SOME PRIMARY PACKAGING OPERATORS WERE INVOLVED IN MORE THAN ONE OCCASION, HOWEVER THE PEOPLE WERE TRAINED IN THE CORRESPONDING PROCEDURE. ALSO, CALIBRATIONS AND MAINTENANCE OF THE EQUIPMENT¿S INVOLVED IN MORE THAN ONE OCCASION WERE REVIEWED AND IT WAS DETERMINED THAT THEY WERE PERFORMED ON TIME AND MET SPECIFICATIONS. IN ADDITION, ALL THE RECORDS INVOLVED IN THIS MONTH WERE REVIEWED AND NO ISSUES WERE FOUND ASSOCIATED TO EITHER EVENT. GIVEN THE FACT THAT THE CAUSE OF THE INFECTION CANNOT BE SPECIFICALLY ASSOCIATED TO MANUFACTURING PROCESS, AND THERE IS NOT AN ADVERSE TREND FOR THIS TYPE OF EVENT NO CORRECTIVE ACTION IS DEEMED NECESSARY AT THIS TIME.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED THAT THE DEVICE WAS FOUND TO BE INTACT AND THAT THE "PATIENT IS SUSPICIOUS FOR BREAST IMPLANT ASSOCIATED ALCL;" A PARTIAL CAPSULECTOMY WAS PERFORMED. FLUID AND CAPSULE SENT FOR CYTOLOGY; THE MARKERS OF CD30+ AND ALK- HAVE NOT BEEN REPORTED OR CONFIRMED. THE FOLLOWING REPORTED EVENTS HAVE BEEN DEEMED NOT RELATED TO THE DEVICE: "HISTORY OF SLE, SJOGREN'S, RA."

    Description of Event or Problem · 0

    HEALTHCARE PROVIDER REPORTED INFECTION AND "FLUID ON THE BREAST." HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED THAT THE DEVICE WAS FOUND TO BE INTACT AND THAT THE "PATIENT IS SUSPICIOUS FOR BREAST IMPLANT ASSOCIATED ALCL;" A PARTIAL CAPSULECTOMY WAS PERFORMED. FLUID AND CAPSULE SENT FOR CYTOLOGY; THE MARKERS OF CD30+ AND ALK- HAVE NOT BEEN REPORTED OR CONFIRMED. THE FOLLOWING REPORTED EVENTS HAVE BEEN DEEMED NOT RELATED TO THE DEVICE: "HISTORY OF SLE, SJOGREN'S, RA."

    Additional Manufacturer Narrative · 1

    THE EVENTS OF SEROMA AND INFECTION ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. REASONS FOR REOPERATION: DEFLATION, INFECTION, AND "FLUID ON THE BREAST."

    Description of Event or Problem · 1

    HEALTHCARE PROVIDER CALLED TO REPORT A LEFT SIDE DEFLATION, INFECTION AND "FLUID ON THE BREAST." THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072839 STYLE 168 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 1090488

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention