BEUDAMED
    FDA Adverse Event Death Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 5893333 · Received August 22, 2016

    Report

    Report Number
    9617229-2016-00098
    Event Type
    Death
    Date Received
    August 22, 2016
    Report Date
    July 29, 2016
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED ;THEREFORE, ANALYSIS OF THE DEVICE IS NOT POSSIBLE. DEVICE HISTORY REVIEW (DHR) RESULTS: REVIEW OF DHR FOR WORK ORDER (B)(4) DID NOT IDENTIFY ANY DEVIATIONS, ERRORS, OMISSIONS OR NON-CONFORMANCES DURING MANUFACTURING PROCESS. ALL GEL BREAST IMPLANTS WERE REVIEWED AS PART OF THE ASSEMBLY OPERATIONS AND THESE TASKS WERE PERFORMED ACCORDING TO APPLICABLE CURRENT PROCEDURES TO ENSURE THAT ASSEMBLY MET THE REQUIRED SPECIFICATIONS. THE DHR ASSEMBLY REPORT FROM SAP WAS VERIFIED AND THERE WAS NOT ANY SCRAP RELATED WITH REPORTED EVENT, TWO DEVICES WERE SCRAPPED (VG). IN ADDITION, DHR FOR SHELL RUNS NUMBER (B)(4) DID NOT IDENTIFY ANY DEVIATIONS, ERRORS, OMISSIONS OR NON-CONFORMANCES DURING SHELL FABRICATION PROCESS. ALL SHELLS WERE REVIEWED AS PART OF THE SHELL FABRICATION OPERATIONS AND THESE TASKS WERE PERFORMED ACCORDING TO APPLICABLE CURRENT PROCEDURES TO ENSURE THAT FABRICATION MET THE REQUIRED SPECIFICATIONS. DEVICE LABELING: BREAST CANCER - REPORTS IN THE MEDICAL LITERATURE INDICATE THAT PATIENTS WITH BREAST IMPLANTS ARE NOT AT A GREATER RISK THAN THOSE WITHOUT BREAST IMPLANTS FOR DEVELOPING BREAST CANCER. REPORTS HAVE SUGGESTED THAT BREAST IMPLANTS MAY INTERFERE WITH OR DELAY BREAST CANCER DETECTION BY MAMMOGRAPHY AND/OR BIOPSY; HOWEVER, OTHER REPORTS IN THE PUBLISHED MEDICAL LITERATURE INDICATE THAT BREAST IMPLANTS NEITHER SIGNIFICANTLY DELAY BREAST CANCER DETECTION NOR ADVERSELY AFFECT CANCER SURVIVAL OF WOMEN WITH BREAST IMPLANTS. A LARGE FOLLOW-UP STUDY REPORTED NO EVIDENCE OF AN ASSOCIATION BETWEEN BREAST IMPLANTS AND CANCER, AND EVEN SHOWED A DECREASED INCIDENCE OF BREAST CANCER COMPARED TO THE GENERAL POPULATION.

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED LEFT SIDE "BREAST CANCER." FROM (B)(6) 2014, RADIATION EXPOSURE WAS PROVIDED AS TREATMENT AND THE PATIENT LATER DIED, DUE TO BREAST CANCER. EVENT OF BREAST CANCER WAS DETERMINED TO BE DEVICE RELATED AND THE PHYSICIAN ASSESSED THE CAUSALITY AS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545938 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2557475

    Patients

    Seq Age Sex Outcome Treatment
    1 Death