BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GEL IMPLANTS

    MDR report key: 8024485 · Received October 31, 2018

    Report

    Report Number
    1645337-2018-06317
    Event Type
    Injury
    Date Received
    October 31, 2018
    Report Date
    October 11, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE "THE" NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. PRODUCT COMPLAINT #: (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. AS REPORTED IN THE LITERATURE PUBLICATION ENTITLED, ¿MECHANICAL IRRITATION BY PROTRUDING BONE: A POSSIBLE CAUSE OF BREAST IMPLANT RUPTURE¿, A (B)(6) FEMALE PATIENT UNDERWENT TOTAL MASTECTOMY OF THE RIGHT BREAST AFTER BEING DIAGNOSED WITH INVASIVE DUCTAL CARCINOMA AND BREAST RECONSTRUCTION SUFFERED CAPSULAR CONTRACTURE (BAKER GRADE IV) AND IMPLANT RUPTURE. THE PATIENT WAS PRESENTED AFTER RADIOTHERAPY, CHEMOTHERAPY, AND HORMONE THERAPY WITH THE DESIRE FOR BREAST RECONSTRUCTION. THE PATIENT APPEARED TO BE VERY ATHLETIC, WITHOUT MUCH SUBCUTANEOUS FAT TISSUE. THEREFORE, ADEQUATE AUTOLOGOUS BREAST RECONSTRUCTION WAS NOT A VIABLE OPTION. DESPITE THE PREVIOUS RADIATION THERAPY, THE PATIENT SHOWED SUFFICIENT SKIN QUALITY, IMPLANTATION OF AN EXPANDER WAS PERFORMED IN A YEAR AFTER ABLATION AND THREE MONTHS LATER, EXPANDER WAS REPLACED WITH AN ANATOMIC TEXTURED 275-ML IMPLANT WITH A MODERATE PROFILE (MENTOR SILTEX, MENTOR WORLDWIDE LLC, IRVINE, CA, USA). SIX MONTHS LATER, THE PATIENT PRESENTED AGAIN, SHOWING SIGNS OF BAKER GRADE IV CAPSULAR CONTRACTURE IN HER LEFT BREAST. THE CAPSULECTOMY WITH IMPLANT EXCHANGE WAS PERFORMED BASED ON THE CLINICAL SYMPTOMS. DURING THE OPERATION, THE LEAKAGE OF THE IMPLANT BECAME OBVIOUS. THE IMPLANT WAS EXAMINED CLOSELY, AND A SMALL AMOUNT OF SILICONE GEL HAD LEAKED OUT THROUGH A SMALL HOLE IN THE SURFACE. TITLE: MECHANICAL IRRITATION BY PROTRUDING BONE: A POSSIBLE CAUSE OF BREAST IMPLANT RUPTURE. BACKGROUND: ALTHOUGH BREAST IMPLANTS HAVE BEEN IN CLINICAL USE FOR ALMOST 6 DECADES AND HAVE UNDERGONE CONSIDERABLE DEVELOPMENT DURING THIS TIME, IMPLANT RUPTURE IS STILL A DREADED LONG-TERM COMPLICATION. SOME OBVIOUS EXTERNAL FACTORS, SUCH AS TRAUMA, CAN LEAD TO IMPLANT RUPTURE, BUT MANY STUDIES HAVE REPORTED A HIGH RATE OF ¿SPONTANEOUS¿ IMPLANT RUPTURE. HEREIN, WE PRESENT TWO CASES WITH THE AIM OF RAISING AWARENESS OF A NEW POSSIBLE CAUSE OF ¿SPONTANEOUS¿ IMPLANT RUPTURE: MECHANICAL IRRITATION BY BONY PROTRUSIONS. MENTOR SILTEX GEL BREAST "IMPLANS" WERE USED IN THIS STUDY; HOWEVER, CATALOG AND LOT NUMBER WERE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865529 UNKNOWN GEL IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention