BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 162371 · Received April 10, 1998

    Report

    Report Number
    162371
    Event Type
    Injury
    Date Received
    April 10, 1998
    Report Date
    April 9, 1998
    Manufacturer
    *
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BILATERAL SYMPTOMATIC BREAST CAPSULES BILATERAL INDETERMINATE MAMMOGRAMS BILATERAL LEAKING SILICONE IMPLANTS WITH EXTENSIVE CAPSULE FORMATION WITH SAPONIFICATION. BILATERAL IMPLANT AND IMPLANT MATERIAL REMOVAL; BILATERAL FORMAL OPEN CAPSULECTOMIES; BILATERAL RETROMAMMARY TEXTURED MENTOR HS GEL-FILLED IMPLANT RECONSTRUCTION RIGHT 300CC LOT 158142) LEFT 300CC, LOT 153608) THE PT WAS MARKED IN AWAKE, SITTING POSITION. ALL OF THE RISKS, ALTERNATIVES AND IMPONDERABLES WERE DISCUSSED WITH THE PT PRIOR TO PROCEEDING. ABSOLUTELY NO GURANTEES, WHATSOEVER, WERE MADE. THIS PT HAD ROCK-HARD IMPLANTS BILATERALLY WITH INDETERMINATE MAMMOGRAMS BILATERALLY AND PROBABLE LEAKING SILICONE IMPLANTS BILATERALLY, WHICH WAS DOCUMENTED CLEARLY DURING THE PROCEDURE. THE PREVIOUS INFRAMAMMARY INCISIONS WERE EXTENDED ON EACH SIDE. DISSECTION WAS CARRIED DOWN THROUGH A VERY THICK CAPSULAR SHELL WITH A LARGE AMOUNT OF WHITISH, CREAMY TISSUE COMPATIBLE WITH SAPONIFICATION. BOTH OF THE IMPLANTS WERE BROKEN. THE MATERIAL WAS CONTAINED WITHIN AN EXTREMELY THICK SHELL, AND THE SHELL ITSELF WAS VERY RAGGED WITH EXTENSIVE CALCIFICATION, WHICH BECAUSE OF THE SHARP EDGES COULD CERTAINLY ACCOUNT FOR THE RUPTURED IMPLANTS. THERE WAS NO EVIDENCE OF ANY GEL OUTSIDE THE CAPSULE. TEDIOUSLY, BILATERAL FORMAL CAPSULECTOMIES WERE DONE REMOVING THE ENTIRE CAPSULE FROM JUST SHORT OF THE MIDSTERNUM, THE UPPER RECTUS AND JUST BELOW THE CLAVICLE TO THE SERRATUS ANTERIOR LATERALLY. METICULOUS HEMOSTASIS WAS ACHIEVED. BOTH POCKETS WERE IRRIGATED WITH COPIOUS AMOUNTS OF KANAYCIN SOLUTION. PREPLACED INTERMUSCULAR SUTURES OF INTERRUPTED 3-0 VICRYL WERE UTILIZED. 19 MM BLAKE DRAIN WAS PLACED IN EACH SUBMAMMARY POCKET AND BROUGHT OUT THROUGH A SEPARATE STAB WOUND. SIZERS WERE TRIED, AND ELECTED TO USE A TEXTURED MENTOR HS GEL-FILLED IMPLANT 300 CC ON EACH SIDE. THE IMPLANTS WERE INTRODUCED AFTER BEING SOAKED IN KANAMYCIN, AND SUTURES TIED DOWN, TRANSECTED AND BREASTS CLOSED WITH INTERRUPTED, BURIED 4-0 AND 5-0 VICRYL. EXTENSIVE REPOSITIONING OF THE IMPLANTS AFTER THE CAPSULECTOMY WAS NEEDED BECAUSE OF THE VERY TIGHT, CONTORTED CAPSULE. AFTER THE TERMINATION OF THE PROCEDURE,HEALTH CARE PROFESSIONAL FELT THAT SYMMETRY WAS EXCELLENT. A LIGHT COMPRESSIVE WRAP AND A BANDEAU BANDAGE WAS APPLIED. BLOOD LOSS AWAKENED AND LEFT THE OPERATING ROOM PER ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * Implant SILICONE BREAST IMPLANT (TWO) FTR * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization