BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATRELLE 133S TISSUE EXPANDER (RIGHT)

    MDR report key: 16952658 · Received May 17, 2023

    Report

    Report Number
    MW5117620
    Event Type
    Injury
    Date Received
    May 17, 2023
    Date of Event
    November 3, 2022
    Report Date
    May 11, 2023
    Manufacturer
    ALLERGAN SALES, LLC
    Product Code
    LCJ
    UDI-DI
    10888628043794
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    (B)(6) 2022, I RECEIVED DOUBLE MASTECTOMY SURGERY FOR LEFT DUCTUS CARCINOMA. THE PLASTIC SURGEON DID NOT COMMUNICATE PREVIOUS APPOINTMENTS, SURGERY INFORMED CONSENT DID NOT STATE THE INFORMATION THAT I SHOULD NO LONGER HAVE MRIS OR POST-SURGERY APPOINTMENTS THAT I COULD NOT HAVE AN MRI WITH THE TISSUE EXPANDERS CONTAINING A MAGNETIC/METAL PORT THAT THEY USE TO HELP LOCATE THE PORT TO PUT IN IV FLUID POST-SURGERY AND EXPAND THE TISSUE. (B)(6) 2022, I HAD THE RIGHT BREAST TISSUE EXPANDER PLACED AND NOT ON THE LEFT. NEXT SURGERY FOR THE LEFT TISSUE EXPANDER SURGERY (B)(6) 2022 - NO INFORMATION WAS PROVIDED ON ANY PLASTIC SURGERY APPOINTMENTS PRIOR TO THIS SURGERY, ON INFORMED CONSENT SURGERY FORM OR POST-SURGERY REGARDING THE RESTRICTION OF NOT HAVING AN MRI COMPLETED. ASKED BY RN TO SIGN A BLANK INFORMED CONSENT. I HAD MULTIPLE SCLEROSIS (MS) PRIOR TO CANCER AND STATED AT MY PRE-SURGERY APPOINTMENTS THAT I HAD MY MS MEDICATION HALTED WITH THE POTENTIAL OF CANCER SECONDARILY TO THIS (LATER NOTED NOT RELATED TO HER2+ CANCER DIAGNOSIS). WHEN I AM NOT TAKING ANY MS MEDICATIONS, MY NEUROLOGIST PREFERS TO HAVE A BRAIN MRI COMPLETED EVERY 6 MONTHS TO MONITOR ANY PROGRESSION IN POTENTIAL BRAIN LESIONS INCREASING IN SIZE OR NEW LESIONS FORMING. WHEN I ARRIVED FOR A BRAIN MRI ORDERED TO BE COMPLETED ON MARCH (B)(6) 2023, AT (B)(6) HOSPITAL (B)(6) THE MRI TECHNICIAN CAUGHT THIS POTENTIAL SAFETY CONCERN WHEN I MENTIONED THAT I CURRENTLY HAVE TWO TISSUE EXPANDERS POST-SURGERY FOLLOWING A DOUBLE MASTECTOMY AND STATED SOME OF THESE EXPANDERS HAVE METAL/MAGNETIC PORTS. MY HUSBAND HAS A PH.D. IN MEDICAL IMAGING AS A PHYSICIST AND NOTED WHEN TOLD OF THE SAME CONCERN - HE WAS PRESENT WHEN I WENT FOR THIS APPOINTMENT AND SPOKE WITH THE MRI TEAM. THIS TECHNICIAN STATED SHE WILL RESEARCH THIS AND CONTACT ME AFTER I HAVE SUPPLIED MY MEDICAL DEVICE INFORMATION AND SHE CAN CONFIRM WHAT IS SAFE. I MESSAGED MY MS NEUROLOGIST AND NOTED THE HOLD ON GETTING THE BRAIN MRI. I THEN RECEIVED A MESSAGE BACK VIA MYCHART THAT MY TISSUE EXPANDERS HAD METAL/MAGNETIC AND I WOULD NOT BE ABLE TO GET AN MRI AT THIS TIME. WITH CONCERNS OF MY CURRENT PLASTIC SURGEON, I SWITCHED SURGEONS AND POST-COVID - EVEN FOR CANCER PATIENTS THERE IS A 6-12 MONTH WAIT TO HAVE THE SALINE BREAST IMPLANTS OF THE RECONSTRUCTIVE SURGERY USING ONE'S OWN TISSUE. THIS WAS PREVIOUSLY NOT A CONCERN OF USING METAL IN TISSUE EXPANDERS PRE-COVID WITH THE ABILITY TO HAVE THEM REMOVED IN 8 WEEKS. WITHOUT THE ABILITY TO HAVE A BRAIN MRI, THIS ALSO ELIMINATED THE OPPORTUNITY TO HAVE AN MRI IF THERE WAS A POTENTIAL OF CANCER RETURNING. THE HIGHEST RISK OF THIS IS WITHIN ONE YEAR OF THE INITIAL CANCER AND I HAD A BREAST MRI PRIOR TO MY FIRST SURGERY FOR THIS REASON - TO MAKE SURE IT HAD NOT SPREAD AND A BETTER IMAGE THAN THE ULTRASOUND USED IN A BIOPSY. TWO POOR HEALTH OUTCOMES - 1) INABILITY TO MONITOR MY MS WITH THE APPROPRIATE TESLA IMAGING USING FLAIR AND T2-WEIGHTED MRI KNOWING THAT ANY PROGRESSION IS PERMANENT AND CAN LEAD TO A VARIETY OF DISABILITIES AND 2) THE INABILITY TO MONITOR MY CANCER RECURRING. WHEN I FELT SCAR TISSUE FORMING I WAS TOLD I CANNOT HAVE A BIOPSY WITHOUT SURGERY WITH THE RISK OF PUNCTURING THE EXPANDERS AND I CANNOT HAVE AN MRI. THE ONLY MONITORING WAS WITH AN ULTRASOUND DEVICE THAT IS A TODDLER LEVEL OF IMAGING COMPARED TO AN MRI. MAIN CONCERNS REVIEWING THE CDC BREAST CANCER AND UP-TO-DATE DATA THERE IS A HIGH MORTALITY RATE FOR BLACK WOMEN IS TWICE AS HIGH COMPARED CAUCASIANS, ALTHOUGH THE INCIDENT RATE IS SIMILAR - NEEDS CHANGED TO MONITOR FOR CANCER RECURRING MRI TISSUE EXPANDERS WITH METAL/MAGNETIC NEED A NEW FDA POLICY THAT NOTES THAT ALL CANCER PATIENTS NEED TISSUE EXPANDERS USED THAT ARE NON-MAGNETIC/NON-METALLIC. THEY ARE BEING MADE. PERSONALLY THE FDA NEEDS TO ELIMINATE ALL TISSUE EXPANDERS WITH METAL AS IN MY SITUATION, A PATIENT MAY HAVE A SECONDARY MEDICAL CONDITION THAT NEEDS MONITORING VIA MRI. UNABLE TO LOAD A COPY OF BOTH TISSUE EXPANDERS BELOW. LOT NUMBER: RH238198015. REFERENCE REPORT: MW5117620.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667304 NATRELLE 133S TISSUE EXPANDER (RIGHT) TISSUE EXPANDER AND ACCESSORIES LCJ ALLERGAN SALES, LLC 133S-FV-13-T 10888628043794

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention| O AMPHETAMINE-DEXTROAMPHETAMINE 20 MG 24 HR CAPSULE (XR), AND 5 MG QUICK RELEASE ADDERALL, LASIX 20 MG BID, POTASSIUM CHLORIDE 20 MEQ ER, ODANSETRON 4 MG PRN, HYDROXYZINE 25 MG PRN, RIZITRIPTAN 10 MG PRN, GLATIRAMER 40 MG/ML PREFILLED (MS MED ON HOLD), ABBVIE ALLERGAN LIFE CELL ALLODERM SELECT ACELLULAR MATRIX CONTOUR.| K2 PO, ACETYLCARNITINE HCL 500 MG CAP, ASPIRIN 81 MG TABLET, NAC (N-ACETYLCYSTEINE) 600 MG, RIBOFLAVIN 400 MG, ASCORBIC ACID WITH ROSE HIPS (VITAMIN C) 1000 MG, CALCIUM ASCORBATE 500 MG, TYLENOL 500 MG PRN, VITAMIN D3 5,000 UNITS, MAGNESOIM 200 MG.