BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 18899157 · Received March 13, 2024

    Report

    Report Number
    1645337-2024-03132
    Event Type
    Injury
    Date Received
    March 13, 2024
    Date of Event
    February 6, 2024
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000327
    PMA / PMN Number
    P030053
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS CAN BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, THE INVESTIGATION WILL BE REOPENED AND CONDUCTED AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: RIGHT AUTOIMMUNE DISORDER SYMPTOMS MENTOR IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH MENTOR HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, MENTOR, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MENTOR, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF CERTAIN INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    DATE OF IMPLANT (FIELDS D6A) AND SERIAL NUMBER (FIELD D4) INFORMATION HAVE CORRECTLY BEEN UPDATED PER INFORMATION FOUND IN THE RECORDS. THIS SUPPLEMENTAL MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4) DATE OF IMPLANT (FIELDS D6A) AND SERIAL NUMBER (FIELD D4) INFORMATION HAVE CORRECTLY BEEN UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED (VIA FDA MEDWATCH 5151325, AND 5151326) THAT A 40-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST SURGERY REVISION WITH 400CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES DEVELOPED SJÖRGEN¿S SYNDROME, RAYNAUD¿S SYNDROME, CONNECTIVE TISSUE DISEASE, SYMPTOMS OF FIBROMYALGIA, BREAST IMPLANT ILLNESS, DRY EYES, IRRITATED EYES, BUTTERFLY RASH, JOINT PAIN, MUSCLE PAIN, WACKY PERIODS, OCULAR MIGRAINES, MOODY, DEPRESSED, ANXIOUS, COLD SORES, HEART PALPITATIONS, DIZZINESS, WEAKNESS, EYE SECRETIONS, WHITE GUNKY EYES, EASY BRUISING, PAIN, STOMACH ISSUES, LOW LIBIDO, SEASONAL AFFECTIVE DISORDER, CHERRY ANGIOMAS, SCIATICA, BRAIN FOG, COLD ALL THE TIME, BODY TINGLING, HOT FLASHES, HYPOTHYROIDISM, FREQUENT URINARY TRACT INFECTIONS, FOOD INTOLERANCES, PHOTOSENSITIVITY, SMELL SENSITIVITIES, CHEMICAL SENSITIVITIES, INCREASE IN COLDS, DIFFICULTY CONCENTRATING, WORD RETRIEVAL, MEMORY LOSS, CHRONIC FATIGUE, WEAKNESS, HAIR LOSS, WEIGHT ISSUES, EASY BRUISING, SLOW HEALING OF WOUNDS, TEMPERATURE INTOLERANCE. LOW LIBIDO, NIGHT SWEATS, INSOMNIA, ISSUES WITH MENSTRUATION, SWOLLEN LYMPH NODES, PARESTHESIA, FOUL BODY ODOR, MUSCLE TWITCHING, VERTIGO, FEVERS, DEHYDRATION, FREQUENT URINATION, NAIL CHANGES, PAPULES, SWELLING, A DECLINE IN VISION, VISION DISTURBANCES, SLOW MUSCLE RECOVERY AFTER ACTIVITY, KIDNEY DYSFUNCTION, GASTROINTESTINAL ISSUES, DIGESTIVE ISSUES, PERSISTENT INFECTIONS, SUICIDAL THOUGHTS, SHORTNESS OF BREATH, HEART PALPITATIONS, ORAL THRUSH, FEEL LIKE DYING, CHRONIC INFLAMMATION, THROAT CLEARING, COUGHING, DIFFICULT SWALLOWING, CHOKING FEELING, HEADACHES, DIZZINESS, METALLIC TASTE IN THE MOUTH, AND RINGING IN THE EARS POSTOPERATIVELY. AS A RESULT, THE DEVICES WERE EXPLANTED ON (B)(6) 2024. IT WAS REPORTED THAT THE PATIENT'S SYMPTOMS IMPROVED AFTER THE SURGERY. MENTOR IS AWARE THAT THE DATE OF IMPLANT IS BEFORE THE MANUFACTURE DATE OF LOT 5914976. FOLLOW-UPS ARE IN PROGRESS. IF ANY CLARIFICATION OR INFORMATION IS RECEIVED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169505 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 5914976 00081317000327

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Required Intervention