BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 19975751 · Received August 13, 2024

    Report

    Report Number
    1645337-2024-09458
    Event Type
    Injury
    Date Received
    August 13, 2024
    Date of Event
    January 1, 2014
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 22-AUG-2024, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT: - THE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH THE SUSPECT MEDICAL DEVICE. - AN EVENT DATE OF 2014 WAS REPORTED. - PATIENT AGE AT THE TIME OF EVENT IS 30 YEARS OLD. - THE IMPLANTATION DATE IS (B)(6) 2006. - THE EXPLANTATION DATE IS (B)(6) 2022. - THE SUSPECT MEDICAL DEVICE IS A MENTOR SMOOTH ROUND MODERATE PROFILE 475CC SALINE BREAST PROSTHESIS, CATALOG #3501680, LOT #5654783, PMA #P990075. 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. - THE BREAST IMPLANT ILLNESS SYMPTOMS THE PATIENT SUFFERED WERE SPECIFIED. IT WAS REPORTED THAT THE PATIENT SUFFERED FROM BRAIN FOG AND COGNITIVE ISSUES, MEMORY LOSS, JOINT PAIN MOSTLY IN THE HIP KNEES AND LEFT ELBOW, SKIN RASHES AND SORES, CHRONIC FATIGUE, HEART ARRHYTHMIA, WEIGHT GAIN, DRY ITCHY EYES, LOSS OF LIBIDO, SENSITIVITY TO LIGHT AND SOUND, DEPRESSION, ANXIETY, SYMPTOMS OF ADDISON¿S DISEASE (LOW CORTISOL), FOOD SENSITIVITIES, AND ALOPECIA. - THE PATIENT DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN HER LEFT BREAST POST IMPLANTATION. ON 29-AUG-2024, MENTOR COMPLETED THE INVESTIGATION ON THE SUSPECT MEDICAL DEVICE. THE INVESTIGATION WAS COMPLETED ON A PHOTO OF THE SUSPECT MEDICAL DEVICE BECAUSE THE PHYSICAL DEVICE HAS NOT BEEN RECEIVED BY MENTOR. DEVICE EVALUATION SUMMARY: ACCORDING TO THE INFORMATION REPORTED, THE PATIENT DEVELOPED VARIOUS SYMPTOMS OF GENERALIZED ILLNESS. UPON VISUAL EVALUATION OF THE IMAGE PROVIDED IN THE COMPLAINT, NO APPARENT DAMAGE OR VISUAL ANOMALIES WERE OBSERVED. AT THE PRESENT TIME, THERE IS NO SUFFICIENT EVIDENCE TO SHOW AN ASSOCIATION BETWEEN BREAST IMPLANTS AND GENERALIZED ILLNESS (ASSESSING THE RISKS OF BREAST IMPLANTS AND FDA¿S VISION FOR THE NATIONAL BREAST IMPLANT REGISTRY). AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. SINCE NO MALFUNCTION WAS OBSERVED DURING THE INVESTIGATION, NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) IS REQUIRED NOW. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE. D4: UDI: AS THE SERIAL NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION REVIEW COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: BREAST IMPLANT ILLNESS. H6 HEALTH EFFECT - CLINICAL CODE E2402: BREAST IMPLANT ILLNESS. 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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH UNSPECIFIED MENTOR SALINE BREAST PROSTHESES DEVELOPED UNSPECIFIED BREAST IMPLANT ILLNESS SYMPTOMS POST IMPLANTATION. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION WITH NO REPLACEMENT BREAST PROSTHESES ON AN UNKNOWN DATE. THE BREAST PROSTHESES WERE REMOVED INTACT, BUT THERE WAS A DEFECT NOTED ON THE REMOVED LEFT BREAST PROSTHESIS THAT ¿LOOKED LIKE A STRING OF MELTED PLASTIC ATTACHED TO THE VALVE¿. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093988 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5654783

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Required Intervention