BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 20182029 · Received September 10, 2024

    Report

    Report Number
    1645337-2024-10476
    Event Type
    Injury
    Date Received
    September 10, 2024
    Date of Event
    July 16, 2024
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000280
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: AS THE SERIAL NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. DEVICE EVALUATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE SM MPP GEL 300CC BREAST IMPLANT HAD A TEAR WITHIN AN AREA OF SHELL ABRASION ON THE POSTERIOR VIEW, MEASURING APPROXIMATELY 0.1 CM. THE EVALUATION DETERMINED THAT THE POSSIBLE CAUSE OF THE RUPTURE IS CONSISTENT WITH NORMAL WEAR. SHELL ABRASION SUGGESTS IN-VIVO FOLDING OR CREASING OF THE DEVICE. THIS MAY BE THE RESULT OF THE FOLLOWING FACTORS: CONTINUOUS AND SUSTAINED STRESSES TO THE DEVICE SUCH AS TOO SMALL BREAST POCKET AND FOLDING OR WRINKLING OF THE SHELL IN THE BREAST POCKET. IN SOME CASES, THE BREAST IMPLANTS MAY ALSO WEAR OUT OVER TIME. IT WAS NOTED THAT, BASED ON THE DATE OF IMPLANTATION PROVIDED AND THE EXPIRATION DATE OF THE REPORTED LOT NUMBER, THE DEVICES WERE IMPLANTED AFTER THE EXPIRATION DATE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN A CLARIFICATION OF THE IMPLANTATION DATE, HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. ACCORDING TO THE PRODUCT, INSERT DATA SHEET STERILITY CANNOT BE GUARANTEED IF THE PRODUCT IS USED AFTER THE ¿USE BY DATE¿ SHOWN ON THE BOX LABEL. AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) IS REQUIRED NOW. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: UNSPECIFIED. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO UNKNOWN MENTOR SMOOTH GEL IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2024. THE REPLACEMENT DEVICES WERE: (LEFT) 240CC MENTOR MEMORYGEL XTRA BREAST IMPLANT CATALOG: SMPX240 LOT: 9992135-046 SN: (B)(6) AND (RIGHT) 240CC MENTOR MEMORYGEL XTRA BREAST IMPLANT CATALOG: SMPX240 LOT: 9992135-046 SN: (B)(6). THE DEVICES WERE RETURNED AND BOTH THE LEFT AND RIGHT IMPLANTS WERE IDENTIFIED TO BE RUPTURED DURING THE PRODUCT INVESTIGATION. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222655 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 5718453 00081317000280

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention