BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL XTRA BREAST IMPLANT

    MDR report key: 19608871 · Received June 25, 2024

    Report

    Report Number
    1645337-2024-07600
    Event Type
    Injury
    Date Received
    June 25, 2024
    Date of Event
    June 5, 2024
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    10081317027857
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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: MATERIAL RUPTURE, DEVICE EXTRUSION. 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

    ON DECEMBER 16, 2024, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. ON DECEMBER 20, 2024, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR THEN CONDUCTED A VISUAL INSPECTION AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT THE SMOOTH MOD HIGH XTRA, 400CC BREAST IMPLANT WAS FOUND TO BE RUPTURED. MICROSCOPIC EXAMINATION WAS PERFORMED ON THE EDGES OF THE RUPTURE, AND PARALLEL STRIATIONS MEASURING LESS THAN 0.1 CM WERE FOUND IN AN AREA OF THE TEAR ON THE ANTERIOR ASPECT. PARALLEL STRIATIONS ARE CONSISTENT WITH MARKINGS MADE BY A SHARP OBJECT PERFORATING THE IMPLANT SHELL. THE CAUSE OF THE RUPTURE IN THE REMAINING AREA OF THE TEAR COULD NOT BE IDENTIFIED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. EXTRUSION MAY OCCUR WHEN THE WOUND HAS NOT CLOSED OR WHEN TISSUE COVERING THE IMPLANTS WEAKENS. THE INCIDENCE OF EXTRUSION HAS BEEN SHOWN TO INCREASE WHEN UNDUE PRESSURE IS APPLIED ON THE TISSUE LOCATED OVER THE DEVICE, TRAUMA TO SURROUNDING TISSUES MAY LEAD TO THROMBOSIS, DELAYED WOUND HEALING, IMPROPER SIZE, PLACEMENT, LARGER SIZED IMPLANTS, USE OF STEROIDS IN THE SURGICAL POCKET AND MICROWAVE DIATHERMY. RADIATION THERAPY HAS BEEN REPORTED TO INCREASE THE LIKELIHOOD OF EXTRUSION. EXTRUSION MAY REQUIRE ADDITIONAL SURGERY AND POSSIBLE REMOVAL OF THE IMPLANT, WHICH MAY RESULT IN ADDITIONAL SCARRING AND/OR LOSS OF BREAST TISSUE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 400CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST IMPLANT RUPTURE. IN ADDITION, THE RIGHT BREAST IMPLANT ALSO SHIFTED AND WAS OOZING OUT OF THE INCISION HOLES. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2024. THE REPLACEMENT DEVICE WAS A 400CC MENTOR MEMORYGEL XTRA BREAST IMPLANT (CATALOG: SMHX400 LOT: 9963329 SN: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433006 MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 9776212 10081317027857

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Required Intervention