BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 20238954 · Received September 17, 2024

    Report

    Report Number
    1645337-2024-10805
    Event Type
    Injury
    Date Received
    September 17, 2024
    Date of Event
    August 20, 2024
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317004189
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON SEPTEMBER 30, 2024, MENTOR RECEIVED ADDITIONAL INFORMATION INDICATING THAT THE PATIENT WAS DIAGNOSED, VIA ULTRASOUND, WITH BILATERAL BREAST CYSTS. IN ADDITION, THE PATIENT'S IMPLANTS WERE REPLACED WITH THE FOLLOWING DEVICES: (LEFT) 550CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3505504BC LOT: 9989186 SN: (B)(6) AND (RIGHT) 550CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3505504BC LOT: 9993720 SN: (B)(6). LASTLY, THE PATIENT WAS ALSO DIAGNOSED WITH RIGHT BREAST IMPLANT GEL BLEED. ON OCTOBER 21, 2024, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS. COMPLICATIONS ON THE RIGHT BREAST/IMPLANT WILL BE REPORTED UNDER MRN: 1645337-2024-12359.

    Additional Manufacturer Narrative · 0

    ON OCTOBER 24, 2024, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED A VISUAL INSPECTION AND LEAK TESTING OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE BREAST IMPLANT HAD AN AREA OF SHELL ABRASION ON THE POSTERIOR VIEW. LEAK TESTING WAS PERFORMED, ACCORDING TO THE MENTOR PROCEDURE, AND A TEAR WITHIN THE SHELL ABRASION MEASURING APPROXIMATELY 0.2 CM WAS IDENTIFIED. THE EVALUATION DETERMINED THAT THE POSSIBLE CAUSE OF THE RUPTURE WAS 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. A BREAST CYST IS A FLUID-FILLED SAC WITHIN THE BREAST. ONE BREAST CAN HAVE ONE OR MORE BREAST CYSTS. THEY ARE OFTEN DESCRIBED AS ROUND OR OVAL LUMPS WITH DISTINCT EDGES. BREAST CYSTS USUALLY AND TYPICALLY DO NOT REQUIRE TREATMENT, BUT THEY CAN BE DRAINED USING FINE NEEDLE ASPIRATION IF THE CYST IS LARGE OR UNCOMFORTABLE. 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.

    Additional Manufacturer Narrative · 0

    SECTION D 6B. EXPLANTATION DATE: (B)(6) 2024. 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. 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 A 385CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION AND SCANS, WITH LEFT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1900969 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 6603674 00081317004189

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention