BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 18522605 · Received January 16, 2024

    Report

    Report Number
    1645337-2024-00609
    Event Type
    Injury
    Date Received
    January 16, 2024
    Date of Event
    August 22, 2022
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317006947
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON JANUARY 23, 2024, MENTOR RECEIVED ADDITIONAL INFORMATION INDICATING THAT THE PATIENT'S IMPLANTS WERE REMOVED INTACT. IN ADDITION, THE PATIENT WAS DIAGNOSED WITH BILATERAL BREAST MASS AND LEFT SIDE BREAST CYST. THE PATIENT ALSO UNDERWENT RIGHT BREAST BIOPSY. LASTLY, THE PATIENT'S IMPLANTS WERE REMOVED AND REPLACED BILATERALLY WITH THE FOLLOWING: (LEFT) 535CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3505535BC LOT: 9888019 SN: (B)(6), AND (RIGHT) 535CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3505535BC LOT: 9921763 SN: (B)(6). A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE COMPLAINT DEVICE. AS A RESULT, THE MANUFACTURING DATE FIELD HAS BEEN UPDATED. THE MANUFACTURING RECORD EVALUATION (MRE) WAS REVIEWED, 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.

    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 IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: BREAST PAIN AND SWELLING. 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 400CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST PAIN AND SWELLING. MRI ALSO DIAGNOSED A LEFT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2023. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS. THE RUPTURE ON THE LEFT BREAST IMPLANT HAS BEEN REPORTED UNDER MRN: 1645337-2023-12892.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1693396 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 6600444 00081317006947

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Required Intervention