BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 22826138 · Received August 18, 2025

    Report

    Report Number
    1645337-2025-08963
    Event Type
    Injury
    Date Received
    August 18, 2025
    Date of Event
    January 29, 2025
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: LEFT RIPPLING, AND MALPOSITION. D4: UDI: AS THE LOT, SERIAL NUMBER, AND CORRESPONDING EXPIRATION DATE FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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 SEPTEMBER 16, 2025, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. PER DEVICE AND PAPERWORK RECEIVED, FOLLOWING UPDATES HAVE BEEN MADE ON THIS FORM AS LOT 7322491 BELONGS TO THE LEFT SIDE, AND LOT 6920306 TO THE RIGHT SIDE: - FIELD D4 FOR LOT NUMBER HAS BEEN UPDATED TO "7322491" - FIELD D4 FOR SERIAL NUMBER HAS BEEN UPDATED TO "(B)(6)" - FIELD D4 FOR UNIQUE IDENTIFIER(UDI) HAS BEEN UPDATED TO "(B)(4)" - DATE OF IMPLANT UNDER FIELDS D6A HAVE BEEN UPDATED TO "(B)(6) 2016". ON SEPTEMBER 17, 2025, DEVICE EVALUATION WAS COMPLETED AS FOLLOWS: MENTOR CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. DURING VISUAL EVALUATION NO APPARENT DAMAGE OR VISUAL ANOMALIES WERE OBSERVED ON THE RETURNED DEVICE. IMPLANT DISPLACEMENT/MIGRATION MAY OCCUR FROM IMPROPER IMPLANT SIZING AND/OR PLACEMENT, I.E., WHEN THE IMPLANT IS TOO LARGE OR THE POCKET TOO SMALL OR WHEN THERE HAS BEEN INADEQUATE PREOPERATIVE ASSESSMENT OF STRESSES CAUSING MOVEMENT OF THE PROSTHESIS. IMPLANT DISPLACEMENT/MIGRATION IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. WRINKLING IS REPORTED TO OCCUR MORE FREQUENTLY IN PATIENTS WITH ONE OR MORE OF THE FOLLOWING: THIN-SKINNED PATIENTS, PATIENTS WITH LITTLE OR NO SUBCUTANEOUS FAT, SUBGLANDULAR RATHER THAN SUBMUSCULAR PLACEMENT, AN IMPLANT THAT IS TOO LARGE RELATIVE TO THE BREAST POCKET SIZE OR FRAME OF THE PATIENT, OVERLYING TISSUE THAT IS MINIMAL OR OF POOR QUALITY, AND/OR WHEN CAPSULAR CONTRACTURE IS PRESENT. AS PART OF MENTOR'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED ACCORDING TO APPROVED SPECIFICATIONS. BASED ON THE RESULTS OF THIS INVESTIGATION, IT WAS DETERMINED THAT THE PRODUCT MET THE MANUFACTURING RELEASE CRITERIA: 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. THIS SUPPLEMENTAL MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 43-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 375CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AND EXPERIENCED RIGHT SIDE BREAST IMPLANT RUPTURE, AND LEFT SIDE MALPOSITION AND RIPPLING POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY WITH SERIAL NUMBERS (B)(6) ON THE LEFT SIDE, AND (B)(6) ON THE RIGHT SIDE ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1590412 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 7322491

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention