BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 22846496 · Received August 19, 2025

    Report

    Report Number
    1645337-2025-09208
    Event Type
    Injury
    Date Received
    August 19, 2025
    Date of Event
    July 25, 2025
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000365
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON AUGUST 21, 2025, THE EVALUATION FOR THE DEVICE WAS COMPLETED. DEVICE EVALUATION SUMMARY: VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE BREAST IMPLANT WAS FOUND TO BE RUPTURED AND RECEIVED IN THREE PARTS. IN ADDITION, AN AREA OF SHELL ABRASION WAS OBSERVED ON THE EDGES OF THE TEAR. THESE FINDINGS ARE CONSISTENT WITH NORMAL WEAR OF THE DEVICE. SHELL ABRASION SUGGESTS IN-VIVO FOLDING OR CREASING OF THE DEVICE, WHICH MAY BE CAUSED BY CONTINUOUS AND SUSTAINED STRESSES TO THE DEVICE, SUCH AS AN EXCESSIVELY SMALL BREAST POCKET OR THE FOLDING OR WRINKLING OF THE SHELL WITHIN THE BREAST POCKET. IN SOME CASES, BREAST IMPLANTS MAY ALSO EXPERIENCE NORMAL WEAR OVER TIME. 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, AND THAT NORMAL WEAR MAY HAVE CAUSED THE OBSERVED DEFECT. NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) IS REQUIRED NOW. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE MENTOR FAILURE ANALYSIS LAB HAS 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. 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: RUPTURE. D4: UDI: AS THE SERIAL NUMBER 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 67-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH A 600CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED DURING SURGERY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025 AND REPLACED WITH A 635CC MENTOR MEMORYGEL BOOST BREAST IMPLANT (CATALOG NUMBER SMHB635) WITH LOT NUMBER 2052812.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1244438 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 6972078 00081317000365

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention