BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 20857066 · Received December 5, 2024

    Report

    Report Number
    1645337-2024-14246
    Event Type
    Injury
    Date Received
    December 5, 2024
    Date of Event
    June 20, 2024
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317004196
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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. A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: PTOSIS, SAGGING. 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON DECEMBER 12, 2024, THE PRODUCT INVESTIGATION WAS COMPLETED. 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. DEVICE INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE SM MOD CLASSIC GEL, 405CC BREAST IMPLANT HAD A TEAR WITHIN AN AREA OF SHELL ABRASION ON THE POSTERIOR VIEW, MEASURING APPROXIMATELY 0.2 CM. THE EVALUATION DETERMINED THAT THE POSSIBLE CAUSE OF THE RUPTURE FOUND IS 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. SOME BREAST PTOSIS IS A NORMAL COMPONENT OF THE MATURE BREAST. PTOSIS BECOMES UNDESIRABLE WHEN THE BREAST PARENCHYMA PREDOMINATES BELOW THE AREOLA, DROOPS CONSIDERABLY BELOW THE INFRAMAMMARY FOLD AND THE NIPPLE POINTS DOWNWARD. AUGMENTATION ALONE, WITHOUT CONSIDERATION OF THE PTOSIS CAN PRODUCE A LESS THAN DESIRABLE COSMETIC RESULT KNOWN AS A "ROCK IN SOCK" DEFORMITY OR AN INCREASED PTOTIC APPEARANCE. PTOSIS IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. 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 405CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MAMMOGRAM, WITH LEFT BREAST IMPLANT RUPTURE. IN ADDITION, THE PATIENT WAS ALSO DIAGNOSED WITH BILATERAL BREAST PTOSIS AND SAGGING. AS A RESULT, THE PATIENT UNDERWENT BILATERAL CAUTERY CAPSULORRHAPHY AND BILATERAL REPLACEMENT SURGERY ON (B)(6) 2024. THE REPLACEMENT DEVICES WERE: (LEFT) 385CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3507385MC, LOT: 9991940, SN: (B)(6) AND (RIGHT) 385CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3507385MC, LOT: 9991940, SN: (B)(6). THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1376319 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 6723723 00081317004196

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention