BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 19106647 · Received April 15, 2024

    Report

    Report Number
    1645337-2024-04485
    Event Type
    Injury
    Date Received
    April 15, 2024
    Date of Event
    January 26, 2024
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000471
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON APRIL 29, 2024, MENTOR RECEIVED ADDITIONAL INFORMATION INDICATING THAT THE PATIENT WAS ALSO DIAGNOSED WITH LEFT BREAST IMPLANT BOTTOMING OUT AND MALPOSITION. THE PATIENT'S IMPLANTS WERE REPLACED BILATERALLY WITH THE FOLLOWING: (RIGHT) 290CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SMPB290 LOT: 9962152 SN: (B)(6) AND (LEFT) 290CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SMPB290 LOT: 9939502 SN: (B)(6). ON (B)(6) 2024, AN ANALYSIS OF THE SUSPECT MEDICAL DEVICE¿S PHOTO WAS COMPLETED. INVESTIGATION SUMMARY: UPON VISUAL EVALUATION OF THE IMAGE PROVIDED IN THE COMPLAINT NO APPARENT DAMAGE OR VISUAL ANOMALIES WERE OBSERVED. 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. 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. ASYMMETRY MAY BE ATTRIBUTED TO ONE OR MORE OF THE FOLLOWING: CONTRACTURE OF THE FIBROUS CAPSULE, SEROMA OR HEMATOMA, DEVELOPMENT OF POSTOPERATIVE BREAST DYSPLASIA, UNILATERAL DISCREPANCY IN MUSCLE DEVELOPMENT, DEFLATION OF THE IMPLANT, INCORRECT CHOICE OF IMPLANT SHAPE OR SIZE, AND SURGICAL TECHNIQUE. ASYMMETRY 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. SINCE NO MALFUNCTION WAS OBSERVED DURING THE INVESTIGATION, 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: PTOSIS. 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 (B)(6) 2024, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. ON (B)(6) 2024, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. DURING VISUAL EVALUATION, NO APPARENT DAMAGE OR VISUAL ANOMALIES WERE OBSERVED ON THE SMOOTH HPG, 325CC 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. ASYMMETRY MAY BE ATTRIBUTED TO ONE OR MORE OF THE FOLLOWING: CONTRACTURE OF THE FIBROUS CAPSULE, SEROMA OR HEMATOMA, DEVELOPMENT OF POSTOPERATIVE BREAST DYSPLASIA, UNILATERAL DISCREPANCY IN MUSCLE DEVELOPMENT, DEFLATION OF THE IMPLANT, INCORRECT CHOICE OF IMPLANT SHAPE OR SIZE, AND SURGICAL TECHNIQUE. ASYMMETRY IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. 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. SINCE NO MALFUNCTION WAS OBSERVED DURING THE INVESTIGATION, NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) IS REQUIRED NOW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO MENTOR MEMORYGEL BREAST IMPLANTS POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III) AND BILATERAL BREAST PTOSIS. THE PATIENT WAS ALSO DIAGNOSED WITH ASYMMETRY, BREAST SCARS, DROOPY BREASTS, AND HARDENING OF THE RIGHT BREAST. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS. COMPLICATIONS ON THE RIGHT BREAST HAVE BEEN REPORTED UNDER MRN: 1645337-2024-02290.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1375921 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 6984469 00081317000471

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Required Intervention