BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 20921209 · Received December 12, 2024

    Report

    Report Number
    1645337-2024-14566
    Event Type
    Injury
    Date Received
    December 12, 2024
    Date of Event
    September 29, 2023
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317003823
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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 DECEMBER 23, 2024, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. ON DECEMBER 30, 2024, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED A VISUAL INSPECTION, MICROSCOPIC EXAMINATION, AND THICKNESS MEASUREMENT OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE SM MPP GEL 525CC BREAST IMPLANT WAS FOUND TO HAVE A TEAR ON THE POSTERIOR MEASURING APPROXIMATELY 12.4 CM. A MICROSCOPIC EXAMINATION WAS PERFORMED, AND THE CAUSE OF THE TEAR COULD NOT BE IDENTIFIED. THEREFORE A THICKNESS MEASUREMENT WAS CONDUCTED ON THE SHELL AT THE TEAR, AND THE THICKNESS WAS WITHIN MANUFACTURING SPECIFICATIONS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. ALTHOUGH NO CONCLUSION COULD BE REACHED ON THE CAUSE OF THE REPORTED TEAR FOUND, THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING CAUTION: RUPTURE CAN OCCUR AT ANY TIME AFTER IMPLANTATION, BUT IT IS MORE LIKELY TO OCCUR THE LONGER THE IMPLANT IS IMPLANTED. THE FOLLOWING THINGS MAY CAUSE IMPLANT TO RUPTURE: DAMAGE BY SURGICAL INSTRUMENTS; STRESSING THE IMPLANT DURING IMPLANTATION AND WEAKENING IT; FOLDING OR WRINKLING OF THE IMPLANT SHELL; EXCESSIVE FORCE TO THE CHEST (E.G. DURING CLOSED CAPSULOTOMY); TRAUMA; COMPRESSION DURING MAMMOGRAPHIC IMAGING; AND SEVERE CAPSULAR CONTRACTURE. BREAST IMPLANTS MAY ALSO SIMPLY 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 525CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MRI, WITH LEFT BREAST IMPLANT RUPTURE. THE PATIENT ALSO SUFFERED BILATERAL BREAST PTOSIS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2024. THE REPLACEMENT DEVICES WERE: (LEFT) 595CC MENTOR MEMORYGEL XTRA BREAST IMPLANT CATALOG: SHPX595 LOT: 9900390 SN: (B)(6) AND (RIGHT) 595CC MENTOR MEMORYGEL XTRA BREAST IMPLANT CATALOG: SHPX595 LOT: 9993157 SN: (B)(6). THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1856995 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 6845451 00081317003823

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Required Intervention