BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 16414922 · Received February 21, 2023

    Report

    Report Number
    1645337-2023-01913
    Event Type
    Injury
    Date Received
    February 21, 2023
    Date of Event
    September 9, 2022
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000099
    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

    ADDITIONAL INFORMATION WAS RECEIVED ON MARCH 8, 2023. THE DEVICE, PREVIOUSLY REPORTED AS UNKNOWN GEL, IS A 300CC MENTOR MEMORYGEL BREAST IMPLANT, LOT #1002831, CATALOG #3507300BC. THE IMPACTED PRODUCT WAS RECEIVED BY THE FAILURE ANALYSIS LAB ON (B)(6) 2023. THE INVESTIGATION OF THE IMPACTED PRODUCT WAS COMPLETED BY THE FAILURE ANALYSIS LAB ON (B)(6) 2023. DEVICE EVALUATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED A VISUAL INSPECTION AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE BREAST IMPLANT WAS FOUND TO HAVE A TEAR ON THE ANTERIOR VIEW, MEASURING APPROXIMATELY 2.2 CM EXTENDING TO A MISSING MATERIAL MEASURING APPROXIMATELY 2.2 X 3.2 CM FROM ANTERIOR AND POSTERIOR VIEWS. ADDITIONALLY, AN AREA OF SHELL ABRASION WAS OBSERVED ON THE EDGES OF THE MISSING MATERIAL ON THE ANTERIOR VIEW. A MICROSCOPIC EXAMINATION WAS PERFORMED, AND NO INSTRUMENT DAMAGE WAS OBSERVED AT THE EDGES OF THE TEAR AND THE MISSING MATERIAL. THE EVALUATION DETERMINED THAT THE POSSIBLE CAUSE OF THE RUPTURE 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. AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 1002831 NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE IMPLANT DATE WAS UPDATED BASED ON DEVICE MANUFACTURE DATE OBTAINED. THE IMPLANT DATE WAS UPDATED TO (B)(6) 2004. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE MADE AVAILABLE FOR RETURN. AS A RESULT, 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 REVIEW COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: CAPSULAR CONTRACTURE/RUPTURE. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 52-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH UNKNOWN MENTOR GEL IMPLANTS EXPERIENCED BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE AND RIGHT SIDED RUPTURE POST PROCEDURE. AS A RESULT, RIGHT SIDED REPLACEMENT WITH A 325CC MENTOR MEMORYGEL BREAST IMPLANT AND OPEN CAPSULECTOMY WAS PERFORMED. THE LEFT SIDED DEVICE WAS NOT REMOVED OR REPLACED; HOWEVER, IT IS INDICATED THAT CAPSULECTOMY WAS PERFORMED. THE PATIENT IS FULLY RECOVERED. SEE 1645337-2023-01912 FOR CONTRALATERAL PROSTHESIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1408165 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3507300BC 1002831 00081317000099

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention