BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 8794199 · Received July 16, 2019

    Report

    Report Number
    1645337-2019-15406
    Event Type
    Injury
    Date Received
    July 16, 2019
    Date of Event
    January 1, 2002
    Report Date
    June 18, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000723
    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 DECEMBER 29, 2023. IN ADDITION TO THE ISSUES REPORTED PREVIOUSLY, THE PATIENT ALSO EXPERIENCED BILATERAL DEVICE MIGRATION, LEFT SIDED RUPTURE, AND BUMPS OVER HER BODY POST PROCEDURE. THE DEVICE HAD MIGRATED TO UNDERNEATH HER ARMPITS. EXPLANT AND REPLACEMENT WAS PERFORMED ON (B)(6) 2023. 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. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: MIGRATION/BREAST PAIN/GRANULOMA. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON FEBRUARY 5, 2024. MENTOR BECAME AWARE THAT THE DEVICE BELONGING TO THIS EVENT WAS ERRONEOUSLY ASSOCIATED WITH THE INCORRECT PRODUCT COMPLAINT. THE DEVICE WAS RETURNED ON (B)(6) 2024. ADDITIONALLY, INFORMATION WAS MADE AVAILABLE INDICATING THAT THE RIGHT SIDED IMPLANT MAY HAVE BEEN RUPTURED. THE INVESTIGATION OF THE RETURNED DEVICE WAS COMPLETED BY THE FAILURE ANALYSIS LAB ON FEBRUARY 15, 2024. DEVICE EVALUATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED VISUAL INSPECTION AND LEAK TESTING OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT NO DAMAGE OR ANOMALIES WERE OBSERVED ON THE BREAST IMPLANT. LEAK TESTING WAS PERFORMED, IN ACCORDANCE WITH MENTOR PROCEDURES, AND NO AREAS OF GEL EXPOSURE WERE DETECTED DURING THE ANALYSIS. ALTHOUGH NO CONCLUSION COULD BE REACHED ON THE CAUSE OF THE REPORTED EVENT, THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING CAUTION: RUPTURE STATUS IDENTIFIED BY MRI EVALUATION INCLUDES BOTH SUSPECTED RUPTURES, WHICH ARE THOSE RUPTURES IDENTIFIED BY MRI BUT NOT CONFIRMED BY EXPLANTATION AND EXAMINATION OF THE DEVICE, AND CONFIRMED RUPTURES, WHICH ARE THOSE RUPTURES THAT ARE CONFIRMED BY EVALUATION OF THE EXPLANTED DEVICES. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE BREAST IMPLANT WAS RETURNED WITHOUT DETECTABLE GEL EXPOSURE. ALTHOUGH NO PRODUCT DEFECT WAS IDENTIFIED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE LABORATORY ANALYSIS. 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 IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: GRANULOMA/PAIN/RUPTURE/DEVICE MIGRATION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    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. 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: N/A. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 450CC MENTOR MEMORYGEL BREAST IMPLANT (RIGHT) AND AN UNKNOWN MENTOR GEL IMPLANT (LEFT) EXPERIENCED BILATERAL PAIN THAT GOES UNDER THE ARM, FOLDING OF THE IMPLANTS, AND SILICONE IN THE LYMPH NODES AROUND THE AXILLARY AREA. IT WAS STATED TO BE WORSE ON THE RIGHT SIDE. SEE 1645337-2019-15405 FOR CONTRALATERAL PROSTHESIS REPORT. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588365 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 209655 00081317000723

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Other| R