BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYSHAPE BREAST IMPLANT

    MDR report key: 19420426 · Received May 29, 2024

    Report

    Report Number
    1645337-2024-06420
    Event Type
    Injury
    Date Received
    May 29, 2024
    Date of Event
    May 3, 2024
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317005346
    PMA / PMN Number
    P060028
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON JULY 30, 2024, MENTOR RECEIVED ADDITIONAL INFORMATION INDICATING THAT THE PATIENT WAS ALSO DIAGNOSED WITH LEFT BREAST IMPLANT RUPTURE DURING THE REMOVAL SURGERY ON (B)(6) 2024. ON AUGUST 12, 2024, MENTOR RECEIVED ADDITIONAL INFORMATION INDICATING THAT THE PATIENT ALSO SUFFERED LEFT BREAST LIPOMA. THE PATIENT UNDERWENT LIPOMA EXCISION AND BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY. THE REPLACEMENT DEVICES WERE: (RIGHT) 430CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SMPB430 LOT: 9990310 SN: (B)(6) AND (LEFT) 430CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SMPB430 LOT: 9981146 SN: (B)(6). ON AUGUST 20, 2024, 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.

    Additional Manufacturer Narrative · 0

    SECTION D 6B. EXPLANTATION DATE: ON (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: DEVICE EXTRUSION 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 AUGUST 28, 2024, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE INVESTIGATION 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 THE MENTOR MEMORYSHAPE¿ MM+ 420CC BREAST IMPLANT HAD AN AREA OF SILTEX CRACKING ON THE POSTERIOR VIEW. 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. EXTRUSION MAY OCCUR WHEN THE WOUND HAS NOT CLOSED OR WHEN TISSUE COVERING THE IMPLANTS WEAKENS. THE INCIDENCE OF EXTRUSION HAS BEEN SHOWN TO INCREASE WHEN UNDUE PRESSURE IS APPLIED ON THE TISSUE LOCATED OVER THE DEVICE, TRAUMA TO SURROUNDING TISSUES MAY LEAD TO THROMBOSIS, DELAYED WOUND HEALING, IMPROPER SIZE, PLACEMENT, LARGER SIZED IMPLANTS, USE OF STEROIDS IN THE SURGICAL POCKET AND MICROWAVE DIATHERMY. RADIATION THERAPY HAS BEEN REPORTED TO INCREASE THE LIKELIHOOD OF EXTRUSION. EXTRUSION MAY REQUIRE ADDITIONAL SURGERY AND POSSIBLE REMOVAL OF THE IMPLANT, WHICH MAY RESULT IN ADDITIONAL SCARRING AND/OR LOSS OF BREAST TISSUE. 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 BREAST AUGMENTATION REVISION WITH TWO 420CC MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST IMPLANTS THAT WERE ALMOST POKING THROUGH THEIR SKIN. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586911 MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 7294958 00081317005346

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention