BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 12492835 · Received September 17, 2021

    Report

    Report Number
    1645337-2021-09670
    Event Type
    Injury
    Date Received
    September 17, 2021
    Date of Event
    June 1, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000761
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED VISUAL INSPECTION. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE BREAST IMPLANT HAD AN AREA OF SILTEX CRACKING ON THE POSTERIOR VIEW. THE SILTEX CRACKING AREA HAS A TEAR MEASURING APPROXIMATELY 3 CM. THE EVALUATION DETERMINED THAT THE CAUSE OF THE RUPTURE WAS CONSISTENT WITH NORMAL WEAR. SILTEX CRACKING IS DEFINED AS A MATERIAL SEPARATION OCCURRING IN THE SILTEX LAYER AND CAN EVENTUALLY PROGRESS THROUGH THE SHELL OF SILTEX DEVICES. SILTEX CRACKING IS ULTIMATELY A RESULT OF HIGH STRESS. MENTOR CONCLUDED THAT THE CAPSULAR CONTRACTURE IN THE PATIENTS BREAST WAS THE RESULT OF THE BODYS INDIVIDUAL PHYSIOLOGICAL RESPONSE TO THE IMPLANTATION OF A FOREIGN OBJECT IN SOFT TISSUE. CAPSULAR CONTRACTURE IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. THE AMERICAN SOCIETY OF PLASTIC SURGEONS RECOMMENDS AND ENCOURAGES MEMBER SURGEONS TO ALWAYS SUBMIT BREAST IMPLANTS, CAPSULE, AND EFFUSION TO PATHOLOGY FOR EXAMINATION. IT SHOULD BE NOTED THAT AS PART OF MENTORS QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 210562 NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: CAPSULAR CONTRACTURE/RUPTURE. MANUFACTURERS REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH 700CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED SPONTANEOUS RIGHT BILATERAL RUPTURE ACCOMPANIED BY A DEFORMED NIPPLE POST PROCEDURE. ADDITIONALLY BAKER GRADE IV CAPSULAR CONTRACTURE WAS PRESENT. THE RUPTURE WAS DIAGNOSED THROUGH A PHYSICAL EXAMINATION AND ULTRASOUND. AS A RESULT, EXPLANT AND REPLACEMENT WITH MENTOR GEL WAS PERFORMED ON (B)(6) 2021. THE RIGHT SIDED RUPTURE WAS REPORTED INITIALLY UNDER 1645337-2021-07418 ON JUNE 30, 2021. ON AUGUST 24, 2021 MENTOR RECEIVED ADDITIONAL INFORMATION AND INITIAL AWARENESS OF BILATERAL ISSUES. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1389676 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3547007 210562 00081317000761

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention