BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 11228208 · Received January 25, 2021

    Report

    Report Number
    1645337-2021-00666
    Event Type
    Injury
    Date Received
    January 25, 2021
    Date of Event
    December 14, 2020
    Report Date
    January 13, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000068
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON MARCH 9, 2021, 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. PATIENT'S INITIALS HAVE BEEN UPDATED TO "K.H.G." AS PER PAPERWORK RECEIVED WITH THE DEVICE. THIS SUPPLEMENTAL REPORT IS FOR THE PATIENT¿S SIDE IMPLANTED WITH DEVICE LOT NUMBER 5834739. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021, PHOTO RE-EVALUATION AND DEVICE EVALUATION WAS COMPLETED. UPON VISUAL EVALUATION OF THE IMAGE PROVIDED IN THE COMPLAINT, NO APPARENT DAMAGE OR VISUAL ANOMALIES WERE OBSERVED. MENTOR CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE GEL MOD-RND 225CC BREAST IMPLANT HAD A CREASE/FOLD ON THE ANTERIOR VIEW. MENTOR CONCLUDED THAT THE CAPSULAR CONTRACTURE IN THE PATIENT´S BREAST WAS THE RESULT OF THE BODY´S 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. AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS SUPPLEMENTAL REPORT IS FOR THE PATIENT¿S SIDE IMPLANTED WITH DEVICE LOT NUMBER 5852453. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    UPON VISUAL EVALUATION OF THE IMAGE PROVIDED IN THE COMPLAINT, NO APPARENT DAMAGE OR VISUAL ANOMALIES WERE OBSERVED. MENTOR CONCLUDED THAT THE CAPSULAR CONTRACTURE IN THE PATIENT´S BREAST WAS THE RESULT OF THE BODY´S 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. AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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: CAPSULAR CONTRACTURE; BAKER GRADE III. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH A 225CC MENTOR MEMORYGEL BREAST IMPLANT ON BOTH SIDES AT AN UNKNOWN DATE AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE III. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MEMORY GEL XTRA DEVICES ON (B)(6) 2020. THIS REPORT IS FOR THE PATIENT¿S SIDE IMPLANTED WITH DEVICE LOT NUMBER 5852453.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122650 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3507225BC 5852453 00081317000068

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention