BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAL SILTEX RND DIAP PKG 425CC

    MDR report key: 8103983 · Received November 26, 2018

    Report

    Report Number
    1645337-2018-07017
    Event Type
    Injury
    Date Received
    November 26, 2018
    Date of Event
    November 1, 2018
    Report Date
    November 1, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001829
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED ON (B)(6) 2018, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE EVALUATION OF THE RETURNED DEVICE WAS COMPLETED BY THE FAILURE ANALYSIS LAB ON (B)(6) 2018. IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SILTEX ROUND MODERATE PROFILE 425CC SALINE PROSTHESIS. ON (B)(6) 2018 LEFT SIDED DEFLATION WAS DIAGNOSED BY A PHYSICIAN. UPON RECEIPT TO MENTOR, THE DEVICE CONTAINED NO FLUID. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE. YELLOW MATERIAL WAS OBSERVED ON THE SHELL SURFACE. VISUAL EVALUATION OF THE DEVICE REVEALED A RENT WITHIN AN AREA OF SILTEX CRACKING ON THE POSTERIOR VIEW MEASURING APPROXIMATELY 0.5 CM. PARALLEL LINES OF SHELL WEAR WERE ALSO OBSERVED EXTENDING TO BOTH ASPECTS, SUGGESTING IN-VIVO FOLDING OR CREASING OF THE DEVICE. NO OTHER ANOMALIES WERE FOUND. MENTOR PRODUCTS ARE 100% VISUALLY INSPECTED PRIOR TO RELEASE IN ADDITION TO THOROUGH IN-PROCESS TESTING DURING SEVERAL STAGES OF THE MANUFACTURING PROCESS. THE MENTOR PRODUCT ANALYSIS LAB CONCLUDED THAT THE RENT, SILTEX CRACKING, AND SHELL WEAR OCCURRED SOMETIME SUBSEQUENT TO THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. THE COMPLAINT OF DEFLATION WAS CONFIRMED SINCE A RENT WAS FOUND ON THE DEVICE. HOWEVER, AT THIS POINT IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF SUCH DAMAGE OR THE ORIGIN OF THE YELLOW MATERIAL OBSERVED. SILTEX CRACKING IS DEFINED AS A MATERIAL SEPARATION OCCURRING IN THE SILTEX LAYER AND CAN EVENTUALLY PROGRESS THROUGH THE SHELL OF SILTEX DEVICES. MENTOR BELIEVES THAT SILTEX CRACKING IS ULTIMATELY A RESULT OF HIGH STRESSES CAUSED BY ACUTE FOLDS (I.E., SEVERE ¿V¿ OR TIGHT FOLDS) IN THE RTV SHELL OF SILTEX BREAST IMPLANTS. NO CORRECTIVE ACTION IS REQUIRED SINCE THERE IS NO EVIDENCE THAT THE FAILURES MODES ARE RELATED WITH MANUFACTURING OR PRODUCT DESIGN. BREAST IMPLANTS ARE NOT CONSIDERED LIFETIME DEVICES AND DEFLATION IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR PRODUCT INSERT DATA SHEET. (B)(4).

    Additional Manufacturer Narrative · 1

    THE MENTOR FAILURE ANALYSIS LAB HAS 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. A DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: MENTOR SILTEX ROUND MODERATE PROFILE 425CC SALINE PROSTHESIS, CATALOG #3542670, LOT #222619. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SILTEX ROUND MODERATE PROFILE 425CC SALINE PROSTHESIS. ON (B)(6) 2018 LEFT SIDED DEFLATION WAS DIAGNOSED BY A PHYSICIAN. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940747 SAL SILTEX RND DIAP PKG 425CC PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 222619 00081317001829

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention