BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX ROUND MODERATE PROFILE

    MDR report key: 8227978 · Received January 8, 2019

    Report

    Report Number
    1645337-2019-07826
    Event Type
    Injury
    Date Received
    January 8, 2019
    Date of Event
    December 17, 2018
    Report Date
    December 17, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001751
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED DEVICE EVALUATION SUMMARY: UPON RECEIPT BY MENTOR, THE DEVICE RETURNED WITHOUT FLUID. YELLOW MATERIAL WAS OBSERVED WITHIN THE DEVICE. NO FOREIGN MATERIAL WAS OBSERVED ON THE SHELL SURFACE. MENTOR PRODUCT ANALYSIS LAB DISCOVERED TWO RENTS MEASURING 0.4 CM WITHIN AN AREA OF SILTEX CRACKING ON THE POSTERIOR ASPECT. NO OTHER ANOMALIES WERE DISCOVERED. THE COMPLAINT WAS CONFIRMED SINCE A RUPTURE WAS FOUND ON THE DEVICE. AT THIS POINT IT IS NOT POSSIBLE TO DETERMINE THE ETIOLOGY OF THE YELLOW MATERIAL FOUND ON THE DEVICE. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING. 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 ROOM TEMPERATURE VULCANIZATION (RTV) SHELL OF SILTEX BREAST IMPLANTS. 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: UPON RECEIPT BY MENTOR, THE DEVICE RETURNED WITHOUT FLUID. YELLOW MATERIAL WAS OBSERVED WITHIN THE DEVICE. NO FOREIGN MATERIAL WAS OBSERVED ON THE SHELL SURFACE. MENTOR PRODUCT ANALYSIS LAB DISCOVERED TWO RENTS MEASURING 0.6 CM AND 0.9 CM LOCATED ON THE POSTERIOR ASPECT. NO OTHER ANOMALIES WERE DISCOVERED. THE COMPLAINT WAS CONFIRMED SINCE A RUPTURE WAS FOUND ON THE DEVICE. HOWEVER, AT THIS POINT IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF SUCH DAMAGE OR THE ETIOLOGY OF THE YELLOW MATERIAL FOUND ON THE DEVICE. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING. 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 1/16/2019, 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    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. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, 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. CONCOMITANT MEDICAL PRODUCTS: MENTOR SILTEX ROUND MODERATE PROFILE 275CC, CATALOG NUMBER 3542640, LOT NUMBER 223300. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH A MENTOR SILTEX ROUND MODERATE PROFILE 225CC BREAST IMPLANT AND EXPERIENCED DEFLATION ON THE LEFT SIDE. DEFLATION WAS CONFIRMED BY PHYSICIAN DURING EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22044 MENTOR SILTEX ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5642290 00081317001751

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention