BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX ROUND MODERATE PROFILE

    MDR report key: 8360375 · Received February 21, 2019

    Report

    Report Number
    1645337-2019-08773
    Event Type
    Injury
    Date Received
    February 21, 2019
    Date of Event
    January 15, 2019
    Report Date
    January 23, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001782
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2019, MENTOR BECAME AWARE THAT THE PATIENT¿S AGE AND DATE OF BIRTH WERE REPORTED INCORRECTLY IN THE INITIAL REPORT. THESE FIELDS HAVE BEEN UPDATED. ADDITIONALLY, THE DEVICE EVALUATION WAS COMPLETED. DEVICE EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO MENTOR WITHOUT FLUID INSIDE. BLACK, WHITE, YELLOW AND BROWN MATERIAL WAS OBSERVED WITHIN THE DEVICE. WHITE, YELLOW AND BLUE MATERIAL WAS OBSERVED ON THE SHELL SURFACE. MENTOR PRODUCT ANALYSIS LAB DISCOVERED A RENT MEASURING APPROXIMATELY 0.4 CM WITH NO INSTRUMENT DAMAGE UNDER MICROSCOPIC EXAMINATION AND AN AREA OF SILTEX CRACKING LOCATED ON THE POSTERIOR ASPECT. NO OTHER ANOMALIES WERE DISCOVERED. THE COMPLAINT WAS CONFIRMED SINCE A RUPTURE WAS FOUND ON THE DEVICE. NONETHELESS, A MICROSCOPIC EXAMINATION OF THE EDGES OF THE RENT WAS PERFORMED AND IT DID NOT PROVIDE CONCLUSIVE EVIDENCE OF WHAT COULD BE THE ROOT CAUSE. A MANUFACTURING RECORD EVALUATION (MRE) OF LOT NUMBER 102293 WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. AT THIS POINT IS NOT POSSIBLE TO DETERMINE THE ETIOLOGY OF THE BLACK, WHITE, YELLOW, BLUE AND BROWN MATERIAL FOUND ON THE DEVICE. THERE IS NO EVIDENCE THAT THE ISSUES ARE RELATED TO 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. THE SEVERITY LEVEL FOR THIS COMPLAINT CODE WAS DETERMINED TO BE A S3, WHICH IS DEFINED AS: NECESSITATES INTRUSIVE MEDICAL OR SURGICAL INTERVENTION. BREAST IMPLANTS ARE NOT CONSIDERED LIFETIME DEVICES, AND DEFLATION IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AS REFERENCED IN OUR PRODUCT INSERT DATA SHEET. ADDITIONALLY, MENTOR PRODUCT ANALYSIS LAB CONCLUDED THE REPORTED COMPLAINT OF 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 ALSO A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS SIMILARLY REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. MANUFACTURER¿S REFERENCE NUMBER: (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 MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A SALINE MENTOR SILTEX ROUND MODERATE PROFILE 300CC AND EXPERIENCED DEFLATION ON THE LEFT BREAST IMPLANT AND BILATERAL CAPSULAR CONTRACTURE WITH BAKER GRADE III. THE DEFLATION WAS CONFIRMED BY PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT REMOVAL OF THE IMPLANTS ON (B)(6) 2019. THIS IS FOR THE LEFT SIDE IMPLANT, SEE MANUFACTURER REPORT NUMBER 1645337-2019-08774 FOR CONTRALATERAL PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152689 MENTOR SILTEX ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 102293 00081317001782

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention