BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX CONTOUR PROFILE HIGH

    MDR report key: 11675812 · Received April 15, 2021

    Report

    Report Number
    1645337-2021-04105
    Event Type
    Injury
    Date Received
    April 15, 2021
    Date of Event
    December 17, 2020
    Report Date
    March 17, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001942
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR THEN CONDUCTED A VISUAL INSPECTION AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT A TEAR WAS FOUND ON THE POSTERIOR ASPECT OF THE BREAST IMPLANT (SAL SILT CONTR DIAP PKG 650CC), MEASURING APPROXIMATELY 2.2 CM. MICROSCOPIC EXAMINATION WAS PERFORMED ON THE EDGES OF THE RUPTURE, AND PARALLEL STRIATIONS WERE FOUND IN THE WHOLE AREA OF THE TEAR. PARALLEL STRIATIONS ARE CONSISTENT WITH MARKINGS MADE BY A SHARP OBJECT PERFORATING THE IMPLANT SHELL. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. BASED ON THE INFORMATION CURRENTLY AVAILABLE, A MICROSCOPIC EXAMINATION OF THE RETURNED PRODUCT INDICATES THAT THE IMPLANT COULD HAVE BEEN DAMAGED DURING OR SUBSEQUENT TO IMPLANTATION. THE PRODUCT INSERT DATA SHEET CAUTIONS TO NOT ALLOW CAUTERY DEVICES OR SHARP INSTRUMENTS, SUCH AS SCALPELS, SUTURE NEEDLES, HYPODERMIC NEEDLES, HEMOSTATS, ADSON FORCEPS, OR SCISSORS TO CONTACT THE DEVICE DURING THE IMPLANTATION OR OTHER SURGICAL PROCEDURES. AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 6978164 NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: DEFLATION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH 650CC TEXTURED MENTOR SILTEX CONTOUR PROFILE HIGH SALINE BREAST IMPLANT EXPERIENCED RIGHT-SIDED IMPLANT DEFLATION POSTOPERATIVELY. THE PATIENT REPORTED THAT THE IMPLANT IS OCCASIONALLY PALPABLE WITH THE VALVE STICKING OUT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH NON-MENTOR (ALLERGAN) BREAST IMPLANTS ON (B)(6) 2021. UPON EXPLANTATION, THE RIGHT BREAST IMPLANT WAS CONFIRMED TO BE DEFLATED, AND THE LEFT BREAST IMPLANT WAS INTACT. THE MENTOR FAILURE ANALYSIS LAB RECEIVED TWO DEVICES FOR EVALUATION, AND IN THE ABSENCE OF CLARIFYING INFORMATION, IT CANNOT BE DETERMINED WHICH DEVICE IS THE SUSPECT MEDICAL DEVICE FOR THE REPORTED ADVERSE EVENT. AS A RESULT, THE SECOND DEVICE RECEIVED WILL BE CONSERVATIVELY REPORTED TO FDA. THIS MEDWATCH REPORT IS FOR THE SECOND OF TWO IMPLANTS. REFER TO MANUFACTURER REPORT NUMBER 1645337-2021-02073 FOR THE FIRST OF TWO IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566883 MENTOR SILTEX CONTOUR PROFILE HIGH PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3542715 6978164 00081317001942

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention