BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 16323540 · Received February 8, 2023

    Report

    Report Number
    1645337-2023-01074
    Event Type
    Injury
    Date Received
    February 8, 2023
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001256
    PMA / PMN Number
    P990075
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON FEBRUARY 15, 2023, 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. AS PER ONE DEVICE RECEIVED, AND AFTER MULTIPLE ATTEMPTS OF CLARIFICATION AND NO CLEAR RESPONSE RECEIVED, THE FOLLOWING UPDATES HAVE BEEN MADE TO THIS FORM: DATE OF IMPLANT STILL IS NOT CLEAR SO REMAINS SOMETIME IN 2015 THE DEVICE RECEIVED INFORMATION IS UPDATED FOR THE LEFT SIDE SINCE THE LOT NUMBER RECEIVED 6953394 WAS CLOUDY FIELD D1 FOR BRAND NAME HAS BEEN UPDATED TO "MENTOR SMOOTH ROUND MODERATE PROFILE" FIELD D4 FOR CATALOG NUMBER HAS BEEN UPDATED TO "3501650" FIELD D4 FOR LOT NUMBER HAS BEEN UPDATED TO "6953394" FIELD D4 FOR UNIQUE IDENTIFIER( UDI) HAS BEEN UPDATED TO "(B)(4)." 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. IF ANY ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE, IT WILL BE DOCUMENTED AND SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS SUPPLEMENTAL MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: LEFT DEVICE MOLD, CAPSULAR CONTRACTURE; BAKER GRADE IV, AND GENERALIZED ILLNESS. HEALTH EFFECT - CLINICAL CODE E2402: GENERALIZED ILLNESS. MENTOR IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH MENTOR HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, MENTOR, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MENTOR, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF CERTAIN INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON MAY 1, 2023, DEVICE EVALUATION WAS COMPLETED. DEVICE EVALUATION SUMMARY: MENTOR CONDUCTED A VISUAL INSPECTION, LEAK TESTING, AND MATERIAL EVALUATION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT WAS FOUND TO HAVE WHITE MATERIAL INSIDE THE SAL SMOOTH RND DIAP 325CC BREAST IMPLANT. LEAK TESTING WAS PERFORMED, IN ACCORDANCE WITH MENTOR PROCEDURES, AND NO LEAK SITES WERE DETECTED DURING THE ANALYSIS. ADDITIONAL INVESTIGATION WAS PERFORMED TO IDENTIFY THE CHEMICAL COMPOSITION OF THE WHITE MATERIAL OBSERVED WITHIN THE SAL SMOOTH RND DIAP 325CC. THE INVESTIGATION CONCLUDED THAT IT IS PRIMARILY COMPOSED OF LANOLIN SPECTRUM REFERENCE. LANOLIN IS A COMPLEX MIXTURE OF HIGH MOLECULAR MASS LIPIDS, INCLUDING FATTY ACIDS AND ALCOHOLS, STEROLS, HYDROXY ACIDS, DIOLS, AND ALIPHATIC AND STEARYL ESTERS. LANOLIN IS WIDELY USED IN COSMETIC AND PHARMACEUTICAL FORMULATIONS. THE MOLD COMPOSITION CAN BE RULED OUT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE MENTOR MICROBIOLOGY DEPARTMENT PROVIDED THE STERILITY ASSURANCE RECORDS OF THE IMPLANTED DEVICE. THE LOT MET ALL THE STERILIZATION PARAMETERS REQUIRED TO PROVIDE STERILITY ASSURANCE PRIOR TO RELEASE FOR DISTRIBUTION. 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. THE AMERICAN SOCIETY OF PLASTIC SURGEONS RECOMMENDS AND ENCOURAGES MEMBER SURGEONS TO ALWAYS SUBMIT BREAST IMPLANTS, CAPSULE, AND EFFUSION TO PATHOLOGY FOR EXAMINATION. AT THE PRESENT TIME, THERE IS NO SUFFICIENT EVIDENCE TO SHOW AN ASSOCIATION BETWEEN BREAST IMPLANTS AND GENERALIZED ILLNESS (ASSESSING THE RISKS OF BREAST IMPLANTS AND FDA¿S VISION FOR THE NATIONAL BREAST IMPLANT REGISTRY). AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. CAPA ACTIVITY WAS NOT REQUIRED. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. THIS SUPPLEMENTAL MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 41-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH UNKNOWN SIZE UNKNOWN SALINE IMPLANT SMOOTH ON THE LEFT SIDE, AND WITH 325CC MENTOR SMOOTH ROUND MODERATE PROFILE ON THE RIGHT SIDE AND EXPERIENCED LEFT SIDE CAPSULAR CONTRACTURE; BAKER GRADE IV, LEFT MOLDY DEVICE, AND GENERALIZED ILLNESS SYMPTOMS INCLUDING ITCHING, PAIN, AND HEAVINESS POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL ONLY SURGERY ON (B)(6) 2023. IT WAS REPORTED THAT PATIENT'S SYMPTOMS IMPROVED AFTER SURGERY. DUE MULTIPLE ATTEMPTS WERE PERFORMED AND NO MORE INFORMATION IS AVAILABLE, THE DATE OF EVENT AND DATE OF IMPLANT IS LEFT BLANK ON THIS FORM SINCE THE ONLY INFORMATION THAT WAS PROVIDED WAS THE YEAR 2015. SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2315768 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3501650 6953394 00081317001256

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention