BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND HIGH PROFILE

    MDR report key: 23700458 · Received December 2, 2025

    Report

    Report Number
    1645337-2025-13377
    Event Type
    Injury
    Date Received
    December 2, 2025
    Date of Event
    August 1, 2009
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 06-DEC-2025, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT: - THE SUSPECT MEDICAL DEVICE IS A MENTOR SMOOTH ROUND HIGH PROFILE 380CC SALINE BREAST PROSTHESIS, CATALOG # 3503380, PMA # P990075. TWO LOT NUMBERS WERE REPORTED: 5793977 & 5777021. IT IS CURRENTLY UNKNOWN WHICH LOT NUMBER BELONGS TO THE LEFT BREAST IMPLANT, AND WHICH LOT NUMBER BELONGS TO THE RIGHT IMPLANT. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED ON BOTH LOT NUMBERS, 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. - THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2025. ON 17-DEC-2025, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT. AN IMPLANTATION DATE (B)(6) 2008) WAS PROVIDED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: GENERALIZED ILLNESS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE MADE AVAILABLE FOR RETURN. AS A RESULT, 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 REVIEW COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: N/A. H6 HEALTH EFFECT - CLINICAL CODE E2402: GENERALIZED ILLNESS. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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 05-JAN-2026, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT. IT WAS CLARIFIED THAT LOT #5777021 CORRESPONDS TO PATIENT¿S LEFT BREAST PROSTHESIS AND LOT #5793977 CORRESPONDS TO PATIENT¿S LEFT BREAST PROSTHESIS. THE FIELD IN BLOCK D HAS BEEN UPDATED ACCORDINGLY. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH UNSPECIFIED MENTOR SMOOTH SALINE BREAST PROSTHESES AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING BRAIN FOG, DRY EYES AND MOUTH, METALLIC TASTE, FATIGUE, WEIGHT GAIN, HAIR LOSS, BACK PAIN, SHARP PAINS IN CHEST AND AROUND BREAST IMPLANT, HORMONAL IMBALANCE, AND SHORTNESS OF BREATH. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1900217 MENTOR SMOOTH ROUND HIGH PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5793977

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female Required Intervention| O