BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL XTRA BREAST IMPLANT

    MDR report key: 22917095 · Received August 28, 2025

    Report

    Report Number
    1645337-2025-09624
    Event Type
    Injury
    Date Received
    August 28, 2025
    Date of Event
    March 25, 2025
    Report Date
    August 28, 2025
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    10081317027826
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2025, MENTOR RECEIVED ADDITIONAL INFORMATION INDICATING THAT THE PATIENT'S IMPLANTS WERE REPLACED BILATERALLY WITH TWO MENTOR GEL IMPLANTS.

    Additional Manufacturer Narrative · 0

    ON SEPTEMBER 27, 2025, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. ON OCTOBER 3, 2025, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. DURING VISUAL EVALUATION, NO APPARENT DAMAGE OR VISUAL ANOMALIES WERE OBSERVED ON THE RETURNED DEVICE. REGARDING THE REPORTED CAPSULAR CONTRACTURE CONDITION, THERE ARE NOT ENOUGH DETAILS TO DETERMINE THE FACTORS THAT MAY HAVE CAUSED THIS CONDITION. CAPSULAR CONTRACTURE IN THE PATIENT¿S BREAST MIGHT BE THE RESULT OF THE BODY¿S INDIVIDUAL PHYSIOLOGICAL RESPONSE TO THE IMPLANTATION OF A FOREIGN OBJECT IN SOFT TISSUE. FURTHER, CAPSULAR CONTRACTURE IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET THE CONTRALATERAL DEVICE WAS ALSO RECEIVED (LOT NUMBER 9984152). THE PATIENT DID NOT REPORT ANY ISSUE WITH THIS DEVICE. THEREFORE, NO FURTHER ANALYSIS OF THE CONTRALATERAL DEVICE IS REQUIRED. AS PART OF MENTOR'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED ACCORDING TO APPROVED SPECIFICATIONS. BASED ON THE RESULTS OF THIS INVESTIGATION, IT WAS DETERMINED THAT THE PRODUCT MET THE MANUFACTURING RELEASE CRITERIA: SINCE NO MALFUNCTION WAS OBSERVED DURING THE INVESTIGATION. NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) IS REQUIRED NOW.

    Additional Manufacturer Narrative · 0

    SECTION D 6B. EXPLANTATION DATE: ON (B)(6) 2025. 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. 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. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: CAPSULAR CONTRACTURE. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 310CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT DEVELOPED RIGHT BREAST PAIN AND HARDENING. SHE WAS DIAGNOSED WITH RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III). AS A RESULT, THE PATIENT HAS BEEN TAKING IBUPROFEN AND MONTELUKAST AND HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240289 MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 9965035 10081317027826

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Required Intervention