BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 21094421 · Received January 7, 2025

    Report

    Report Number
    1645337-2025-00231
    Event Type
    Injury
    Date Received
    January 7, 2025
    Date of Event
    November 7, 2024
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000266
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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. SINCE THE DEVICE WITH LOT NUMBER 5842327 WAS RECEIVED RUPTURED AND THE DEVICE WITH LOT NUMBER 5834420 WAS RECEIVED INTACT, THE FOLLOWING UPDATES WERE MADE: THE LOT NUMBER 5842327 WAS ADDED, AND THE CONCOMITANT PRODUCT WAS UPDATED TO REFLECT THE LEFT LOT NUMBER 5834420. THE MANUFACTURING RECORD EVALUATION (MRE) 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. 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: SILENT RUPTURE. 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. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED ON JANUARY 14, 2025, INDICATED THAT THE PATIENT UNDERWENT BILATERAL REPLACEMENTS WITH ALLERGAN PROSTHESIS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION COMPLETED ON FEBRUARY 06, 2025: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE SM MPP GEL 250CC BREAST IMPLANT WAS FOUND TO HAVE A TEAR ON THE POSTERIOR VIEW MEASURING APPROXIMATELY 6.2 CM. ADDITIONALLY, AN AREA OF SHELL ABRASION WAS OBSERVED ON THE EDGES OF THE TEAR. THESE FINDINGS ARE CONSISTENT WITH NORMAL WEAR OF THE DEVICE. SHELL ABRASION SUGGESTS IN-VIVO FOLDING OR CREASING OF THE DEVICE, WHICH MAY BE CAUSED BY CONTINUOUS AND SUSTAINED STRESSES TO THE DEVICE, SUCH AS AN EXCESSIVELY SMALL BREAST POCKET OR THE FOLDING OR WRINKLING OF THE SHELL WITHIN THE BREAST POCKET. IN SOME CASES, BREAST IMPLANTS MAY ALSO EXPERIENCE NORMAL WEAR OVER TIME. THE CONTRALATERAL DEVICE WAS ALSO RECEIVED (LOT NUMBER 5834420). 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 AND THAT NORMAL WEAR MAY HAVE CAUSED THE OBSERVED DEFECT. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    A REPORT HAS BEEN SUBMITTED CONCERNING A FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE UTILIZING AN UNKNOWN MENTOR SILICONE PROSTHESIS, DURING WHICH SHE EXPERIENCED RIGHT-SIDED SILENT RUPTURE POSTOPERATIVELY, DIAGNOSED THROUGH AN MRI EXAMINATION. CONSEQUENTLY, THE PATIENT HAS SCHEDULED REMOVAL SURGERY FOR (B)(6) 2025, TO ADDRESS THE IDENTIFIED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1235506 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 5842327 00081317000266

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention