BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 19877184 · Received July 31, 2024

    Report

    Report Number
    1645337-2024-08930
    Event Type
    Injury
    Date Received
    July 31, 2024
    Date of Event
    June 26, 2024
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000327
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 04-MAR-2025, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT: - THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT 430CC GEL BREAST PROSTHESES ON (B)(6) 2024. - THE SUSPECT MEDICAL DEVICE IS A MENTOR MEMORYGEL BREAST IMPLANT 400CC GEL BREAST PROSTHESIS, CATALOG #3504001BC, LOT #6459447, SERIAL #(B)(6), PMA #P030053. 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. ON 18-MAR-2025, 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. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: BREAST PROSTHESIS RUPTURE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 16-APR-2025, MENTOR COMPLETED THE INVESTIGATION ON THE SUSPECT MEDICAL DEVICE. DEVICE EVALUATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, THE PATIENT EXPERIENCED A RUPTURE IN THE BREAST IMPLANT. 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 BREAST IMPLANT WAS FOUND TO BE RUPTURED. IN ADDITION, AN AREA OF SHELL ABRASION WAS OBSERVED ON THE EDGES OF THE RUPTURE. 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. 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. NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) IS REQUIRED NOW. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE. 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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS 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. 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 AN UNSPECIFIED MENTOR GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED VIA MAMMOGRAM AND MRI. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884242 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 6457527 00081317000327

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Other| R