BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 22518918 · Received July 16, 2025

    Report

    Report Number
    1645337-2025-07819
    Event Type
    Injury
    Date Received
    July 16, 2025
    Date of Event
    April 11, 2025
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPON CLINICAL REVIEW PERFORMED ON JUL 16, 2025, H6. HEALTH EFFECT - CLINICAL CODE E0308 (SWOLLEN LYMPH NODES/GLANDS) HAS BEEN ADDED AND E1403 (BREAST MASS) HAS BEEN REMOVED. ON JUL 16, 2025, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE REPLACEMENT DEVICES WERE MENTOR GEL BREAST IMPLANTS (SERIAL NUMBERS (B)(6)). ON JUL 21, 2025, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE IMPACTED PRODUCT WAS IDENTIFIED AS A MENTOR MEMORYGEL BREAST IMPLANT, CATALOG NUMBER 3542757, LOT NUMBER 5935469. 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. DEVICE EVALUATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE BREAST IMPLANT HAD A TEAR ON THE POSTERIOR VIEW, MEASURING 3.5 CM APPROXIMATELY, WITHIN AN AREA OF SILTEX CRACKING. THE EVALUATION DETERMINED THAT THE POSSIBLE CAUSE OF THE RUPTURE IS CONSISTENT WITH NORMAL WEAR. SILTEX CRACKING IS DEFINED AS A MATERIAL SEPARATION OCCURRING IN THE SILTEX LAYER AND CAN EVENTUALLY PROGRESS THROUGH THE SHELL OF SILTEX DEVICES. SILTEX CRACKING IS ULTIMATELY A RESULT OF HIGH STRESSES. LYMPHADENOPATHY OR PALPABLE LYMPH NODES MAY BE THE RESULT OF BACTERIAL OR VIRAL INFECTION, NEOPLASM (PRIMARY OR METASTATIC), OR AS THE RESULT OF AN IDIOPATHIC INFLAMMATORY PROCESS OR FOREIGN BODY REACTION. THERE HAVE BEEN REPORTS REGARDING MOVEMENTS OF SILICONE GEL MATERIAL TO LYMPH NODES EVEN WITH OR WITHOUT EVIDENT OF RUPTURE LEADING TO LYMPHADENOPATHY. A NUMBER OF EPIDEMIOLOGY STUDIES HAVE EVALUATED LARGE POPULATIONS OF WOMEN WITH BREAST IMPLANTS FROM A VARIETY OF MANUFACTURERS AND IMPLANT MODELS. THE STUDIES DO NOT, TAKEN TOGETHER, SUPPORT AN ASSOCIATION OF BREAST IMPLANTS AND A DIAGNOSED RHEUMATIC DISEASE. OTHER THAN ONE STUDY, THESE STUDIES DO NOT DISTINGUISH WHETHER THE WOMEN HAD RUPTURED OR INTACT IMPLANTS. BECAUSE THERE WERE NO SUPPORTING PATHOLOGY REPORTS OR PHYSICIAN CONSULTATION SUMMARIES FORWARDED TO PRODUCT EVALUATION, WE ARE UNABLE TO CONFIRM THE PRESENCE OF OR THE POSSIBLE ETIOLOGY OF THE REPORTED LYMPHADENOPATHY. LYMPHADENOPATHY IS A KNOWN COMPLICATION ASSOCIATED WITH THIS SURGERY AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. 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).

    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. 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 CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: RUPTURE, BREAST MASS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH UNSPECIFIED MENTOR GEL BREAST IMPLANTS EXPERIENCED RUPTURE ALONG WITH A LUMP UNDER HER ARM ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539881 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 5935469

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention