BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GEL IMPLANTS

    MDR report key: 24326597 · Received February 12, 2026

    Report

    Report Number
    1645337-2026-01534
    Event Type
    Injury
    Date Received
    February 12, 2026
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE NUMBER: (B)(6). D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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 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

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: PARK TH, MOON JS, KANG B, LEE J, PARK HY, RYU JY, CHOI KY, YANG JD, CHUNG HY, LEE JS. CONSIDERING FACTORS FOR DECIDING BETWEEN SUBPECTORAL AND PREPECTORAL PLANES IN DIRECT-TO-IMPLANT BREAST RECONSTRUCTION. J CLIN MED. 2025 DEC 23;15(1):109. DOI: 10.3390/JCM15010109. PMID: 41517359; PMCID: PMC12787154. THE AIM OF THIS STUDY WAS TO SUMMARIZE THE PRINCIPLES FOR SELECTING BETWEEN THE SUBPECTORAL AND PREPECTORAL PLANES IN SINGLE-STAGE DIRECT-TO-IMPLANT BREAST RECONSTRUCTION (DTIBR). IN THIS RETROSPECTIVE STUDY, WE EVALUATED 543 PATIENTS WITH BREAST CANCER WHO UNDERWENT DTIBR BETWEEN (B(6) 2018 AND (B)(6) 2025. LOT, MODEL AND CATALOG NUMBERS ARE NOT AVAILABLE, BUT THE SUSPECTED MENTOR DEVICES POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: MENTOR SMOOTH ROUND HIGH PROFILE, MENTOR MODERATE PLUS. CONCOMITANT: SEBBIN (GROUPE SEBBIN SAS), NATRELLE (ALLERGAN), BELLAGEL (HANSBIOMED), POLYTECH (POLYTECH HEALTH & AESTHETICS). THE FOLLOWING COMPLICATIONS HAVE BEEN REPORTED: QTY 12: CAPSULAR CONTRACTURE QTY 15: INFECTION QTY 18: BREAST IMPLANT RUPTURE QTY 12: SKIN NECROSIS QTY 26: CHRONIC SEROMA OR HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384914 UNKNOWN GEL IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other