BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 23560401 · Received November 14, 2025

    Report

    Report Number
    1645337-2025-12679
    Event Type
    Injury
    Date Received
    November 14, 2025
    Date of Event
    October 23, 2025
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317004387
    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

    ON DECEMBER 11, 2025, MENTOR BECAME AWARE THAT THIS COMPLAINT HAS BEEN IDENTIFIED AS A DUPLICATE OF MANUFACTURER REPORT NUMBER: 1645337-2025-12768, AND 1645337-2025-13072. THIS PC WILL BE UPDATED TO REFLECT ALL OF THE MOST CURRENT AND CORRECT INFORMATION, AND FINAL REPORTING/DOCUMENTATION OF THIS EVENT WILL TAKE PLACE ON THIS PC. PER ADDITIONAL INFORMATION IN THESE PCS, PATIENT RIGHT SIDE IMPLANT DOUBLE IN SIZE; PROCEDURE-BREAST AUGMENTATION PRIMARY; PATIENT AGE AT THE TIME OF THE EVENT 65 YEARS OLD; PATIENT ETHNICITY-NOT HISPANIC/LATINO AND RACE-WHITE. LOT NUMBER ADDED AS 6813564. SERIAL NUMBER UPDATED TO (B)(6). THE PATIENT DEVELOPED LATE ONSET OF SEROMA AND SCHEDULED FOR REMOVAL SURGERY ON (B)(6) 2026. DATE OF EVENT WAS ON OCTOBER 3, 2025. 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

    PER ADDITIONAL INFORMATION RECEIVED ON FEB26, 2026, THE PATIENT ALSO EXPERIENCED RIGHT SIDED IMPLANT SITE CALCIFICATION AND THE IMPLANT POST -OP WAS CLOUDY. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    PER ADDITIONAL INFORMATION RECEIVED ON DECEMBER 17, 2025, THE PATIENT ALSO EXPERIENCED POSSIBLE SILENT RUPTURE AND WILL REPLACE BOTH IMPLANTS TO NON-MENTOR PROSTHESIS. THE MRI WAS INCONCLUSIVE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ACCORDING TO ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 9, 2026, THE PATIENT DEVELOPED A RECURRENT SEROMA OF THE RIGHT BREAST. THE SEROMA WAS DRAINED AND THE FLUID SENT FOR CYTOLOGY, WHICH WAS NEGATIVE FOR MALIGNANCY. ALTHOUGH A RUPTURE OF THE RIGHT IMPLANT WAS INITIALLY REPORTED, THIS WAS NOT CONFIRMED DURING THE BILATERAL EXPLANTATION PERFORMED ON (B)(6) 2026. BOTH THE PREOPERATIVE AND POSTOPERATIVE DIAGNOSES DOCUMENTED ONLY RIGHT BREAST SEROMA AND BREAST PTOSIS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON JANUARY 6, 2026, MENTOR BECAME AWARE THAT FOLLOW UP #:2 FAILED TO UPDATE THE CODING. CORRECTION: PC SERIOUS INJURY AND PEC SILENT RUPTURE (POST-IMPLANT) WERE REMOVED. PC MEDICAL DEVICE REMOVAL AND PEC RUPTURE SYMPTOMATIC (POST-IMPLANT) WERE ADDED. 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. 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: NA. 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).

    Description of Event or Problem · 0

    A FEMALE PATIENT WHO UNDERWENT BREAST SURGERY WITH AN UNKNOWN MENTOR SILICONE PROSTHESIS EXPERIENCES UNKNOWN SIDED SILENT SYMMETRY POST OPERATION. 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
    2563268 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 6813564 00081317004387

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Other| R