BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL XTRA BREAST IMPLANT

    MDR report key: 23658452 · Received November 26, 2025

    Report

    Report Number
    1645337-2025-13203
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    April 1, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317025276
    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 30, 2025, MENTOR RECEIVED THE FOLLOWING ADDITIONAL INFORMATION: THE PATIENT WAS REPORTED TO HAVE ALSO EXPERIENCED BREAST IMPLANT ILLNESS, FATIGUE, BRAIN FOG, MUSCLE ACHES, WEAKNESS, SORENESS, HAIR LOSS, DRY SKIN, DRY EYES, TEMPERATURE INTOLERANCE, LOW LIBIDO, AUTOIMMUNE ISSUES, NIGHT SWEATS, ESTROGEN/PROGESTERONE IMBALANCE, MUSCLE TWITCHING, PHOTOSENSITIVITY, EDEMA AROUND THE EYES, PREMATURE AGING, THYROID PROBLEMS, DECLINED CHANGES IN VISION, SLOW MUSCLE RECOVERY AFTER ACTIVITY, GASTROINTESTINAL DIGESTIVE ISSUES, CHEMICAL SENSITIVITIES, PERSISTENT INFECTIONS, CHRONIC INFLAMMATION, RECURRING SINUS, URINARY TRACT INFECTIONS, PANIC ATTACKS, MOOD SWINGS, EMOTIONAL INSTABILITY, AND RINGING IN THE EARS. DURING THE PHYSICAL EXAM SHE WAS ALSO NOTED TO HAVE BOTTOMING OUT AND LATERALIZATION OF BOTH IMPLANTS WITH ASSOCIATED BREAST ASYMMETRY. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: GENERALIZED ILLNESS, MIGRATION. H6. HEALTH EFFECT - CLINICAL CODE E2402: GENERALIZED ILLNESS. ON JANUARY 02, 2026, MENTOR UPDATED THE EVALUATION PER THE NEW INFORMATION RECEIVED. UPDATED DEVICE EVALUATION: IMPLANT DISPLACEMENT/MIGRATION MAY OCCUR FROM IMPROPER IMPLANT SIZING AND/OR PLACEMENT, I.E., WHEN THE IMPLANT IS TOO LARGE OR THE POCKET TOO SMALL OR WHEN THERE HAS BEEN INADEQUATE PREOPERATIVE ASSESSMENT OF STRESSES CAUSING MOVEMENT OF THE PROSTHESIS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON DECEMBER 17, 2025, THE MENTOR ANALYSIS LAB RECEIVED THE SUSPECT MEDICAL DEVICE FOR EVALUATION. ON DECEMBER 29, 2025, MENTOR COMPLETED AN EVALUATION ON THE RETURNED DEVICE. DEVICE EVALUATION: MENTOR CONDUCTED A VISUAL INSPECTION OF THE DEVICE. DURING VISUAL EVALUATION NO APPARENT DAMAGE OR VISUAL ANOMALIES WERE OBSERVED ON THE RETURNED DEVICE. REGARDING THE REPORTED CAPSULAR CONTRACTURE CONDITION, THERE ARE NOT ENOUGH DETAILS TO DETERMINE THE FACTORS THAT MAY HAVE CAUSED THIS CONDITION. CAPSULAR CONTRACTURE IN THE PATIENT¿S BREAST MIGHT BE THE RESULT OF THE BODY¿S INDIVIDUAL PHYSIOLOGICAL RESPONSE TO THE IMPLANTATION OF A FOREIGN OBJECT IN SOFT TISSUE. FURTHER, CAPSULAR CONTRACTURE IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. 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. 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: CAPSULAR CONTRACTURE, EMOTIONAL CHANGES. 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 415CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED PAIN, ANXIETY, AND DISCOMFORT. DURING A CONSULTATION WITH A MEDICAL PROFESSIONAL, SHE WAS DIAGNOSED WITH BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL IMPLANT REMOVAL WITHOUT REPLACEMENTS ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2620406 MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 9451519 00081317025276

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female Required Intervention