BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 24157303 · Received January 22, 2026

    Report

    Report Number
    1645337-2026-00764
    Event Type
    Injury
    Date Received
    January 22, 2026
    Date of Event
    December 29, 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

    ON JANUARY 20, 2026, MENTOR RECEIVED ADDITIONAL INFORMATION THAT INDICATED THAT THE PATIENT WAS ALSO DIAGNOSED WITH LEFT BREAST WOUND DEHISCENCE. ON FEBRUARY 9, 2026, 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. PER THE RETURNED DEVICES, MENTOR BECAME AWARE THAT THE SUSPECT MEDICAL DEVICES WERE: (LEFT) 425CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3504254BC LOT: 9991535 AND (RIGHT) 375CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3503754BC LOT: 9925030. A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ON FEBRUARY 13, 2026, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR THEN CONDUCTED VISUAL INSPECTION, LEAK TESTING AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED DEVICE DETERMINED THAT THE BREAST IMPLANT DID NOT SHOW ANY APPARENT DAMAGE. LEAK TESTING WAS PERFORMED, IN ACCORDANCE WITH MENTOR PROCEDURES, AND A TEAR WAS IDENTIFIED IN THE POSTERIOR ASPECT OF THE BREAST IMPLANT, MEASURING APPROXIMATELY 0.5CM. MICROSCOPIC EXAMINATION WAS PERFORMED ON THE EDGES OF THE RUPTURE, AND PARALLEL STRIATIONS WERE FOUND IN AN AREA OF THE TEAR ON THE POSTERIOR ASPECT, MEASURING APPROXIMATELY 0.2 CM. PARALLEL STRIATIONS ARE CONSISTENT WITH MARKINGS MADE BY A SHARP OBJECT PERFORATING THE IMPLANT SHELL. THE CAUSE OF THE RUPTURE IN THE REMAINING AREA OF THE TEAR COULD NOT BE IDENTIFIED. MENTOR ALSO PERFORMED A MANUFACTURING RECORD EVALUATION RELATED TO THE REPORTED COMPLAINT FOR THE FINISHED DEVICE LOT NUMBER. NO MANUFACTURING NON-CONFORMANCES WERE IDENTIFIED AS PART OF THIS EVALUATION. WOUND DEHISCENCE IS A SURGICAL COMPLICATION IN WHICH A WOUND RUPTURES ALONG A SURGICAL INCISION. RISK FACTORS INCLUDE AGE, COLLAGEN DISORDERS, DIABETES, OBESITY, POOR KNOTTING OR GRABBING OF STITCHES, AND TRAUMA TO THE WOUND AFTER SURGERY. SYMPTOMS OF DEHISCENCE CAN INCLUDE BLEEDING, PAIN, INFLAMMATION, FEVER, OR THE WOUND OPENING SPONTANEOUSLY. A PRIMARY CAUSE OF WOUND DEHISCENCE IS SUB-ACUTE INFECTION, RESULTING FROM INADEQUATE OR IMPERFECT ASEPTIC TECHNIQUE. DEHISCENCE CAN ALSO BE CAUSED BY INADEQUATE UNDERMINING (CUTTING THE SKIN AWAY FROM THE UNDERLYING TISSUES) OF THE WOUND DURING SURGERY OR EXCESSIVE TENSION ON THE WOUND EDGES CAUSED BY LIFTING OR STRAINING. 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: NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) IS REQUIRED NOW.

    Additional Manufacturer Narrative · 0

    D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: MATERIAL RUPTURE. 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 BREAST AUGMENTATION REVISION WITH TWO UNKNOWN MENTOR GEL IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST IMPLANT RUPTURE AND RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. THE REPLACEMENT DEVICES WERE TWO MENTOR GEL IMPLANTS. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515373 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 9991535

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Required Intervention