BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 24330364 · Received February 13, 2026

    Report

    Report Number
    1645337-2026-01570
    Event Type
    Injury
    Date Received
    February 13, 2026
    Date of Event
    January 20, 2026
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317001058
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MENTOR BECAME AWARE THAT THE INITIALLY REPORTED SUSPECT MEDICAL DEVICE, LOT 6910913, WAS INTACT UPON RETURN, AND THE RUPTURED IMPLANT IS LOT 6990002. THE SUSPECT MEDICAL DEVICE HAS BEEN UPDATED TO 325CC MENTOR MEMORYGEL BREAST IMPLANT (CATALOG: 3544325 LOT: 6990002 SN: (B)(6). ON MARCH 20, 2026, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED A VISUAL INSPECTION AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE BREAST IMPLANT WAS FOUND TO HAVE A TEAR AT THE JUNCTION BETWEEN THE SHELL AND PATCH. MICROSCOPIC EXAMINATION WAS PERFORMED, AND THE CAUSE 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. ALTHOUGH NO CONCLUSION COULD BE REACHED ON THE CAUSE OF THE REPORTED EVENT, THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING CAUTION: RUPTURE CAN OCCUR AT ANY TIME AFTER IMPLANTATION BUT IS MORE LIKELY TO OCCUR THE LONGER THE IMPLANT IS IMPLANTED. THE FOLLOWING MAY CAUSE IMPLANT TO RUPTURE: STRESSING THE IMPLANT DURING IMPLANTATION AND WEAKENING IT; FOLDING OR WRINKLING OF THE IMPLANT SHELL; EXCESSIVE FORCE TO THE CHEST (E.G. DURING CLOSED CAPSULOTOMY); TRAUMA; COMPRESSION DURING MAMMOGRAPHIC IMAGING; AND SEVERE CAPSULAR CONTRACTURE. BREAST IMPLANTS MAY ALSO SIMPLY WEAR OUT OVER TIME. A SEROMA IS A BUILD-UP OF FLUID AROUND THE IMPLANT. SYMPTOMS FROM A SEROMA MAY INCLUDE SWELLING, PAIN, AND BRUISING. A SEROMA MAY OCCUR SOON AFTER SURGERY, OR ANY TIME LATER ON, WHICH WOULD BE REFERRED TO AS A LATE SEROMA. WHILE THE BODY MAY ABSORB SEROMAS, SOME MAY REQUIRE SURGERY FOR DRAINAGE. YOU SHOULD CONSIDER THE POSSIBILITY OF BIA-ALCL WHEN A PATIENT PRESENTS WITH LATE ONSET, PERSISTENT PERI-IMPLANT SEROMA. IN SOME CASES, PATIENTS PRESENTED WITH CAPSULAR CONTRACTURE OR MASSES ADJACENT TO THE BREAST IMPLANT. WHEN TESTING FOR BIA-ALCL, COLLECT FRESH SEROMA FLUID AND REPRESENTATIVE PORTIONS OF THE CAPSULE, AND SENT TO A LABORATORY WITH APPROPRIATE EXPERTISE FOR PATHOLOGY TEST TO RULE OUT ALCL, INCLUDING IMMUNOHISTOCHEMISTRY TESTING FOR CD30 AND ALK (ANAPLASTIC LYMPHOMA KINASE). IF YOUR PATIENT IS DIAGNOSED WITH PERI-IMPLANT BIA-ALCL, DEVELOP AN INDIVIDUALIZED TREATMENT PLAN IN COORDINATION WITH A MULTIDISCIPLINARY CARE TEAM. THE NATIONAL COMPREHENSIVE CANCER NETWORK (NCCN) RECOMMENDS SURGICAL TREATMENT THAT INCLUDES IMPLANT REMOVAL AND COMPLETE CAPSULECTOMY IPSILATERALLY AS WELL AS CONTRALATERALLY, WHERE APPLICABLE. 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

    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: 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).

    Additional Manufacturer Narrative · 0

    ON FEBRUARY 26, 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. ON FEBRUARY 27, 2026, MENTOR BECAME AWARE THAT THE PATIENT, POST-OPERATIVELY INITIALLY DEVELOPED LATE ONSET SEROMA IN THE RIGHT BREAST AND HAD AN OPEN WOUND FOR SOME TIME AND HAD MULTIPLE COURSES OF ANTIBIOTIC. THE RUPTURE WAS ONLY DISCOVERED WHEN THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL. ON MARCH 3, 2026, MENTOR BECAME AWARE THAT THE RETURNED SUSPECT MEDICAL DEVICE WAS INTACT AND THE INITIALLY REPORTED CONCOMITANT DEVICE (PATIENT'S KNOWN LEFT BREAST IMPLANT LOT 6990002) WAS THE ONE RETURNED RUPTURED. FOLLOW-UPS ARE IN PROGRESS AND THIS WILL BE REASSESSED WHEN CLARIFYING INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 325CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH RIGHT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393753 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 6990002 00081317001058

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention