BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BOOST BREAST IMPLANT

    MDR report key: 19478102 · Received June 6, 2024

    Report

    Report Number
    1645337-2024-06665
    Event Type
    Injury
    Date Received
    June 6, 2024
    Date of Event
    May 11, 2024
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317027102
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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: EXTRUSION. 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 JUNE 27, 2024, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR THEN CONDUCTED A VISUAL INSPECTION, LEAK TESTING, AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE. DURING VISUAL EVALUATION, NO APPARENT DAMAGE OR VISUAL ANOMALIES WERE OBSERVED ON THE SMO RO HIGH PRO BOOST GEL545CC RETURNED DEVICE. LEAK TESTING WAS PERFORMED, ACCORDING TO THE MENTOR PROCEDURE, AND IT REVEALED (4) FOUR PUNCTURES ON THE ANTERIOR VIEW, MEASURING APPROXIMATELY 0.1 CM. MICROSCOPIC EXAMINATION WAS PERFORMED ON THE EDGES OF THE PUNCTURES, AND PARALLEL STRIATIONS WERE FOUND IN THE WHOLE AREA OF THE PUNCTURES. PARALLEL STRIATIONS ARE CONSISTENT WITH MARKINGS MADE BY A SHARP OBJECT PERFORATING THE IMPLANT SHELL. BASED ON THE INFORMATION CURRENTLY AVAILABLE, MICROSCOPIC EXAMINATION OF THE RETURNED PRODUCT INDICATES THAT THE IMPLANT COULD HAVE BEEN DAMAGED DURING OR SUBSEQUENT TO IMPLANTATION. THE PRODUCT INSERT DATA SHEET CAUTIONS TO NOT ALLOW CAUTERY DEVICES OR SHARP INSTRUMENTS, SUCH AS SCALPELS, SUTURE NEEDLES, HYPODERMIC NEEDLES, HEMOSTATS, ADSON FORCEPS, OR SCISSORS TO CONTACT THE DEVICE DURING THE IMPLANTATION OR OTHER SURGICAL PROCEDURES. EXTRUSION MAY OCCUR WHEN THE WOUND HAS NOT CLOSED OR WHEN THE TISSUE COVERING THE IMPLANTS WEAKENS. THE INCIDENCE OF EXTRUSION HAS BEEN SHOWN TO INCREASE WHEN UNDUE PRESSURE IS APPLIED ON THE TISSUE LOCATED OVER THE DEVICE, TRAUMA TO SURROUNDING TISSUES MAY LEAD TO THROMBOSIS, DELAYED WOUND HEALING, IMPROPER SIZE, PLACEMENT, LARGER SIZED IMPLANTS, USE OF STEROIDS IN THE SURGICAL POCKET AND MICROWAVE DIATHERMY. RADIATION THERAPY HAS BEEN REPORTED TO INCREASE THE LIKELIHOOD OF EXTRUSION. EXTRUSION MAY REQUIRE ADDITIONAL SURGERY AND POSSIBLE REMOVAL OF THE IMPLANT, WHICH MAY RESULT IN ADDITIONAL SCARRING AND/OR LOSS OF BREAST TISSUE. AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) IS REQUIRED NOW.

    Additional Manufacturer Narrative · 0

    ON JUNE 6, 2024, MENTOR RECEIVED ADDITIONAL INFORMATION INDICATING THAT THE PATIENT WAS ALSO DIAGNOSED WITH RIGHT BREAST IMPLANT RUPTURE UPON REMOVAL OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH A 545CC MENTOR MEMORYGEL BOOST BREAST IMPLANT ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST IMPLANT EXTRUSION. THE PATIENT HAD AN IMPENDING EXTRUSION WITH A THINNED-OUT SKIN AT THE INFERIOR ASPECT OF HER RIGHT BREAST AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON MAY 11, 2024. THE REPLACEMENT DEVICE WAS A 475CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE (CATALOG: SDC130H LOT: 9984187 SN: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2244815 MENTOR MEMORYGEL BOOST BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 9984691 00081317027102

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention