BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 10221873 · Received July 1, 2020

    Report

    Report Number
    1645337-2020-08107
    Event Type
    Injury
    Date Received
    July 1, 2020
    Date of Event
    June 11, 2020
    Report Date
    June 11, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000464
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 3-AUG-2020, IT WAS FOUND THAT THE UPDATED CATALOG NUMBER AND UDI WERE OMITTED ON THE PREVIOUS REPORT. THE DEVICE WAS A 325CC MENTOR MEMORYGEL BREAST IMPLANT (CATALOG #: 3503254BC, UDI: (B)(4)). THE RELEVANT FIELDS HAVE BEEN UPDATED. ON 3-AUG-2020, THE INVESTIGATION ON THE SUSPECTED MEDICAL DEVICE WAS COMPLETED. INVESTIGATION SUMMARY : DURING THE VISUAL EVALUATION, AN ANOMALY WAS OBSERVED ON THE ANTERIOR VIEW OF THE DEVICE, CONSISTENT WITH A CREASE/FOLD. A TEAR WAS ALSO OBSERVED STARTING WITHIN THE CREASE/FOLD ON THE ANTERIOR VIEW AND EXTENDING TO THE POSTERIOR VIEW, MEASURING APPROXIMATELY 9.4 CM. THE EVALUATION DETERMINED THAT THE LOSS OF SHELL INTEGRITY IS CONSISTENT WITH A CREASE FOLD RUPTURE OF THE IMPLANT SHELL, WHICH IS A KNOWN INHERENT RISK OF GEL-FILLED MAMMARY PROSTHESIS. RUPTURE CAN OCCUR AT ANY TIME AFTER IMPLANTATION, BUT IT IS MORE LIKELY TO OCCUR THE LONGER THE IMPLANT IS IMPLANTED. CREATING WRINKLES OR FOLDS SHOULD BE AVOIDED DURING IMPLANTATION OR OTHER PROCEDURES AS IT CAN RESULT IN A RUPTURE IN A LATER TIME. BREAST IMPLANTS MAY ALSO SIMPLY WEAR OUT OVER TIME. EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6)2020, THE MENTOR FAILURE ANALYSIS LAB RECEIVED TWO DEVICES. HOWEVER, THE SUSPECTED MEDICAL DEVICE, LEFT-SIDED DEVICE WITH LOT NUMBER 5863611, APPEARED TO BE INTACT, AND RIGHT-SIDED DEVICE WITH LOT NUMBER 5902952 APPEARED TO BE RUPTURED. THUS, AT THIS TIME OF REPORT, IT WAS DETERMINED THAT THE RIGHT-SIDED DEVICE IS THE ACTUAL SUSPECTED MEDICAL DEVICE, AND PRODUCT INVESTIGATION WILL BE PERFORMED ON THE RIGHT-SIDED DEVICE. THE RELEVANT FIELDS HAVE BEEN UPDATED. FOLLOW-UP WAS INITIATED TO OBTAIN CLARIFICATION REGARDING THE AFFECTED SIDE. IF ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    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: RUPTURE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 300CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED LEFT-SIDED RUPTURE POSTOPERATIVELY. THE PATIENT HAD A CONSULTATION ON (B)(6) 2020, AND THE DIAGNOSIS WAS CONFIRMED BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH TWO 335CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESES (CATALOG #: SHPX335, LEFT SERIAL #: (B)(4), RIGHT SERIAL #: (B)(4)) ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685952 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3503004BC 5902952 00081317000464

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention