BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 9154149 · Received October 3, 2019

    Report

    Report Number
    1645337-2019-20871
    Event Type
    Injury
    Date Received
    October 3, 2019
    Date of Event
    February 21, 2013
    Report Date
    September 14, 2017
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION HAS BEEN UPDATED, AND THE DETAILS ARE PROVIDED BELOW. THE EVALUATION CODES REMAIN UNCHANGED. DEVICE EVALUATION SUMMARY: DURING EVALUATION OF THE SAMPLE, IT WAS OBSERVED CREASES ON THE POSTERIOR EXTENDING TO THE ANTERIOR ASPECT. A TEAR MEASURING APPROXIMATELY 0.1 CM WAS ALSO DISCOVERED WITHIN THE CREASE ON THE POSTERIOR ASPECT. NO OTHER ANOMALIES WERE DISCOVERED. A CREASE/FOLD FAILURE MAY BE THE RESULT OF THE CONTINUOUS AND SUSTAINED STRESSES TO THE DEVICE CAUSED BY THE CAPSULAR CONTRACTURE. THE MANUFACTURING RECORDS WERE REVIEWED, AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. POSTOPERATIVE FORMATION OF A FIBROUS TISSUE CAPSULE AROUND A MAMMARY PROSTHESIS IS A NORMAL PHYSIOLOGIC RESPONSE TO THE IMPLANTATION OF A FOREIGN OBJECT AND OCCURS IN ALL PATIENTS IN VARYING DEGREES. IN SOME CASES, CONTRACTURE OF THE FIBROUS CAPSULE MAY OCCUR. THIS CONDITION HAS ALSO BEEN ASSOCIATED WITH DEVICE DEFLATION/ RUPTURE, WRINKLING AND/OR DISPLACEMENT OF THE PROSTHESIS. CAPSULAR CONTRACTURE MAY BE MORE COMMON FOLLOWING INFECTION, HEMATOMA, AND SEROMA, AND THE CHANCE OF IT HAPPENING MAY INCREASE OVER TIME. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. BASED ON THE INFORMATION REPORTED AND/OR THE PRODUCT INVESTIGATION, THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH THE MANUFACTURING PROCESS. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR PSR REPORT NUMBER (B)(4). DEVICE EVALUATION SUMMARY: UPON RECEIPT BY MENTOR, THE DEVICE WEIGHED 319.6 GM W/TRAY. THE GEL APPEARS CLEAR. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE. GEL AND RED MATERIAL WAS OBSERVED ON THE SHELL SURFACE. PE¿S VISUAL EXAMINATION REVEALED CREASES ON THE POSTERIOR ASPECT EXTENDING TO THE ANTERIOR. A RENT MEASURING APPROXIMATELY 0.1 CM WAS ALSO DISCOVERED WITHIN THE CREASE ON THE POSTERIOR ASPECT. BECAUSE THE AUTHORIZATION FOR RETURN AND EXAMINATION OF MEDICAL DEVICE FORM WAS NOT SIGNED AND/OR RETURNED TO MENTOR, PE WAS PRECLUDED FROM FURTHER EVALUATING THE DEVICE. NO OTHER ANOMALIES WERE OBSERVED. MENTOR PERFORMS 100% INSPECTION AND TESTING OF ALL DEVICES PRIOR TO RELEASE; PE CONCLUDED THAT THE RENT AND CREASE OCCURRED SOMETIME SUBSEQUENT TO THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. THE COMPLAINT FOR RUPTURE WAS CONFIRMED. BECAUSE PE WAS UNABLE TO CONFIRM ANY UNUSUAL FAILURE MODE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. RUPTURE AND CAPSULAR CONTRACTURE ARE BOTH KNOWN INHERENT RISKS OF THESE DEVICES, AS REFERENCED IN OUR PRODUCT INSERT DATA SHEET. A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: CAPSULAR CONTRACTURE (GRADE III). (B)(4).

    Description of Event or Problem · 1

    THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR PSR REPORT NUMBER (B)(4). IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH A 300CC MENTOR MEMORYGEL BREAST IMPLANT AND SUFFERED GRADE III CAPSULAR CONTRACTURE POSTOPERATIVELY. THE PATIENT HAD AN OPEN CAPSULOTOMY/CAPSULECTOMY PERFORMED ON (B)(6) 2013, WHICH DID NOT APPEAR TO FULLY RESOLVE THE ISSUE. AS A RESULT, THE PATIENT UNDERWENT A SIMILAR PROCEDURE ON (B)(6) 2017. DURING THIS PROCEDURE, THE DEVICE WAS FOUND TO HAVE RUPTURED. THE PATIENT HAD THE DEVICE REPLACED WITH ANOTHER 300CC MEMORYGEL DEVICE (SERIAL # (B)(4)) DURING THE PROCEDURE. ON 9/17/2019, MENTOR BECAME AWARE THAT PSR REPORT SUBMISSION NUMBERS (B)(4) WERE DUPLICATED. ANY ADDITIONAL EVENT INFORMATION RECEIVED WILL BE REPORTED UNDER THIS MANUFACTURER'S REPORT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946025 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 6635810 00081317000464

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention