BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 9152438 · Received October 3, 2019

    Report

    Report Number
    1645337-2019-20806
    Event Type
    Injury
    Date Received
    October 3, 2019
    Date of Event
    January 15, 2019
    Report Date
    May 1, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000082
    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 · 1

    THE INVESTIGATION OF THE RETURNED DEVICE WAS COMPLETED BY THE FAILURE ANALYSIS LAB ON 6/19/2019. DEVICE EVALUATION SUMMARY: DURING ANALYSIS OF THE SAMPLE A CREASE WAS OBSERVED ON THE ANTERIOR VIEW. ADDITIONAL TESTING WAS NOT PERFORMED TO AVOID COMPROMISE OF THE DEVICE INTEGRITY. NO ADDITIONAL ANOMALIES WERE OBSERVED. SINCE THE AUTHORIZATION FOR RETURN AND EXAMINATION OF MEDICAL DEVICE FORM WAS NOT SIGNED AND/OR RETURNED, THE MENTOR PRODUCT ANALYSIS LAB WAS PRECLUDED FROM FURTHER EVALUATING THE DEVICE. A CREASE/FOLD FAILURE MAY BE THE RESULT OF THE CONTINUOUS AND SUSTAINED STRESSES TO THE DEVICE CAUSED BY THE CAPSULAR CONTRACTURE. 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 PHENOMENON IS REFERRED TO AS CAPSULAR CONTRACTURE. THE REPORTED COMPLAINT WAS NOT CONFIRMED. RUPTURE IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR PRODUCT INSERT DATA SHEET. 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. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 5771651, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR ASR/PSR REFERENCE NUMBER (B)(4). THIS DEVICE REPORT IS BEING SUBMITTED LATE AS A RESULT OF THE EXEMPTION TRANSITION PERIOD FOLLOWING THE REVOCATION OF MENTOR¿S PSR EXEMPTION #E2007003. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: RUPTURE AND CAPSULAR CONTRACTURE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6)-YEAR-OLD ASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 275 CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL BAKER¿S GRADE III CAPSULAR CONTRACTURE WITH RUPTURE POST PROCEDURE. THESE ISSUES WERE DIAGNOSED BY A PHYSICIAN. AS A RESULT, BILATERAL PROSTHESIS REPLACEMENT WITH 325 CC MENTOR MEMORYGEL BREAST IMPLANTS WAS PERFORMED ON (B)(6) 2019. SEE 1645337-2019-20805 FOR CONTRALATERAL PROSTHESIS REPORT. THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR ASR/PSR REFERENCE NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946753 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 5771651 00081317000082

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention