BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 7732465 · Received July 30, 2018

    Report

    Report Number
    1645337-2018-04588
    Event Type
    Injury
    Date Received
    July 30, 2018
    Date of Event
    June 5, 2018
    Report Date
    July 6, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000693
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 08/10/2018, THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. ON 08/16/2018, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT. PATIENT DEVELOPED A SEROMA IN HER LEFT BREAST. CLINICAL TEST RESULTS WERE RECEIVED FOR THE REPORTED SEROMA. THE SEROMA PRESENTED AS YELLOW PERIPROSTHETIC FLUID THAT WAS ENCOUNTERED UPON DISSECTION INTO THE CAPSULES. THIS WAS SENT FOR CULTURE AND PATHOLOGY. THE RESULTS WERE NEGATIVE BILATERALLY FOR ANY MALIGNANCY. NO OVERT CYTOLOGIC ATYPIA, NECROSIS OR PROMINENT MITOTIC ACTIVITY IS NOTED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 10/29/2018, MENTOR COMPLETED THE INVESTIGATION ON THE SUSPECT MEDICAL DEVICE. UPON RECEIPT BY MENTOR, THE GEL CONTAINED IN THE DEVICE APPEARS CLOUDY. BROWN MATERIAL WAS OBSERVED WITHIN THE DEVICE AND ON THE SHELL SURFACE. MENTOR PRODUCT ANALYSIS LAB DISCOVERED TWO RENTS MEASURING APPROXIMATELY 2.3 CM AND 1.4 CM WITHIN AN AREA OF SILTEX CRACKING ON THE POSTERIOR ASPECT. SILTEX CRACKING IS DEFINED AS A MATERIAL SEPARATION OCCURRING IN THE SILTEX LAYER AND CAN EVENTUALLY PROGRESS THROUGH THE SHELL OF SILTEX DEVICES. MENTOR BELIEVES THAT SILTEX CRACKING IS ULTIMATELY A RESULT OF HIGH STRESSES CAUSED BY ACUTE FOLDS (I.E., SEVERE ¿V¿ OR TIGHT FOLDS) IN THE HTV (HIGH TEMPERATURE VULCANIZATION) SHELL OF SILTEX BREAST IMPLANTS. ALSO, PARALLEL LINES OF SHELL WEAR WERE NOTICED ON THE ANTERIOR ASPECT, SUGGESTING IN-VIVO FOLDING OR CREASING OF THE DEVICE. NO OTHER ANOMALIES WERE DISCOVERED. THE COMPLAINT WAS CONFIRMED FOR RUPTURE SINCE A RENT WAS FOUND ON THE DEVICE. HOWEVER, AT THIS POINT IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF SUCH DAMAGE OR THE ETIOLOGY OF THE BROWN MATERIAL FOUND ON THE DEVICE. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING. RUPTURE IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR PRODUCT INSERT DATA SHEET; HOWEVER, COMPLAINT TRENDS FOR MENTOR DEVICES WILL CONTINUE TO BE MONITORED BY QUALITY ASSURANCE. MENTOR PERFORMS 100% INSPECTION AND TESTING OF ALL DEVICES PRIOR TO RELEASE. EXCESSIVE POSTOPERATIVE ACCUMULATION AND/OR TRANSIENT REACCUMULATION OF FLUID AROUND AN IMPLANT MOST LIKELY OCCUR SOON AFTER SURGERY; HOWEVER, IT CAN OCCUR AT ANY TIME. SYMPTOMS FROM SEROMA MAY INCLUDE SWELLING, PAIN, AND BRUISING. WHILE THE BODY ABSORBS SMALL HEMATOMAS AND SEROMAS, SOME WILL REQUIRE SURGERY. SEROMAS PRESENTING AFTER THE IMMEDIATE POST-OPERATIVE PERIOD MAY REQUIRE ADDITIONAL WORK-UP BY THE SURGEON. SEROMA IS A KNOWN COMPLICATION ASSOCIATED WITH THIS SURGERY AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. GRANULOMAS ARE NONCANCEROUS NODULES THAT ARE A COMMON TISSUE REACTION TO THE PRESENCE OF A VARIETY OF FOREIGN MATERIALS, SUCH AS SILICONE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    THE MENTOR FAILURE ANALYSIS LAB HAS 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 DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: MENTOR MEMORYGEL BREAST IMPLANT 400CC GEL BREAST PROSTHESIS, CATALOG #3544007, LOT #231741. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    GEL BLEED IN THE SUSPECT MEDICAL DEVICE WAS REPORTED IN THE INITIAL REPORT, WITH THE DEVICE CODE "GEL LEAK" USED FOR THE PRODUCT ISSUE. INFORMATION RECEIVED BY MENTOR SHOWS THAT THERE WAS A RENT FOUND ON THE SUSPECT MEDICAL DEVICE. THE APPROPRIATE DEVICE CODE FOR THIS PRODUCT ISSUE IS "MATERIAL RUPTURE". DEVICE CODE "MATERIAL RUPTURE" HAS BEEN ADDED. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 350CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYGEL BREAST IMPLANT 400CC GEL BREAST PROSTHESIS (RIGHT DEVICE). THE RIGHT DEVICE RUPTURED AFTER IMPLANTATION. RUPTURE WAS DIAGNOSED BY A MAMMOGRAM. GEL BLEED WAS REPORTED FOR THE LEFT DEVICE. IN ADDITION, THE PATIENT DEVELOPED A SEROMA IN HER RIGHT BREAST AND GRANULOMAS IN BOTH BREASTS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL BREAST IMPLANT 375CC GEL BREAST PROSTHESIS AND A MENTOR MEMORYGEL BREAST IMPLANT 400CC GEL BREAST PROSTHESIS ON (B)(6) 2018. THIS MEDWATCH REPORT IS FOR THE LEFT BREAST PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573847 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 224633 00081317000693

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention