BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 8767492 · Received July 8, 2019

    Report

    Report Number
    1645337-2019-14966
    Event Type
    Injury
    Date Received
    July 8, 2019
    Date of Event
    May 16, 2019
    Report Date
    August 9, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    P060028
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED DEVICE EVALUATION SUMMARY: DURING EVALUATION OF THE SAMPLE A PARALLEL LINES OF SHELL WEAR WERE OBSERVED ON THE ANTERIOR ASPECT, SUGGESTING IN-VIVO FOLDING OR CREASING OF THE DEVICE. LEAK TESTING WAS PERFORMED IN ACCORDANCE WITH MENTOR PROCEDURES AND NO LEAK SITES WERE DETECTED. NO ADDITIONAL ANOMALIES WERE OBSERVED. THE MANUFACTURING RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 08/06/2019, MENTOR BECAME AWARE THAT THE LOT NUMBER OF THE DEVICE WAS HIDDEN ON THE BOTTOM OF THE DEVICE IMAGE AND WAS HARD TO CAPTURE, THEREFORE INADVERTENTLY NOT SUBMITTED IN PREVIOUS SUBMISSION.THE DEVICE INFORMATION IS AS FOLLOW: CATALOG NUMBER 3544550, LOT NUMBER 5943592. THIS REPORT IS FOR THE RIGHT SIDE. A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION REVIEW COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: INJURY, GEL BLEED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH MENTO SILTEX 800 CC GEL IMPLANTS IN 2003 WAS SEEN IN 2013 POST CHEST TRAUMA TO CHECK FOR POSSIBLE RIGHT IMPLANT RUPTURE. SHE WAS AT WORK AND SOMETHING HIT HER CHEST. THE PATIENT HAD AN MRI IN 2013 THAT SHOWED LEFT INTRACAPSULAR RUPTURE. THE SURGEON DID NOT FEEL LIKE COMFORTABLE REVISING AND REPLACING THE IMPLANTS DUE TO THE PATIENTS CONDITION AT THE TIME. THE PATIENT SAW ANOTHER SURGEON IN (B)(6) 2014 WHO ALSO RECOMMENDED REMOVAL OF THE IMPLANTS WITH STAGED POSSIBLE MASTOPEXY, HOWEVER, THE PATIENTS DID NOT WANT TO BE WITHOUT IMPLANTS. THE PATIENT WAS ALSO SEEN IN (B)(6) WHO STATED HE WOULD DO A ONE STAGE REMOVAL AND REPLACEMENT OF THE IMPLANTS. ON (B)(6) 2015, THE SURGEON RECOMMENDED SHE SEE A HIGH RISK BREAST CENTER WHERE PROCEDURE MIGHT BE COVERED BY INSURANCE. SHE DID NOT KEEP THAT APPOINTMENT. NO INTERVENTION WAS CARRIED OUT POST DEVICE PLACEMENT IN 2003. THE PATIENT DEVELOPED LEFT BREAST REDNESS SUBSEQUENT TO UPPER RESPIRATORY INFECTION THAT SHE HAD AROUND (B)(6) 2018. AROUND (B)(6) 2019, THE PATIENT NOTICED A BRIGHT RED COLORING ON THE MEDIAL LEFT BREAST WITH YELLOW CLEAR FLUID DISCHARGE BEGINNING (B)(6) 2019. THE PATIENT DENIED ANY SYSTEMIC SYMPTOMS OF FEVER, CHILLS, NAUSEA, VOMITING AND SHE MINIMIZED PAIN. THE PATIENT UNDERWENT REMOVAL OF BILATERAL IMPLANTS WITHOUT REPLACEMENT ON (B)(6) 2019. THE RIGHT IMPLANT APPEARED GROSSLY INTACT BUT SHOWED GEL BLEED. THE LEFT BREAST SHOWED A NECROTIC OPEN WOUND OF APPROXIMATELY 6 X 3 CM. THE LEFT BREAST IMPLANT WAS COMPLETELY RUPTURED, AND THE CAPSULE WAS IN PIECES. THE SURGEON REMOVED THIS AS WELL AS A LARGE AMOUNT OF SILICONE. THERE WAS NON VIABLE SKIN AS WELL AS NECROTIC APPEARING PEC MAJOR MUSCLE. THE DEAD NECROTIC SKIN PLUS BREAST TISSUE WAS EXCISED AND SEND TO PATHOLOGY. THERE WAS AN INTENSE INFLAMMATORY REACTION IN THE LEFT BREAST CAPSULE. THE BORDERS OF THE PEC MAJOR MUSCLE WERE UNABLE TO BE IDENTIFIED. PIECES OF THE LEFT BREAST WERE SENT TO PATHOLOGY. CULTURE SWABS WERE TAKEN FROM THE UNVIOLATED FLUID WITHIN THE BREAST CAPSULE, BUT THE RESULTS WERE NOT PROVIDED. THE SURGEON NOTED THAT THERE WAS NO LARGE SEROMA FLUID COLLECTIONS OR NO PURULENCE WITHIN THE CAPSULE ON THE LEFT SIDE. NO CAPSULECTOMIES WERE PERFORMED DUE TO SURGEONS ASSESSMENT REGARDING PATIENTS SMOKING STATUS AND THIN SKIN. THE LEFT BREAST CAPSULE WAS SENT TO PATHOLOGY AND SHOWED AN EXTENSIVE INFLAMMATORY REACTION INCLUDING MARKED ACUTE INFLAMMATION AND ABSCESS WITHIN THE SOFT TISSUE. IT WAS NEGATIVE FOR MALIGNANCY. THE LEFT BREAST SKIN AND TISSUE SHOWED MARKED DERMAL AND SUBCUTANEOUS ACUTE INFLAMMATION AND ABSCESS AND WAS NEGATIVE FOR MALIGNANCY. NO EVIDENCE OF AN ATYPICAL LYMPHOID INFILTRATE/POPULATION IS SEEN. BREAST IMPLANTS ARE NOT LIFETIME DEVICES. BREAST IMPLANTS RUPTURE WHEN THE SHELL DEVELOPS A TEAR OR HOLE. RUPTURE CAN OCCUR AT ANY TIME AFTER IMPLANTATION, BUT IT IS MORE LIKELY TO OCCUR THE LONGER THE IMPLANT IS IMPLANTED. SILICONE GEL-FILLED IMPLANT RUPTURES ARE MOST OFTEN SILENT, MEANING MOST OF THE TIME NEITHER THE PATIENT NOR THE SURGEON WILL KNOW IF THE IMPLANT HAS A TEAR OR HOLE IN THE SHELL. HOWEVER, SOMETIMES THERE ARE SYMPTOMS ASSOCIATED WITH GEL IMPLANT RUPTURE. THESE SYMPTOMS INCLUDE HARD KNOTS OR LUMPS SURROUNDING THE IMPLANT OR IN THE ARMPIT, CHANGE OR LOSS OF SIZE OR SHAPE OF THE BREAST OR IMPLANT, PAIN, TINGLING, SWELLING, NUMBNESS, BURNING, OR HARDENING OF THE BREAST. THE FOLLOWING THINGS MAY CAUSE IMPLANTS TO RUPTURE: DAMAGE BY SURGICAL INSTRUMENTS; STRESSING THE IMPLANT DURING IMPLANTATION AND WEAKENING IT; FOLDING OR WRINKLING OF THE IMPLANT SHELL; EXCESSIVE FORCE TO THE CHEST (E.G., DURING CLOSED CAPSULOTOMY); TRAUMA; COMPRESSION DURING MAMMOGRAPHIC IMAGING; AND SEVERE CAPSULAR CONTRACTURE. BREAST IMPLANTS MAY ALSO SIMPLY WEAR OUT OVER TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS CASE WILL BE RE-ASSESSED AND NOTES WILL BE UPDATED. THIS REPORT IS FOR THE RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561393 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 5943592

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention