BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREAST IMPLANTS

    MDR report key: 8991831 · Received September 10, 2019

    Report

    Report Number
    MW5089696
    Event Type
    Injury
    Date Received
    September 10, 2019
    Date of Event
    September 26, 2018
    Report Date
    September 5, 2019
    Manufacturer
    SIENTRA, INC.
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD IMPLANTS PUT IN SUBMUSCULAR, SILICONE. BODY WAS REJECTING RIGHT AWAY. SHOOTING PAIN DOWN MY RIGHT ARM, NUMBNESS, PAIN. DR CONFIRMED AT 3 WEEK APPT THAT I HAD CAPSULAR CONTRACTURE. I HAD SURGERY IN (B)(6) TO REPLACE THE RIGHT IMPLANT DUE TO CAPSULAR CONTRACTURE. WENT IN FOR MY F/U APPT AND FOUND OUT MY LEFT IMPLANT WAS IN CAPSULAR CONTRACTURE. ON (B)(6) 2019, ANOTHER REPLACEMENT SURGERY FOR THE LEFT IMPLANT. WENT FOR MY F/U AND THE LEFT WAS IN SEVERE CAPSULAR CONTRACTURE AGAIN. I HAD TO REMOVE THEM IN (B)(6) 2019. SIENTRA HAS NOT PAID ME A SINGLE PENNY FROM THEIR WARRANTY. (B)(6) GOT BREAST IMPLANTS. SHOOTING PAIN DOWN ARM, NUMBNESS, PAIN. DOC CONFIRMED CAPSULAR CONTRACTURE ABOUT 3 WEEKS LATER. HAD IMPLANT REPLACED ON (B)(6) 2018. THIS ONE SEEMED TO BE OK. WHEN I WENT IN FOR MY APPROX 3 WEEK F/U, THE LEFT BREAST IMPLANT WAS IN CAPSULAR CONTRACTURE. AT THIS POINT MY SEVERE DEPRESSION / ANXIETY THAT I DEVELOPED AFTER THE IMPLANTS HAD ME AN EMOTIONAL MESS. I HAD TO SEE A PSYCHIATRIST. ON (B)(6) 2019, REPLACED THE LEFT IMPLANT 2-3 WEEKS LATER DOC CONFIRMED SEVERE CAPSULAR CONTRACTURE ON THE NEW LEFT IMPLANT. ON (B)(6) 2019 HAD TO REMOVE THEM. I COULDN'T MENTALLY HANDLE ANYMORE. I REPLACED IMPLANTS BECAUSE THE IMPLANT COMPANY SAID UNDER THE WARRANTY, THEY WOULD REIMBURSE ME (B)(6) TO REPLACE EACH IMPLANT. I HAVE NOT SEEN ANY MONEY FROM SIENTRA. I HAVE FILED MY COMPLAINT WITH FDA BECAUSE IN ORDER TO GET MY WARRANTY MONEY FROM SIENTRA, I HAVE TO BASICALLY GIVE UP ALL MY RIGHTS FOR ANY FUTURE LITIGATION. MY DR LEFT MY FIBROUS CAPSULES AND ALL THE SCAR TISSUE IN MY CHEST FROM THE LAST CAPSULAR CONTRACTURE. I STILL FEEL LOTS OF PAIN IN MY LEFT BREAST. IT FEELS LIKE A BIG HARD LUMP IN MY CHEST THAT WASN'T THERE PRIOR TO IMPLANTS AND PS RECOMMENDED I SHOULD GET IT CHECKED WITH MY NORMAL DOCS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780432 BREAST IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR SIENTRA, INC. 10621-455MP
    780433 BREAST IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR SIENTRA, INC. 10621-455MP
    780434 BREAST IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR SIENTRA, INC. 10621-455MP
    780435 BREAST IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR SIENTRA, INC. 10621-455MP

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other