BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALINE BREAST IMPLANTS

    MDR report key: 8464706 · Received March 28, 2019

    Report

    Report Number
    MW5085330
    Event Type
    Injury
    Date Received
    March 28, 2019
    Date of Event
    January 1, 2019
    Report Date
    March 26, 2019
    Manufacturer
    ALLERGAN
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE HAD BREAST IMPLANTS FOR ABOUT 14 (?) REPLACED A COUPLE OF YEARS AGO DUE TO RUPTURE (SALINE). SILICONE WERE PUT BACK IN. I HAVE HAD RANDOM JOINT ISSUES LATELY. FIRST IN MY RIGHT FOOT. HAD IT X-RAYED. NO FRACTURE. IT¿S A PAIN THAT ISN¿T ISOLATED TO A SPECIFIC AREA OF MY FOOT. IT RADIATES AND I¿VE LOST SOME FLEXIBILITY. I AM ONLY (B)(6) AND I WORK OUT REGULARLY AND WEIGHT TRAIN AND AM AT A HEALTHY WEIGHT. THE FOOT PAIN HAS BEEN GOING ON FOR ABOUT A YEAR NOW, AND THEY CAN¿T PINPOINT WHAT IT IS. JUST A COUPLE WEEKS AGO, I NOW HAVE SIMILAR PAIN IN MY RIGHT ELBOW. I HAVEN¿T BEEN TO THE DOCTOR YET. I FIGURED THEY WOULD AGAIN FIND NOTHING WRONG. BUT THE PAIN IS REAL! NOW I SEE ALL THESE REPORTS ABOUT BREAST IMPLANT ILLNESS. I¿M WONDERING IF THIS COULD BE RELATED?!? I DON¿T KNOW EVEN WHERE TO START!

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253247 SALINE BREAST IMPLANTS PROSTHESIS, BREAST INFLATABLE, INTERNAL SALINE FWM ALLERGAN
    253248 SALINE BREAST IMPLANTS PROSTHESIS, BREAST INFLATABLE, INTERNAL SALINE FWM ALLERGAN
    253249 NATRELLE SILICONE-FILLED BREAST IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL SILICONE GEL-FILLED FTR ALLERGAN
    253250 NATRELLE SILICONE-FILLED BREAST IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL SILICONE GEL-FILLED FTR ALLERGAN

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Disability