BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVISALIGN

    MDR report key: 2626276 · Received June 18, 2012

    Report

    Report Number
    MW5025890
    Event Type
    Other
    Date Received
    June 18, 2012
    Date of Event
    March 1, 2012
    Report Date
    June 18, 2012
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I STARTED MY EXPRESS INVISALIGN TREATMENT ON (B)(6) 2012. IN (B)(6) 2012, I BEGAN TO EXPERIENCE BREAST PAIN. I MADE AN EMERGENCY APPOINTMENT WITH MY DOCTOR A SURGEON, AND HE PERFORMED AN ULTRASOUND. HE LOCATED MULTIPLE CYSTS IN MY BREASTS AND PERFORMED NEEDLE ASPIRATIONS ON BOTH. OUCH!!!!!!!!!. THE CYSTS WERE BENIGN THANKFULLY. SOME DAYS LATER, I HAD A MAMMOGRAM DONE. I WAS UNSURE OF THE OUTCOME, AND MUCH TO MY DISMAY, I RECEIVED A LETTER FROM THE RADIOLOGY CENTER STATING THAT SOMETHING WAS ABNORMAL OR SUSPICIOUS. SO, I HAD TO RETURN TO THE RADIOLOGY CENTER AND HAVE A RADIOLOGIST REVIEW MY MAMMOGRAM RESULTS. THE OUTCOME WAS THE FOLLOWING: THERE WAS A CHANGE IN A CYST THAT CAUSED SUSPICION. HE SUGGESTED THAT I GET A BIOPSY OF IT TO RULE OUT MALIGNANCY. ON (B)(6) 2012, I HAD A BREAST BIOPSY PERFORMED. AGAIN, OUCH!!!!!!!!. FROM LOOKING AT THE ULTRASOUND, MY DOCTOR ASSURED ME THAT THE SOLID MASS LOOKED BENIGN ABOUT 99%. I RECEIVED THE RESULTS ON (B)(6) 2012. THE RESULT WAS NEGATIVE FOR MALIGNANCY!!! WHEW AND HALLELUJAH! I HAVE A FOLLOW-UP APPOINTMENT SCHEDULED FOR (B)(6) 2012. SOMETIME AGO, I READ ABOUT STUDIES REGARDING THE COMPOSITION OF PLASTICS BPAS, PHTHALATES, ETC., AND BREAST CANCER. I SAW THAT INVISALIGN DOESN'T USE BPAS, BUT ITS COMPOSITION IS (B)(4). SO, I HAVE TO WONDER, COULD THE PLASTIC COMPOSITION OF INVISALIGN BE A CONTRIBUTING FACTOR IN MY HEALTH ISSUE. I THINK THERE IS A CORRELATION. THE PLASTIC/COMPOSITION OF THE ALIGNERS CAN BE HAZARDOUS. I HAVE ONE MONTH LEFT IN MY INVISALIGN TREATMENT, THANKFULLY. I HOPE THAT I WILL SEE A POSITIVE CHANGE IN MY HEALTH AFTER I STOP USING INVISALIGN. AMOUNT: 10 ALIGNERS. FREQUENCY: WEAR EACH FOR 2 WEEKS. REASON FOR USE: FIX SHIFTED TEETH. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISALIGN NONE NXC ALIGN TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other