Description of Event or Problem · 1
I AM A DENTAL PT. I RECENTLY CONTACTED ALIGN TECHNOLOGIES INC. BECAUSE OF A CONCERN THAT I HAD REGARDING INVISALIGN BRACES. I ALSO INFORMED MY DENTIST ABOUT THE CONCERNS I HAD. SHE WASN'T SURE OF WHAT I DESCRIBED BUT WOULD TRY TO FIND OUT. MY CONCERN WAS THAT SINCE I'VE BEEN WEARING THEM FOR ALMOST A YR, I BEGIN TO CHOKE IN THE MIDDLE OF THE NIGHT. I WANT TO KNOW IF AMYLASE IS BREAKING DOWN THE PLASTIC INTO A MELTED LIQUID MIXED WITH MY SALIVA, AND IF I AM POSSIBLY INGESTING IT. WHEN I CALLED THE HEADQUARTERS, ALIGN TECHNOLOGY, INC. LOCATED IN CALIFORNIA, I SPOKE WITH SOMEONE WHO SAID THAT EVEN THOUGH THE PRODUCT HAS BEEN APPROVED BY THE FDA, THERE WASN'T AN ACTUAL STUDY OF THE SALIVA TAKEN TO LABS FROM PTS WHO ARE WEARING INVISALIGN BRACES. SHE TRIED TO COVER FOR THE COMPANY BY TRYING TO GET RID OF THE CALL BY SAYING OVER AND OVER THAT THE FDA HAS APPROVED OF THE PRODUCT WITHOUT ANSWERING MY QUESTIONS. HOWEVER, I WAS VERY SPECIFIC TO FIND OUT ABOUT THE PLASTIC BEING DIGESTED AND FIRM WITH MY QUESTIONS WHEN I ASKED HER "HAS THERE EVER BEEN AN ACTUAL STUDY WITH THE PT'S SALIVA BEING SENT TO LABS TO FIND TRACES OF PLASTIC THAT COULD POSSIBLY BE INGESTED AS IT MIXES WITH THE SALIVA, AND THEN SWALLOWED?" SHE PLACED ME ON HOLD, AND THEN CAME BACK TO SAY "NO THERE HASN'T." SHE DID TAKE MY NAME AND TELEPHONE NUMBER. BUT I'D LIKE TO KNOW IF THE -FDA- CAN INVESTIGATE THIS? I NEED TO KNOW. AND ALSO, I HAD A CLASSMATE LAST SEMESTER WHO ALSO WORE INVISALIGN BRACES AND DESCRIBED THE SAME EVENTS WHICH CONCERNED US. WHAT WE DO KNOW IS THAT SCIENCE HAS FOUND THAT AMYLASE, AN ENZYME THAT THE MOUTH USES TO BREAK DOWN FOOD OR ANY FOREIGN PRODUCT THAT ENTERS THE MOUTH, WILL ACTUALLY BECOME MIXED INTO THE SALIVA WHEN SWALLOWED. I NEED AND WANT TO KNOW IF I POSSIBLY SWALLOWED THIS PLASTIC INTO A LIQUID FORM. JUST AS THE STOMACH WORKS WITH THE ENZYME PEPSIN, SO DOES THE MOUTH WORK WITH THE ENZYME AMYLASE. SINCE THE STUDIES HAVE NOT BEEN DONE REGARDING THE PT'S SALIVA AND POSSIBLY HAVING TRACES OF PLASTIC BROKEN DOWN FROM AMYLASE, WHICH THEY CAN INGEST THROUGH SWALLOWING THEIR SALIVA, CAN YOU PLEASE INVESTIGATE? AND IF SO, WILL THE INGESTED PLASTIC CAUSE DETRIMENTAL SIDE AFFECTS? I HAVE A RIGHT TO KNOW. INVISALIGN BRACES. STARTED TREATMENT IN MARCH, 2006 UNTIL PRESENT. GREAT CHOKING IN THE MIDDLE OF THE NIGHT ON MY SALIVA. WENT FOR A PHYSICAL EXAM, BUT NOTHING WAS FOUND IN THE EXAM REGARDING A THROAT PATHOLOGY. I NEVER BEFORE HAD THROAT CLEARING OR CHOKING.