MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-17 for INVISALIGN BRACES manufactured by Align Technology, Inc..

Event Text Entries

[145742464] Below is a history of events leading up to surviving my allergy to invisalign. Since this history was written, ending with the allergy diagnosis. I have had a miserable nearly 3 years. It took 18 months of medications to cure the many ulcers bottom of esophagus - caused by invisalign. I have still not gained any weight back. I have an extremely high histamine level in my body, caused by invisalign plastics - causing me er visits, cannot go outside, have severe skin eruptions, have incurred nearly $(b)(6) in dental / medical bills to fix damaged teeth, by the braces. Original dentist, dr (b)(6) refused to provide me with continuing care, so it is all out of pocket. I honestly believe my quality of life will never return, and i am afraid of a fatal allergic reaction. History of health issues during and after wearing invisalign (b)(6) 2016 - began invisalign; (b)(6) 2016 - as noted above, scaling began on right side of lower lip. (b)(6) 2016, saw dermatologist - advice, could be irritation from plastics, referred me to dr (b)(6) for further consultation. Saw dr (b)(6) the following week, as the scaling had moved to left side. Left things alone, kept vaseline to lip to help. Only had 3 months left wearing plastics. Then i became unhealthy, not sure of the case, was rather scared until late (b)(6) that i had cancer, somewhere. I later suspected, though, that i had a "sensitive reaction to plastics", (b)(6) - noticeable "unintentional weight loss"; (b)(6) - (b)(6) 2017 - several blood panels to determine cause of continuing "unintentional weight loss. " (b)(6) - (b)(6) 2017, several blood tests were abnormal, still looking for the cause. Then blood smear showed monocytosis, often associated with chronic inflammation. Correlation with clinical history is necessary. I still have no idea why my health was declining. By the end of (b)(6), i had lost 10% of my body weight. Of course i worried about cancer, somewhere (b)(6) - i had finished wearing the invisalign. I saw a hematologist. My blood counts started to improve, though i had not gained weight. I had also lost my sense of taste, but not smell. I was wearing "retainers" at that point. (b)(6) - saw 2 more physicians, the 2nd an endocrinologist. Still concerned about weight loss - had full body ultrasounds and ct scans (looking for cause, i'm very concerned). Only significant finding was a thickening of my esophagus. No urgency to have that checked. Systemic allergies / ulcers. (b)(6) (late) - consulted with dermatologist again. The growth on my lip was large and painful. I scheduled a consultation for a biopsy with a (b)(6) plastic surgeon. I also started seeing a new pcp in (b)(6), close to specialists. I also saw my neurologist, this month. He did more blood work, looking for "unintentional weight loss causes". All tests were fine. Couldn't find cause for "loss of taste". He did order an mri, which i have normally, every few years. No new findings there. I had a severe tbi years ago, which requires regular monitoring. (b)(6) - saw plastic surgeon, scheduled plastic surgery, (b)(6). I had stopped wearing the retainers, 2 weeks prior to this, to quiet my lip, knowing i would have a large incision. (b)(6) - my new pcp ordered an endoscopy to examine the "thickening in esophagus" and do my colonoscopy, which was due. Also had f/u appts, discussed above with pcp and plastic surgeon. (b)(6) - had scope tests, gi dr colon fine, found several ulcers, base esophagus - unrelated to h pylori stomach ulcers i had 2 yrs prior. No cause known, but given 300 mg zantac twice daily, for one year. Had to add more meds, as would not heal. (b)(6) (late) saw dr (b)(6), decided to try retainers during the day, which lasted 3 weeks, above. (b)(6) - only dr was the allergist. Confirmed i have severe allergy to invisalign plastics. Did a patch test with the material for several days on my back. I had an obvious allergy. I doubt invisalign reported this letter, written by dr (b)(6) (b)(6) 2017. From: (b)(6)> subject: allergic reaction to invisalign; date: (b)(6) 2017 at 4:23:02 pm pst to: (b)(6); (b)(6), i am writing to inform you of an untoward reaction from invisalign treatment and ask you to forward this info on to the corporation. I have a middle aged female that i did treatment on last year. During the course of the treatment, she developed severe sensitivity on her lower lip which resulted in ulceration of her lower lip and lots of discomfort. It appeared to me as mechanical trauma from the aligners and we treated it as such. She continued to have symptoms and sought care from a dermatologist and eventually a plastic surgeon that performed a biopsy and stripping of her lower lip mucosa. To this day she continues to experience oral symptoms and sensitivity in her oral cavity. She was also unable to tolerate retainers and even minor lengthening of her maxillary incisors subsequent to treatment. She has asked that i inform you of this in case other pts experience similar symptoms. This is a first for me. In my treatment of hundreds of pt over a 15 yr period. I have never encountered a similar reaction. What do you advise? She is very dissatisfied with the treatment she has received and may seek financial compensation. Sincerely, (b)(6). Dr (b)(6) retired. I'm stuck with all the dental bills (over $(b)(6) total) including medical bills. I believe invisalign should be off the market. My allergy has ruined my life. Once a healthy, active woman - my body has given out. My severe weight loss has made me so weak that i cannot keep in shape. I apologize, last night and today i tried to add add'l info to my report made yesterday. I was not successful and was given a few phone numbers to call. None of which worked. I am adding this info to my report sent to you about this time yesterday. Please, include it with first report, if possible: here is my add'l info: since left out what i believe is an important fact in my medwatch report to you today. I included an email letter dr (b)(6) wrote to invisalign, reporting my lip damage / surgical removal from the invisalign plastic. (the dentist who gave me invisalign braces) the letter was written in (b)(6) 2017. I had actually asked dr (b)(6) in early (b)(6) if he had reported my lip / health damage, early that month to invisalign. He said that he had not "as he didn't have enough proof". He must have changed his mind on that. In (b)(6) 2018, after dr (b)(6) had retired, we had a phone conversation. From that conversation, though dr (b)(6) had notified invisalign of my horrible health side effects. I believed that invisalign would not be reporting my allergic reaction to you, the fda. That's when i made my initial phone call to the (b)(4) fda office, speaking to (b)(4). She encouraged me to contact fda medwatch and gave me some guidance on that process. It took me 17 months to make my report to you. My health has been so horrible, i could make that step until today. Therefore, i'm replying, with this info, to the confirmation email i received from you. Replying did not work, so i'm creating a new report. Dr (b)(6) did not warn me of the possibility of any adverse health problems created by invisalign plastics, in my introduction to invisalign, nor did the pamphlet i read and signed. I found 3 words "allergic reaction possible" months later, dr (b)(6) told me, when i became ill, he'd neer heard of an allergic reaction to invisalign. Invisalign did not report this to you. I'm sure they certainly should have, as i see with searching that invisalign has been known not to report adverse effects of their product to the fda. Now i've reported it. I believe invisalign should be held responsible and reliable for making a product, which one wears in their mouth nearly 24 hrs daily for months or years that can "poison" a person like i have experienced. Poison is a strong word, but i'm fighting to gain my health back, and i'm not making much progress. Thank you for your time, sincerely (b)(6). Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report NumberMW5086741
MDR Report Key8623943
Date Received2019-05-17
Date of Report2019-05-15
Date of Event2016-09-14
Date Added to Maude2019-05-20
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Product CodeNXC
Date Received2019-05-17
Device Expiration Date2016-09-14
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0


Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening; 3. Other; 4. Deathisabilit 2019-05-17

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