[66002704]
I am reporting a safety concern regarding materials used in my daughter's orthodontic treatment and presence of a characteristic smell in her breath following use of these products (i. E. Invisalign aligner material and orthodontic plastic retainers (vivera)). My daughter completed her invisalign orthodontic treatment and has now been prescribed vivera orthodontic retainers (plastic) for use each night to prevent her teeth from shifting. We have noticed a characteristic smell/breath from her mouth every time she uses these retainers. It is not the same as a "normal morning bad breath but similar to a ketonic breath". My wife noticed a similar kind of smell/breath from her mouth when she was on a strict high protein diet (which is believed to produce high levels of ketones). When my daughter stops using the retainers for a couple/few days, we notice the "smell" is gone. We had noticed this smell even earlier when she was on the initial invisalign orthodontic treatment (prior to starting the retainers) but was assured about the safety of the product by her orthodontist who also shared the product msds with us. We notice this smell again with the retainers. She is careful about following the routine care for her retainers, as instructed by her orthodontist i. E. Washing it with mouthwash etc. The msds for the invisalign aligners and retainers were provided by our orthodontist upon our request. My wife, a toxicologist, noticed that the msds for invisalign lists diisocyanates and the safety information from the makers of vivera retainers states that the product contains polyurethane resins (msds has more detailed information). As a toxicologist, she is concerned about the safety of these products because some diisocyanates are sensitizers and diisocyanate contain acidic groups that may break down to form aldehydes and ketones (and hence maybe the "ketonic breath" she noticed from our daughter's mouth due to breakdown of product), possibility of plasticizers/other chemicals (and associated reproductive/developmental toxicity/other) health effects that our daughter may be exposed to due to breakdown of the plastic orthodontic/retainer material in her mouth following grinding her teeth at night or reaction between the product material and saliva/salivary enzymes. As concerned parents and scientists, we request you to please investigate these materials and help provide assurance that these materials are safe for use by our daughter under the conditions of use.
Patient Sequence No: 1, Text Type: D, B5