The oasys oral/nasal airway system, a mandibular advance device for mild obstructive sleep apnea, was prescribed to me in (b)(6) 2012.I have worn it nightly since then, but now i have a severe underbite, crooked teeth, and had to have a dental implant in 2020, all of which are attributable to use of this device.The product literature that i received did not talk about these issues, nor does the website, or as near as i can tell, the fda 510k filing.I visited an orthodontist last week and she is recommending 18-24 months of invisalign, with rubber bands, to correct these issues.I am (b)(6) years old and have never had malocclusion problems or crooked teeth.I have no other implants other than the one i had last year, to replace a front tooth that broke off at the gumline.I am very unhappy and believe that had the prescribing dentist more closely monitored me, he may have seen the misalignment in the earliest stages and many of the problems could have been mitigated.At the very minimum, it should be made clear in the product literature that malocclusion is a potential side effect and that patients should be monitored on a regular basis.Fda safety report id # (b)(4).
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