Your doctor has recommended the Invisalign system for your orthodontic treatment. Although orthodontic treatment can lead to a healthier and more attractive smile, you should also be aware that any orthodontic treatment (including orthodontic treatment with Invisalign aligners) has limitations and potential risks that you should consider before undergoing treatment.
Invisalign aligners, developed by Align Technology, Inc. (“Align”) consist of a series of clear plastic, removable appliances that move your teeth in small increments. Invisalign’s product combines your doctor’s diagnosis and prescription with sophisticated computer graphics technology to develop a treatment plan which specifies the desired movements of your teeth during the course of your treatment. Upon approval of a treatment plan developed by your doctor, a series of customised Invisalign aligners is produced specifically for your treatment.
You may undergo a routine orthodontic pre-treatment examination including radiographs (x-rays) and photographs. Your doctor will take impressions or intra-oral scans of your teeth and send them along with a prescription to the Align laboratory. Align technicians will follow your doctor’s prescription to create a ClinCheck® software model of your prescribed treatment. Upon approval of the ClinCheck treatment plan by your doctor, Align will produce and ship a series of customised aligners to your doctor. The total number of aligners will vary depending on the complexity of your malocclusion and the doctor’s treatment plan. The aligners will be individually numbered and will be dispensed to you by your doctor with specific instructions for use. Unless otherwise instructed by your doctor, you should wear your aligners for approximately 20 to 22 hours per day, removing them only to eat, brush and floss. As directed by your doctor, you will switch to the next aligner in the series every two weeks or as directed by your doctor. Treatment duration varies depending on the complexity of your doctor’s prescription. Unless instructed otherwise, you should follow up with your doctor at a minimum of every 6 to 8 weeks.
Some patients may require bonded aesthetic attachments and/or the use of elastics during treatment to facilitate specific orthodontic movements. Patients may require additional impressions or intra-oral scans and/or refinement aligners after the initial series of aligners.
Like other orthodontic treatments, the use of Invisalign product(s) may involve some of the risks outlined below:
I have been given adequate time to read and have read the preceding information describing orthodontic treatment with Invisalign aligners. I understand the benefits, risks, alternatives and inconveniences associated with treatment as well as the option of no treatment. I have been sufficiently informed and have had the opportunity to ask questions and discuss concerns about orthodontic treatment with Invisalign® products with my doctor from whom I intend to receive treatment. I understand that I should only use the Invisalign products after consultation and prescription from an Invisalign trained doctor, and I hereby consent to orthodontic treatment with Invisalign products that have been prescribed by my doctor.
Due to the fact that orthodontics is not an exact science,
I acknowledge that my doctor and Align Technology, Inc. headquartered in San Jose, California (“Align”) have not and cannot make any guarantees or assurances concerning the outcome of my treatment. I understand that Align is not a provider of medical, dental or health care services and does not and cannot practice medicine, dentistry or give medical advice. No assurances or guarantees of any kind have been made to me by my doctor or Align, its representatives, successors, assigns, and agents concerning any specific outcome of my treatment.
I understand and consent to my doctor collecting and using my medical records, including, but not limited to, radiographs (x-rays), reports, charts, medical history, photographs, findings, plaster models, impressions of teeth, or intra-oral scans, prescriptions, diagnosis, medical testing, test results, ethnicity, billing, and other treatment records in my doctor’s possession (“Medical Records”) to the extent necessary for treatment, customer service, and billing. If I do not provide my consent to these uses of my Medical Records then I may not be able to receive Invisalign treatment.
I will not, nor shall anyone on my behalf seek legal, equitable or monetary damages or remedies for such disclosure. I acknowledge that use of my Medical Records is without compensation and that I will not nor shall anyone on my behalf have any right of approval, claim of compensation, or seek or obtain legal, equitable or monetary damages or remedies arising out of any use such that comply with the terms of this Consent.
A copy of this Consent shall be considered as effective and valid as an original. I have read, understand and agree to the terms set forth in this Consent as indicated by my signature below.
Your doctor is the controller of any personal data included in your Medical Records. Align and other members of its corporate group (“Align Group”) will receive your medical records, which may be stored on Align Group’s servers outside your country of residence. However, the Align Group will continue to protect your information in accordance with the Align Group’s Binding Corporate Rules (“BCRs”), which can be found at www.aligntech.com.
Your Medical Records will only be shared with other third parties if otherwise permitted by the applicable law, such as if necessary to protect your vital interests or those of another person or if necessary for the establishment, exercise or defence of legal claims. Your doctor and the Align Group will process your Medical Records for the purpose of your treatment. The Align Group may also anonymise your Medical Records and use it for internal, analysis and research purposes. Your doctor and the Align Group will retain your Medical Records for only as long as it has an ongoing legitimate need to do so, for example, to provide you with treatment and to comply with regulatory obligations. The Medical Records will then be either deleted or anonymised or, if this is not possible (for example, because your Medical Records have been stored in backup archives), then they will be securely stored until deletion is possible.
If you have any questions about how your Medical Records are being used you can ask your doctor, including about any of your rights to:
You also have the right to complain to your local data protection authority about the collection and use of your Medical Records.