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By Daniel J. DeNoon
WebMD Health News
Reviewed by Laura J. Martin, MD
Dec. 3, 2010 -- The FDA says Align Technology Inc., maker of the popular Invisalign "invisible braces," didn't tell the agency about several life-threatening allergic reactions to the product.
The FDA learned of the allegedly unreported events during a July 2010 inspection of the firm. In its warning letter, the FDA says Align Technology failed to tell the agency how it was going to improve its reporting procedures.
In a news release, Align Technology says it did send the FDA the information it requested, but that "our response of November 8, 2010 may have crossed in the mail with the FDA's warning letter." The FDA letter is dated Nov. 17, 2010.
Align Technology is based in San Jose, Calif. Company CEO Thomas Prescott told the San Jose Mercury News that the Invisalign system has been used by more than 1.3 million patients.
Some of those patients appear to suffer serious allergic reactions to the product. The FDA letter describes two complaints:
•On Nov. 2, 2007, a patient reported "swollen, irritated, and sore" lips and gums. Similar incidents previously reported to the FDA required hospitalization of the patient.
•On May 11, 2010, a patient reported "a burning tongue sensation, sore throat, ulcerations in the mouth, and swollen lymph nodes."
The FDA letter does not imply that the Invisalign device is unsafe, only that Align Technology failed to make the timely reports the agency needs to monitor safety.
SOURCES: FDA warning letter to Align Technology Inc., Nov. 17, 2010.News release, Align Technology Inc.San Jose Mercury News: "FDA Issues Warning to Invisalign Maker."
Most of this info came from:
Be sure to follow this blog & post all comments, questions and request below
Let's face it. You've got school, sports, hanging out with friends, work etc.☺ So getting metal braces is not at the top of your list of favorite things to do. You want the confidence of a great smile -Invisalign will get you there, with it's virtual invisibility www.youtube.com/ladyen7 this blog is also about oval all oral health before-during- & after your invisalign treatment
Thursday, February 17, 2011
Invisalign teen
Let's face it. You've got school, sports, hanging out with friends. So getting metal braces is not at the top of your list of favorite things to do. You want the confidence of a great smile - let Invisalign Teen® get you there, with the virtual invisibility of our clear aligners.
With Invisalign Teen, you could be straightening your teeth without most of your friends even noticing. You don't have to worry about sharp metal wires and brackets irritating your cheeks and gums - especially handy if you play sports. And if you like popcorn or candy, go for it! With its removable aligners, Invisalign Teen lets you pretty much eat whatever you want. Try doing that with braces!
And don't forget about all the pictures you'll be taking—school pictures, prom, team photos or even just snapshots with friends. Since Invisalign aligners are virtually invisible, you can smile confidently while wearing them, or easily take them out for that perfect shot. You won't end up with a lifelong reminder that you were getting your teeth straightened way back when.
While Invisalign Teen works the same way as Invisalign for adults, we've made it even easier for you to track your progress. Each aligner has a Blue Dot Wear Indicator in an inconspicuous location that is designed to fade over a two-week period, letting you know when a new aligner tray needs to be used.
Plus, we know that things can happen, like when you accidentally throw out your aligner with your lunch bag. That's why you get up to six free replacement aligners. Mom will be happy about that
But before you fully decide if Invisalign Teen is the right choice for you, take the Self Assessment, and make sure you discuss your results and how much Invisalign costs thoroughly with your parents. They're the ones who can make this all happen.
Good Luck!!☻
*Majority of this info was obtained from:
-♥Essie
***be sure to follow this blog and post any and all comments and questions bellow ☺
With Invisalign Teen, you could be straightening your teeth without most of your friends even noticing. You don't have to worry about sharp metal wires and brackets irritating your cheeks and gums - especially handy if you play sports. And if you like popcorn or candy, go for it! With its removable aligners, Invisalign Teen lets you pretty much eat whatever you want. Try doing that with braces!
And don't forget about all the pictures you'll be taking—school pictures, prom, team photos or even just snapshots with friends. Since Invisalign aligners are virtually invisible, you can smile confidently while wearing them, or easily take them out for that perfect shot. You won't end up with a lifelong reminder that you were getting your teeth straightened way back when.
While Invisalign Teen works the same way as Invisalign for adults, we've made it even easier for you to track your progress. Each aligner has a Blue Dot Wear Indicator in an inconspicuous location that is designed to fade over a two-week period, letting you know when a new aligner tray needs to be used.
Plus, we know that things can happen, like when you accidentally throw out your aligner with your lunch bag. That's why you get up to six free replacement aligners. Mom will be happy about that
But before you fully decide if Invisalign Teen is the right choice for you, take the Self Assessment, and make sure you discuss your results and how much Invisalign costs thoroughly with your parents. They're the ones who can make this all happen.
Good Luck!!☻
*Majority of this info was obtained from:
-♥Essie
***be sure to follow this blog and post any and all comments and questions bellow ☺
Monday, February 7, 2011
all about Invisalign treatment
Invisalign treatment -->This is a video explaining everything about Invisalign. Enjoy :]
Monday, January 31, 2011
What is invisalign?
What is Invisalign?
About Invisalign
All You Need to Know About Invisalign is Right Here!
The Process
The invisalign process starts out with your first trip to the orthodontist. See our {PROVIDER DIRECTORY} for some suggested providers. Keep in mind that not all orthodontists are licensed to do invisalign, as it takes a lot of training to be able to offer this. Once you decide to do it, your orthodontist will take some molds of your teeth. This is relatively painless but not the most pleasant feeling to have that gooey stuff in your mouth. The whole process takes under 10 minutes after which your orthodontist sends your molds to invisalign. Once they have your molds, they construct a customized video which you will be shown on your next appointment. This video will show how your teeth will move after each tray, and you will basically see the shifting of your teeth from beginning to end result. It’s very motivating to see what your teeth will look like upon completion. Once you approve the video, it could take up to around three weeks for your trays to arrive.
Invisalign ships your complete package of trays to your orthodontist, who will then schedule for you to come in so that they can teach you how to put on and remove your first tray. There are also 2 things that may need to happen before starting your invisalign. This is where the importance of having a really good orthodontist comes in.
1- Attachments – Some cases require attachments, which are little clear bumps that are glued to your teeth and hardened with a light. The purpose of them is to help the aligners shift certain teeth more than others. These are clean and usually unseen, and are removed once your invisalign treatment is complete.
2- Filing your teeth – In some cases, your orthodontist might need to file down your teeth from the sides a bit to create room for your teeth to shift (if your mouth is overcrowded). Invisalign will send them a chart of which specific teeth need to be filed and how much from each tooth.
Once You Begin
Will Invisalign Affect my Speech? Many people wonder if invisalign will impact their speech. Some people may temporarily experience a slight lisp for a day or two. Once the tongue gets used to having aligners in your mouth, speech will be normal again.
Is Invisalign Painful? Invisalign is generally much less painful than traditional braces. In fact, you mostly only experience some pain and discomfort for the first day or two of each tray, since each tray will be tighter and put more pressure for your teeth to move. It is recommended to put each of your new trays in at night and take an Advil if necessary. This way, your tray will loosen up a bit by the time you wake up.
After starting invisalign, you have to keep your tray on for at least 22 hours each day. That gives you 2 hours a day to have them off for meals and brushing. You CANNOT eat while wearing your tray. You are allowed to drink water. Make sure to never drink any hot beverages while wearing your trays, as this will melt the plastic. According to the invisalign site, you are allowed to have your trays off for 4 hours a day, but this is NOT recommended. When you were given your ‘estimated’ treatment time, it is estimated based on how well you follow your regimen. The closer you stick to your schedule of switching trays and the less you have them out, the sooner you will see results.
Caring for your Teeth and Invisalign Trays
You should be taking extra better care of your teeth while using invisalign! You should brush your teeth after every meal. In addition to that, make sure you brush the trays as well to prevent odor. Most invisalign users will notice an odor when they remove their invisalign, and this is normal but can be aided by brushing the inner and outer part of the trays with the remainder of your toothpaste after brushing. You should also floss every day! In addition to brushing and flossing, we recommend a cleaning agent for your retainer such as RetainerBrite. This will keep your trays clean and odorless. You must soak your invasalign in water with retainerbrite at least ONCE a day, or two if you can fit it in morning and night.
About Invisalign
If you want a gorgeous smile and straight teeth, but don’t want the show of metal braces, invisalign is the way to go. Invisalign (commonly misspelled as invisaline) consists of a series of clear trays, called aligners, which are custom designed for your teeth and your teeth only. Barely visible, and less painful that traditional braces, it’s no wonder there have already been over a million people nationwide who completed treatment. Using advanced 3-D computer-imaging technology, Invisalign depicts your complete treatment plan, from the initial position of your teeth to the final desired position. Then a series of clear aligners are custom-made for your teeth. These ‘trays’ are made of thermoplastic material.
You change aligners every 2 weeks, so your teeth move little by little. Average treatment time is about a year but varies depending on the severity of your case. Mild cases might even wear invisalign for as little as six months! This is a major plus compared to metal braces, as metal braces typically take a lot longer to get the job done. This is because with metal braces, you have to come in to see your orthodontist about every 6 weeks to get the metal and wires tightened. With invisalign, you change trays every 2 weeks, so teeth are moving and adjusting more frequently. This also makes invisalign a lot less painful than traditional braces because since you’re changing trays so often, you can do smaller movements each time. Whereas with braces, they are tightened less frequently, so you will have a lot of tooth movement with each adjustment, causing much greater pain.
All You Need to Know About Invisalign is Right Here!
The Process
The invisalign process starts out with your first trip to the orthodontist. See our {PROVIDER DIRECTORY} for some suggested providers. Keep in mind that not all orthodontists are licensed to do invisalign, as it takes a lot of training to be able to offer this. Once you decide to do it, your orthodontist will take some molds of your teeth. This is relatively painless but not the most pleasant feeling to have that gooey stuff in your mouth. The whole process takes under 10 minutes after which your orthodontist sends your molds to invisalign. Once they have your molds, they construct a customized video which you will be shown on your next appointment. This video will show how your teeth will move after each tray, and you will basically see the shifting of your teeth from beginning to end result. It’s very motivating to see what your teeth will look like upon completion. Once you approve the video, it could take up to around three weeks for your trays to arrive.
Invisalign ships your complete package of trays to your orthodontist, who will then schedule for you to come in so that they can teach you how to put on and remove your first tray. There are also 2 things that may need to happen before starting your invisalign. This is where the importance of having a really good orthodontist comes in.
1- Attachments – Some cases require attachments, which are little clear bumps that are glued to your teeth and hardened with a light. The purpose of them is to help the aligners shift certain teeth more than others. These are clean and usually unseen, and are removed once your invisalign treatment is complete.
2- Filing your teeth – In some cases, your orthodontist might need to file down your teeth from the sides a bit to create room for your teeth to shift (if your mouth is overcrowded). Invisalign will send them a chart of which specific teeth need to be filed and how much from each tooth.
Once You Begin
Will Invisalign Affect my Speech? Many people wonder if invisalign will impact their speech. Some people may temporarily experience a slight lisp for a day or two. Once the tongue gets used to having aligners in your mouth, speech will be normal again.
Is Invisalign Painful? Invisalign is generally much less painful than traditional braces. In fact, you mostly only experience some pain and discomfort for the first day or two of each tray, since each tray will be tighter and put more pressure for your teeth to move. It is recommended to put each of your new trays in at night and take an Advil if necessary. This way, your tray will loosen up a bit by the time you wake up.
After starting invisalign, you have to keep your tray on for at least 22 hours each day. That gives you 2 hours a day to have them off for meals and brushing. You CANNOT eat while wearing your tray. You are allowed to drink water. Make sure to never drink any hot beverages while wearing your trays, as this will melt the plastic. According to the invisalign site, you are allowed to have your trays off for 4 hours a day, but this is NOT recommended. When you were given your ‘estimated’ treatment time, it is estimated based on how well you follow your regimen. The closer you stick to your schedule of switching trays and the less you have them out, the sooner you will see results.
Caring for your Teeth and Invisalign Trays
You should be taking extra better care of your teeth while using invisalign! You should brush your teeth after every meal. In addition to that, make sure you brush the trays as well to prevent odor. Most invisalign users will notice an odor when they remove their invisalign, and this is normal but can be aided by brushing the inner and outer part of the trays with the remainder of your toothpaste after brushing. You should also floss every day! In addition to brushing and flossing, we recommend a cleaning agent for your retainer such as RetainerBrite. This will keep your trays clean and odorless. You must soak your invasalign in water with retainerbrite at least ONCE a day, or two if you can fit it in morning and night.Article created by: http://invisalignfacts.com/
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