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Submitted by sammamishAdmin on April 16th

I often hear about injectable fillers being used for treatments that are "off-label", which I understand refers to a use not approved by the FDA. This sounds fairly common, but is it something to be concerned about?

It is best to seek a professional cosmetic surgeon who uses FDA approved injections. It is essential for a very well qualified doctor who has a lot of experience in the use of fillers to treat the patient. There is a lot of debate in the media about off-label use of medical devices, and it is illegal for any company to offer a drug or device for any off-label use. When there is a lot of money involved, as there is with cosmetic procedures and injectable devices, some doctors and manufacturers may be tempted to cross this line with off label products. With off label injectable fillers, the patient does not know if it is safe or not. The meaning of "Off-label" is the proposed use of a product that is not approved by the FDA. Off-label is perfectly legal, but as a patient, you cannot know if it is safe or effective. Medical corporations present drugs or devices to the FDA hoping for approval. To get this FDA approval, clinical studies must be conducted showing the FDA that it is effective and safe for a particular indication. Some drugs and devices are only FDA approved for moderate treatments and therefore would not be appropriate for some surgical procedures. Only when a company presents a specific indication to the FDA, with proof that it is safe, can be "FDA approved" for that use. This is also true for medications. Once a medication or surgical device is FDA approved for any indication, it is up to the doctor for what purpose it is used and how to prescribe. Sometimes doctors need to be able to use drugs and devices for off-label purposes because it allows for the treatment of many diseases and serious conditions, without having to wait years for FDA approval.



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