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Entries in FDA (2)
FDA recommends Restylane for Lip Plumping
An FDA advisory panel recommends Restylane, an injectable filler, for approval for lip enhancement. In 2003, the FDA approved Restylane for nasolabial wrinkles, the lines that form along the sides of the nose.
Jonah Shacknai, Chairman and Chief Executive Officer of Medicis, Restylane’s maker, said in a statement that the panel’s recommendation reflects its “confidence in the robust clinical data provided by Medicis.” FDA approval would make Restylane the first hyaluronic acid dermal filler in the U.S. indicated for use in the lips.
Currently, many physicians already use Restylane in the lips and other "off-label" areas, so the FDA approval would be unlikely to significantly change treatment habits among cosmetic providers. Restylane tends to last between 3-6 months with a single treatment. It consists of a gel called hyaluronic acid, which is natural broken down by the body in the same way as sugar. Overdone lips are often the result of too much filler; natural-appearing lips can result from a well performed treatment.
BOTOX for headaches and wrinkles
In October 2010, the FDA cleared the wrinkle filler Botox® to treat headaches.
Botox® has long been the most popular world-wide anti-wrinkle treatment with millions of people experiencing it's rather amazing effects.
Botox® for Headaches:
For years we have observed that people with chronic headaches can get substantial relief when we perform cosmetic Botox® . A large study was done comparing Botox® to placebo (salt water) injected into various muscles of the scalp, and the Botox® relieved headaches better than placebo.
What was interesting was where they chose to inject the Botox® for the headaches, and the amount of response that was noticed. In my practice, I treat people every day with Botox® Many of these patients have a history of headaches, even though that is not what they are there for. When asked about headaches on subsequent visits, they often note that they had a substantial reduction in headaches. In fact, many times I hear from my patients "I know my Botox® is wearing off, because I am getting the headaches again". This was why they decided to do a study: To prove what we have observed, that is, Botox® injected for wrinkles relieves headaches. And this is after injecting Botox® in a standard pattern for wrinkles. In the FDA study, they injected in a totally different fashion, and had only a marginal improvement over placebo.
What can this mean? When a study is done for the FDA, they are looking to prove it works and it is effective. They did that. From here we will probably see several studies to see if injectors like myself and others have observed "a better way". Now that it is approved (Botox® for headaches), there will be substantial interest, progress, and adaptation of the use of this amazing medication for a sometimes debilitating painful condition.
Botox® for Wrinkles:
Botox® works by weakening the connection of nerves and muscles. Wrinkles that are caused by repeated overuse, or even normal use of muscles include the "crow's feet" wrinkles on the sides of the eyes, the deep frown between the eyes, and the forehead horizontal lines. There is virtually no treatments that come anywhere close to the effects of Botox® for these lines, not even plastic surgery.
Botox® is typically injected right into the muscles that cause the wrinkles, and is very dose dependant, so the doctor doing the injection needs to understand the anatomy of the muscles as well as be able to estimate the ideal dose for any individual. I evaluate the size of the muscle by having the patient look into a mirror and frown, squint, and raise the forehead.
If you look in a mirror and do a strong frown, you will see that your brow lowers and you develop a crease between your eyes. But you can also see the outline of the muscles that are like bat wings. These bat wing muscles cause the vertical lines. In the very middle of your eyes is a muscle that runs up and down, and this can cause horizontal lines, and is also responsible for the brow dropping over time.
When we use Botox® for these wrinkles, not only do we see improvement or vanishing of the wrinkles, but the brow elevates and creates a more refreshed, happy, and youthful look. I think of it like this: "They come in for the wrinkles, and stay for the brow", because individuals are pleasantly surprised to see the refreshed look of the tired eyes that seemingly had nothing to do with their wrinkles.
Dr Charles Mok