SMOOTHING WRINKLED BROWS FDA APPROVES BOTOX FOR COSMETIC THERAPY.Byline: Greg Hernandez Staff Writer Botox treatments - those wrinkle-smoothing injections of treated toxins so popular in Hollywood - won approval Monday from the Federal Drug Administration as a cosmetic, a move that will make them far more available for everyday folk. ``People who have this done don't want to have a frown unless they intentionally make one,'' said Dr. Shane Sceibani of Facelift Without Incisions, based in Toluca Lake and Beverly Hills. ``That's what Botox is great for. This gives us somewhat more freedom to now use this type of therapy with the full backing of the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. .'' While the FDA had already approved medical use of Botox - a purified strain of the toxin that causes botulism botulism (bŏch`əlĭz'əm), acute poisoning resulting from ingestion of food containing toxins produced by the bacillus Clostridium botulinum. - its action Monday allows for maker Allergan Inc. to directly advertise the injections as a way to ease wrinkles. Within a few months, Irvine-based Allergan plans to launch an initial $50 million advertising campaign of television and print ads aimed directly at wrinkle-conscious consumers. The 2002 campaign will also include outreach to physicians, offering them information on Botox training as well as other details, the company said Monday. Lester J. Kaplan, Allergan's president of research and development, called the FDA approval ``an important corporate accomplishment.'' ``Our clinical work shows that Botox is safe and effective for this aesthetic use,'' Kaplan said in a statement. ``Along with the previous approvals in the U.S. for Botox in the treatment of certain neurological disorders, this new indication firmly establishes the versatility of the product.'' Botox injections, in use since 1991, are one of the fastest-growing procedures performed by U.S. surgeons, increasing by 46 percent since 2000, according to the American Society for Aesthetic Plastic Surgery The American Society for Aesthetic Plastic Surgery (ASAPS) is an organization devoted to the advancement of cosmetic surgery. It has approximately 2,400 members. U.S. members are certified by the American Board of Plastic Surgery. . At an average of $400 a treatment, Botox is injected into flexed facial muscles facial muscles, n See muscles, facial. in order to weaken and paralyze par·a·lyze v. To affect with paralysis; cause to be paralytic. them temporarily, leaving the skin smooth and unlined. The procedure is a series of shots that last five to 10 minutes. A reapplication Re`ap`pli`ca´tion n. 1. The act of reapplying, or the state of being reapplied. is usually needed after about three months when the wrinkles begin to return. Other than some initial swelling, few side effects Side effects Effects of a proposed project on other parts of the firm. have been reported - although some patients experience headache, droopy droop v. drooped, droop·ing, droops v.intr. 1. To bend or hang downward: "His mouth drooped sadly, pulled down, no doubt, by the plump weight of his jowls" eyelids eyelids, n.pl a moveable fold of thin skin over the eye. The orbicularis oculi muscle and the oculomotor nerve control the opening and closing of the eyelid. and nausea. Less-frequent adverse reactions adverse reactions, n.pl unfavorable reactions resulting from administration of a local anesthetic; responsible factors include the drug used, concentration, and route of administration. include pain in the face and redness at the injection site. ``The benefits truly outweigh the risks,'' said Ferzaad Moosa, head of Encino-based Excel Laser Vision Institute. ``I think the FDA approval helps boost the patients' confidence in the process. The consumers' concerns about the procedure are that much more diminished.'' In image-conscious Los Angeles, the anti-aging industry is preparing for an influx in both female and male Botox-seeking clients. Sceibani, who performs the procedure on countless actors, actresses and models, said he expects to see more middle-class clients. ``The bottom line is, the better you look out there, the better chances of success in whatever profession you are in - even more so in the entertainment industry,'' he said. ``It is quite competitive to stay young and youthful and appear your best at all times.'' Many high-profile performers, including Cher, Madonna and Carrie Fisher, are widely reported to regularly undergo Botox treatments. It has become so prevalent in the industry that film directors Baz Luhrmann and Martin Scorcese complained to The New York Times that the faces of some performers are not as animated or expressive as they once were because of the treatments. ``Their faces can't really move properly,'' Luhrmann was quoted as saying. Sceibani and others defend Botox, saying too many people are perceived as stressed out by their family, friends and colleagues because of unwanted expressions created by lines between and above the brow. ``They may actually feel comfortable and relaxed inside,'' Sceibani said. ``It takes away the unwanted deep lines and the facial grimace grimace Neurology A humorless facial 'mask' typically seen in Pts with catatonia. See Amimia. that people create, giving them the look of fatigue or perhaps anger.'' CAPTION(S): box Box: NO MORE WRINKLES? |
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