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A smaller nose. Bigger breasts. Slimmer thighs. Plumper lips. Less hair on the body. More hair on the head. Whether we're looking to tighten our tummies or lighten our laugh lines, America's fascination with youth and beauty has long fueled the development of medical products for cosmetic purposes. And if such "vanity drugs" can be shown to be safe and effective, the Food and Drug Administration just may approve. The ongoing fight to delay or reverse the aging process has dermatologists and cosmetic plastic surgeons responding with products like Restylane (hyaluronic acid), one of a handful of soft tissue fillers recently approved by the FDA to treat facial wrinkles. Restylane is an injectable gel that acts as a filler to remove the wrinkle, producing instantaneous results. Such products are not as invasive as facelifts, eyelid surgery, and other reconstructive procedures. And they are more effective and last longer than creams, lotions and other topical products, whether over-the-counter or prescription. In addition, the fact that the treatments result in little or no downtime makes them more attractive to those seeking a quick fix. Without making a single incision, doctors can erase wrinkles, acne scars and sun damage in a matter of minutes. "This is a huge industry," says Jonathan K. Wilkin, M.D., a medical officer in the FDA's Division of Dermatologic and Dental Drug Products. "The way people try to move the clock back is through the skin." Basically, he says, through various products and procedures, "they are addressing the effects of gravity on the skin over time." Aging Skin 101 With aging, all skin cells begin to produce excess amounts of free radicals--unstable oxygen molecules that, under ideal circumstances, are removed by naturally occurring antioxidants within the skin's cells. In aging skin cells, antioxidants are in short supply. The free radicals generated are left unchecked and cause damage to cell membranes, proteins, and DNA. These free radicals eventually break down a protein substance in connective tissue (collagen) and release chemicals that cause inflammation in the skin. It is a combination of these cellular and molecular events that leads to skin aging and the formation of wrinkles, the AAD says.
Illustration by Renйe Gordon. Source: National Institute on Aging. Considerable research has been done to understand the aging process, and studies now show that products containing bioactive ingredients (those that interact with living tissues or systems) can benefit sun-damaged, discolored, and aging skin, giving consumers new choices for restoring their overall appearance. But why is the FDA reviewing products that simply make people look and feel good when typically the agency evaluates disease-fighting treatments? "If something that is being implanted into the body could have health consequences, we're concerned about it," says Stephen P. Rhodes, M.S., chief of the FDA's Plastic and Reconstructive Surgery Devices Branch. "Wrinkle fillers affect the structure of the face and could have such health consequences." Facing Facts The hyaluronic acid in Restylane, although biosynthetically produced (formed of chemical compounds by the enzyme action of living organisms), is almost identical to that in all living organisms. Hyaluronic acid is a structural component of skin that creates volume and shape. Concentrations of hyaluronic acid throughout the body decline with age, causing undesirable changes in the skin. Restylane binds to water and provides volume to easily fill in larger folds of skin left by tissue loss around the mouth and cheeks. "This makes it a structural action," says Rhodes, "much like a chin implant." In contrast, cosmetics are defined as substances that cleanse, beautify, promote attractiveness, or alter the appearance, without affecting the body's structure or function. This definition includes skin-care products such as creams, lotions, powders and sprays; perfume; lipstick; fingernail polish; and more. Different laws and regulations apply to each type of product. Some products must comply with the requirements for both cosmetics and drugs. This happens when a product has two intended uses, such as an antidandruff shampoo. A shampoo is a cosmetic because it is intended to clean hair. An antidandruff shampoo is a cosmetic and a drug because it is intended to treat dandruff (which affects the follicles where the hair is formed) and clean hair. Warning letters issued by the FDA recently to firms that marketed hair care products with claims such as restoration of hair growth and hair loss prevention illustrate an important distinction between the legal definitions of cosmetics and drugs. Warning letters officially inform companies that they may be engaged in illegal activities, and instruct manufacturers on how to bring their products into compliance with the law. Hair growers and hair loss prevention products, because of their mechanism of action, are considered drugs, not cosmetics, and these firms were not meeting the legal requirements for marketing a drug. Unlike drugs and medical devices, neither cosmetic products nor cosmetic ingredients are reviewed or approved by the FDA before they are sold to the public. The agency only acts against cosmetic products found to cause harm after they are on the market. Cosmetics or
Drugs? According to the AAD, the answer to whether or not cosmeceuticals really work lies in the ingredients and how they interact with the biological mechanisms that occur in aging skin. The regulatory question the FDA faces when considering such products, Katz says, "is whether or not a manufacturer is making a structure or function claim." The FDA uses different standards when evaluating the risks and benefits of products used for cosmetic treatments than for therapeutic uses of products. Steven K. Galson, M.D., M.P.H., acting director for the FDA's Center for Drug Evaluation and Research, adds that products like tretinoin and Restylane that are not indicated for serious or life-threatening conditions are subject to close examination by the agency because of the benefit-to-risk ratio. "Because these products are for cosmetic purposes, they must be extraordinarily safe," Galson says. This means that the FDA may allow someone to incur a greater risk from products that treat medical conditions, rather than from those that are intended for cosmetic purposes. "We generally won't tolerate much risk for a drug whose primary use is cosmetic," he says. Welcome Side
Effects "There's a lot of serendipity in drug development," says the FDA's Wilkin. A pill to help smokers quit, for example, evolved out of the unexpected observation that a drug intended to treat depression also seemed to take away the desire to smoke. Bupropion was first marketed in 1989 by GlaxoSmithKline as an antidepressant under the name Wellbutrin. After doctors noticed that patients being treated with Wellbutrin gave up smoking spontaneously, studies were done to show that the product could help smokers quit, as well. As a result, the slow-release form of bupropion, marketed as Zyban, was approved by the FDA in 1997 as an aid to smoking cessation treatment. Some pharmaceutical companies, however, apparently aren't ready to enter the vanity drugs arena. Patrick Davish, the global product communications spokesman for Merck & Co. Inc., says that the drug company has no "cosmetic" drugs in its product pipeline at this time. "The fact that we don't participate in that market right now-I'm not sure that's reflective of any particular deliberation or decision," he says. "That's just not where the science has taken us." Before electing to
have a cosmetic procedure Despite the sudden explosion of such "lunchtime" techniques as Restylane for erasing wrinkles, and Botox (botulinum toxin type A) for smoothing out frown lines, Bradbard, of Gaithersburg, Md., opted for a longer-lasting reconstructive facelift that included a chin implant, eyelid surgery, and surprisingly, only a few days of pain-free recovery. "None of this was medically necessary," admits Bradbard, a 48-year-old FDA press officer, "but I had been feeling worn out and tired. What I saw in the mirror was sad." Bradbard says she didn't get a facelift to look younger; she only wanted her face to look more balanced. In the end, she says, "My doctor gave me a chin that geometrically fit my face," and a look that she says makes her feel better about herself. Like Bradbard, others are spending a lot of money to look good. "With patients living 90-plus years, today's anti-aging modalities offer people noninvasive procedures that mimic true facelifts," says Craig R. Dufresne, M.D., a plastic and reconstructive surgeon in Chevy Chase, Md., who performed Bradbard's surgery. However, Dufresne says he suggested reconstructive surgery for Bradbard because "she wanted to deal with structural changes to restore facial balance," which was more than the chemical action of a drug could produce. "And skin product application (such as wrinkle fillers) following a facelift," adds Dufresne, "will actually allow the facelift or any other reconstructive procedure to last longer and make a great result even better." Top 5 Cosmetic
Nonsurgical Procedures (2002) microdermabrasion collagen injection laser hair removal chemical
peel Source: American Society for Aesthetic Plastic Surgery Top 5 Cosmetic
Surgical Procedures (2002) breast augmentation eyelid surgery rhinoplasty (nose reshaping) breast
reduction Source: American Society for Aesthetic Plastic Surgery
"A good place to start is with a dermatologist," says Arielle N.B. Kauvar, M.D., clinical associate professor of dermatology at the New York University School of Medicine. "Dermatologists are trained in the health, function and disease state of the skin, and people could save time, money and confusion by seeking the advice of a dermatologist rather than guessing what might work for them." Kauvar says a dermatologist's recommendations can help consumers make informed decisions. "People shouldn't hunt and peck for products," she adds. "Not knowing what type of skin you have is why so many people try unnecessary products that can often do more harm than good." An expert in laser procedures, Kauvar says that, in the past, techniques for improving aging skin required invasive laser or surgical procedures, which produced open wounds and required long recovery times. Today, she says, people can choose from a variety of non-ablative (non-wounding) laser treatments that are designed to reverse, improve or erase the early signs of aging, take very little time to perform, and have a minimal, if any, recovery time. While Bradbard wasn't interested in removing wrinkles at the time of her facelift, given what she knows about new technologies and drug delivery systems today, she says, "I would consider both non-invasive procedures and another facelift down the road, depending on how much my skin changes. I would ask my doctor what would give me the best results with the longest-lasting effects." Buyer Beware According to the ASAPS, it's important to realize that although certain products and procedures are effective, they are also limited by the skin's normal aging process. A product that has been deemed effective for erasing wrinkles doesn't necessarily erase wrinkles--there are lots of variables that determine its effectiveness. For example, the active ingredient in a drug must be delivered to the skin at a therapeutic concentration and remain in the skin long enough to have an effect. Also, because the composition of a man's body differs from a woman's, products or procedures can have different effects. The facial area in men contains hair, for example, and their skin is thicker. This means the blood supply is greater--and so is the risk of bleeding--but it also could mean better healing. And cosmetic procedures come with risks. If a procedure is performed poorly, the physical and emotional scars could be carried for life. Understand the risks and side effects that may be involved. "My wanting to improve my appearance is like my husband's desire to restore a vintage automobile," says Bradbard. "We both want something to look good for as long as it can." For More
Information American Society
for Dermatologic Surgery American Society
for Aesthetic Plastic Surgery
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Conditions/Aspects Organizations
Pictures/Diagrams Research Specific
Conditions/Aspects Treatment Dictionaries/Glossaries Directories Organizations
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This page contains content from the ACPS Plastic Surgery Center in Texas. The Aesthetic Center for Plastic Surgery was founded in 1996 by Dr. German Newall , Dr. Christopher K. Patronella , and Dr. Henry A. Mentz , III. ACPS is currently ranked as the largest private plastic surgery center in Texas. The practice surgical facility, the ACPS Surgicenter, is a AAAA certified surgical facility exceeding accepted standards for private surgical facilities and is licensed by the Texas Department of Health. The offices of The Aesthetic Center for Plastic Surgery are located in the Galleria area of Houston at 4400 South Post Oak, Suite 2260 and in the Memorial/Town and Country area of Southwest Houston at 12727 Kimberley, Suite 300. ACPS has a toll free number of (1-877-707-2277) to coordinate your plastic surgery arrangements and accommodations. The anticipation of your new look is very exciting, but the decision to have plastic surgery isa very important one. Reviewing a broad list of before and after photos is also important to see the desired result that you wish to obtain. Choosing the right plastic surgeon is the first step. After you have utilized the ACPS checklist for selecting a plastic surgeon , it is important that you consider where you will be having your surgery.
Breast Implant | Liposuction Body Contouring | Facial Refinement | Cirugia Plastica | Mentz MD | MediSpa | Dermatology Colorado | Dermatology Colorado Springs