Whole Life Magazine

August/September 2012

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Page 35 of 51

The Price of Looking Botox and Restylane are approved by the FDA, but that doesn't mean they're without risk By Tracy krulik I now give second, third and fourth thoughts to buying new socks to replace the ones with metastasizing holes, but I will drop $1,000 for under-eye gel, line reducer and night cream? I turned 40. Over the past year I started noticing something horrible when I went to H the hairdresser. Forced each time to stare in a mirror for an hour while Kelly cut and dried my hair, I didn't recognize the face staring back—I looked haggard. Each time I smiled, little lines formed around my eyes, and when the smiling ceased, two long canyons remained curved from my nose to the outside corners of my mouth. Those images kept replaying in my mind like Groundhog Day, so when I visited my dermatologist for my annual mole check, I asked her what I could do to "stay young forever." After she stopped laughing she suggested a wrinkle filler in the "nasolabial folds" around my mouth and Botox for the crows' feet. She handed me a couple of glossy tri-fold brochures to learn about the injectables, and I left feeling uneasy. I'm careful about the foods I eat and cautious of the medications I take, ow did my life sink to a series of clandestine trips to the mall, pray- ing that my "dealer" would slip me enough samples to tide me over until I could afford to buy the next $400 bottle of serum? Why do and Drug Administration (FDA) lists them as "medical devices," and there- fore applies a less stringent approval process. Advocacy organizations like the National Research Center for Women & Families (NRC) have been lobbying the FDA for better standards and procedures to approve medical devices, which run the gamut from tongue depressors and bandages (Class I, low risk) to contact lens solutions and electrocardiographs (Class II, intermediate risk), to implantable devices such as pacemakers and heart valves, most injectables, and even the vision procedure LASIK (Class III, high risk). "There are many wonderful medical devices that save people's lives and Surprisingly, rather than categorize cosmetic injectables as drugs, the Food Young so injecting foreign substances into my face does not fit well into my approach toward health. Hoping for a better option, I stopped to chat with a depart- ment store saleswoman with skin like a teenager's. In support of my quest to find a primer to fill in wrinkles, she hooked me up with that and more. After vanishing some cracks under my eyes with a cream that I like to call "Magic," she sent me home with a bag of miracle potions to try. My American Express card and I returned within the week. A few months went by and my stash was running low, so I started weigh- ing the effects of the skincare products on my fiscal health against the poten- tial risks of injectables to my physical health. The time had come to research how "safe" these injectables really are. 36 wholelifetimesmagazine.com forward. At a Union of Concerned Scientists conference in November 2011, Zuckerman pointed out that FDA approval for a drug or device does not necessarily guarantee safety. She clearly stated what FDA approval does not mean: "Nobody will die from this product; few will be harmed by this product; this product is safe for long-term use; this product is more effective than other products on the market." As consumers we need to understand that even rigor- ous testing has its limitations, and all drugs and medical devices come with risks. improve their quality of life," Diana Zuckerman, Ph.D. and president of NRC, told me in an email. "What concerns me is that the standards for FDA approval are so low and there is such a lack of well-designed clinical trials that patients and physicians are often unable to make informed decisions about which are the safest and most effective devices—and in many cases, whether a device even works as advertised." I asked renowned Washington, D.C.-based cosmetic dermatologist Tina Alster—whose clients include Hollywood actresses, members of Congress and heads of state—if she has any concerns about the risks of injectables. "As a consumer and a provider I'm just not concerned," she replied. "I don't lose sleep over that." Alster has firsthand knowledge about the FDA's over- sight of these treatments—her practice participated in phase III FDA trials for the approval of Botox for cosmetic use. From a patient's perspective, however, the answer may not be so straight-

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