Botox and Restylane are approved by the FDA, but that doesn’t mean they’re without risk
By Tracy Krulik
How did my life sink to a series of clandestine trips to the mall, praying 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 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 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, 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 department 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 weighing the effects of the skincare products on my fiscal health against the potential risks of injectables to my physical health. The time had come to research how “safe” these injectables really are.
Surprisingly, rather than categorize cosmetic injectables as drugs, the Food and Drug Administration (FDA) lists them as “medical devices,” and therefore 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 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 oversight 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 straightforward. 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 rigorous testing has its limitations, and all drugs and medical devices come with risks.
And the FDA agrees. Its website includes a warning to patients that LASIK (a surgical procedure where the shape of the cornea is changed to improve vision) is not a good choice over contacts or glasses for someone who is risk averse. The procedure, while adored by many, can leave patients blurry, in pain and in some cases blind. Ironically, even contact lens solutions can carry high risk. Bausch & Lomb’s FDA Class II-designated medical device “ReNu with MoistureLoc” was recalled in 2006 for causing fungal infections and blindness.
The FDA states that known risks of commonly-used wrinkle fillers, such as Restylane and Juvederm, include bruising, pain and rashes, and in rarer cases, raised bumps under the skin, open wounds, allergic reactions and even necrosis (tissue death). In addition, if you’ve ever had a cold sore (caused by one of the strains of the herpes virus), these fillers can reactivate the dormant virus and cause a new outbreak.
Botox, which gets doled out like Tupperware in living rooms and kitchens, can have some extremely worrisome effects: blurred or double vision, drooping eyelids, hoarseness, trouble breathing and difficulty swallowing.
In addition, studies conducted on rats in 2008 showed that botulinum toxin migrated to their brains and impaired memory, prompting the FDA to post warnings that Botox can spread from its injection site. One Botox user who asked not to be named told me she suffers memory loss in the days following each Botox injection. She said she’s so happy with her smooth skin that she’s willing to forget where she put her keys a few times a year. I found similar comments on Internet discussion boards, but so far there is no scientific evidence to support any of these claims beyond the studies performed on rats. Although there are potential side effects no matter what the conditions of treatment, Alster noted that the medical risks of Botox and other injectables are dramatically reduced if trained doctors in sterile environments administer the treatments. Beware the Botox home party, but know, too, that professional administration is no guarantee against all potential side effects.
As much as my vanity-driven mind wants me to shoot filler into my nasolabial folds, after this research my gut still screams No! What if I’m that extremely rare individual who has an allergic reaction or my tissue becomes necrotic? What if we find out 50 years from now that the injections turn skin fuchsia? What if I look like a duck? Clearly the FDA will not be recommending too many elective medical devices to me.
So I asked Dr. Alster if she thought I was insane for spending gobs of money on my skin-care habit. Fully expecting her to guffaw, she instead told me I’m treating my skin well. The creams aren’t going to fill in the canyons, but with the right products, she said, fine lines and wrinkles can be smoothed away— if started at an early enough age. Thirties would be ideal, Alster added, but at 40, I can still preserve a good bit of my youthfulness.
It looks like I’ll be making another shopping run this week. Luckily I gave my husband a couple of skin-care samples to try. Instead of holding an intervention to get me to put down the vitamin C gel, he’ll be placing an order of his own.
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