BOTOX®:
The Wrinkle Free Facts
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By Susan Archer(e)
Everyone already knows plastic surgery is booming and the fastest growing segment of the industry is non-surgical injection procedures. The BOTOX® procedure is one of the main factors behind this explosive growth. From 1997-2004 these procedures grew by an astounding 4,300% from 65,000 to 2.8 million procedures annually. BOTOX® is by far the most popular cosmetic procedures accounting for 23.9% of all plastic surgery (throughout this article I may use the term ‘plastic surgery’ even when talking about non-surgical procedures because it is a popular naming convention). There were also 785,000 collagen injections and 882,000 hyaluronic acid injections in 2004* to give us some perspective.a
The BOTOX® injection is a procedure where an injection is made into the dermis or skin and a small deposit of the drug, BOTOX®, is injected. The purpose of this injection is to reduce the appearance of wrinkles in a patients face. The procedure usually targets wrinkles in the eyes or 'crows feet', brow, mouth, and even neck.
With so many procedures taking place each year it is more important than ever to understand what this non-surgical procedure entails, what complications might arise, and what kind of expectations one should have when considering BOTOX® injections.
BOTOX®: A Brief History
Once a fad for the wealthy, BOTOX® looks like it is here to stay for quite some time. With the number of procedures growing astronomically year over year it would seem there are a lot of people ready to commit themselves to having this cosmetic procedure repeatedly for a long period of their lives.
BOTOX® stands for Botulinum Toxin Type A and is a protein that is produced by the bacteria that causes the nasty food poisoning botulism. Some of the severe symptoms of botulism are caused by this same protein we now use for medical and cosmetic purposes. The story behind botulinum is actually quite interesting. It was originally approved for use by the FDA for eye muscle disorders where paralysis of the muscles was helpful in alleviating symptoms. As doctors used this new procedure they realized that certain wrinkles around the eyes were becoming less prominent in their patients.d
Are There Dangers with BOTOX®?
“Botulinum toxin has been called the ‘most poisonous poison’, and thought to be the most lethal substance known (on a per molecule or per weight basis).” This quote is found on the FDA website in an assessment of clinical studies on BOTOX® and may give you reason for pause. One could draw the immediate conclusion that injecting the ‘most poisonous poison’ into your body is not a very smart or healthy idea. It does bring to mind the Darwin Awards.b
It also is somewhat disturbing to read in another document found on the FDA website that seems to be a clinical study produced by Allergan, Inc.(the makers and marketers of BOTOX®): “The most serious adverse events … include rare spontaneous reports of death … adverse events involving the cardiovascular system … some with fatal outcomes. … The exact relationship of these events to the botulinum toxin injection has not been established.”c
On the bright side the same report indicates that in a controlled study, 43.7% of subjects given BOTOX® injections report negative side-effects; in the same study 41.5% of subjects given a placebo reported negative side-effects. To me this seems to indicate that most of the negative side effects reported are due to the distasteful thought of getting a needle poked in your face.
In my estimation, and apparently that of FDA’s, these side effects are relatively minor. On the other hand, I’m definitely hesitant to recommend a procedure that is purely cosmetic in nature, has to be constantly repeated and has some potentially life threatening and not well-studied side effects.
How Does BOTOX® Really Work?
The best information you’ll get from most literature on BOTOX®, whether it is company marketing or a more neutral report is that it blocks neurotransmitters preventing the contraction of muscles thus reducing the depth and appearance of wrinkles and not killing any tissue. That sounds great to me, it is temporary and everything comes back online within 3-6 months, so if I don’t like the effects of the procedure in naturally undoes itself, unfortunately this also means your wrinkles come back.
And this is basically true; however, BOTOX® does permanently alter your physiology. Without getting into too much detail and jargon here are the facts about how BOTOX® works straight from the doctors the company hired to produce it’s own study for FDA approval.
BOTOX® works by ‘paralyzing’ the muscles it comes into contact with. It does this by blocking the neurotransmitters in the part of the nerve that ‘connects’ to the muscle. These blocked connections are permanently disabled. But yet there is hope, or maybe not depending on how you look at it. The reason that BOTOX® injections don’t work on a permanent basis is because your nerve cells grow new connections to your muscles, not because the original connection begins to function properly again.c
This is at once a cause for the celebration of the resilience of the human body to overcome a challenge to it’s proper functioning and a cause for concern about the long-term impact of asking your nerves to grow new connections every 3-6mos. It brings to mind some obvious questions that will remain unanswered until we begin to see any unanticipated long-term effects cropping up over the next 5-15 years. Can your nerves lose the ability to re-grow the connection? No one knows, what is for sure is that some people would like this and others wouldn’t.
Another Danger of BOTOX®: Toxin Spread and Bad Medicine
While relatively rare, there is also the possibility that the BOTOX® injection can spread to unintended areas causing paralysis in unintended muscles. This is of particular concern when used medically in the throat and neck and not too much of a concern when used cosmetically in the face. However one can imagine situations where badly placed injections from those poorly trained to administer the injection could cause paralysis of unintended muscles.
As the popularity of BOTOX® increases with the advent of uber-casual ‘BOTOX® parties’ the likelihood of user failure (i.e. injections from an unqualified source) greatly increases; that’s why the manufacturer, industry groups, and the FDA all insist that people getting this seemingly simple procedure see a doctor in their office, one at a time. Contrary to the popular misconception it requires skill, accuracy, and experience to properly administer BOTOX®.
Buyer Beware: BOTOX® is Serious Business
Unfortunately the high price of a BOTOX® procedure (costing $387 per), the popularity of the procedure, and the convenience and lower cost usually found at ‘BOTOX® parties’ all collude to thwart the industries best efforts to prevent these shenanigans. This is not a medicine to be treated lightly, when applied properly it is a relatively safe and benign medicine; however, if misused and improperly handled it can cause very serious problems that may be as permanent as death. When considering whether to go to a qualified doctor or attend your next ‘BOTOX® party’ do the smart thing and let your mantra be: “most poisonous poison”.
What is BOTOX® Usually Used for?
BOTOX® does show obviously promising results for a few areas of great cosmetic concern to many people. It is generally utilized for between the eyes ‘furrowed brow wrinkles’, ‘crows feet’ (on the lateral aspect or ear-side crease of each eye), or to alleviate some types of wrinkling in the neck. If your doctor suggests another area for use, it could be more risky or it could be just fine. Almost all of the most popular uses for BOTOX® are known as off-label uses.
An off-label use is one that an approved medicine hasn’t been specifically approved for. This does not mean that it cannot be used for unapproved purposes, what it does mean is that a company is only allowed to market the product for FDA approved procedures. What it also means is that doctors are given leeway to decide what other uses may be appropriate. To keep this all in perspective we should remember that BOTOX® is approved specifically for some cosmetic procedures in the face and that many medicines are commonly used for off-label purposes.
The most important consideration when thinking about off-label uses of a medicine is the opinion of a qualified and experienced doctor. That is why the FDA gives such broad latitude to doctors when it comes to making decisions about how to use FDA approved drugs.
BOTOX®, as with all medicines, has some undesirable side effects and serious risks associated with use. However, the FDA has made it clear that these side effects and risks are not high enough to counter act the potential benefits one may receive. The key to good decision making about whether to have the procedure or not is to understand the risks, talk to a qualified doctor about your goals for treatment and make an informed decision about the BOTOX® choice.
Notes and References
a. All statistics on number of procedures and costs as reported by the American Society for Aesthetic Plastic Surgery.
b. Information from publication on FDA website.
c. Information from publication on FDA website.
d. Information from FDA BOTOX® Fact Sheet
e. Susan Archer is not a doctor and does not claim to dispense nor imply to give medical advice. Her opinions are her own and do not reflect the viewpoint of GetBeautyTips.com or any member of said organization. For complete medical advice please consult a competent and licensed physician.
Other Sources Used for General Information for this article
American Society of Plastic Surgeons
National Research Center for Women and Families
FDA Warning
Letter to Allergan, Inc. Re: Marketing of BOTOX®