BOTOXed To A Better World?

This blog post is about Botulinum toxin – A use. I would like to make it clear right at the outset that I have no financial disclosures whatsoever to make for or against the same or the use of any particular trade name under which the same is sold i.e. Botox, Dysport, Neuronox, etc. Though Botulinum toxin A is the pharmacological name of the substance, since BOTOX is to Botulinum toxin type A what XEROX is to photocopying, for the sake of simplicity of the post, the trade name BOTOX is used interchangeable for Botulinum toxin – A.

Botulinum toxin is a material that has been known for over a century and used for medical purposes for more than 50 years. It’s initial uses were for strabismus (commonly known as a squinting eye), blepharospasm (inability to open the eyes), and cervical dystonia (wry neck). In 2002, it was approved for improving and relaxing frown lines in the area between the eyes on the forehead (glabella) and has been used successfully in more than half a million patients since that time. Currently, the Food and Drug Administration (FDA) has approved botulinum toxin A for blepharospasm , strabismus, cervical dystonia, and the aesthetic improvement of glabellar (brow) rhytides (frown lines).

Common clinical uses

Currently, botulinum toxin is most commonly used in the management of hyperfunctional lines. Previously, hyperfunctional lines were the source of much consternation for those affected by them. These lines often caused patients to be misinterpreted as angry, anxious, fearful, or fatigued. In the past, plastic surgeons only had surgical options in their armamentarium, including excision or implantation of fat, collagen, or silicone. These procedures often provided minimal improvement and exposed patients to the risks associated with surgery. Injections of botulinum toxin A provide an opportunity to manage these hyperfunctional lines with minimal morbidity. The 3 most common sites for injection are the glabella, periorbital crow’s feet, and forehead areas.

Pathophysiology

Etiology of hyperfunctional facial lines

Hyperfunctional lines result from the contraction of the underlying facial musculature. The facial musculature is complex and is responsible for facial expressions.  The repeated contraction of these muscles over many years however also produces many facial lines.

Pharmacology

The Clostridium botulinum bacterium produces 7 distinct toxins lettered A through G. All 7 toxins are antigenically distinct; however, Botulinum toxin A is the most commonly used one. Botulinum toxin A (BOTOX®) causes muscle relaxation by inhibiting acetylcholine (a neuro-transmitter) release at the neuromuscular junction.

The toxin requires 24-72 hours to take effect, reflecting the time necessary to disrupt the synaptosomal process. In very rare circumstances, some individuals may require as many as 5 days for the full effect to be observed.

The effect of botulinum toxin lasts 12-24 weeks. The length of action depends! Generally, the effect lasts longer for muscles which are not used that often and decreases as the frequency of action increases. For example, the effects last lesser in the under-eye areas, where the skin is thinner and most active (3 to 4 months) and lasts longer on the forehead where the skin is relatively less mobile (lasting 5 to 8 months).

Indications

Current indications for BOTOX® injections include the following:

• Hyperfunctional lines (eg, glabellar, forehead, crow’s feet, platysma, laugh lines)
• Hemifacial spasm
• Post–facial paralysis
• Blepharospasm (forced, uncontrolled closure of eyelids)
• Strabismus (Cross eyes or squinting)
• Cervical dystonia (Neural problem causing muscle rigidity)
• Hyperhidrosis – Reducing sweating in the axillae, palms and soles of the feet.
• Sialorrhea – Excessive salivation
• Migraines and migraine like headaches

Contra-indications

Contra-indications to BOTOX® injections include the following:

• Pregnancy
• Lactation
• History of reaction to toxin or albumin
• Infection at the injection site

There is no scientific evidence to prove Botox is unsafe in the pregnant or those who are breast feeding. Moreover, there is absolutely NO reason to believe that Botox which is injected into the muscles LOCALLY should have any systemic effect whatsoever. So, technically there is no reason to believe that Botox usage is unsafe in the pregnant or those breast-feeding! However, we still prefer not to use Botox in those pregnant or breast-feeding, just to be more than safe in these vulnerable situations.

Current Splash

Botox has made a huge splash in the health and beauty market because of its ability to erase and minimize wrinkles. The stunning success of the BOTOX solution has had beauty enthusiasts lining up to receive their wrinkle treatments. Are Botox treatments safe? After all BOTOX is a protein toxin produced by clostridium botulinum bacteria. This is the first cousin to the deadly botulism bacteria. Well, let’s discuss the pros, the cons, the great and the not so great with this buzzword that is now officially responsible for a lot of youthful faces world over.

The manner in which Botox works is that it is injected into the muscle where the wrinkles appear. When the Botox is injected into the muscle the frown lines, crow’s feet and laugh lines temporarily disappear. I stress the use of the word ‘temporary’ because a botox treatment normally lasts about 3 to 6 months. Botox treatments were approved by the Food and Drug Administration (FDA) as a treatment of muscles that produce frown lines.

Botox injections have quickly become the fastest growing cosmetic procedure and are anticipated to be used on over 4.5 million patients in 2006. They are more popular than breast augmentation. Current botox patients report that after several treatments that the effects of this wrinkle cure last much longer. Botox treatments however, do not work for everyone. That said, over 90% of patients who have been surveyed are extremely happy with this procedure. This temporary cure for wrinkles has created much excitement in the health and beauty field.

Misconception

A common misconception is that BOTOX actually paralyzes the muscles in the face and makes folks have a mask like face! Although, with extreme amounts of BOTOX, this can happen, most physicians strive to inject just the amount that allows the patient to have some limited activity of the muscles, thereby preserving normal facial expressions, but not so much expression that they have over-activity of the areas and resultant lines. Patients should know that BOTOX is not used to keep them from expressing themselves but simply to keep them from making facial grimaces and frowns that have become habits and are unintended. When done correctly, most people who are not trained cosmetic surgeons will not notice that a BOTOX procedure has been performed but simply that the patient looks more rested or happier. Remember, it is NOT the gun that is as important as the person using the gun!

The material BOTOX® comes as a crystalline substance from the manufacturer, which then has to be reconstituted with saline. Practitioners add varying amounts of liquid when reconstituting it. Although there is no right or wrong amount of liquid to add, most physicians add about 2 or 3 mL of saline to each vial. Some physicians add much more, which can lead patients to think they are getting more BOTOX when, in reality, they are getting the same or less amount of BOTOX than samples reconstituted in a stronger way. It is the total dose of medication, not the volume of liquid, that leads to the desired effect.

During the Procedure

The patient is placed in a somewhat raised position on the exam table, and the areas to be injected are cleansed with a non-alcohol cleanser, such as Hibiclens or Betadine. Some physicians will apply a skin anesthetic cream, such as EMLA cream, at this time. After this, the BOTOX is injected into the desired areas. Typical injection patterns include about 4 or 5 areas on each side of the forehead and 2 or 3 areas on either eye area. More areas can be injected by skilled physicians, depending on the type of wrinkles and the desired effect for the patient. It is common for pressure to be applied if an area seems to be bleeding after the injection.

After the Procedure

After the injections, the patient will usually lay upright or semi-upright on the exam table for about 2-5 minutes to make sure he or she feels good after the procedure, and, then, the patient should avoid lying down for 2-4 hours. If bruising is a concern, it will be important for the patient to avoid taking aspirin or related products, such as ibuprofen (eg, Advil) or naproxen (eg, Aleve) if possible after the procedure to keep bruising to a minimum.

There are many physicians who urge their patients to use the muscles injected several times during the next several days (by scowling etc), as studies tend to suggest that this increases the uptake of the Botox into the muscles and the resultant effectivity of the treatment.

Next Steps

Results will be evident within 3-10 days. Photographs may be taken before the procedure so that patients can check their results themselves rather than relying on their memory. It is surprising to see how many people do not recall how they looked before the procedure and are amazed at the difference when shown a picture. Prior to having the procedure done, the patient should be prepared to realize that BOTOX does not actually erase lines but relaxes them. What this means is that deeper lines will become somewhat less deep and superficial lines will nearly disappear. This can be likened to the act of steaming a garment’s wrinkles rather than ironing them.

It may be necessary for the patient to have additional procedures, such as the use of filler substances (eg, Restylane, Collagen) in order to plump up the wrinkles that are now relaxed. Additionally, it may be necessary to have 2 or 3 sessions of BOTOX® treatment for deeper wrinkles before results become optimal.

Risks

Risks are very minor with this procedure. The main risks consist of headache, pain, and flu-like illness. In this author’s practice, side-effects occur in less than 0.0001% of injections. These complications are typically very minor occurrences and resolve with time.

If the patient is allergic to eggs, it is very important not to use this material because it is prepared with an albumin (egg protein) base. Additionally, if the patient is pregnant, BOTOX is not recommended.

Results

As stated before, the results usually start to be noticed within 3-10 days or even sooner. They tend to last in most people for up to 3 to 6 months. As time passes, the muscle activity will gradually return to normal. Additionally, other areas may return to activity sooner or later depending on the amount injected. The interesting thing about BOTOX® is that it tends to do fairly well even up to the third or fourth month, as opposed to many other cosmetic procedures that last a very short time at full strength and then go away quickly (collagen injections are an example of this type).

Results can vary depending on who is performing the injection on the patient. It is very important to go to a physician who is experienced at this procedure, does it himself or herself (rather than having a nurse, physician’s assistant [PA], or other non-physician do it), and has a good reputation for performing this type of procedure. The manufacturers of BOTOX® recommend physicians inject the medication themselves. As with most procedures, the skill of the practitioner is related to how often he or she performs the procedure.

When to Seek Medical Care

If you have eyelid drooping after a BOTOX® procedure, it is a good idea to let the cosmetic surgeon know because there is a medicine available to help this condition. Any other difficulties, such as difficulty breathing or rashes, should be reported to the surgeon.

Prices

This can be the most difficult question an office gets in a day. Prices charged can vary from $5 in India to as much as $ 25 in California per unit. The cost of the procedure varies as it depends upon the total number of units injected and the number of sites treated.

Competing Products

There are numerous competing products developing of Botulinum Toxin type A. Dysport is currently available in Europe and seems to have relatively the same results as the current BOTOX®. An Indian firm now produces a Botulinum Toxin type A as well. While equivalence studies of these competing molecules have been fairly proven, this has not stymied the popularity of the BOTOX and the addition of competitors has not driven down the price of BOTOX®.

Cons From Industry

In 2005, four hundred thirty six “serious adverse event” reports related to Botox® had been reported. Two hundred one of these cases were possibly or probably due to remote spread of the toxin, including 42 cases reported after wrinkle injections. Also in 2005, industry had reported to the FDA that they had identified 38 patients — 20 children, most of them with cerebral palsy, and 18 adults — who had suffered seizures after Botox® injections. Neurological uses like use of Botox for cerebral palsy are not FDA approved and typically require very large dosages of Botox injections. Stands to reason then that most of these adverse reactions were due to the injection of unwarranted large dosages of BOTOX by ill-trained persons.

What is also worrying is how industry educates physicians for the use of Botox both for cerebral palsy (when it is not approved for this indication), and for cosmetic uses as well? Pharmaceutical companies have created a vast array of courses they sponsor through assorted CME (Continuing Medical Education) programs. In the deposition for an oft repeated trial in which a consumer died because of Botox usage in cerebral palsy, the treating physician (Dr X) stated that he went to two company-sponsored symposiums to learn how to treat cerebral palsy with Botox. Indeed, companies have been known to pay the travel expenses of physicians to attend such meetings. While the physician named in this suit was not a neurologist, he was trained to use Botox in cerebral palsy by a company appointed pediatric neurologist. Similarly, in aesthetics and cosmetics, the cases where there are many physicians who are not Board certified in either aesthetic, cosmetic or plastic surgery care, but are using Botox for these indications is rampant and ever increasing. In India as well as in the US, the top most physicians using Botox (by the number of vials and units used) for cosmetic purposes are all family physicians or worse, cosmetologists – The word cosmetologist of course is not something that denotes anything because even some beauticians use the word and inject Botox. The mind does not fear what it does not know and I feel that in these situations, Botox almost gets treated like a play thing by these persons and used indiscriminately by these persons in this unholy industry-user nexus!Now, the question is, as a consumer would you not think injections with a potentially lethal substance be best left to physicians trained in these particular specialties or should industry in an unbridled attempt to increase ROI’s and unit usage train every Tom, Dick and Harry in the use of the same, who then goes on to inject stuff into you?

What is scarier is that this particular physician (Dr. X) in the above mentioned case was apparently taught to use a dose of Botox in treating children which in reality is twice the maximum dose. What makes no sense is that even though sales representatives of the company visited the physician’s office over 50 times; maximum dosing was never discussed nor was why the patient was hospitalized 10 times for difficulties breathing while undergoing Botox therapy. This is a well known side-effect which occurs with spread of a botulism based toxin. Why was the treating physician unaware of this sign that the toxin had spread? Was he unaware that death can happen as a complication if you have severe problems with swallowing or breathing after treatment? Or is industry only interested in number of units used, vials used and ROI’s to the detriment of the human race?

For instance, while it is widely known that Botox will reduce the spasticity of the leg and arm muscles in individuals with cerebral palsy, the question that must be answered is “Is it safe?”What is meant by maximum dose is even confusing. Some individuals consider the maximum dose in cerebral palsy to be 400 units per visit. However, the individual’s weight, muscle mass and acute nature of the illness will modify this dose. So the idea of a maximum dose for a specific condition is indeed variable and physicians should be aware that there are no specific rules, but rather the physician must understand the toxin, the disease and various factors that determine the treating dose to be used in a given patient.

Cons From Individuals

Sometimes people’s desire to save cash takes some beating – while I am all for cutting a few cosmetic corners by bagging bargains on EBay, there are certain things you should never, ever try to scrimp on. Your health, for example.

It is not a hugely new thing but you can buy Do It Yourself Botox kits on the internet which allow you to freeze your own face. Yes, you too can be a cosmetic surgeon with a skill to rival that of Debraj Shome’s. J

Never mind now that it actually takes training to firstly even learn how to give an injection, not to mention the added essential extra of having the knowledge of where the facial muscles are, and where it is safe to stick a hypodermic syringe. Bad news – and a bad idea – all around.

Cons From Trade

Recent years have seen the use of Botox Facials at salons, parlors and the works. What this actually means is that Botox apparently is added in the concentration of a few drops to the facial and this apparently leads to lines from the face disappearing! This is a joke!

Let’s say it once and for all, topical Botox is a sham! It cannot work, simply because Botox is water soluble so it cannot enter the skin unless it is injected (the skin allows entrance of only those substances which are soluble in oil)! Many parlors claim success taking gullible folks for a ride. So, a facial may cost only $ 100, instead these parlors call it a ‘Botox Facial’ and charge $ 800! Thus, Botox has to be injected into the muscles. Stop fooling yourself and stop allowing con artists from fooling you!

The Verdict

Given those statistics, however, it must be stated that the Botulinum Toxin type A’s (Botox Cosmetic ®) are extraordinarily safe drugs when used correctly by a qualified physician. Issues occur when greed overtakes discriminatory sensibilities and when you have a manufacturer who is unwilling to admit the true number of adverse reactions. Also, the accurate and safe usage of this toxin becomes problematic when a physician’s or injector’s expertise and knowledge become questionable. Therefore, one must choose their physician carefully.

What I also use in these arguments of Botox safety is the debate of drug vs poison. What I like to highlight is that even the oft misused over-the-counter available acetaminophen (Tylenol, Crocin, Dolo), a drug which is randomly used by us humans for every small niggle and which can be bought from the pharmacy even without a prescription, can be dangerous at large concentrations! For the average healthy adult, the recommended maximum dose of acetaminophen over a 24 hour period is four grams (4000 mg) or eight extra-strength pills. (Each extra-strength pill contains 500 mg and each regular strength pill contains 325 mg.) On the other hand, a single dose of 7 to 10 grams of acetaminophen (14 to 20 extra-strength tablets) can cause liver injury in the average healthy adult, this level being even lesser in the person who consumes alcohol regularly! So, what I am trying to say is that at the recommended dosage, a substance is a drug but the same substance used inappropriately or at extremely high dosages is a poison! The same is true in case of Botulinum toxin use as well.

So, in summary, Botox is one of the wonders of modern medicine, when used appropriately and in the right hands. It is truly almost a painless procedure as a very thin needle is used! Many folks in whom a decade ago we would have no option but to perform surgery on for many indications, can now just be Botoxed and these folks can thus avoid the side-effects and the time required for healing associated with surgery.

© The Esthetic Clinic 2010.

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