Many prospective patients worry about side effects or any potential dangers of Botox® injections. Often they ask “Is BOTOX safe?” This concern was recently heightened by the FDA, which early in 2009 decided to require Allergan, Inc. and Medicis, Inc. to include a so-called “Black Box” warning in the package inserts of their respective products, BOTOX® and Dysport®, the two FDA approved Botulinum toxin A products. The warning, which is the strongest the FDA requires of drug manufacturers, calls physician’s attention to a potentially serious or life threaten complication of a drug. The warning gets its name because it is enclosed in a black box in the package insert. In the case of BOTOX® and Dysport®, the FDA is concerned about a rare but potentially fatal complication of these products when they are used to treat very small children with cerebral palsy. These treatments are not specifically FDA approved and the dose used can be 10 or more times higher that what is used for cosmetic purposes.
Dr. Unger of the FDA has been quoted as saying that the risk of these complications when the drugs are used for approved cosmetic purposes “may well be zero.” In fact there are absolutely no cases of worrisome systemic complications reported when these products are used in the recommended dosages for cosmetic reasons. The warning also applies to another similar product called Myobloc® that is sold by Solstice Neuroscience. Myobloc® is a botulinum toxin B product that is primarily used for medical purposes. When it was initially introduced, physicians tried the product for cosmetic purposes but the product did not gain favor for this application. The reason for this is that even for the small doses used for cosmetic purposes there seem to be some evidence of systemic side effects. While none of these reactions were serious, these side effects are not seen with Dysport® or BOTOX® and these remain the agent of choice for creating temporary cosmetic improvement in the face that requires selective muscle relaxation.
“Dose is very important in the safety of all drugs, not just BOTOX® and Dysport®” says Dr. Steinsapir a leading authority, teacher, and much sought after BOTOX® injector. Even the safety of Aspirin, which is present in almost every American household, is dependent on dose. Take two Aspirin and your headache feels better, take 20 Aspirin and you could develop a stomach ulcer.
Another important issue with both BOTOX® and Dysport® is how treatment is performed. This can very much influence local side effects due to these agents. Local side effects include unwanted muscle weakening. The effect very much depends on which muscles are involved. The two most common unwanted local side effects are: 1) over relaxation of the forehead, 2) treatment induced recruitment of forehead muscles. The first of these is so common that some have been lead to believe that this is the desired effect of BOTOX® and Dysport®.
This is the frozen forehead or BOTOX freeze. It is true that the forehead is glass smooth with not a line in sight but the aesthetic cost is that this type of treatment causes the eyebrows to fall and the eyes look small and closed in. This effect is seen in many well-known models and actresses. The second type of unwanted effect is when these agents have been injected in the central forehead. The localized treatment stimulates the outer portions of the forehead muscle to over work. This has the effect of causing muscle recruitment lines where there has not been treatment. The so-called “bat face” effect in a very well known actress is the result of this type of treatment. These are examples of awful plastic surgery. These types of results are undesirable and with proper placement of the BOTOX® and Dysport® are completely avoidable.
A very important factor in your safety with any treatment is who is performing the treatment. It might surprise you to learn that licensed registered nurses are not allowed to inject BOTOX®, Dysport®, or fillers on their own. It has become common to see nurses injecting clients at beauty salons. They might also suggest that they are supervised by a “medical director.” However, these are generally illegal practices. In the State of California for example, registered nurses are only permitted to inject under the immediate supervision of a licensed physician. The physician needs to have performed an examination and be physically present in the same office where the treatment is taking place. In the State of California, licensed dentists are not permitted to inject BOTOX® or Dysport® for cosmetic treatment. Additionally many physicians have begun offering these treatments as a means to cash in on the demand for these treatments. However, these treatments and avoiding unwanted complications are very technique dependent. Dr. Steinsapir, an Associate Clinical Professor of Oculofacial Surgery at UCLA and in private practice in West Los Angeles, has been working with BOTOX® since 1988 and has vast experience with safely working with these products. He is the developer of the patent pending MicrodropletTM forehead lift and the innovative DeepfillTM method for injecting Restylane to improve dark circles and under eye hollows.
About Dr. Steinsapir and LidLift.com
Dr. Steinsapir is a board certified Ophthalmologist and fellowship trained Cosmetic, Facial and Eye Plastic surgeon who administers Botox in Los Angeles / Beverly Hills of California. People travel from all over the United States and the world for his care and expertise.
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