With the rapid increase in BOTOX® usage, certain concerns have been raised regarding BOTOX safety. Critics of BOTOX have tried to give it a bad name, to discredit the doctors who administer BOTOX , and to try to get it off of the market. It is difficult to say why the critics feel this way.
I have the distinct pleasure of having a Diamond Elite Status in the use of BOTOX Cosmetic ® and with this; I have injected more Botox Cosmetic than any other physician in North Texas. I believe BOTOX Cosmetic is a very safe treatment if performed in the right hands. Over the past few years I have performed over 5000+ BOTOX treatments in my practice without a single known significant complication.
The popularity of BOTOX for the use in cosmetic facial wrinkles, known as BOTOX Cosmetic ®, is due to its simplicity and tremendous effectiveness. Recent negative publicity with its use in children with neuromuscular disorders has not accurately represented its safety record in cosmetic applications. On February 8th 2008, the FDA announced it was reviewing certain serious adverse events following the use of botulinum toxins, particularly for the management of juvenile cerebral palsy. However, the FDA made clear in its communication that "the posting of this information does not mean that there is a causal relationship between the product and the adverse events." The AAFPRS further clarifies that the adverse side effects under investigation by the FDA occurred in children with cerebral palsy where the therapeutic benefit of using BOTOX was achieved in doses that were 15-20 times the dose used for cosmetic purposes.
BOTOX has a ten-year history of use for non-cosmetic purposes such as the treatment of muscle spasms and gastrointestinal disorders. It was through the treatment of such ailments that doctors discovered an alternate use for BOTOX - that of an anti-wrinkle remedy.
BOTOX is currently the most common medical cosmetic treatment today. According to the American Society of Plastic Surgery last year over 4.1 million BOTOX cosmetic treatments were performed. These people range from the celebrities who endorse BOTOX such as the famous actresses Elizabeth Hurley and Vanessa Williams to the common, everyday, average consumer. It is currently FDA approved for treatment of glabellar wrinkles, which are the frown lines between the eyebrows. Any other treatments are considered 'off-label.' BOTOX is recommended for people between the ages of 18 and 65. It is also not recommended if you are pregnant or presently breastfeeding.
BOTOXhas been approved as an anti-wrinkle remedy by the American Food and Drug Administration (AFDA). Since this is a public and federally funded institution, they are primarily concerned with public safety. Such an institution would not approve BOTOX for general public usage without conducting all the sufficient and necessary tests to determine whether or not it is safe. The FDA believes that the safety issues identified are currently addressed in the manufacturer labeling. The main side effects listed are minimal. These include slight bruising, minor facial pain and skin irritation, potential respiratory problems, headaches, and flu-like symptoms. These side effects however are rare. No long-term side effects were discovered.
The bottom line is that despite critics of BOTOX, it is here to stay. This is good news for those of us who do not wish to incur the risk and cost of plastic surgery yet who are also looking for a more effective wrinkle remedy than what over-the-counter skin creams can offer. When used properly, BOTOX is one of the best risk-to-reward products within the cosmetics industry.
