Botox Fact Sheet

NEW YORK, NY (July 18, 2003) — According to statistics from the American Society for Aesthetic Plastic Surgery (ASAPS), more than 1.6 million botulinum toxin (commonly referred to as Botox) procedures were performed in 2002, making it the most popular nonsurgical procedure, up 2446% since 1997.

Background:

Since its FDA-approval for multiple neurological uses in 1989, Botox has been used millions of times. Widely tested over two decades, Botox has an excellent safety record. On April 15, 2002, the U.S. Food and Drug Administration (FDA) approved Botox for the treatment of moderate to severe glabellar frown lines (vertical creases between the brows). Other cosmetic uses of botulinum toxin continue to be off-label - that is, used at the physician's discretion with patient informed consent. Such uses include treatment of other facial areas such as crow's feet (wrinkles around the eyes) and horizontal forehead wrinkles, and use of Botox for facial shaping such as achieving improved eyebrow symmetry. Continued clinical research appears to indicate other uses for Botox, including relief of migraine headaches and excessive underarm and palm sweating, but these uses also have not, as yet, been specifically approved by the FDA.

How it Works:

There are several different varieties of botulinum toxins produced by the bacterium Clostridium botulinum. Botox® is a Type A strain. Botox blocks the transmission of impulses from nerve cells to the muscle. By selectively interfering with the muscle's ability to contract, thereby reducing excessive contractions, existing lines are smoothed out over time and future lines may be prevented. Initial effects are usually noted within 3-4 days after injection and reach peak in about 2 weeks.

Benefits:

  • Botox generally remains only in the treated muscle, gradually disappearing without breaking down or traveling throughout the body, which may explain why serious side effects are uncommon.
     
  • To date, no systemic complications associated with Botox have been documented.
     
  • Side-effects are temporary and typically disappear within a few hours.

Other Considerations:

  • In clinical trials of Botox, 44% of patients experienced some adverse side-effect, such as headaches, nausea, swelling or bruising. However, it should be noted that, in the same trial, 41% of placebo treated participants also experienced some type of side-effect.
     
  • Bruising and swelling may persist for several days.
     
  • Botox injections last for approximately 1-to-5 months (generally around 3-4 months). Improvements are temporary and injections must be repeated to maintain the desired effect.

Conclusions:

Decades of use and recorded studies in peer-reviewed journals have documented the safety of Botox. However, ASAPS, the leading organization of board-certified plastic surgeons who specialize in cosmetic surgery of the face and body, emphasizes that Botox has been approved by the FDA as a Biologic Drug and, as with any medical treatment, patients should be fully informed as to the approved and off-label uses of the drug, as well as the benefits and risks of the procedure. A patient's full medical history should be taken prior to injection. While the injection of Botox is a nonsurgical procedure, it is still a medical one and should take place in a medical setting under the supervision of a qualified physician with a thorough understanding of the facial musculature.

About ASAPS
The American Society for Aesthetic Plastic Surgery (ASAPS), is recognized as the world’s leading organization devoted entirely to aesthetic plastic surgery and cosmetic medicine of the face and body.  ASAPS is comprised of over 2,600 Plastic Surgeons; active members are certified by the American Board of Plastic Surgery (USA) or by the Royal College of Physicians and Surgeons of Canada and have extensive training in the complete spectrum of surgical and non-surgical aesthetic procedures. International active members are certified by equivalent boards of their respective countries. All members worldwide adhere to a strict Code of Ethics and must meet stringent membership requirements.

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