FAQs about Wrinkle-Reducing Injections
FAQs about Botox® Cosmetic and Dysport® Wrinkle – Reducing Injections
What are Botox® Cosmetic and Dysport®?
How are Botox® Cosmetic and Dysport® used cosmetically?
Are Botox® Cosmetic and Dysport® interchangeable?
What are the potential complications if I am in jected with Botox® Cosmetic or Dysport®?
When injected for cosmetic purposes the potential risks most commonly reported include redness and mild bruising or swelling at the injection site. These are normal side effects of any injection and should only raise concern if symptoms persist beyond a few days of your injection. In very rare cases you may develop a droopy eyelid, a mild headache or mild flu-like symptoms.
Report any potential or perceived symptoms as described above immediately to the doctor who prescribed your injection. You will be examined and your physician will determine if any follow-up treatment is necessary. He or she may also report the specific complication or “adverse event” to theU.S. FDA Adverse Event Reporting System (AERS).
Since 1997, 21.9 million injections* of the neurotoxins Botox® Cosmetic and Dysport® have been performed by board-certified plastic surgeons, facial plastic surgeons, oculoplastic surgeons and dermatologists, with a consistent record of safe and successful outcomes.
Why do Botox® and Dysport® carry a “boxed” warning?
Botox® and Dysport® are also approved for treatment of specific medical disorders in addition to the cosmetic treatment of wrinkles. Myobloc® is the brand name of a third neurotoxin that is FDA approved for therapeutic or medical purposes; Myobloc® is not approved for cosmetic purposes.
The dosing to treat these medical conditions is many multiples higher than treating cosmetic indications, such as wrinkles. As with most drugs, significantly higher doses carry a higher potential for adverse outcomes. There have been reports in medical patients treated with these much higher doses of drug dispersion beyond the injection site causing symptoms ranging from unexpected muscle weakness to trouble speaking, trouble breathing, loss of bladder control or vision problems.
To better educate patients on the potential complications when treating specific neuromuscular conditions, the U.S. FDA has required a boxed warningon the label, and a REMS or Risk Evaluation and Mitigation Strategy for all neurotoxins. In April 2009, Dr. Ellis F. Unger, acting deputydirector of the FDA’s Office of Drug Evaluation stated specifically that none of the cases of adverse events reported that prompted the boxed warning are associated with the use of botulinum products in cosmetic or dermatologic procedures, such as treating furrows between the eyebrows.
* As compiled from the Cosmetic Surgery National Data Bank Statistics