Medical products go through rigorous testing prior to their official launch into wide availability to the public. The US Food and Drug Administration oversees this process, ultimately approving products to be marketed with specific uses and results that have been confirmed through trials and research. The body’s mission is to ensure the safety and efficacy of drugs and devices used throughout the country, from skin lasers to BOTOX® Cosmetic. Beverly Hills’ own Dr. Derek Jones has participated in numerous such trials over the years, including as principal investigator.
Due to his experience with the process, he frequently encounters people unsure of what an FDA approval means, as well as whether a lack of approval for certain products or applications means it isn’t safe.
First, it’s important to establish what an FDA approval indicates. The stamp from the administration, given after its teams are satisfied that a product or device is safe and that it effectively does what the manufacturers say it will do, allows companies to market accordingly across state lines. It is not a blanket approval, which is why advertisements tend to get specific, saying something like: “BOTOX® Cosmetic is FDA approved for the treatment of frown lines between the eyebrows and crow’s feet.”
That does not mean certain products can’t be used in other ways—just that they can’t be officially marketed as having other approved uses.
To that end, many doctors apply FDA-approved products in what are known as “off-label” uses. That means the drug, such as BOTOX® Cosmetic, is being used for something other than what the FDA gave approval for in terms of marketing.
While BOTOX® Cosmetic has its two approved used—as noted above—it can be applied in a variety of other ways, including to provide temporary lip lifts, soften a jawline, and reduce a “gummy smile” that reveals too much of the gums. These are considered off-label uses.
An off-label use may be currently under investigation, but not yet approved by the FDA. Doctors familiar with a product are frequently aware of its versatility, as well as how to safely administer it to achieve a range of results. They may participate in studies intended to explore FDA approval for potential new uses.
In any case, it is important to seek out an experienced, certified, and licensed medical professional when choosing to receive any medical treatment, whether on or off label. BOTOX® Cosmetic is a powerful injectable with the potential for serious side effects if not handled correctly. A doctor using it at all—even strictly for FDA-approved treatments—should be thoroughly versed and properly certified in its application. Ideal cosmetic results and the continued good health of the patient depend on extreme precision, as BOTOX® Cosmetic relaxes the muscles into which it’s injected.
To that end, choosing the right injector is crucial for anyone considering the treatment. Men and women alike should start with a consultation, during which they can ask their potential injector a series of questions to explore the person’s background, education, and relevant experience.
The doctor should demonstrate not just a familiarity with the product, but a commitment to understanding correct dosages and obtaining thorough patient histories, as well as forthrightness when it comes to describing what to expect in terms of both results and possible complications.
Though injections are not surgery, they are significant, whether the cosmetic is being used on or off label. An important factor in positive outcomes for patients is in choosing the right injector.
Board-certified dermatologist Dr. Derek Jones has a long history with BOTOX® Cosmetic, stretching back even prior to his work as an investigator in the trial that led to the product’s FDA approval for the treatment of crow’s feet. At the physician-only Skin Care & Laser Physicians of Beverly Hills, he works with fellow board-certified dermatologists Dr. Naissan Wesley and Dr. Jeanette Black. Visit skincareandlaser.com or call 310-246-0495 to learn more about BOTOX® Cosmetic and other treatments available.