Injectable treatments have become mainstream due to their effectiveness and ease of use. Their growth is also fueled by the use of a growing and diverse base of injectors from every physician specialty to nurses and medical assistants. The other unspoken and forgotten reason for injectable treatment growth is their off-label uses. Botox and injectable fillers have been granted very specific indications by the FDA and are much more restrictive than what they are actually used for today.

Botox and Dysport has FDA indications only for glabellar wrinkles while injectable fillers has an FDA indication for nasolabial (lip-cheek groove) reduction only. Yet everyone knows that Botox and Dysport are widely used and advertised for forehead and crow’s feet wrinkles and injectable fillers are put in as many lips as it is in the nasolabial folds. How can this be? This is the common practice of ‘off-label’ use, which is misunderstood by many physicians and most patients.

Contrary to popular perception, the FDA does not really approve a medical product for anything. Receiving product clearance by the FDA means that is has evaluated the safety and effectiveness of the product for a very specific purpose. This seems like it is splitting hairs from the concept of approval but it is different. It clears a product based on the evidence (studies) that was submitted to it for evaluation. This also indicates to the manufacturer how it can and cannot market the product. They are not legally permitted to say that a product works for something when it is not an indication that has been cleared.

In the case of Botox, for example, all the original work was done on glabellar wrinkle patients only. Studies were never submitted for more widespread on other patient areas. Thus when you are receiving injections in the crow’s feet, lips or neck, it is being used for areas that were not cleared by the FDA. This is known as off-label because it is being used for something that is not on the package label and the FDA has never evaluated its safety and effectiveness for these uses. It may work quite for these indications but that doesn’t mean it has ‘FDA approval’ for doing so.

The off-label use of aesthetic neuromuscular toxins and fillers is common practice. Such uses probably make up more than half of all such product uses and sales. Physicians can widely use these products for a diverse number of facial indications based on their medical judgment and discretion. Manufacturers are bound by FDA regulations based on their product’s indication clearances.

While off-label uses of these aesthetic products is widely done, that does not mean they are necessarily as effective as they are for on-label indications. Patients should be aware when they are receiving an off-label use of a product and, thus, no assurances can be made as to its absolute effectiveness for this indication.

Dr. Barry Eppley

www.eppleyplasticsurgery.com

Indianapolis, Indiana

The growth of injectable aesthetic treatments is largely fueled by the number of products that are available to use. Between neuromuscular paralyzing agents, volumizing fillers and sclerotherapy agents, there are over fifteen products currently available. That is about to grow by two new products and on-label indications.

Moving alongside Botox and Dysport will be Xeomin offered by Merz Aesthetics with its recent approval earlier this year. Like its predecessors, it has been approved by the FDA for temporary improvement in the appearance of moderate to severe glabellar (between the eyebrow) lines in adults. (between ages 21 to 65) What its advantages may be, if any, over Botox and Dysport remain to be forthcoming. As a different molecular structure of botulinum toxin, incobotulinumtoxin A, it is likely to have most of the working properties of the botulinum toxins such as delayed onset of action, limited zone of diffusion and a lifespan of three to four months. Its unit dosage and its pricing point will be interesting to see what the company offers and how it compares to its competitors.

While Restylane and many other injectable fillers have been around for awhile, it would surprise many that they have never been approved by the FDA for lip augmentation. This is interesting given that lip injections make up a significant percentage of the product’s use in most practices. This means that lip enhancement by fillers has been used off-label for more than a decade. Restylane, introduced initially in the U.S. in 2004 by Medicis Aesthetics, has been recommended recently by an FDA advisory panel to expand its approved indications to that of the lips. While this does not formally mean the FDA will do so, it is more likely than not. While this doesn’t provide any new benefits to injectable lip augmentation per se, it is comforting to know that its well known safety and effectiveness is scientifically recognized.

Sclerotherapy has used injectable products such as hypertonic saline and sodium sotradecol for decades without any new technology innovations. In the past year, a new sclerotherapy solution has been introduced that is widely used around the world. Asclera, pilodocanol, has been FDA-approved and released by Merz Aesthetics. This is for sclerosing uncomplicated spider veins (very small varicose veins less than 1mm in diameter) and small varicose veins (1 to 3mms) known as reticular veins. Asclera works similarly to other sclerosing agents by damaging the endothelium which is the lining inside of blood vessels. This causes blood platelets to attach to the lining of the vessels, causing the blood vessel to clot. Over time, the clotted vein will be replaced with scar tissue. Without blood flow, the spider veins ‘disappear’. With a similar mechanism of action, the question is how Acsclera may be superior to existing products. It is believed that it works more effectively and with less injection discomfort than its predecessors.

The infusion of new products like Xeomin and Asclera and expanding indications of existing products, like Restylane for lips, will continue to fuel the growing field of office-based injectable cosmetic treatments.

Dr. Barry Eppley

www.eppleyplasticsurgery.com

Indianapolis, Indiana