In Texas, medications like Botox can only be obtained by a qualified physician (with a medical license). Within a doctor’s office however, the treatment can be delegated to and then administered by, anyone.

Because the market for Botox and cosmetic procedures can be very lucrative, there is a strong allure for physicians with inadequate training to begin offering these treatments. Currently there are no regulations pertaining specifically to the training and qualifications of those who administer a cosmetic injection. Such regulations would also apply to treatments like Juvederm, Sculptra, Radiesse and other popular wrinkle reducers.

The medical board will discuss a regulation that would allow only doctors, nurses and physician assistants to administer a controlled substance such as Botox.

The aesthetic laser and light therapy markets for skin resurfacing, hair removal and laser lipolysis will be the fastest growing segments, according to the report, and the market for botulinum toxin-A drugs, such as Botox, is estimated to grow to $543 million by 2017.

“Allergan has had a monopoly on botulinum toxin A drugs since 2002, but now faces competition from Dysport by Medicis as well as other new competitors expected to enter the market,” said Dr. Kamran Zamanian, CEO of iData. One of those future competitors may be a botulinum toxin called PurTox by Mentor. PurTox is now in Phase III clinical trials in the U.S., according to Mentor’s website.

The use of botulinum toxins is also expected to increase due to an increasing number of therapeutic treatments, such as upper limb spasms, neck malpositioning and certain types of eye muscle disorders. The FDA is also currently evaluating Botox as a treatment for severe migraines.

“A growing number of doctors are looking at the therapeutic potential of Botulinum-A. There are more cosmetic procedures performed using Botulinum-A than therapeutic, however therapeutic procedures use higher doses of the drug, therefore these two markets are similar in value,” said Dr. Zamanian.

The report, titled “Markets for Cosmetic Surgery, Facial Aesthetics and Medical Laser Devices 2011,” states that the U.S. market for injectables is valued at almost $860 million. The three-report series includes data, analyses, and competitor profiles for botulinum toxins, dermal fillers, breast augmentation implants, liposuction aspirators, laser/light devices, and microdermabrasion.

Juvederm XC, Restylane-L, and Perlane-L are three injectables that won FDA approval in February 2010 for lidocaine versions in the U.S.

Dr. Michael H. Gold, a clinical assistant professor of dermatology at Vanderbilt University School of Medicine and School of Nursing, says the products performed similarly to their lidocaine-free predecessors in terms of safety  and efficacy.

Furthermore, in the clinical trials, he says, “The incorporation of lidocaine has surely provided a higher comfort level for patients.”

In the 72-patient trial of Juvederm XC, patients were blindfolded and their nasolabial folds were treated with either Juvéderm or Juvederm XC. Patients assessed pain levels during treatment and then 30 minutes and 24 hours post-treatment. In the study, 93 percent reported less pain when treated with the lidocaine formulation versus the non-lidocaine formulation of Juvederm.

Dr. Gold says that, based on his clinical experience, when a patient receives an injection that includes even a small percentage of lidocaine, “Most patients say they barely feel the second stick. To me that is the home run of lidocaine in these fillers.”

The FDA also cleared a method for physicians mixing lidocaine with Radiesse last year. “Originally, I was against doctors mixing a lot of fillers because I was afraid of potential changes in the products themselves,” says Dr. Gold. But once the FDA clears these products, especially those premixed by manufacturers, “I’m pretty comfortable with it.”

Juvederm, Restylane, and Radiesse are performed at Dr. Frenzel’s Arlington, Texas office.

The full story, “Fillers with lidocaine among latest injectable advancements,” is available online at Modern Medicine.

We sincerely hope nobody in Texas (or elsewhere) has attempted this kind of thing.  Injectable treatments might seem easy and quite comfortable in our office, but attempting to perform them yourself is very unwise.  When the person administering treatment doesn’t know proper injection techniques, the risks are much greater and the cosmetic result will probably be very poor.

You’ll be in much better hands if you see a qualified cosmetic or plastic surgeon for your injectable treatments.