Artefill (Now called Bellafill), the permanent injectable filler, is returning to the U.S. market.

Yesterday, I had the opportunity to speak with the CEO of the new company, Suneva Medical, that has purchased all the production facilities and intellectual property of Artes Medical, the now-defunct owners of the Artefill brand.

Suneva Medical has now had their manufacturing facilities inspected and certified as GMP, and are ready to re-launch Artefill in selected physician practices. Artefill is a possible treatment for patients who have been using standard fillers for quite some time to improve their naso-labial creases, and who want a more long lasting (i.e. semi-permanent) option. Studies show that Artefill has a five-year proven duration.

The use of permanent fillers is debated amongst plastic surgeons. Injection technique has to be more exact, in terms of the amount and placement of the filler. This is not a product for physicians who are just starting their injection practices. Unlike the HA fillers which can be dissolved with an “antidote”, Artefill injections are not easily reversible. Skin testing is required before the use of Artefill, to check for reactions to the product prior to use. People who have prior reactions to collagen should not have Artefill. Rare reactions, known as granulomas, are still possible, even with this newest formulation.

I’m pleased to announce two new specials for our Botox and filler (Juvederm, Restylane, Sculptra, etc.) patients.

Special #1: Bring a Friend and Save.

Book a filler or Botox appointment for yourself and a good friend at the same time. If the friend is a new patient to our practice, we’ll give you a credit of 15% of the value of your friend’s first completed treatment, which can be used for your own botox or filler treatment, or used in our medi-spa, either on the same day, or sometime in the future.

One small restriction: The credit can not be applied to surgical procedures.

Special #2: Internet special for loyal patients

Have you had three or more treatments with Botox in the past 15 months with us? Or three or more treatments with injectable fillers in the past 15 months in our office? Then you are a loyal patient and we’d like to give you a reward. Just mention the internet-only password of “PSB” when you come in, and we’ll give you 50% off your next maintenance treatment with botox or fillers, up to the average dose that you usually get.

This is only for our loyal patients, as defined above.

See, it pays to read PSB – the plastic surgery blog!

We’re pleased to announce a new service for our patients. We call it “Same Day Botox” – and just like the name implies, we’re opening up a limited number of appointments each day for people that want to have their treatment with Botox or any of the injectable fillers that same day. Just call early in the day to set this up.

Patients who have scheduled appointments for these treatments will still be seen at their usual times.

Talk about “instant gratification”! Call us for details: (407) 339-3222

Sculptra, the injectible PLA filler, received official FDA approval today for cosmetic use. It had initially approved several years ago for the treatment of lipo-atrophy, (most commonly seen in HIV patients) and was used on an “off-label” basis for cosmetic purposes. It’s a very useful product.Sculptra can be very helpful to restore volume loss in the face and other body areas with a non-surgical method. Usually several treatments are required over the course of several months, but I’ve been very pleased with the results of these treatments. It also represents a nice alternative to fat grafting techniques, avoiding donor site issues.

One key with the use of Sculptra is to use it in a highly diluted form; this helps to avoid the formation of small lumps, known as granulomas. I also do not recommend it for use in the lips.

Dysport – the recently approved competitor to Botox Cosmetic – is now being shipped to U.S. physicians. We have both products in our office now, and are testing Dysport, seeing how it compares to Botox, the market leader. So far, there are some subtle differences, but both seem to work well in relaxing dynamic wrinkles of the face.It will take a little education for patients to get used to the fact that the drug doses are measured differently. Botox units are not the same as Dysport units, even though they sound similar. It’s a bit like measuring someone’s height in feet, compared to measuring it in yards. Same height, just different numbers. Dysport comes in a 300 unit bottle, Botox comes in a 100 unit bottle – but the clinical effect is approximately the same, as far as we can see, with a 3:1 ratio.

Dysport is priced so that it is a little less expensive than Botox (at the 3:1 conversion ratio), so patients who wish to save a little money while they are fighting their wrinkles may want to give Dysport a try.

Here’s an interesting press release from ASAPS (American Society for Aesthetic Plastic Surgery), discussing a new survey in which Botox Cosmetic and fillers like Restylane and Juvederm were now “mainstream” topics of discussion amongst patients, and not any big “secret”. This matches with our experience – our female patients openly discuss their treatments, much like they were sharing make-up tips! What I find interesting in this survey is that 7 of 10 Botox users also have HA fillers done.Survey Shows Majority of Respondents Openly Discuss Use of BOTOX® Cosmetic and Hyaluronic Acid Dermal Fillers

NEW YORK, NY (June 1, 2009) — Despite what some may think, people aren’t hiding their use of BOTOX® Cosmetic and hyaluronic acid dermal fillers. In fact, according to survey statistics released today by The Aesthetic Surgery Education & Research Foundation (ASERF), the research arm of the American Society for Aesthetic Plastic Surgery (ASAPS), nearly nine out of 10 respondents (87 percent) openly discuss their BOTOX® Cosmetic and hyaluronic acid dermal filler treatments with others, with seven out of ten (70 percent) receiving support from the people they told.

“In a similar survey issued four years ago, we dispelled the myth that Hollywood and corporate wives were the typical BOTOX® Cosmetic patient,” says ASERF President Laurie Casas, MD, a plastic surgeon practicing in suburban Chicago. “Now, demographic and perception data trends show us that aesthetic injectable treatments have continued to evolve into mainstream and accepted options for the everyday woman.”

Survey results found that the typical aesthetic injectable patient is a married, working mother between 41-55 years of age with a household income of under $100,000. The survey also found that women receiving aesthetic injectable treatments are health-conscious and philanthropy minded, with the majority incorporating exercise (95 percent) and healthy eating habits (78 percent) into their lives, and many volunteering with charitable organizations that matter to them (32 percent). In addition, nearly seven out of 10 respondents believe that BOTOX® Cosmetic (72 percent) and hyaluronic acid dermal fillers (65 percent) are important parts of their aesthetic routine.

“Interestingly, among BOTOX® Cosmetic patients, nearly seven out of 10 respondents also received treatment with hyaluronic acid fillers with the majority of respondents being treated with JUVÉDERM®,” says Dr. Casas. “Most people have great success with BOTOX® Cosmetic and dermal fillers; however, we need to make patients aware that even though injectables are not ‘surgery,’ their administration is a medical procedure with risks that depend on the training and experience of the clinician, the clinical setting and the technique used.”

Additional findings of the survey found that 72 percent of respondents received BOTOX® Cosmetic injections to treat their glabellar lines – the frown lines in between the brows, while 63 percent of those surveyed received hyaluronic acid dermal filler injections to treat their nasolabial folds – also known as the “parentheses” – the lines around the nose and mouth. A few of the most frequently cited reasons to receive treatment with BOTOX® Cosmetic was “to look more relaxed, less stressed” while patients reported choosing treatment with hyaluronic acid dermal fillers to “look more rejuvenated.”

This week, Q-Med, the Swedish pharmceutical company that is the home to Restylane and Perlane, announced Restylane® Lidocaine and Restylane Perlane™ Lidocaine as the latest additions to their Restylane family of dermal fillers. These products have the familiar Restylane and Perlane hyaluronic gel fillers, together with a small amount (0.3 %) of lidocaine, a commonly used local anesthetic, to help minimize the discomfort of the procedure.

According to the studies, the fill effect of the products is unchanged, but 90% of the patients tested said the new products made the treatments more comfortable than the standard formulation.

This allows the company to catch up with Allergan’s Juvederm Ultra with Lidocaine product, which has been available in Canada and Europe for several months.

Availability of these products in the USA has not been announced. Hopefully, we’ll see these later in 2009. It should be a pretty straightforward approval path with the FDA.

Here in the USA, Prevelle Silk has the combination of lidocaine and HA gel filler – but it is a much less concentrated product than either Restylane or Juvederm. I don’t use Prevelle Silk often, as I don’t find it is as long lasting around the mouth or smile lines.

Botox competitor “Reloxin” (sold in Europe as “Dysport”) received its FDA approval today.

The FDA decided to approve both the cosmetic indications (for wrinkles) and the functional indications (cervical dystonia) at the same time – and decided that the drug should be sold under the same name for both categories. So, it’s now officially “Dysport” – just like in Europe.

We’re waiting for details to be released about the pricing, marketing incentives – such as potential combinations with Medicis’ line of fillers, and so forth. These details will be key to the success or failure of the product, I believe.

The next 6 months should prove to be very interesting, to see how pharma giant Allergan responds to the “new kid on the block”. I’m expecting sparks to fly!!

“Reloxin”, a form of botulinum toxin, and potential competition for Botox, could go on sale in the U.S. soon.

The FDA is currently evaluating the product, which has been sold in Europe for approximately 15 years under the name Dysport. It’s a wrinkle-fighter, similar to Botox, and it also has a good track record of success and a good record of safe use.

Medicis, the U.S. distributor, said it is hoping for FDA approval of their application in early 2009.

It will be interesting to see how this situation works out. Will the newcomer try to under-cut the price of Botox? Will patients be willing to try the newcomer, or stick with the original? The dosing of Dysport and Botox is not directly comparable – so it wouldn’t be a simple 1:1 substitution – but both have been shown to be effective for dynamic facial wrinkles.

Botox, made by Allergan, has been the No. 1 cosmetic medical treatment in the United States for the last few years, according to the American Society for Aesthetic Plastic Surgery (ASAPS) procedural statistics.

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