A recent study conducted in by the Aesthetic Surgery Education & Research Foundaton (ASERF) found that the typical aesthetic injectable patient is a married, working mother between the ages of 41 to 55 years of age with a household income of less than $100,000.

Among Botox cosmetic patients, nearly 70% also received treatment with hyaluronic acid fillers (Restylane, Juvederm). The areas most commonly treated included glabellar lines for Botox users (72%) and nasolabial folds for hyaluronic acid patients (63%).

Since this study was completed, the collagen stimulating injection product Sculptra has been FDA approved for cosmetic use. In the near future, Sculptra should become one of the more popular aesthetic treatments as it is the most cost effective product for restoring the volume loss in the face assoiciated with aging.
The porcine (pig) based collagen product from Israel, EVOLENCE, will no longer be available. Johnson and Johnson announced yesterday that they will no longer sell the product because of poor sales. Since buying the rights to EVOLENCE from the Israeli company Colbar, J & J is out a little over $1 million. This week, Ortho Dermatologics notified plastic surgeons using EVOLENCE that marketing and manufacturing of the wrinkle filler would be discontinued, effective immediately.

According to the official notification, the company may “talk to interested parties about the possibility of EVOLENCE® market re-entry under different ownership.”

They also assured physicians that EVOLENCE was, and remains, an “effective option” for wrinkle reduction, with a “favorable safety profile.” I have used the product in a handful of patients. My patients have had excellent results with the product without any adverse effects. It will still be available (while it lasts) in my practice for those patients who either prefer it or who are unable to have hyaluronic acid fillers because of allergic reactions.

Was EVOLENCE® destined to fail? An Israeli company called ColBar LifeScience was responsible for development of Evolence (they even had rabbi's approve it as Kosher because the pigs used to produce the collagen product were not allowed to have their hoofs touch the floor), and they had been marketing the drug outside the U.S. since 2004.

When Johnson & Johnson acquired the company and received FDA clearance for Evolence in the summer of 2008, they were optimistic about the filler because of its unique composition of naturally sourced porcine collagen. Evolence was radically different than the popular hyaluronic acid offerings that dominate the market; it had all the benefits of the old collagen fillers, lasted longer, and required no allergy test.

However, some experts predicted a struggle for the animal-based collagen filler. The Wall Street Journal quoted J&J consultant Kenneth Beer saying, “they couldn’t have picked a worse time [to enter the market.]” Others expressed concern about the drug’s source: “Porcine products historically haven’t done well, and many people prefer lab-grown products,” said analyst Ronny Gal in a 2008 report.

It might be a stretch, but could it be fear of the swine flu and all things porcine that killed Evolence? Doubt it, it's the economy.

Allergan (Botox) Sues FDA

Monday, October 5. 2009 posted in Botox and Facial Fillers

Allergan has filed a federal lawsuit seeking a court ruling that would allow it to share relevant information with the medical community on the safe use of botulinum toxin A for certain off-label therapeutic uses, the company announced in a press release.

In the suit, "Allergan contends that the government's legal position that it is a crime for a pharmaceutical company to proactively communicate truthful information to physicians about off-label uses of its products violates the First Amendment and is inconsistent with the Federal Food, Drug & Cosmetic Act," the release said. "The lawsuit does not involve Botox Cosmetic."

The suit does not challenge the government's ability to prohibit pharmaceutical companies from distributing false or misleading information about products.

"Rather, the lawsuit only seeks to permit Allergan to proactively provide the medical community with truthful, important information about common off-label uses of Botox," the release said. "Moreover, far from seeking freedom from regulation, Allergan hopes this suit will lead to clear regulatory guidance on how it can lawfully provide accurate and relevant information on the full range of issues physicians should consider in determining the best therapies for their patients."
UBS Aesthetics and Plastic Surgery Practice report that Sephyl is a new dermal filler from UBS Aesthetics (Bethlehem, Pa) that allows the natural promotion of cell regeneration and aids in the removal of wrinkles. The FDA-approved product is in limited use around the United States and early reports from physicians claim that the results are as good as a face lift.

Rather than using other dermal fillers, this technology uses the patients own blood to help fill in and build up wrinkles. The patented system enables the preparation of an activated Platelet-rich Fibrin Matrix (PRFM). A small volume of the patient’s blood is collected and the platelets and fibrin are concentrated during a simple centrifuge process. The resulting product -- in a liquid, gel, or membrane structure -- can be applied to a treatment area of the body to stimulate natural, new tissue growth, according to the company. The resulting product is injected into the treatment area below the surface of the skin.

The technology used to create Selphyl is not new. It's been around for years for other purposes, such as helping heal sports injuries. It is approved for use on glabella lines, nasolabial folds, acne scars, and postop scars. Cost is estimated at $1,100 for four cubic centimeters (4 "cc's" or the equivalent of 4 syringes of Restylane).
According to a report appearing in Plastic Surgical Products, there is a new filler in town. "Hydrelle, the first hyaluronic acid-based dermal filler approved by the FDA that contains the anesthestic lidocaine", has been released.

"The drug, manufactured by Anika Therapeutics and distributed in the United States by Coapt Systems Inc, is injected into the mid-to-deep dermis for the correction of moderate to severe facial wrinkles and folds, and is reportedly a cheaper alternative to traditional fillers, such as Allergan’s Juvederm and Medicis Pharmaceutical’s Restylane."

According to the firm, "patients require about 50% of typical injection volumes, meaning that fewer injections are needed to fully correct facial wrinkles. In addition, Hydrelle is marketed to produce results that are longer lasting. Side effects include swelling, redness, bumps, bruising and tenderness which might be experienced by some patients."

Preville Silk is a hyaluronic based dermal filler that was previously released. I look forward to hearing more about Hydrelle and welcome the comments from patients who were a part of the clinical studies to get Hydrelle FDA approved. I will reserve my personal endorsement of the product until I have first hand experience with Hydrelle.
Ortho Dermologics announced on June 8, 2009 that Evolence is the first collagen injection product proven to last over one year. The long lasting effect allows physicians to give their patients the natural look of collagen at a great value.

Another advantage of Evolence over other fillers is that there is much less swelling and redness, with the least chance of bruising of all injectable fillers so that patients can have the treatment during the day, and carry on social activities immediately.

In addition, the company is offering a $150 rebate. To find out more about Evolence, where to find a local physician, and the rebate go to:
http://www.evolence.com/email/evolence-experience/july-2009/july-2009.html?utm_source=Q3Newsletter&utm_medium=ViewOnline&utm_campaign=Email%2BNewsletters.
Allergan Inc said on Thursday that its popular Botox wrinkle-smoother "worked as a treatment for adults suffering from chronic migraines", according to late-stage clinical data.

Allergan said, "data from its phase III clinical trials showed a significantly greater decrease in headache days among patients receiving Botox, compared with those receiving a placebo. The treatment was well tolerated in patients suffering from chronic migraine."

Based on this top-line analysis of its studies, Allergan hopes to file a supplemental biologics license application with the U.S. Food and Drug Administration for the use of Botox in chronic migraine by mid-2009.

Turn Mad, Sad Into Glad

Saturday, July 18. 2009 posted in Botox and Facial Fillers

As many of us age, we develop an unhappy appearance because of the "scowling" vertical lines between our eyebrows caused by years of using those muscles (hear you mother saying, "Don't make that face, it will stay like that!"). Combined with volume loss in around the corners of a down turned mouth, otherwise very "happy" men and women can take on a sad, angry appearance. But fret not anymore, with a little filler (Restylane, Juviderm, Evolence, or Radiesse) in the corners of the mouth, that unhappy turned down mouth can be uplifted into a happier place. Likewise, a few dabs of Botox between the eyebrows will take that angry scowl away, giving you no choice but to appear happier. Your actual happiness is up to you, but here's to a little superficial happiness. Be well. Dr. P
Bioform, the manufacturer of the popular facial and hand filler Radiesse has received FDA approval for mixing local anesthetic Lidocaine into its product. In clinical trials, the technique of mixing the dermal filler Radiesse with lidocaine showed an improvement in patient comfort and an increase in patient satisfaction, the company said in a statement. Radiesse is the longest lasting of temporary fillers. It is reported to last from one to two years. It is a great filler for replacing lost volume in the face in the battle against the appearance of aging. Its use in hand rejuvenation is very impressive, giving the dorsum (back) of the hand a more youthful look (less wrinkles and prominent veins). Bioform's stock price nearly doubled today after the announcement. Shares of the company were up 22 percent at $2.49, making them one of the top percentage gainers on Nasdaq. Physicians have been manually mixing a small amount of Lidocaine into syringes of Radiesse for the past few years, so I do not expect a large increase in its use among experienced physician injectors. So much for "No pain, no gain!"
For those of you who have ever contemplated buying 100% Silicone online and self injecting, just click on the link below and look at the photographs of this "patient's" results. She had recently paid $2300 to a physician for medical silicone injections (some physicians do use medical grade silicone "off label" for cosmetic injections in the face, I do not), she liked her results, but saw no reason why she couldn't save a few bucks and do it herself. Silicone must be surgically removed (very difficult), and it is near impossible to get it all out. Once again, often times you get what you pay for. Choose your injector carefully. To read the full article go to http://inyourface.freedomblogging.com/2009/07/02/horror-results-when-woman-injects-her-own-face/7557/ Another patient apparently had the same thought process and here are her photos http://inyourface.freedomblogging.com/2009/06/25/how-to-save-money-and-disfigure-your-face/7091/

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At the recent Facial Cosmetic Surgery 2009 in Las Vegas, both Woffles Wu, M.D., Singapore, while presenting "Innovative Uses of Neurotoxins (read Botox) and Fillers (Restylane and Juvederm) in My Practice" and Timothy Marten, M.D., San Francisco while presenting "Refining Our Aesthetic Goals for Age Appropriate Brow and Forehead Rejuvenation" emphasized the importance of brow shape. It has been shown that the shape or configuration of the brow contributes much more to beauty than the height of the brow. In other words, no matter if the brow is too high or too low, it is most attractive when the proper shape of the brow is maintained. That shape can be attained by judicious use of Botox injections to control the muscles of the forehead to shape the brow. Dr. Marten not only creates beautiful brows, but his results using his facelift technique combined with fat transfer were beautiful. He truly has the "eye" for beauty. Choose your Botox injector carefully.

The Injectable Lift

Monday, April 27. 2009 posted in Botox and Facial Fillers

The Injectable Face/Eye Lift is an excellent way to look years younger in minutes. Dr. Persky performs the Injectable Lift in his office. The treatment takes from 30 to 60 minutes as Dr. Persky injects small amounts of filler (Restylane, Juvederm, and/or Evolence) in areas that have lost volume with aging. By re-inflating strategic areas, a natural youthful appearance is restored. The results last up to 18 months. To see an example of the Injectable Lift before and after photographs, go to http://www.facebook.com/n/?photo.php&pid=396494&id=1079958675&comments&mid=602773G405edc93G6fa9c6G9
The current recession (it's a recession if someone else loses their job, it's a depression when you lose yours) has resulted in savings for patients who desire to keep up their appearance while all else around them is falling. Allergan Inc, maker of Botox cosmetic, will be offering a $50-off coupon for Botox treatments. CEO David Pyott during Allergan’s fourth quarter conference also mentioned that the company will be offering a $100 rebate on two syringes of Juvéderm. Currently our office is offering the second syringe of Juvederm at 50% off, and when combined with the $100 rebate results in a savings of $450 when two syringes are purchased.
Peri Basel, New York City beauty consultant has a great beauty web site/blog that can be subscribed to at www.itsthelatest.com. Her January 18, 2008 blog includes the following about Radiesse filler for aging hands, a procedure that we are offering our patients: "One of the most age-telling body features is our hands. As we age, our hands lose firmness and plumpness and begin to look bony and fragile....with vein and joint protrusion, thin crepey skin texture and often they've become flecked with brown spots from sun exposure. Combating the aging hand syndrome takes more than hand cream (though that simple step does make a difference). The latest technology has given us a set of procedures that will have similar effects as those we have been able to accomplish for the face. Radiesse injections immediately re-plump and replenish volume to the back of the hands to provide a supple and youthful appearance instantly. Placed beneath the skin, Radiesse raises the skin level so that tendons, joints and veins lose their prominence. Radiesse provides instant and durable long lasting results. Radiesse. Because Radiesse provides scaffolding for collagen-building, the body's own collagen interweaving into this structure keeps the skin feeling softly natural and smooth. To see before and afters... http://www.totaldermatology.com/pages/aging-hands.html"

Botox and the Economic Downturn

Friday, December 19. 2008 posted in Botox and Facial Fillers

Many physicians and clinics have been accused of injecting bogus Botox from a lab (T.R.I.) in Arizona that has distributed ”experimental Botox, not for use in humans" to many unethical practioners. There have been indictments against "practioners" in Las Vegas, in Houston, and in Florida for the same offense. In this economic downturn I fear that we will hear about more of these cases. We will also be seeing "discounted" "units" of Botox. Buyer beware, if it sounds too good to be true, it usually is. Not only that, your well being may be at stake. Therefore we must emphasize how important it is to choose your injecting physician most carefully. Choose a board certified physician experienced and trained in one of the core cosmetic specialties (facial plastic surgery, plastic surgery, ENT, opthalmoplastic surgery, or dermatology). Good luck and be well



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