Many patients present to our practice complaining that they are being told that they "look tired", even though they are getting enough sleep and don't feel tired. Due to a slight loss of volume in the face either due to normal aging or dietary weight loss, the face may give an appearance of looking tired.
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Belotero (Merz, Germany) is soon to be the newest hyaluronic acid product on the US market as it nears FDA approval for facial wrinkles. It will join other hyaluronic acid filler products such as Juvederm, Restylane, Perlane, and Preville Silk.
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We have been using Botox "off-label" for many years to treat migraine headaches. Initially it was found that many migraine headache sufferers who were treated with Botox for cosmetic reasons for forehead wrinkles reported that their migraine headaches were both less frequent as well as less severe.
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Now there is a more comfortable solution for patients who are hesitant to start or maintain their facial filler injection treatments because of perceived discomfort during injection.
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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 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).
