Skin Speaks Blog

Company spokespersons from pharmaceutical company sanofi-aventis announced yesterday that federal clearance had been given to use their dermal filler Sculptra in cosmetic procedures.   Although (off-label) cosmetic use of Sculptra has been happening for years, the original FDA approval of Sculptra was for treating lipoatrophy, i.e. facial fat loss, in AIDS patients.  People in the industry are excited to get official clearance for this long-lasting dermal filler.

The Food and Drug Administration gave clearance for the following cosmetic purposes:

• Correction of mild-severe nasolabial folds
• Wrinkles and contour irregularities

Regulators based their evaluation of Sculptra on a study of 233 patients that had received treatment with the filler for their nasolabial folds.   According to the official press release, the aesthetic results of Sculptra “were maintained up to 25 months after the last treatment session.”

Radiesse and Bioform Medical Inc. recently announced that one million syringes of Radiesse dermal filler have been shipped worldwide since 2002.

Radiesse is Bioform’s most popular product and most commonly used to fill wrinkles, nasolabial folds and restore facial volume.

Radiesse has been marketed for cosmetic and therapeutic use in Europe since 2002.  In 2006 FDA approval for subdermal implantation in aesthetic facial treatments was granted in the United States, expanding Radiesse’ use beyond therapeutic treatments.

At this point, approximately ten-thousand practices have used Radiesse, an achievement that solidifies the company’s position as one of the international market leaders.  The only comparable products with such widespread appeal are fillers composed of collagen or hyaluronic acid, both of which have been on the market longer.

To read more about Radiesse, see our Radiesse page on the Skin Speaks website here.

On November 18, 2008, the US Food and Drug Administration convened a panel of outside experts to review the various complications that have been associated with cosmetic dermal fillers like Juvederm, Restylane, Radiesse and others that continue to flood the market. They discussed the possibility of labeling changes, because over the last six years, the FDA has received about 900 reports about complications related to injectable wrinkle-fillers.  Is this a reason to worry?

It might sound alarming, but the complications and side effects associated with these products are still extremely rare.  Demand for fillers and Botox has exploded in recent years, leading many inadequately trained persons to administer them in non-medical settings.

The vast majority of industry professionals will attribute the reported complications to issues like these.  There are also well known complications that occur, like minor swelling or allergic reactions, with the latter being a subject of greater FDA interest.

According to a recent MSNBC news article, Allergan spokeswoman Caroline Van Hove said “no serious problems were seen in clinical trials of Juvederm, and the most common complaint since its approval was swelling in 0.4 percent of patients.”  Also, Food and Drug Administration officials noted that the “reports had several limitations such as failing to say when the problems started.”

Safety and proper training is of the utmost importance with almost any cosmetic procedure, so we recommend that all patients seek a knowledgeable physician with the right qualifications.

For more information on the FDA panel discussion, the briefing is located here.

Florida doctor (and Survivor contestant) Dr. Sean Kenniff recently reported about Evolence for the Miami CBS affiliate, explaining its benefits over other dermal fillers.  Dr. Kenniff is trained in neurology, biology and spokesman for non-profit brain tumor research organization, The Four Foundation.  He got voted off the island, but that doesn’t mean we can’t take his advice about Evolence.

Kenniff talks dermal fillers with dermatologist Dr. Mark Steven Nestor, explaining just one of the popular remedies that Evolence can perform – hiding those pesky “laugh lines.”  You might also call them “parentheses”; the indentations on each side of your mouth from smiling and laughing (or scowling) all those years.  Dr. Nestor says they happen because of a combination of facial fat loss and skin that is “more lax.”

Dermal fillers are the best remedy for such issues and Evolence is one that provides a long lasting effect.  The main structural component of Evolence is “purified porcine collagen” and with the company’s high-tech “cross linking” process, the natural sugar D-Ribose gets added to increase longevity and consistency.

We’ve got Evolence in the office now, and Dr. Carney was one of the first dermatologists in the US to be trained with it. Several of the staff have had Evolence treatment now too, so ask us about our experience with it, we’re happy to share.

Tennis champion and Olympic gold medalist Lindsay Davenport is speaking up about her use of Juvederm dermal filler to combat pesky laugh lines around her mouth. She wanted to avoid surgery, but felt her skin needed a little extra something after all those years in the sun. Four months after her procedure, Ms. Davenport reports that she is still very satisfied with the fresh, rejuvenated look Juvedrum has given her.

If you want to get rid of your “parentheses,” as they say in the advertising, Juvederm may be right for you.

You can learn more about Juvederm in the Twin Cities on our website, or talk to us about all of the options we have for non-surgical face lift and wrinkle reduction, including Sculptra, Botox, the new Evolence, and a multitude of laser rejuvenation treatments.