Archive for the ‘Wrinkle Fillers’ Category

New “No Pain” Juvederm XC Now FDA Approved

Friday, February 5th, 2010

At Skin Speaks, we are planning to carry the new Juvederm XC immediately! You can look forward to trying it at your next Juvederm appointment.

As with the original Juvederm, the product lasts up to 1 year from initial treatment. The addition of 0.3% lidocaine numbs the treatment area within seconds, potentially decreasing the need for additional anesthetic.

“Patients want a smooth and natural-looking result from a dermal filler treatment, but as a physician I am also interested in managing my patient’s discomfort during the injection. Before the introduction of Juvederm XC, it often took up to 30 minutes for an anesthetic block to take effect.” said Charles Boyd, MD, Boyd Cosmetic Surgical Institute and clinical investigator in a company news release. “[W]ith the new formulation, patients can receive the same smooth results as demonstrated with Juvederm but enjoy a more comfortable injection experience.”

FDA approval was based on data from a multicenter, double-blind, randomized clinical trial in which 72 patients received 1 of the 2 formulations in each nasolabial fold. Results showed that 93% of patients reported less procedural pain when treated with the lidocaine-containing dermal filler compared with the original version.

The safety profile was similar for both products, with temporary injection-site erythema, inflammation, pain/tenderness, firmness, lumps/bumps, and bruising most commonly reported. Most adverse events were mild to moderate in nature and of short duration (≤7 days).

With FDA approval, the lidocaine-containing dermal filler is available by prescription nationwide. As with the original formulation, it should only be administered by a trained medical professional.

EVOLENCE® Discontinued, Patient Support To Continue

Wednesday, November 4th, 2009

evolence-boxPhysicians providing EVOLENCE were notified today that the porcine collagen wrinkle filler is being discontinued, at least until further notice. Effective immediately, marketing and manufacturing of the drug will cease, according to the official website.

Although the wrinkle filler could resume a position in the market under new ownership, no such plans are being made public. Patients who have received treatment with Evolence will continue to receive support regarding medical inquiries or reporting of adverse reactions.

Along with the discontinuation announcement, manufacturer Ortho Dermatologics maintains that Evolence is still an effective treatment with a “favorable safety profile.”

Market May Be to Blame

Although Evolence had been used in other countries as far back as 2004, its U.S. market presence has been relatively short-lived, with FDA approval being granted just last year.

With its advanced, yet natural composition, optimism surrounded Evolence from the beginning . It was seen as radically different than the dominant hyaluronic acid offerings on the market, touting all the benefits of the old collagen fillers, with longer lasting results and no allergy test required.

However, some experts predicted a struggle for the animal-based collagen filler early on. In 2008, the Wall Street Journal quoted J&J consultant Kenneth Beer saying, “they couldn’t have picked a worse time [to enter the cosmetics 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.

If you have received treatment with Evolence at any of our Minneapolis/St. Paul locations, contact us to learn about comparable alternatives that can meet your needs in the future.

Sculptra Aesthetic on the NBC Today Show

Friday, September 11th, 2009

The NBC Today Show recently ran a “Today’s Health” segment featuring the wrinkle filler Sculptra. You can watch a professional treatment demonstration, hear some patient testimonials, and in the second half of the segment Dr. Roshini Raj of the NYU school of medicine appears to explain the details. She covers advantages and disadvantages of the filler and of course, makes a comparison to Botox.

Sculptra was recently FDA approved for cosmetic use. While the wrinkle filler has been used off-label in cosmetic applications for a long time, the recent FDA clearance has spawned a renewed interest of the drug in the cosmetic surgery industry and in the media.

Sculptra Treatment Featured on Early Show

Thursday, August 13th, 2009

After the dermal filler Sculptra was granted additional FDA clearance in July, dermatologist Jeannette Graf appeared on the CBS Early show to demonstrate treatment. This video features Sculptra before and after photos, a live demonstration, and a professional explanation of the benefits of this great new wrinkle filler.

For more information on Sculptra in Minneapolis, see our homepage or contact us at Skin Speaks Spa.

A Cosmetic Touch Up Can’t Hurt Your Job Prospects

Wednesday, August 12th, 2009

istock_000008859561xsmallAlthough people are definitely becoming more optimistic about the economy these days, competition on the job market is still fierce.  We’ve had more than a few patients at our Minneapolis locations say they suspect their age, or appearance is affecting their job prospects to some extent.

Everyone is looking for an advantage to land a good position, and many have turned to their hair stylist for a new look, or their local surgeon for Botox or Dysport wrinkle injections.  When you have to compete with young adults just out of college, who often accept a much lower wage, you need to present yourself in the best possible light.

Men and women are using some of their extra time to get a little touchup with injectables like Botox or Restylane, and some even go as far as having eyelid surgery.  Botox is the most popular non- invasive cosmetic procedure in the U.S.  More than 5 million treatments were done just last year. The cost of a single treatment will vary, and it pays to keep an eye out for monthly specials and events.

If you are going for treatments prior to a job interview, give yourself at least 1 week to heal and let the treatment take effect. Remember, doing well on an interview is not only about how you look, but whether you exude confidence about yourself and your ability to do the job.

Sculptra Receives FDA Clearance for Cosmetic Use

Thursday, July 30th, 2009

Sculptra in MinneapolisCompany 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.”

Why Do Patients Like Botox and Wrinkle Fillers?

Monday, June 1st, 2009

The American Society for Aesthetic Plastic Surgery (ASAPS) has given us a bit of insight about patients who choose wrinkle treatments. Last March, researchers sent questionnaires to 687 patients who had received Botox and/or dermal filler treatment.

The following statistics illustrate the opinions of the ‘typical’ patient. Who is the ‘typical’ patient?  According to the survey results, she is a married, working mother between 41-55 years of age with a household income of under $100,000.”

Approximately 70 percent of the respondents claimed that Botox and dermal fillers played an important role in their cosmetic routine.

When asked what their motivation was for pursuing Botox treatment, 34 percent said their appearance looked “stressed” or “angry”. Others said that a friend, family member, or their physician had recommended it, or they were preparing for a social event. 66 percent said they received Botox treatment 2-3 times per year. 72 percent of the respondents chose Botox to treat glabellar lines ‚ the vertical lines that appear between your eyebrows.

When asked about their motivation to use hyaluronic acid fillers, the majority (63 percent) of patients reported a desire to remove facial wrinkles and folds – mostly the nasolabial folds that travel from the nose to each side of the mouth.

A full summary of the results is available (in MS Word) here. For more information on wrinkle treatments in Minneapolis, see our homepage.

1 Million Syringes of Radiesse Dermal Filler Shipped

Wednesday, January 28th, 2009

radsyringe2Radiesse 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.

As Demand For Dermal Fillers Increases – FDA Reviews Labeling, Complications

Saturday, December 13th, 2008

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.

Votes Have Been Cast, Evolence Stays On The Island

Friday, October 3rd, 2008

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.