Posts Tagged ‘Restylane’

FDA Panel Backs Approval of Restylane for Lip Enhancement

Wednesday, May 4th, 2011

Restylane as lip enhancerAn FDA panel has recommended that Restylane uses be expanded to include lip augmentation. The filler is already approved to treat facial wrinkles and folds, such as the nasolabial folds on the sides of the mouth.

The FDA will make the final decision on Restylane for lip augmentation, but it usually follows the advice of its advisory panels. If the FDA does expand its use, then Restylane can be marketed for the lip procedure.

Jonah Shacknai, Chairman and Chief Executive Officer of Medicis, Restylane’s maker, said in a statement that the panel’s recommendation reflects its “confidence in the robust clinical data provided by Medicis.”

Restylane was the first hyaluronic acid dermal filler approved by the FDA for use in the United States (in 2003), and if granted the new FDA approval, it would make Restylane the first hyaluronic acid dermal filler in the U.S. indicated for use in the lips.

Restylane is injected into the tissue and over time is resorbed by the body as the treatment results gradually wear off; results typically last about six months.

Common Off-Label Uses of Restylane

Many doctors are already using Restylane for the lips. Doctors can use drugs for off-label uses — meaning, uses that aren’t approved by the FDA — but for a drug maker to market it for a certain purpose, it must have FDA approval.

Plastic surgeon Dr. Farhad Rafizadeh uses Restylane for lip enhancement and said he often recommends it because it stays put and doesn’t seep into other areas of the face as other dermal fillers do. “Restylane allows me to define the shape of the lip in a more precise manner,” he added.

In addition to the lips, common off-label uses for Restylane include treating the tear trough (the saggy skin under the eyes), marionette lines and sunken cheeks.

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New Study Examines Botox’s Effects on Reading Emotions

Wednesday, April 27th, 2011

Does Botox affect ability to read emotionsBotox injections may actually inhibit the ability to read others’ facial emotions, according to a new study published in Social Psychological and Personality Science. The study found that people who had Botox injections were significantly less accurate at reading others’ emotions in photos compared to those who had Restylane injections.

Study researcher David R. Neal, PhD, a psychology professor at the University of Southern California, said, “If you have a poker face because your facial muscles are paralyzed, you can’t read others emotions as well.”

Why would Botox have this effect and not other fillers? According to Neal, evidence suggests that people use mimicry to register and label the emotional states of others, so something that limits one’s ability to reproduce another person’s expression of emotions, such as Botox — which has a paralyzing effect on facial muscles in the immediate vicinity of the injection site — would likely impair one’s ability to register or label those emotions.

Women who had their facial folds treated with Restylane were able to read others’ emotional states with about 77% accuracy, while those who had Botox had 70% accuracy.

Neal admits that it’s a “fairly subtle” effect. “People are not becoming automatons. It’s just a matter of weighing whether the aesthetic and self-esteem boost outweighs any subtle impact on your ability to perceive others emotions,” he added.

Andrew Jacono, MD, a facial plastic surgeon in New York City, who reviewed the study, said that the findings likely only apply to those who use excessive amounts of Botox.

“When Botox is overdone, it doesn’t look right and people aren’t perceived in the right way,” Jacono said. “The goal is to try to make sure when you get Botox, it is done in a subtle way so you can look better and maintain your ability to emote and read others.”

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Study Looks at First Impressions after Restylane Injections

Monday, November 15th, 2010

filler injection in laugh linesHyaluronic acid fillers, such as Restylane, are effective at correcting nasolabial folds — commonly known as smile lines — and a new study also shows receiving the treatment can affect the first impression you make on others.

The Chicago Center for Facial Plastic Surgery had 22 participants who received Restylane injections in their nasolabial folds, and then photos were taken of their faces at the baseline, optimal correction visit and four weeks after optimal correction.

Next 304 evaluators rated their first impressions in several categories for each photo; in total, 5,776 first impressions were recorded.

The study’s findings indicated a significant improvement in mean first impression at the optimal correction visit in several categories, including attractiveness, financial success, relationship success and athletic success.

“Full correction of the nasolabial folds with hyaluronic acid filler significantly and positively influences the first impression an individual projects,” the authors concluded.

Dermatologist Dr. Kenneth Beer commented on the study: “When used correctly, they [hyaluronic acid fillers] help restore more youthful proportions. For women, this includes higher cheekbones, fuller temporal areas, and more sculpted facial features. Hyaluronic acids may also be used to camouflage the bone loss associated with menopause and its loss of reproductive capacity. Transforming a postmenopausal face into one that has the features of a premenopausal face will have a profound effect on first impressions.”

The abstract is available online, and the study was published in the November issue of the Dermatologic Surgery journal.

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New Report Says Cosmetic Surgery Market to Grow to Over $3 Billion by 2017

Tuesday, September 21st, 2010

Woman receiving facial injectionThe cosmetic surgery, facial aesthetics and medical lasers market is expected to double in size by 2017, exceeding $3 billion, according to a new report by by iData Research, a medical device and pharmaceutical market research company.

The report estimated that the market for Botox and Dysport, botulinum toxin-A injectables, is estimated to grow to $543 million by 2017. It also anticipated that the aesthetic laser and light therapy markets for skin resurfacing, hair removal, and laser lipolysis will  be the fastest growing cosmetic procedure markets in the next seven years.

Dr. Kamran Zamanian, CEO of iData, had this to say: “Allergan has had a monopoly on botulinum toxin A drugs since 2002, but now faces competition from Dysport(R) by Medicis as well as other new competitors expected to enter the market. Allergan and Medicis have been fierce rivals, as their Juvederm and Restylane facial dermal fillers compete in the lucrative dermal filler market.”

The report also said that competition in the botulinum toxin market will further intensify with expected newcomer PurTox by Mentor. According to Mentor, PurTox is in Phase III clinical trials in the U.S.

The use of botulinum toxins is also expected to increase due to a growing number of therapeutic treatments that go beyond filling wrinkles. “A growing number of doctors are looking at the therapeutic potential of Botulinum-A. There are more cosmetic procedures performed using Botulinum-A than therapeutic, however therapeutic procedures use higher doses of the drug, therefore these two markets are similar in value,” says Dr. Zamanian.

Currently the U.S. injectables market for is valued around $860 million, according to the report “Markets for Cosmetic Surgery, Facial Aesthetics and Medical Laser Devices 2011,” which includes data, analyses, and competitor profiles for botulinum toxins, dermal fillers, breast augmentation implants, liposuction aspirators, laser/light devices, and microdermabrasion.

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Collagen Injectables Discontinued as Popularity of Hyaluronic Acid Fillers Grows

Monday, July 12th, 2010

Radiesse before & after photosThe latest issue of Dermatology Times reports on the changing U.S. injectables market, given the news that most collagen fillers will be gone from the market at year’s end.

In January 2010, Allergan announced it would be discontinuing its collagen line of fillers— CosmoPlast, CosmoDerm and bovine products Zyderm and Zyplast—at the end of the year. The company halted production of the products last year, but manufactured sufficient inventory to meet estimated market demand through the end of 2010, according to Kelly Lao, manager of corporate communications.

In late 2009 Johnson & Johnson had announced that it was discontinuing its collagen filler Evolence.

“For my generation of dermatologists, collagen was the gold standard of fillers—this is what we were taught to use,” says Seth L. Matarasso, M.D., clinical professor of dermatology, University of California School of Medicine, San Francisco. “But the market is changing. Welcome to the brave new world of fillers.”

“The discontinuation of the sale of our collagen products … is in response to declined market interest … since the introduction of hyaluronic acid dermal fillers like Juvéderm have become more popular,” Ms. Lao says.

“There is an overwhelming popularity of the new kid on the block: the hyaluronic acids. They have been embraced universally, and suddenly collagens aren’t as popular,” says Dr. Matarasso.

The popularity of hyaluronic acid products, which includes Restylane, Perlane, Juvéderm, Radiesse and Sculptra, is due to factors that include:

  • Longer-lasting results
  • Appear to give a better fill
  • Some contain lidocaine for less painful injections

Upcoming improvements of hyaluronic acids, according to Dermatology Times, will provide more volume and contour-changing ability and the ability to fill deeper lines.

Read the full story, “Dermatologists prepare for departure of collagen from U.S. market,” online at Modern Medicine. (Before and after photos of Radiesse patient, courtesy of radiesse.com)

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Injectables with Lidocaine Offer Pain Relief

Tuesday, June 22nd, 2010

Restylane logoOne of the latest advancements in the U.S. injectable fillers market is lidocaine-containing versions of popular hyaluronic acid fillers, reports the July 2010 issue of Cosmetic Surgery Times. Lidocaine is a local anesthetic that is injected directly into the body area and decreases pain by temporarily numbing that area, according to WebMD.

Three injectables won FDA approval in February 2010 for lidocaine versions in the U.S.:

The products performed similarly to their lidocaine-free predecessors in terms of safety and efficacy, according to Dr. Michael H. Gold, a clinical assistant professor of dermatology at Vanderbilt University School of Medicine and School of Nursing. Furthermore, “The incorporation of lidocaine has surely provided a higher comfort level for patients [in the clinical trials],” he says.

Dr. Gold adds that in his clinical experience when patients undergo an injection that includes even a small percentage of lidocaine, “Most patients say they barely feel the second stick. To me that is the home run of lidocaine in these fillers.”

In clinical studies by Medicis to support FDA approval, the addition of lidocaine to Restylane and Perlane substantially reduced pain experienced by patients, while demonstrating adverse event safety profiles similar to those of Restylane and Perlane, according to the Medicis release.

A method for doctors mixing lidocaine with Radiesse was cleared in July 2009. “Originally, I was against doctors mixing a lot of fillers because I was afraid of potential changes in the products themselves,” says Dr. Gold. But once the FDA clears these products, especially those premixed by manufacturers, “I’m pretty comfortable with it.”

“Fillers with lidocaine among latest injectable advancements” is available online at Modern Medicine. Learn more about Restylane, Perlane, and Radiesse in Seattle.

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Which Dermal Filler is Right For Me?

Thursday, July 9th, 2009

istock_000008969660xsmallRemember when the FDA first approved Collagen in 1982?  There was hope of looking more youthful, fear of potential allergic reactions, painful injections, and lots of swelling. Sometimes it took as long as a week before you finally looked normal.

Today we have a much wider range of safe, effective dermal fillers to choose from. They can be injected into the tiny lines around the eyes, the lines that have formed below the mouth, and the folds around the nose. They even can even fill-in areas that have lost volume, such as thinning lips and those deep furrows that develop between the eyebrows. Having any of these areas injected can take years off the face. It may even allow you to postpone cosmetic surgery, like a face-lift, for years.

All these new fillers can be used quickly, in an outpatient setting, and you’ll look great almost immediately.  Of course the downside is, fillers are temporary (lasting anywhere from a few months to a year), and some patients experience minor bruising and swelling.

The question many people want answered is: “Which one should I choose?”
The majority of the new fillers (not all) are made from Hyaluronic Acid, a natural substance found in the body. Below is a list and brief description of the dermal fillers that are available only from qualified practitioners:

  1. Restylane – a hyaluronic acid based filler touted as “the world’s best-selling dermal filler.” It is used for correcting moderate facial wrinkles and folds.
  2. Perlane – very similar to Restylane, it is designed primarily for treating deeper and more severe wrinkles and folds.
  3. Radiesse – this thick compound is made with (natural, biocompatible) calcium based microspheres in water based gel.
  4. Prevelle Silk – this hyaluronic acid gel filler is commonly used for lip augmentation treatments.
  5. Juvederm – Like Perlane, this popular filler is designed for treating deeper wrinkles and restoring volume to the face. It’s been called the “liquid facelift” treatment.
  6. Evolence – one of the newer injectables on the market, Evolence is made with purified porcine collagen. It helps create plumper cheeks and lips, and has a reputation for quick results and minimal bruising.

As with any cosmetic procedure, you should choose a doctor you trust and one who operates a practice that makes you feel comfortable. Remember, the use of injectables is an art, not just a science.  At our Seattle surgery office, we can help you make the right choice among the best dermal fillers available today.

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