Liposonix is a new treatment that uses high-intensity, focused ultrasound to eliminate fat that is just beneath the skin. The company reportedly received FDA approval for “non-invasive waist circumference reduction.”

Medicis doesn’t plan to launch the treatment in the United States. In a press release issued this morning, the company stated:

“Medicis is not planning to launch the LIPOSONIX system in the U.S., and would anticipate that plans for a U.S. launch will be announced by an acquiring company, if any, if and when such acquiring company deems appropriate.”

The treatment is available in Canada, Japan and Europe. Although the procedure is officially cleared for sale in the U.S., people interested in it may need to wait until another company acquires the rights to market Liposonix technology from Medicis.

Medicis is best known for providing high quality injectable products, including Restylane and Perlane, some of the world’s most popular wrinkle fillers; and Dysport, the injectable botulinum toxin medication that works in a similar manner to Botox Cosmetic.

An advisory panel on plastic surgery devices recently voted to expand the listed indications for the popular wrinkle filler, which could allow Restylane to be marketed for lip enhancement procedures.

Restylane is already approved for non-surgical correction of facial wrinkles – typically the nasolabial folds on each side of the mouth. The filler was one of the first hyaluronic acid based products to receive FDA approval (in 2004).

Expansion of its approved indications would make Restylane the first HA filler approved for lip augmentation. In lip augmentation, the filler is injected along the borders of the patient’s lips, accentuating their natural size and shape, while also reducing lip lines.

Jonah Shacknai, CEO and Chairman of Medicis, says his company is “pleased with the panel’s recommendation,” and they believe the recommendation “reflects confidence in the robust clinical data provided by Medicis.”

What is Restylane?

Restylane is a wrinkle filler made from hyaluronic acid, a naturally occurring substance in the connective tissue of your skin. The product is made with a special form of HA, a non-animal stabilized hyaluronic acid, which restores volume in the tissue. Treatment can address wrinkles and folds to provide a more youthful appearance.

Restylane Before and After Pictures (courtesy of Qmed)

Wrinkles form over time as fatty tissue degrades, collagen breaks down and the skin loses elasticity. These normal signs of aging can be accelerated by factors like weight loss, smoking and sun exposure. Wrinkles and vertical lines on both sides of the mouth are common. The rounded fat pads in the cheeks can also become thin and migrate downward, giving the face a tired or worn look.

Products like Restylane and Perlane are ideal for addressing these skin problems without surgery and its associated downtime.

Doctors followed 233 people for 25 months during their treatments with either Sculptra or, for comparison, injectable human collagen (hyaluronic acid was not approved yet when this study was designed).

Among the group treated with Sculptra, a total of 106 out of 116 continued their treatments and remained in the study’s “long-term surveillance phase.” Their results indicate that Sculptra (poly-L-lactic acid) is superior to human collagen for treatment of nasolabial folds.

Photos courtesy of Sanofi-Aventis

The initial results of both treatments were comparable, but after three months, the collagen group experienced a sharp decline in their results. Their “scores declined from 95.7 percent at week 3 to 15.3 percent by the month-13 follow-up visit, representing an 84 percent reduction from the maximum measurement of overall improvement,” write the authors.

The Sculptra group, however, saw results that endured much longer. At week 3, more than 99 percent of them reported “overall aesthetic improvement” in their nasolabial folds. These results were maintained for 90 percent of the patients at 13 months, and 81 percent of the patients at the 25 month follow-up visit.

You can find this study in the April 2011 PRS Journal

233 patients were treated randomly with Cosmoplast or Sculptra Aesthetic at 3-week intervals.  Injections were performed to reduce the appearance of the nasolabial folds – the lines that travel from the nose to the corner of the mouth. Post treatment visits were conducted at 3 weeks, 3 months, 6 months, 9 months and 13 months after the final injection.

Highlights of the study:

• During post-operative evaluations, Sculptra scored much higher on the wrinkle assessment scale.
• When the patients treated with Sculptra were followed an additional 12 months, they exhibited results lasting over two years.
• Results had a very natural appearance. “[Sculptra] works gradually to replace lost collagen due to aging, resulting in a more natural-looking appearance” said Dr. Gary Monheit of the University of Alabama Medical Center.
• Side effects were mild or moderate in intensity and overall, they occurred more frequently in the collagen group.

You can read more about this study on CNN, with the official press release. If you’re interested in Sculptra or another injectable treatment, contact Hess Plastic Surgery.

Devon says she has experience with wrinkle fillers, which makes her an excellent voice for the campaign:

“In my 30s, I began receiving treatment with a dermal filler when I noticed these deep lines starting to form around my nose and mouth that looked like two parentheses and couldn’t be filled in with the creams I was using,” says Devon.

Become a fan of Juvederm on Facebook and you’ll receive useful information from Dayna Devon about fitness, health, beauty and “switching up” your aesthetic routine to look better.

While you’re at it, tell your friends about Hess Plastic Surgery on Facebook.

The duration of results

Prevelle Silk is composed of hyaluronic acid, just like the popular fillers Juvederm and Restylane.  The difference lies in the HA concentration, which is slightly lower in Prevelle Silk, meaning the results of Prevelle Silk will probably wear off quicker.

That might sound like a drawback, but it’s not:  a filler with short-term results is actually a great way to “test drive” this type of treatment.  Dr. Hess says the results of Prevelle Silk will usually last 2 months at most, and if you like the results, you can return for treatment with a comparable, but longer lasting wrinkle filler.

The addition of lidocaine

Prevelle is one of the latest fillers to be manufactured with lidocaine as a component.  While the significance of this addition may be exaggerated somewhat in the marketing for these new fillers, when combined with traditional pain management techniques it may enhance the comfort level of your injection.  According to the Prevelle website, clinical trials demonstrated a significant improvement over the filler Captique:

In the clinical study, 69% (29) of the 42 patients who responded to the questionnaire preferred treatment with PREVELLE Silk over Captique. Of these 29 patients, 97% (28) preferred PREVELLE Silk because it was less painful.

You can find more information (prices, treatment areas, etc) about Prevelle Silk with these links.

• Mentor Corp: Prevelle Silk
• Prevelle Silk official Website
• Prevelle Silk at Hess Plastic Surgery Fairfax

The following is a guide to the most popular injectables, ordered based on their relevance.

Click on links below for related blog posts about each topic and FDA approval summaries.

Botox Cosmetic maintained its position in 2009 as the top cosmetic treatment. Botox is so popular it’s basically become a fixture in the American vocabulary. Senators even tried to enact a Botax! Composed of a bacteria called botulinum type a, Botox creates a temporary paralysis of facial muscles to reduce wrinkles.

What it treats: glabellar lines, frown lines, forehead furrows, crow’s feet, cervical dystonia, blepharospasm, strabismus, hyperhidrosis, headaches, etc.

Read:

• New Botox Uses Still on the Horizon
• Allergan Disputes Botox Marketing Restrictions
• Free Botox for the Unemployed?

Dysport received FDA clearance last year, becoming the second cosmetic treatment with botulinum type A. Expect to hear more about this product as people choose between Dysport and Botox in the coming year.

What it treats: glabellar lines, forehead furrows, crow’s feet.

Read:

• Dysport soon to arrive
• New Botox competitor receives FDA clearance

The advanced porcine collagen dermal filler Evolence was discontinued in 2009. If you were happy with Evolence treatment in the past, you could wait and see if another company resurrects the drug, or you could ask us about other options.

What it treat[ed]: Smile lines, moderate to deep facial wrinkles and folds

Read:

• Orthoneutrogena puts the brakes on Evolence
• FDA Overview of Evolence

Juvederm, the hyaluronic acid wrinkle filler has only increased in popularity since receiving FDA approval in June 2006.  Last year, Allergan Inc. ramped up marketing of Juvederm with TV advertising and special rebate offers.

What it treats: nasolabial folds, marionette lines, facial lipoatrophy

Alternatives: Restylane

Read:

• Lip augmentation with dermal fillers
• Media buzz about liquid facelifts
• FDA overview for Juvederm

Bioform Medical announced worldwide shipment of over one million Radiesse syringes since 2002. Composed of a calcium hydroxylapatite gel, Radiesse has been ideal for deeper injections.

What it treats: tear trough deformities, moderate to severe facial wrinkles/folds

Read:

• Dermal fillers vs. Eyelid Surgery
• Radiesse ships one-millionth syringe
• FDA Overview for Radiesse

Until last year, Sculptra had only been approved for treating persons with HIV-related facial lipoatrophy (loss of fat). The FDA granted clearance for cosmetic applications and Sculptra was then rebranded as “Sculptra Aesthetic.” Many physicians jumped on the Sculptra bandwagon and started offering the drug.

What it treats: deep smile lines, contour deficiencies, folds, wrinkles

Read:

• Sculptra receives FDA clearance for cosmetic use
• Today Show features Sculptra Aesthetic
• FDA Overview for Sculptra Aesthetic

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.” The news however, is puzzling when you consider how short the drug’s lifespan was in the United States.

Was EVOLENCE® destined to fail?

An Israeli company called ColBar LifeScience was responsible for development of Evolence, 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?

The NBC Today Show recently featured Sculptra aesthetic on their “Today’s Health” segment. Along with a treatment demonstration and some patient testimonials, Dr. Roshini Raj of the NYU school of medicine appears on the show to explain the details regarding Sculptra treatment. She covers the advantages and disadvantages of Sculptra and of course, compares the filler 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.

There’s no harm in revisiting the topic if we can help clear up some confusion about the application of dermal fillers and how those procedures compare to surgery.

While the liquid facelift is basically soft tissue augmentation with Botox and injectable fillers, people say the goal is to achieve results that are similar to surgery. Yet the results are said to be “typically more subtle than surgery.”  As Dr. Hess pointed out, “a facelift tightens the deeper tissues of the face including the neck muscles and removes excess skin – things that a “liquid facelift” will never achieve.

Despite the subtle inconsistencies or perhaps, the misuse of terms, the topic is getting lots of media attention: Harper’s Bazaar is the latest to pick it up and interview some of the physicians that say they’re doing it.  The Best Beauty section of their September ’09 issue includes before and after pictures and a discussion of professional techniques for administering injectables.  The magazine’s website also has a decent article with some facts and figures about soft tissue augmentation with wrinkle fillers.

Apparently, the liquid facelift isn’t exactly a “touch up” here and there, but a relatively extensive  series of injections.  According to the authors, you can expect to pay at least $3,000 – $5,000 for a full liquid facelift.  A Florida dermatologist by the name of Dr. Fredric Brandt explains, “I re-suspend the face with Botox, lifting up the brows, neck, jawline, and tip of the nose and then fill in and replace volume around the eyes and cheeks.”

The liquid facelift has also been featured on The Doctors (NBC), Rachel Ray Show, New Beauty Magazine, Dr. 90210, FOX News, Cosmetic Surgery Times, and more exposure is said to be in the works.