Restylane Gets Approved for Lip Enhancement

Tuesday, October 18th, 2011

Medicis has just announced FDA clearance for Restylane injectable gel to be used in lip augmentation. As one of the world’s most popular wrinkle fillers, Restylane has been used for years to treat moderate to severe facial wrinkles and folds.

The new FDA clearance includes indications for lip enhancement in patients over 21.

New Restylane packaging will include the new indication and clinical results that studied the lip augmentation procedure. Medicis is reportedly planning to incorporate the clinical study in their training and promotional materials.

Medicis CEO Jonah Shacknai commented:

This marks another significant milestone for Restylane, now the first and only hyaluronic acid dermal filler approved in the United States for lip augmentation.

To evaluate Restylane for lip augmentation, researchers carried out a randomized, evaluator-blinded, no-treatment-as-a-control, multi-center study of 180 patients. Subjects randomized to Restylane treatment at the beginning of the study were retreated at six months, and subjects randomized to no treatment received their first Restylane treatment at six months.

The study measured safety through use of:

• Adverse events that were reported during the study
• Patient diaries kept for two weeks after Restylane lip augmentation
• Nine lip safety assessments performed at various intervals throughout the 7-month study

Medicis Introduces Lip Fullness Scale™

The Medicis Lip Fullness scale is an innovative, 5-point measurement tool that evaluates the effectiveness of lip augmentation. To design the scale, they collaborated closely with the FDA and clinicians during the validation process.

A blinded lip evaluator, physician and photo reviewer all measured effectiveness of Restylane lip augmentation for the upper and lower lip. They also employed the GAIS – Global Aesthetic Improvement Scale. Researchers measured effectiveness for seven months. In addition, three independent physicians performed photo evaluations after the study.

The Results: Research showed that Restylane lip augmentation is well tolerated and effective for up to 6 months. Adverse events were not serious, and included pain, swelling, tenderness, bruising and erythema. 80 percent of patients chose to be treated again after 6 months.

Read more about Restylane in New Jersey

Tags: restylane lip augmentation
Posted in Injectable Fillers | 1 Comment »

Maker of Restylane, Dysport Receives FDA Clearance for Body Contouring System

Thursday, September 8th, 2011

Medicis, the pharmaceutical company behind Restylane, Perlane and Dysport, recently announced FDA approval for Liposonix.

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 does not 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.

Tags: dysport, perlane, restylane
Posted in Injectable Fillers | 4 Comments »

More Couples Choose Plastic Surgery Together

Friday, July 1st, 2011

As more men choose cosmetic procedures, a new phenomenon among the plastic surgery clientele has been on the rise: more couples are appearing together in surgeons’ offices across the country.

America’s recovery from the recession has seen a modest resurgence of cosmetic surgery procedures. While women still make up about 80 percent of plastic surgery patients, the number of men has jumped 88 percent since 1997. The most popular choices among men include procedures like Botox, liposuction, and rhinoplasty.

The Pittsburgh Tribune Review recently told the story of Marsha and Mike Gavula, a couple from Evans City, PA, who do just about everything together. Recently, the 50-year-olds both stepped into a plastic surgeon’s office.

Marsha has undergone chemical peels, dermabrasion, and other minimally invasive procedures, while Mike opted for Botox and wrinkle-filling injections for the first time on his fiftieth birthday.

One medical spa with three offices in the Pittsburgh area reports that it offers cosmetic procedures for nearly 30 couples annually, compared with a half-dozen couples in the mid-2000s.

What could be driving this increase in couples’ procedures?

• Cosmetic surgery no longer carries a stigma among men, particularly as the baby boomer generation ages.
• More non-invasive options for those who don’t want a surgical procedure
• Men desire a more youthful appearance in order to compete in a younger workplace. .
• Reduced recovery times for many procedures, thanks to cutting-edge techniques
• Couples having surgery around the same time can “leapfrog” their procedures, alternating care and recovery.

Tags: couples get plastic surgery
Posted in Facial Plastic Surgery, Injectable Fillers | 5 Comments »

Texas Considers New Regulations for Botox and Other Cosmetic Treatments

Tuesday, June 7th, 2011

On Friday, the Texas Medical Board will be considering a change in regulations for physicians performing cosmetic procedures like Botox, Restylane and other prescription medications, reports WFAA.

In their state, real prescription medications like Botox can only be obtained by a qualified physician (with a medical license). Within a doctor’s office however, the treatment can be delegated to and then administered by, anyone.

“As long as I’m the one purchasing it, right now I can delegate to whoever I want to,” explains dermatologist Dr. Lori Stetler to WFAA.

Because the market for Botox and cosmetic procedures can be very lucrative, there is a strong allure for physicians with inadequate training to begin offering these treatments. Currently there are no Botox regulations pertaining specifically to the training and qualifications of those who administer the injection. Such regulations would also apply to treatments like Juvederm, Sculptra, Radiesse and other popular wrinkle reducers.

According to WFAA, the medical board will discuss a regulation that would allow only doctors, nurses and physician assistants to administer a controlled substance such as Botox.

Tags: botox regulations, laws regulating botox treatment
Posted in Botox, Injectable Fillers | 43 Comments »

Restylane May Soon Be FDA Approved for Lip Augmentation

Monday, May 2nd, 2011

Approved FDA indications for Restylane may soon be expanded to include lip augmentation, according to a recent press release from Medicis Pharmaceutical. An advisory panel on plastic surgery devices voted to expand approved indications for the popular wrinkle filler, which could allow Restylane to be marketed for lip augmentation purposes.

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.

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.”

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 Photos – 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.

Tags: lip augmentation with dermal filler, restylane perlane
Posted in Injectable Fillers | 26 Comments »

New Topical Botox Still Being Studied, Awaiting Approval

Tuesday, March 8th, 2011

As the economy rebounds, sales of wrinkle-blockers like Botox and Dysport are increasing in plastic surgeon’s offices nationwide. Many consumers however, may be waiting for a game-changing version of botulinum toxin – in the form a topical wrinkle treatment.

Both Botox and Dysport, while they are distributed by different companies, contain similar formulations of botulinum toxin. (though the products are not considered “interchangeable”). The active ingredient stops muscle movement in the tiny muscles of the brow, effectively diminishing wrinkles between the brows after injection.

Aside from cosmetic use, botulinum toxin-based products have been used for therapeutic treatments for reduction in excessive sweating and migraine headaches.

Now the next logical step is to make Botox widely available to patients who are less inclined to undergo a facial injection.

At this point, the news looks good for these consumers. The second phase in trials for topical botulinum toxin, which was completed in October, was successful. While no market date has been set for the topical version of Botox, nor for its Medicis-produced rival Dysport, needle-shy individuals can still test the possible effects of Botox by using Allergan’s Treatment Visualizer.

Tags: botox cosmetic, dysport
Posted in Injectable Fillers | No Comments »

Plump Enough: Is the Injectable Filler Market Overrun?

Saturday, January 29th, 2011

As consumer demand for non-surgical wrinkle reduction, lip enhancement and chin and cheek augmentation continues to increase, so does the vast array of injectable filler products designed to smooth wrinkles and plump facial tissues.

Today, are so many filler options available to consumers that it’s a wonder to some why pharmaceutical companies continue rolling out new injectables, especially when some existing products are already considered highly effective favorites in the aesthetic medical community and do not broker much room for competition.

But according to Dr. Gary Monheit, who commented on the topic in a recent Cosmetic Surgery Times article, unique new filler formulations and, to a lesser extent, new “me, too” products (fillers that closely resemble existing formulations) will still have a place in facial rejuvenation.

Despite the array of injectables available for wrinkle treatment, patients with fine lines around the eyes and mouth are still currently underserved, an issue which will likely be exacerbated by the fact that collagen injectables long used to treat superficial wrinkles (Zyderm, CosmoDerm) were recently discontinued by Allergan.

In addition, Dr. Monheit says patients are presently hard-pressed to find fillers that provide long-lasting results without a host of potential safety issues. Other than Sculptra and Radiesse, most fillers that can last longer than one year have generally proven problematic.

“To date, many long-lasting and permanent fillers, including both volumizing and structural products, have been associated with a number of problems. Reported complications include development of fibrotic nodules, granulomas and biofilm formation. These adverse events have not been reported with any filler materials approved by the FDA, but limited experience acquired in premarketing clinical trials may not be sufficient to fully understand product safety and biocompatibility issues,” Dr. Monheit says.

Joining the existing gamut of widely used hyaluronic acid (HA) injectable fillers, such as Restylane, Juvederm and Prevelle Silk are Juvederm Voluma (Allergan), Prevelle Lift (Genzyme/Mentor) and Belotero (Merz).

While Juvederm Voluma will primarily focus on chin and cheek augmentation and Prevelle Lift on correcting deep creases, Belotero is expected to be versatile, longer-lasting than many existing HA fillers and capable of correcting both deeper facial folds and superficial fine lines.

“In theory, this filler should be able to improve both superficial and deep lines. In patients enrolled in the clinical trial, effects lasted 6-12 months,” says Dr. Monheit, who serves as a consultant for Merz. “However, further evaluation of its benefits awaits use in clinical practice.”

As consumers eagerly await the latest and greatest fillers poised to enter the U.S. market, it is more important than ever to keep in mind that while the filler product certainly affects your facial rejuvenation results, the skill and expertise of your injector makes the biggest difference in the success (or failure) of your injectable filler experience.

Whether you’re seeking lip augmentation, wrinkle reduction or facial contouring, be sure to choose an experienced New Jersey plastic surgeon with a variety of FDA approved injectable fillers available to customize your facial rejuvenation treatment.

Tags: hyaluronic acid, injectable fillers, juvederm, lip augmentation, prevelle silk, radiesse, restylane, sculptra, wrinkles
Posted in Injectable Fillers | 1 Comment »

Plastic Surgery Organization Predicts Fat Melting, Facial Rejuvenation Hot in 2011

Tuesday, December 28th, 2010

Tags: body jet lipo, botox, breast implants, coolsculpting, injectable fillers, liposuction, liposuction alternative, plastic surgeons, smart lipo, vaser lipo, zeltiq, zerona
Posted in Breast Implants, Facial Plastic Surgery, Injectable Fillers, Liposuction, New Technology, Plastic Surgery | 132 Comments »

New HA Filler Bests Collagen in Study

Tuesday, December 21st, 2010

Belotero, a new injectable filler made of hyaluronic acid and distributed by Merz, was found to provide longer-lasting wrinkle correction than bovine collagen injectables in a 24-week study, the results of which were published in 2010 spring and fall editions of Dermatologic Surgery.

The study results come at a time when Belotero is awaiting FDA approval and pharmaceutical competitor Allergan is pulling its bovine collagen injectables Zyderm and Zyplast, as well as its human-derived collagen injectables CosmoDerm and CosmoPlast from the market. Johnson & Johnson also announced in 2009 that it would discontinue its porcine collagen injectable Evolence.

“As one would expect with a good HA (hyaluronic acid filler), [Belotero] lasted longer than bovine collagen, which lasts much longer than human collagen, and it was just as safe as bovine collagen,” said Dr. Rhoda Narins, the study’s principal investigator and clinical professor of dermatology at New York University.

Dr. Narins and other investigators at six U.S. sites conducted the double-blind study on 118 subjects with moderate-to-severe bilateral nasolabial folds, injecting Belotero on one side of the face and a bovine collagen filler on the other. Touch-up treatments were occasionally needed, and study participants were evaluated at two, four, eight, 12, 16 and 24 weeks after their last treatment.

While the greatest wrinkle correction was seen in both Belotero and collagen injectables at week eight, patients treated with Belotero had noticeably better wrinkle correction at weeks 12, 16 and 24, according to both blinded and treating investigators.

In fact, patients who participated in a study extension received another round of Belotero injections after their initial results were evaluated at 24 weeks, and Dr. Narins found that about 80 percent of patients didn’t need to be retreated for 12 to 18 months.

In addition, study participants experienced more adverse side effects with collagen, as more patients reported injection site nodules with collagen (7.6 percent) versus with Belotero (5.9 percent).

Dr. Narins also noted that in addition to offering longer-lasting results, Belotero will not cause the Tyndall effect (bluish skin tint in treated areas) and can be injected both superficially and deeply, unlike some injectable fillers.

“I believe Belotero will take its place among the best of the HAs (hyaluronic acid fillers),” says Dr. Narins. She also pointed out that Merz, the company that distributes Belotero, also distributes the popular injectable filler Radiesse (calcium hydroxylapatite).

“The duo of Radiesse with an HA (hyaluronic acid filler) is an excellent filler combination,” says Dr. Narin.

Tags: hyaluronic acid, injectable fillers, plastic surgery research, radiesse, skin rejuvenation
Posted in Injectable Fillers, New Technology | No Comments »

Acquisition on the Horizon for Maker of Restylane

Tuesday, December 14th, 2010

Q-Med AB, the Swedish maker of the Restylane family of injectable fillers, recently announced that the company has accepted a conditional acquisition offer from Switzerland-based Galderma SA, for as much as 7.45 billion kronor ($1.08 billion).

Galderma plans to make its offer public in January, and Q-Med’s board has unanimously recommended that its shareholders accept the cash payout offer of 75 kronor a share, which is 13 percent more than Q-Med’s Dec. 10 closing price of 66.25 kronor per share.

All shareholders would purportedly receive this buyout offer with the exception of Q-Med’s founder and Chairman Bengt Aagerup, who would receive 58.94 kronor a share in cash for his 47.5 percent stake in the company.

The one condition of the offer is that Medicis Pharmaceutical Corp., the U.S. company that licenses the Restylane family of injectable fillers and serves as a business partner to Q-Med, must also accept Galderma’s offer, presumably so the Swiss company can achieve its goal of investing in more cosmetic treatment products.

The products that make up the Restylane family of fillers include Restylane, Restylane-L, Perlane and Perlane-L, which have been approved for cosmetic use in Europe since 1996 and in the U.S. since 2003.

Each of these products is derived from hyaluronic acid and used by doctors like New Jersey plastic surgeon Dr. Barry DiBernardo to fill in wrinkles, plump thin lips and restore volume to facial features that have inadequate projection, such as the cheeks and chin.

Nestle SA and L’Oreal SA, the two companies that own Galderma, would each be paying half of the billion-dollar bill to acquire Q-Med, a relatively small amount of the 5 billion Swiss francs ($5.1 billion) that Nestle plans to spend on investments this year.

The acquisition would balance out Galderma’s other cosmetic holdings, such as Cetaphil skin care products and Azzalure, an injectable wrinkle-relaxer similar to Botox approved for use outside the U.S.

Tags: botox, injectable fillers, restylane, skin care, skin rejuvenation
Posted in Botox, In The News, Injectable Fillers, Products | 3 Comments »