Artefill--it's back!

Artefill, approved by the FDA in October of 2006 is a long-term filler for nasolabial folds and marionette lines. Lots of us liked it very much but during the recent economic slowdown the company went bankrupt. The product retained its FDA-approved status, however, and the company waited for another pharmaceutical firm to take over.

Artefill’s efficacy and safety profile have been validated through many clinical trials pre- and post-FDA approval and over 20,000 patients have been treated with Artefill since it’s introduction to the U.S. market.

I am happy to say Artefill is again available since Suneva Medical purchased the company for over $200 million for the rights to produce the product.

Botox Rival Issues a "Pepsi Challenge"

Remember the Pepsi Challenge? Commercials showing everyday folks surprising themselves by how much more they enjoyed Pepsi than Coke in a blind taste-test?

Medicis Pharmaceutical Corp. is taking its Botox competitor, Dysport, to the streets with a similar come-on. According to the Dysport Challenge, consumers can enjoy a two-pronged wrinkle option: use Medicis' generous rebates to try Dysport, but if you don’t like it as much as Botox, they’ll give you $75 toward your next Botox injection.

Over the year since Dysport gained FDA approval, it has captured less than 10% of Botox’s marketshare. Spurred by growing competition at its heals, Allergan has been pushing Botox into consumer awareness as a treatment for migraines and sweating. In fact, although such off-label uses for Botox aren’t technically approved by the FDA, they account for over 50% of the drug’s annual revenue.

While this kind of marketing may be raising eyebrows among medical ethicists, we don’t see a problem with it. After all, the Dysport promotion is targeted at cosmetic patients. How is this unlike a competition between Maybelline and Cover Girl mascaras?

Drs. Jason Pozner & David J. Goldberg
Sanctuary Medical Aesthetic Center, Boca Raton
Sanctuary Plastic Surgery, Boca Raton
Skin Laser Surgery Specialists of NY/NJ

Florida Medspa Death Highlights Need for Tougher Regulation

According to the International Medspa Association, medspas (defined as a spa that provides medical services) have grown by 85% in last 2 years – despite the US economic recession. Medspa annual revenues are now in excess of $2 billion, according to the Aesthetic Medicine News. Some of these medspas are within the offices of cosmetic dermatologists and plastic surgeons. Many other medspas are not. Some of the medspas that are not within physician offices are overseen by on-site cosmetic dermatologists and plastic surgeons; others, often, are not. This past week an ABC News Nightline episode highlighted what can go very wrong in this latter setting. ABC News highlighted a patient who died during a liposuction procedure performed at an unlicensed Florida medspa by a physician with almost no cosmetic training.

I, as a NY and NJ cosmetic dermatologist and attorney who teaches Health Care Law at NY’s Fordham Law School, was interviewed by ABC's Nightline about the lack of medspa regulations in so many states. The issue arises not only with procedures such as liposuction, but with techniques that range from laser hair removal to wrinkle filler injections. It should be noted that the states of New York, Vermont and Georgia do not even consider laser hair removal the practice of medicine–even though horrendous facial scarring can occur when this procedure is not performed correctly.

Societies such as the American Academy of Dermatology (AAD), American Society for Dermatologic Surgery (ASDS), the American Society for Lasers in Medicine and Surgery (ASLMS), and the American Society for Aesthetic and Plastic Surgery (ASAPS) have put forth guidelines to promote safety for medspa type procedures. Guidelines are not law. No medspa is forced to follow these guidelines. It will ultimately be up to society, through their pressure on legislators, to push through tougher regulations for the growing medspa industry.

There is no question that procedures performed at the unlicensed medspa in Florida are much less expensive than similar procedures performed within our offices. It can also be argued that complications can occur during any procedure. This is certainly true. However one must also wonder if the unfortunate death that occurred in the Florida medspa is a terribly tragic example of “you get what you pay for”.

Dr. David J. Goldberg
Sanctuary Medical Aesthetic Center, Boca Raton
Skin Laser Surgery Specialists of NY/NJ

The Sturge-Weber Foundation Honors Dr. David J. Goldberg

The Sturge-Weber Foundation honored Dr. David Goldberg with one of the industry’s highest awards at a tribute dinner held in Miami on March 05, 2010. As our regular readers know, Dr. Goldberg is a pioneer in the field of dermatology and director of Skin Laser & Surgery Specialists of New York and New Jersey.

According to Karen Ball, President of the Sturge-Weber Foundation, “Each year, the Sturge-Weber Foundation singles out one outstanding leader in dermatology to receive what has become one of the highest accolades that can be achieved in our field. Dr. Goldberg is one of the true pioneers in dermatology, who has worked tirelessly to bring cutting edge technologies, innovative techniques and promising new treatments to the practice of medical and cosmetic dermatology. His work with skin lasers is unparalleled, and he is widely recognized as one of the world’s leading dermatologists. We are extremely pleased to honor him at our annual dinner.”

Dr. Goldberg is world-renowned for his innovative work with skin lasers, cosmetic dermatology and facial rejuvenation techniques. The Sturge-Weber Foundation honor is another in a long list of awards and honors received by him. He was the first recipient of the prestigious Leon Goldman award, named after the founder of laser surgery. In addition, he was named one of the top ten laser surgeons in the United States by Self magazine; one of the best doctors in America by both Woodward/White, Inc. and Doctors Inc.; and one of the best dermatologists in New Jersey by New Jersey Monthly. A prolific author who has contributed to more than 10 academic textbooks and 125 papers, Dr. Goldberg also serves as a clinical professor and Director of Laser Research at the Mt. Sinai School of Medicine.

Dr. Goldberg said, “I am extremely humbled to be named the Sturge-Weber Foundation honoree this year. The Foundation has accomplished so much in their mission to improve the quality of life for people with port wine stain birthmarks and associated conditions. I look forward to continuing to contribute to finding new treatments that can bring hope and relief to patients and their families.”

I'm proud to be a business partner, friend and colleague of David Goldberg, and am delighted to share his award with our readers.

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center, Boca Raton
Sanctuary Plastic Surgery, Boca Raton

The future of facial fillers, the Liquid Facelift, and the latest facial rejuvenation techniques

Demand for non-surgical cosmetic treatments continues to increase dramatically as a new generation of facial fillers and liquid facelift techniques promises better results in the battle against aging, while avoiding the risks inherent in facial plastic surgery. While hyaluronic acid fillers have earned an excellent track record for safety and effectiveness in treating fine lines and wrinkles around the eyes, nose and mouth, there are exciting new volumizers in the pipeline that are able to accomplish large-scale facial sculpturing without surgery.

Juvéderm™ VOLUMA™, a long-lasting hyaluronic acid volumizer that has been widely available in Europe over the last 2 years, is currently undergoing FDA studies in the United States. It is hoped that this product will be available in 2011. VOLUMA™ works to restore fuller, softer, and more youthful contours to the face by replacing lost volume in the cheeks, chin and cheekbones. VOLUMA™ provides smooth, natural-looking results that have been shown, in European studies, to last up to 18 months.

Belotero® is another hyaluronic acid material that is expected to be FDA approved in 2010.

The proliferation of facial filler and volumizer products available today is both a blessing and a challenge for people seeking non-surgical facial rejuvenation. With such a wide range of treatment choices available, it can be difficult for patients to know how to choose the treatment that’s best for them. A qualified, experienced physician can help you navigate the facial filler landscape and choose a treatment best suited to achieve your specific goals.

The 34^th Annual Hawaii Dermatology Seminar, sponsored by the Skin Disease Education Foundation (SDEF), brings together the world’s leading dermatologists to discuss current challenges and future directions in the field of dermatology. For further information about the SDEF, visit www.sdefderm.com.

Dr. David J. Goldberg
Sanctuary Medical Aesthetic Center, Boca Raton
Skin Laser Surgery Specialists of NY/NJ

NY Plastic Surgeon Group Pleads Guilty to Felony Misbranding of a Drug

A large Albany, NY plastic surgery group has pleaded guilty in federal court to felony misbranding of a drug. The Plastic Surgery Group, a well-known association of seven board-certified plastic surgeons, pleaded guilty to using a non-FDA approved TRI-toxin on its patients seeking treatments with BOTOX® for facial wrinkles. During the time period of February 2004 until December, 2004, approximately 150 patients were injected with the unapproved substance, believing they were being treated with BOTOX®.

The group, whose members include Dr. Douglas Hargrave, Dr. E. Scott Macomber, Dr. Steven Lynch, Dr. John Noonan, Dr. William DeLuca, Jr., Dr. Jeffrey Rockmore and Dr. Susan Gannon, was ordered to pay restitution in the amount of $106,686, and a fine of $200,000, in connection with it's plea of guilty to one felony count of misbranding drugs. Additionally, Doctors De Luca, Hargrave, Rockmore, Lynch and Noonan were sentenced to probation with community service, and ordered to pay restitution in the amount of $106,686, as well as a fine of $5,000. The group's practice administrator, Peter M. Slattery, and RN Susan F. Knott, were also sentenced and ordered to pay restitution in the amount of $106,686, and fines in the amount of $1,000 and $500, respectively. Drs. Macomber and Gannon were not individually charged.

We see the use of non-approved toxins and fillers in South Florida, New York and New Jersey all the time. However, it is unusual to see plastic surgeons involved. Usually the people serving up non-approved injectables are non-physicians from other countries. Consumers need to be aware of this practice and seek appropriate providers for their aesthetic care.

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center, Boca Raton
Sanctuary Plastic Surgery, Boca Raton

Dr. David J. Goldberg
Sanctuary Medical Aesthetic Center, Boca Raton
Skin Laser Surgery Specialists of NY/NJ

SmoothShapes Cellulite Treatment on The Doctors

Cellulite treatments are extremely popular, inasmuch as approximately 90% of all women will develop cellulite, which is normal fat pressed up against the tissues beneath the skin. At Sanctuary Medical Aesthetic Center in Boca Raton, cellulite treatments are in demand on a daily basis, especially since Floridians show so much skin in our warm weather. Various treatments, including lasers, massage, diet and exercise, have been touted to effectively treat the challenge of cellulite.

SmoothShapes is a combination of two laser energies that work together to mobilize the fat from the fat cell so it can be taken up by the body. In addition to the laser energies, it uses gentle massage and suction to stimulate blood flow to the treated areas. It's one of several treatments for cellulite, and was recently featured on The Doctors, NBC's daily medical program.

Click this link to see the SmoothShapes segment from The Doctors program. You'll need to click Featured Videos and then the SmoothShapes video on the right.

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center, Boca Raton
Sanctuary Plastic Surgery, Boca Raton

It's the big things that move you...

A long-standing problem with breast implants, particularly saline implants that are a bit on the larger size, has been their tendency to move around over time, often requiring a breast lift to shore them up. The tiny silk worm is coming to the rescue in the form of a silk-based biodegradable mesh that provides more support than skin alone.

As Colin Stewart reported last week in his "In Your Face" blog, Allergan’s recent purchase of the cosmetic and reconstructive surgery unit of Serica Technologies, SeriScaffold, the above-mentioned silk-based mesh, joins Allergen’s ever-growing product line which includes the Natrelle brand of breast implants, Botox, Juvederm and Latisse, all big favorites among the beautiful.

“Serica’s scaffold biomaterial expertise provides Allergan with a new tissue engineering platform technology for use in tissue regeneration, including breast augmentation, revision and reconstruction and bariatric applications,” said company spokeswoman Caroline Van Hove.

“The technology represents the first silk-based medical device cleared by the FDA. We are always looking for ways to bolster our medical aesthetic franchise, and our acquisition of Serica is another example of our intent to further develop our leadership and expertise in breast aesthetics and reconstruction.”

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center, Boca Raton
Sanctuary Plastic Surgery, Boca Raton