Thursday, February 25, 2010

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.

Wednesday, February 24, 2010

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

Tuesday, February 23, 2010

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

Monday, February 22, 2010

Hawaii Dermatology Seminar #2

The recently-ended 34th annual Hawaii Dermatology Seminar has lived up its reputation of being the original and, perhaps, the most well organized of all the Hawaii dermatology meetings. The first 4 days of the meeting were dedicated to medical and pediatric dermatology. The last 2 days were dedicated to advances in cosmetic dermatology. Some of the most well know leaders in the field lectured. These included Drs. Suzanne Kilmer from Sacramento, Michael Gold from Nashville, Roberta Sengelman from Santa Barbara, Thomas Rohrer from Boston and Christopher Zachary from Irvine, CA.

Among the more interesting discussions was a talk about Zeltiq cryolipolysis of women’s fatty upper arms, the soon-to-be-released Belotero wrinkle filler and the role of Matrix fractional radiofrequency treatment. Also discussed were more controversial issues such as Zerona low level light treatment’s effect on dissolving fat. Attendance was up at this year’s Hawaii Dermatology Seminar. Dermatology, and specifically Cosmetic Dermatology, is alive and well.

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

Wednesday, February 17, 2010

The Hawaii Dermatology Seminar

I am currently co-directing the Hawaii Dermatology Seminar on the Big Island of Hawaii. This meeting has a long 34-year history of providing quality education to dermatologists from throughout the United States. My co-directors, Joe Fowler, MD from Louisville, KY and Christopher Zachary, MD from the University of California at Irvine, are well-recognized leaders and teachers of all aspects of dermatology. The meeting is divided into 5 segments expanding into 5 days.

The first day is dedicated solely to melanoma – a timely topic considering that the meeting takes place in sunny Hawaii. The next 2 days are dedicated to medical dermatology including acne and psoriasis. The 3rd day covers pediatric dermatology with the final 2 days dedicated to cosmetic laser treatments and other new aspects of cosmetic dermatology. I will give you an update on these last 2 days at the beginning of next week.

David J. Goldberg, MD

Saturday, February 13, 2010

Allergan acquires Serica's graft technology

Allergan, Inc, makers of Botox, Latisse, lapband and breast implants, acquired the cosmetic and reconstructive surgery unit of Serica Technologies yesterday. The primary products of this Serica division, and a logical addition to Allergan’s product line, are biodegradable silk-based scaffolds for skin grafting, reconstructive surgery and breast augmentation. The transaction did not include rights to Serica's veterinary or orthopedic products, which were spun-out to a new company, Alacer Technologies, Inc.

The news came on the heels of the Monday's FDA approval of Allergan's Juvederm XC, a new version of its popular Juvederm dermal filler. Juvederm XC numbs the treatment area within seconds, reducing the need for other anesthetic.

It’s our view that this is one more example of the onrush of integration among the larger aesthetic companies.

Wednesday, February 10, 2010

Antioxidants in Berries Prevent UV Skin Damage, Wrinkles

A study done by researchers at Hallym University in the Republic of Korea shows that the topical application of the antioxidant ellagic acid markedly prevents collagen destruction and inflammatory response—major causes of wrinkles—in human skin cells following the exposure to UV-B. UV-B is the sun’s skin-damaging ultraviolet radioactive rays that accounts for 90% of the symptoms of premature skin aging.

Ellagic acid is an antioxidant found in raspberries, strawberries, cranberries, pomegranates, and an assortment of other fruits, vegetables, and nuts. The study showed that ellagic acid worked to protect against
UV damage by blocking the production of MMP (matrix metalloproteinase), an enzyme that breaks down collagen in damaged skin cells and causes coarseness. Ellagic acid also reduces the expression of ICAM, a molecule involved in inflammation.

This study is consistent with the view that topical application of materials containing a variety of berries can be helpful for the skin. This is the basis of the CoffeeBerry product in Stifel’s Revale skin care line since 2006.
CoffeeBerry itself is rich in antioxidants and is often recommended over green tea for anti-aging purposes.

Because of ellagic acid’s ability to inhibit skin tumors at various stages their typical life cycle, it may be valuable in cancer therapy or possible prevention in the future. Even if you are feeding your skin a good dose of berries, I wouldn’t skip out on the
sunscreen just yet.

Friday, February 5, 2010

3D Imaging Coming-of-Age

A lot of patients wonder about what the results of their plastic surgery procedure will look like. Although in depth explanation of the technical aspects of the surgery can provide significant insight into what the outcome will be, some patients want something more visual. Many medical professionals in the cosmetic industry now use Vectra 3D imaging to assist patients in envisioning their procedure. Using advanced hardware and imaging equipment, Vectra is able to create a full 3D rendering of patients that simulates the results of rhinoplasty, facial rejuvenation, breast augmentation, or facial implants.

Vectra Before/After

A key feature of this device is the ability to visualize changes in one’s physical features in real time. This means doctors can adjust the image to reflect the cosmetic goals of their patients for the most desirable surgical outcome. The Vectra 3D Scanner represents a fundamentally new approach to helping patients decide how they want to look.

In our cosmetic surgery practice, we use the Vectra to help "size" patients with different volume implants although we will also fill a brassiere with implants to give patients an impression of how they look in clothes. We find the combined sizing method helps us better understand patients wishes.

On the technical side, this 3D consultation can acquire a full set of data in as little as 1.5 milliseconds, with one-shot, multi-capture, continuous and rotatable views. This gives patients unprecedented flexibility and confidence in participating in the details of different procedures. Keep in mind, surgery is both art and science, so actual outcomes may not precisely match that of the 3D projection.

Three-dimensional imaging is a coming-of-age technology that will soon be a norm in the cosmetic surgery industry. While at the International Master Course on Aging Skin Annual Meeting in Paris, many doctors presented using Vectra 3D imaging. I foresee this technology becoming a standard for both presentations at medical conferences as well as in cosmetic practices.

Wednesday, February 3, 2010

Added Benefits of Beautiful Lashes

Following the FDA approval of Latisse® (active ingredient Bimatoprost), there has been an ongoing buzz surrounding the proven effects of the eyelash enhancing drug. Latisse®, however, did not originate as a cosmetic product. The popular eyelash treatment was originally used to treat glaucoma patients. Bimatoprost was re-approved by the FDA for cosmetic purposes once lash growth was acknowledged as a side effect to the drops.

Although Lattise® was originally used for glaucoma treatment, more benefits of the common cosmetic product having been discovered. The use of Latisse® for hair growth on the scalp is now being explored, as well as eyebrow growth. Patients seeking full eyebrows like Megan Fox or Kiera Knightly may benefit from the alternative uses of Latisse. There may be a future for Bimatoprost in the hair-loss industry, although treatments may be costly.

The compound Bimatoprost has also been shown to reduce adipose tissue in mammals, or what is commonly referred to as body fat. Studies are currently underway to test injections of the compound on fatty deposits in the human body. The cosmetic industry may see a future fat reduction treatment that mirrors Botox and filler injections, making weight loss more attainable for patients. That doesn’t mean its time to bail on a healthy diet and exercise. It may take many years for said treatments to be approved by the FDA. Bimatoprost is currently only used in the U.S. for glaucoma treatment and eyelash growth under the Lumigan and Latisse® labels.

Latisse® is also a very safe treatment with minimal side effects. During clinical trials, only about 4% of users reported having the most common side effect: itchy and/or red eyes. Bimatoprost has passed FDA regulations twice now, for both medical and cosmetic purposes, similar to Botox’s dual approvals in 1989 and 2002.

Monday, February 1, 2010

A Nutritional Approach to Sun Protection?

Since we never fail to mention it, we hope that all our patients understand the importance of applying a high-level sunscreen to reduce their exposure to damaging ultraviolet A rays. Some recent news suggests that the Greek-style Mediterranean diet may also play a part in avoiding skin cancer.

Although the Mediterranean region is known for its hot and sunny weather, it’s been found that the area’s population has a relatively low level of skin cancer. This suggests a strong correlation between diet and skin cancer prevention.

What’s in the Mediterranean diet that might influence this? Dietary antioxidant vitamins, minerals, and phytochemicals, and n-3 polyunsaturated fatty acids, n-9 monounsaturated fatty acids, and low pro-inflammatory n-6 polyunsaturated fatty acids all have protective properties. It appears that these protective properties extend not only to functional issues, such as cardiovascular health, but to the skin’s ability to ward off photo-oxidative radiation from then sun.

More studies are in the works, and we’ll keep you updated with them as we receive them.