Why we never touch a study without FDA approval

Last week, the U.S. Attorney's office announced that medical device maker Norian Corporation is being charged in connection to unlawful clinical trials. In a nutshell, they were conducting clinical trials for a device that was not FDA approved, for surgeries involving treating spinal compression in the elderly. The device was actually putting people at risk, and they still went ahead with the trials.

This is why many devices cannot be rushed to market; we must follow strict FDA guidelines. We are conducting many clinical trials with FDA-regulated botulinum injections (Botox alternatives), fillers, and laser studies, such as with Invasix, Scar Revlite, and more. This is something we are mindful of at Sanctuary Plastic Surgery, SMAC, and Skin Laser Surgery Specialists.

Despite being widely available throughout the world, it took Dysport a long time to release in the U.S. due to FDA guidelines that simply have to be followed. A paperwork snafu pushed it back from the first half of 2008 to just becoming available now.

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

5th Multispecialty Cosmetic Surgery Meeting in Vegas: Primaeva, Miratone info

Dr. Pozner and I both lectured at the 5th Multispecialty Cosmetic Surgery meeting in Las Vegas this past weekend. This unique meeting is attended by some of the best plastic surgeons and cosmetic dermatologists in the country.

One of the highlighted techniques was the Primaeva non-surgical RF (radiofrequency) skin tightening approach.

Our NJ office was one of the study sites for this technique over the last year. The procedure, performed with topical anesthesia, applies deep skin tightening heat through many tiny skin embedded needles. Sensors embedded in the system provide real-time feedback of skin temperature and tissue resistance within the treatment zone, overcoming the variability of patient response due to differences in tissue characteristics.

The goal is to produce more non-invasive skin tightening than is seen with the Thermage approach, with the realization that greater skin tightening will always occur with more invasive surgery.

The data presented at the Multispecialty meeting was also presented by me at the recent American Society for Lasers in Surgery and Medicine meeting. The machine, known as Miratone, represents the latest approach to non-surgical skin tightening.

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

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

Interview with Global Medical News Network: Rundown of upcoming filler products

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

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

The New Mentor Implant

We're proud to say that we're participating in Mentor's study for their upcoming adjustable implants.

The new Mentor adjustable breast implant is 80% silicone and up to 20% saline. I am one of 30 plastic surgeons chosen by them to be an investigator for it.

The photo is of Dr. Hilton Becker of Boca Raton (co-investigator and inventor of the implant) and Dr. Robert Ray of Dr. 90210 fame (also a co-investigator). As you can see, this is a high-profile implant and becomes even more so when saline is added to the inner lumen.

Doctors can adjust size on the table, or with a buried port can adjust up to 6 months after surgery. The study is for primary augmentations and revision surgeries, with sizes ranging up to over 900cc.

This is the first in an innovative series of adjustable silicone implants that Mentor in working on. Women who are interested in this implant, please e-mail me and I'll refer to the closest investigator.

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center

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

Kythera on track to treat under-chin fat soon

Kythera is trying to make some scientific sense of the injectable lipolysis market, specifically for submental (under the chin, or neck) fat. Based upon this press release they are making some headway with their new pharmaceutical.

Dr. Goldberg pointed out that studies in the U.S. have only looked at lipomas (benign tissues composed of fatty tissue) thus far, but will soon evaluate neck fat.

We applaud the way they are approaching this in a scientific, controlled manner and eagerly await further results. As the press release notes, in a random evaluation of 220 Botox and filler patients, 73% had excessive submental fat.

Thanks for reading,

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center, Boca Raton

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

IMCAS Wrap-Up

I have co-directed the IMCAS for a decade and this was the most exciting ever. Among the 3,500 attendees were cosmetic dermatologists, plastic surgeons and a variety of other physicians interested in cosmetic and anti-aging medicine. Much of the newer skin cosmetic techniques are presented at this meeting before they become available in the US. For example there were a variety of new wrinkle fillers discussed at IMCAS that are not yet sold in the US. This will soon change.

Currently we have great wrinkle fillers in the US . These include Restylane, Juvederm, Radiesse, Evolence and Sculptra. Soon we will have new fillers. These include Novielle, Voluma and Revanesse (see generic stock photo below).


Novielle represents a group of wrinkle fillers that contain a unique gel polymer. This material is currently undergoing FDA evaluations at several centers, including our New Jersey and Boca Raton, FL offices.

Voluma contains hyaluronic acid, the same wrinkle filler material contained in Restylane and Juvederm. However, the material in Voluma is thicker and will be used for facial sculpturing – an attempt to expand the concept of the liquid facelift.

Finally, Revanesse is another hyaluronic acid now available in both Europe and Canada. All these substances will help to continue the development of non-invasive, non-surgical medicine.

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

Jason Pozner MD
Sanctuary Medical Aesthetic Center
Boca Raton, FL

Here Comes Latisse

We've blogged about it here and here, and Natasha Singer of the NY Times is also on the scene, with today's article "Love the Long Eyelashes. Who's Your Doctor?"

The article cites annual revenue estimates for Allergan's upcoming eye-lash lengthening drug Latisse, ranging from $80 million in 2012 (via Gary Nachman of Leerink Swan), to $500 million "long-term" (coming from Allergan CEO David Pyott).

The meat of the article comes here:

"Allergan held a clinical trial with about 280 volunteers, half of whom used Latisse daily for 16 weeks. The study results were reviewed by the Food and Drug Administration, which approved the drug in late December. In that study, eyelashes typically grew 25 percent longer, 106 percent thicker and 18 percent darker. While 3.6 percent of patients experienced eye itching and red eyes, none had a change of eye color, Allergan said."

Stay tuned for more on this... articles like this hint that Latisse may become a household name next to Botox someday.

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center

Dr. David J. Goldberg
Sanctuary Medical Aesthetic Center
Skin and Laser Surgery Specialists of New York/New Jersey

Guest Post: Dr. Michael Gold on IMCAS

One of the most well-known speakers at IMCAS was Dr. Michael Gold, from Nashville, TN.

My IMCAS was varied this year - I talked about re-absorbable fillers in the U.S. - what differentiates them and what we need to look for from the FDA as far as safety is concerned - and these products are very safe in the right hands. I was also introduced to Europe Mentor's new toxin - PurTox - a pure neurotoxin finishing clinical trials in the U.S. - and the data associated with those trials.

I also presented on complications of lasers and IPLs - something that we don't usually spend a lot of time on at meetings but is one of the more important topics - I also did this with David Goldberg in the European Laser session. I reviewed what was new in cellulite and fat removal, focusing on the newer devices that are either new to the market or are close to becoming available on the market including for cellulite - SmoothShapes by Eleme (www.elememedical.com). and for body contouring Accent by Alma (www.almalasers.com), Skin Tyte by Sciton (www.sciton.com), Aluma by Lumenis (www.lumenis.com), Smartlipo by Cynosure (www.cynosure.com), ProLipo by Sciton (www.sciton.com), Liposonix for ultrasound fat destruction (www.liposonix.com), Zeltiq for cold fat destruction (www.zeltiq.com).

And I participated in two sessions on marketing - and how we do things in the US versus some of the restrictions in Europe.

The hottest topics by far were toxins and fillers - different from previous years where lasers were right up there - but seemed to be a little bit behind this year. The global economy seemed to have had this influence.

Dr. Michael Gold

Gold Skin Care

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

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center

IMCAS: Glimpse of Ulthera

We are still extremely hot on Ulthera. This revolutionary device has the potential to upend the non-surgical facial rejuvenation market. It's still not approved in the US, but we feel that its skin thickness measuring aspects and ability to put targeted thermal zones into specific deeper tissue layers may be a way to non-surgically tighten facial skin.

As you can see, Dr. Pozner is very happy with the device.
Dr. David J. Goldberg
Sanctuary Medical Aesthetic Center
Skin Laser Surgery Specialists NY/NJ

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center

Glimpse of the future at IMCAS conference...

There are a wide variety of excellent cosmetic dermatology and plastic surgery meetings in the US each year. However, there are almost no meetings in the US where these 2 groups can learn from each other. This is not true in Paris where the annual International Masters Course on Aging Skin (IMCAS) meets from January 8-11, 2009. This international forum brings cosmetic dermatologists, plastic surgeons and other aesthetic physicians all under one roof at the Palais des Congress de Paris – the major meeting convention center in Paris.

IMCAS, a meeting that I have co-directed for almost a decade, represents the place where US dermatologists and plastic surgeons have a chance to learn about a variety of cosmetic treatments not yet available in the US. Similarly the large US faculty, including Dr. Pozner and myself have the opportunity to teach our colleagues from Europe, Asia, Africa and the Middle East about some of the latest techniques that are popular in the US – yet not available elsewhere in the world.

The topics run the full gamut from true surgical procedures, to the latest in lasers, fillers and botulinum toxins – as well advances in the treatment of cellulite, skin stem cell anti-aging advances for beautiful skin and mesotherapy.

The 20 US physicians who will teach at this meeting will not only bring US knowledge to their international peers, but will come back with the latest cosmetic treatments for our US patients as well. Stay tuned in a couple of weeks for highlights of the meeting.

David J. Goldberg, MD

Skin Laser & Surgery Specialists of NY/NJ

Sanctuary Medical Aesthetic Center

Jason Pozner, MD

Sanctuary Medical Aesthetic Center

Upcoming filler will use discarded baby foreskins

You'll be hearing a lot about this filler soon. From today's NY Daily News:

"Vavelta is a clear liquid derived from baby foreskins, donated by mothers whose babies have just been circumcised. The liquid is injected into adult skin damaged by acne or burns.

The results look promising so far, but it's a bit early to get too excited. Vavelta, developed by a British biomedical company called Intercytex, is at least four years away from being available in the U.S. If it does win FDA approval, chances are Vavelta would be used only in the treatment of burns and acne, at least initially, a company spokesperson says.

The treatment, which claims to be permanent, is different from skin fillers like Juvederm and Restylane because it contains tiny skin cells, called fibroblasts. The cells rejuvenate and revitalize damaged, aging skin from the inside by actually repopulating the lower skin layers with millions of healthy young skin cells."

The article goes on to add that one foreskin is enough to create thousands of treatments, as the skin cells can be grown into cultures and frozen. We will back soon with Dr. Goldberg's recent publishedstudy on growth factors in foreskin cells used by Neocutis that lead to healthier skin.