Study Continue’s Reloxin’s Path to FDA Approval: How is it Different from Botox?
A study released on Monday afternoon regarding Reloxin is making headlines. Many may wonder why, since it has been discussed in the U.S. media for at least a year and has been used even longer than that in Europe as Dysport.If you want to check out the study yourself, click here for a PDF .Dr. Goldberg says: “This Reloxin study is important because it represents the first published US study involving an alternative to Botox?. It should be noted that although this is the first published US study on Reloxin, this wrinkle softening agent is not new. Reloxin, called Dysport in Europe, is a very popular alternative to Botox? over there. It has been shown to be both safe and effective. This first US study will be far from the last. We and others are currently involved in several other Reloxin trials. Many of these trials involve evaluating injections of Reloxin every few months and over the course of several years. Reloxin will be the first US competitor to Botox?. It will not be the last. We and others are studying even more alternatives such as Mentor’s Purtox and Merz’s Xeomin. The future is exciting for non-invasive cosmetic treatments.” Disclaimer: we know the authors of this study very well and I am on the Reloxin advisory board. American consumers are interested in the bottom line of this product. Other research seems to say that it has a faster onset than Botox?, and a softer look. It is a good option for using on patients with resistance to Botox?. But generally, Reloxin will be very similar to Botox? and patients should not have any different expectations. Link: Medicis’ Reloxin May Vie with Botox in U.S. to Clear Wrinkles [Bloomberg News] Dr. Jason Pozner Sanctuary Medical Aesthetic Center Dr. David J. Goldberg Sanctuary Medical Aesthetic Center Skin Laser Surgery Specialists of NY/NJ
Report: Laser skin resurfacing is recession proofThe 2008 American Society for Aesthetic Plastic Surgery report polled over 16,000 plastic surgeons, dermatologists and ENT doctors to provide an estimate on the total number of procedures performed last year.
The report drops this morning, and there are three big things you need to know:
1) Almost every procedure is down 10-20%. Total procedures are down 12.3%.
2) Laser skin resurfacing is up 12%, with 570,880 total procedures performed.
3) Breast augmentation has overtaken liposuction as America’s most popular surgery.
Patients aged 35-50 continue to dominate, having 45% of the cosmetic procedures, and most commonly getting liposuction and Botox. After the age of 51, the top procedures were blepharoplasty and Botox (32% of the total patient population). For the 19-34 set, the top procedures were breast augmentation and laser hair removal, and for everyone below 18, it was rhinoplasty and laser hair removal.
If you’ve been reading this blog, you know we are huge on laser technology and will be addressing the big jump in procedures in later posts. There is a lot of great information in the ASAPS report so we will also be uncovering other narratives inside of it.
2008 Statistics from American Society for Aesthetic Plastic Surgery [Link]
Dr. Jason Pozner
Sanctuary Medical Aesthetic Center
Dr. David J. Goldberg
Sanctuary Medical Aesthetic Center
Skin Laser Surgery Specialists of NY/NJ
Botox, fillers remains a hot item at Sanctuary Medical Aesthetic CenterBotox is the new comfort luxury during tough economic times. The old adage about lipstick sales remaining solid during tough economic times is now true for Botox as well. At Sanctuary Medical Aesthetic Center in Boca Raton, Allergan’s forehead wrinkle-killing Botox is a hot alternative to getting a more expensive facelift, along with fillers like Juvederm, Radiesse, and Perlane, which can fill in lines and plump up other areas of the face. Due to their affordable price and short-term nature, injectable fillers are an effective “pay as you go” shortcut to beauty. For more information, visit board-certified plastic surgeon Dr. Jason Pozner and renowned cosmetic dermatologist Dr. David J. Goldberg athttp://www.smacboca.com, or at their leading blog Cosmetic MD Nation, athttp://www.cosmeticmdnation.blogspot.com. A. Cohen Marketing represents Sanctuary Medical Aesthetic Center. For media inquiries, contact Alex Panagiotopoulos at 212-330-8337 x2. To make an appointment at Sanctuary Medical Aesthetic Center, call 561-886-0970.
Sanctuary Medical Aesthetic Center Launches BlogNationally respected by the cosmetic surgery community, Drs. David J. Goldberg and Jason Pozner, a cosmetic dermatologist and surgeon, respectively, have launched Cosmetic MD Nation, the first blog by cosmetic doctors focusing on upcoming technology. Jan 19, 2009 – Boca Raton, FL Drs. David J. Goldberg and Jason Pozner have launched the Cosmetic MD Nation blog, at http://cosmeticmdnation.blogspot.com. Dr. Goldberg, a cosmetic dermatologist and owner of Skin Laser Surgery Specialists of NY/NJ (http://www.skinandlasers.com), co-owns Sanctuary Medical Aesthetic Center in Boca Raton (www.smacboca.com) with Dr. Jason Pozner, a plastic surgeon. The blog focuses on topics such as cosmetic surgery trends, upcoming technology, tracking FDA approvals of products, and tips for using minimally invasive procedures like fillers and lasers to get great results. Recent posts have been about products like Latisse (http://cosmeticmdnation.blogspot.com/search?q=latisse) Reloxin (http://cosmeticmdnation.blogspot.com/search?q=reloxin) PurTox (http://cosmeticmdnation.blogspot.com/search?q=purtox) Botox (http://cosmeticmdnation.blogspot.com/search?q=botox), and procedures like Ultrashape (http://cosmeticmdnation.blogspot.com/search?q=ultrashape). Sanctuary Medical Center in Boca Raton is a state of the art anti-aging clinic, led by plastic surgeon Dr. Jason Pozner and cosmetic dermatologist Dr. David J. Goldberg. They offer traditional and minimally invasive cosmetic surgery procedures as well as weight loss programs, hormone replacement therapy, skin care, and permanent makeup solutions.
Bioidentical Hormones in Boca RatonFor bioidentical hormone replacement in Boca Raton, Sanctuary Medical Aesthetic Center is pleased to offer the services of Dr. Mitchell Matez, who has over 20 years of experience in General Surgery and in Alternative and Complementary Medicine. Jan 29, 2009 – For bioidentical hormone replacement in Boca Raton, Sanctuary Medical Aesthetic Center is pleased to offer the services of Dr. Mitchell Matez, who has over 20 years of clinical experience in General Surgery and in Alternative and Complementary Medicine. There has been an unprecedented boom in interest in bioidentical hormone replacement therapy due to Oprah Winfrey’s ringing endorsements on her show and in her magazine. Women and men use bioidentical hormone replacement to treat symptoms such as decreased libido, energy, mental clarity, and slowed metabolism due to reduced levels of hormones produced in their bodies, such as with menopause and andropause. There are no cookie cutter cases with bioidentical hormones as each patient requires treatment that is customized to what their body used to produce; hence the term bioidentical. For an instant reaction to today’s episode of Oprah featuring bioidentical hormone advocate Suzanne Somers, visit SMAC’s blog athttp://www.cosmeticmdnation.blogspot.com. Sanctuary Medical Center in Boca Raton is a state of the art anti-aging clinic, led by plastic surgeon Dr. Jason Pozner and cosmetic dermatologist Dr. David J. Goldberg. They offer traditional and minimally invasive cosmetic surgery procedures as well as weight loss programs, hormone replacement therapy, skin care, and permanent makeup solutions. They are located at 4800 North Federal Highway, C100 in Boca Raton, Florida. Visit them at http://www.smacboca.com.
Sanctuary Medical Aesthetic Center Treats First Patient In Investigational Study Of UltrashapeOct 13, 2008 – Boca Raton, Florida- Sanctuary Medical Aesthetic Center announced today the first treatment performed at its center for the IDE (Investigational Device Exemption) study of the UltraShape® Contour PlusTM, the first non-invasive fat reduction and body contouring device using non-thermal selective focused ultrasound. Due to its expertise in advancing aesthetic technology and goal to provide measurable, long-lasting results for its patients, SMAC was selected as one of six centers in the United States, and the only center in Florida, to participate in the study. “We have witnessed a growing demand for non-invasive procedures for measurable fat reduction for body contouring. We are excited to participate in this groundbreaking study to evaluate the ability of the Contour Plus to selectively target and break down fat cells through non-thermal, acoustic effects,” said Dr. David Goldberg, cosmetic dermatologist and co-director of SMAC. The revolutionary technology of the Contour Plus is supported by the Contour I platform, which is currently available outside the U.S. and has been shown in pre-clinical and clinical studies to target and selectively breakdown fat cells, while protecting vital structures such as skin, blood vessels, nerves, and connective tissue. As it incorporates advanced technology, the Contour Plus is intended to provide a non-invasive, fat reduction and body contouring solution for men and women alike. About The UltraShape® Contour Plus™ IDE Study The UltraShape Contour Plus IDE study will enroll patients at six centers in the United States. The primary endpoint will be an objective, quantifiable fat reduction assessment. UltraShape intends to submit the pivotal study results to the U.S. Food and Drug Administration (FDA) in a premarket approval (PMA) submission. The study builds upon positive clinical studies conducted with Contour I including two peer-reviewed published studies. The first study, a multi-center worldwide study, was published in the industry-leading peer-reviewed Plastic and Reconstructive Surgery, “Body Contouring by Non-Invasive Transdermal Focused Ultrasound: Safety and Efficacy of the Contour I Device in a Multi-center, Controlled, Clinical Study,” Teitelbaum, et al. The study demonstrated measurable and durable body circumference and fat thickness reduction after only a single UltraShape treatment. The second study, an independent clinical trial showing the efficacy of multiple treatments with the UltraShape Contour I, published in Lasers in Surgery and Medicine, “Body Contouring by Non-Invasive Transdermal Focused Ultrasound,” Moreno-Moraga, et al. The study, using Contour I as a non-invasive method for reducing unwanted fat deposits, produced a 100 percent response rate with a mean reduction in fat thickness of 2.28 cm, and as much as 3.94 cm, and a mean reduction in circumference of 3.95 cm, and as much as 10 cm. The study demonstrated definitive, measurable results of the UltraShape system. [Patients interested in obtaining more information on the study should contact Krystie Lennox, Sanctuary Medical Aesthetic Center, at 561-886-0970]. About the UltraShape® Contour Plus™ The UltraShape Contour Plus system, an investigational device in the U.S., is based on the Contour I platform and incorporates patented focused ultrasound technology. Contour I, which is authorized for marketing outside the U.S., is the first non-invasive fat reduction and body contouring device for both men and women. The device is designed to produce mechanical, non-thermal, acoustic effects which target and selectively disrupt fat cells, leaving surrounding critical structures such as skin, blood vessels, nerves, and connective tissue intact. The UltraShape procedure is available in 60 countries and over 60,000 patient treatments have been performed worldwide with high patient satisfaction. The UltraShape procedure is guided by proprietary real-time tracking and guidance technology designed to deliver smooth, uniform body contouring results. The software provides a pre-determined treatment algorithm designed to minimize risk of contour irregularities, a common side effect of liposuction. The UltraShape procedure is performed during a convenient, “walk-in, walk-out” session carried out in an office-based environment; it requires no anesthesia or sedation. After treatment, patients immediately resume their daily routines with no need for maintenance treatments. The UltraShape Contour I received the CE Mark in 2005 and a medical device license from Health Canada in 2007. The Contour Plus system is an investigational product limited by U.S. law to investigational use only. About SMAC Sanctuary Medical Aesthetic Center (SMAC) is the hub of South Florida’s commitment to revolutionary wellness and rejuvenation. Our unrivaled physician-led team of specialists treats virtually every area of the body with the latest in science-based beauty and age management techniques. The center features Jason Pozner, M.D., Kurt Wagner, M.D., and Christine Haugen, M.D., and celebrated cosmetic dermatologist David Goldberg, M.D., all armed with the most advanced technologies to promote beauty and health. About UltraShape® UltraShape is redefining aesthetic medicine by developing, manufacturing and marketing innovative non-invasive technologies for body contouring. The company is dedicated to providing clinically proven safe and effective solutions that enhance the lives of patients worldwide. The UltraShape proprietary non-invasive body contouring technology is based on focused ultrasound that targets and selectively disrupts fat cells without affecting surrounding structures. Founded in 2000, UltraShape is a privately held and venture backed company with offices in the United States, Israel, United Kingdom, Italy, and France. The UltraShape system is not approved by the FDA for marketing in the United States. For more information visitwww.ultrashape.com.
The Palm Beach Post Homework counts when choosing a plastic surgeonHomework counts when choosing a plastic surgeon July 13, 2008 – Careful re search yields best results By Michal R. Abramowitz Barry Hirshfield once weighed 600 pounds. In 1998, he decided enough was enough, so he went under the knife to have bariatric surgery to shed the obesity. The operation was a success. After patiently waiting a year for the fat content in his body to disappear, he needed plastic surgery to rid the flaps of skin on his stomach that still overhung from the weight-loss procedure. This was not unusual, considering that Hirshfield had dropped 420 pounds, to weigh in at a svelte 180. But in November 1999, Hirshfield, then 48, of Coconut Creek, went to a Fort Lauderdale plastic surgeon, based on a referral from his gastric doctor. Hirshfield wanted his stomach flattened and contoured. “I realized I was never going to look like Arnold Schwarzenegger, but I did have some expectations,” he said. Hirshfield had the surgery and went home from the hospital. That night, despite being warned by his surgeon not to do so, Hirshfield bent over to pick up something. He felt a pop in his stomach. That pop served as a prologue to a tidal wave of problems, Hirshfield said, including staph infection, massive leakage from the incision, intense pain, and a botched follow-up procedure. Last year, desperate for help, Hirshfield went to Dr. Jason Pozner, a Boca Raton plastic surgeon, to find a solution. It would take two surgeries – one major, and a second touch-up procedure in which Pozner removed a substantial amount of scar tissue. Hirshfield repeatedly credits Pozner for saving him from the abyss of plastic surgery gone bad. All told, Hirshfield spent more than $15,000 on his plastic surgeries. While Hirshfield’s situation is extreme, patients need to understand that they need to do their homework when shopping for a plastic surgeon. After all, plastic surgery is a surgical procedure, even if the insurance companies classify it as merely cosmetic. “You should not shop like it’s a pair of shoes,” cautioned Dr. Rod Rohrick, chairman of plastic surgery at the University of Texas Southwestern, In Dallas. “You have only one face.” Any doctor can perform plastic surgery, but only those who are board-certified plastic surgeons – certified by the American Association of Plastic Surgeons – have had full training in all aspects of it. What makes matters confusing is that doctors who are not trained as plastic surgeons can legally form a board and claim they are board certified as cosmetic surgeons. “A doctor could be an internist and call themselves a plastic surgeon,” said Dr. Michelle Copeland, an assistant professor of the School of Surgery at Mt. Siani Scholl of Medicine in New York, and author of Change Your Looks, Change Your Life. With any doctor or medical professional able to run an advertisement in the paper, it’s critical to shop around and not go with the cheapest price you find. “When people get their stomach stapled, they think like they are going in for a shoe shine or for their clothes hemmed,” said Hirshfield. “But it’s much more than that – it’s major surgery.” Plastic surgeons are divided on whether patients should allow other doctors, such as dermatologists, ear-nose-throat specialists, and dentists who have specialized training in certain procedures, to perform plastic surgery. Some say its fine, as long as the doctors stick to their specialty. For example, an ENT should not perform liposuction, but a rhinoplasty (nose job) makes sense. Other plastic surgeons worry that some specialists might not have enough training to treat a patient, should a major problem occur. For example, a dermatologist typically does not have the proper training to treat you should if you go into shock. “Anyone who says they are an expert on the skin and says that qualifies them as a plastic surgeon is really missing the beat,” said Dr. Louis Villar, a Stuart plastic surgeon. Anyone with a medical background can legally perform plastic surgery in his or her own office. Worried about the dangers that legal loophole creates, plastic surgeons strongly encourage patients to make sure that their doctor is admitted as a staff member to a fully accredited hospital for the specific procedure he or she will perform on you. If a doctor is admitted to a hospital for that procedure, he or she is board certified to perform that particular plastic surgery. After Hirshfield had enough with his original doctor, he learned a valuable lesson in choosing a plastic surgeon. “Oh, boy!” he said. “Make sure the doctor has worked before on your specific problem.” How to find a plastic surgeon Dr. Louis Villar, a board-certified plastic surgeon in Stuart offers these tips:
- Look for training. Talk to two to three surgeons. Find out which one has the best training – which one went to the best medical school and internship program.
- Personality is important. When you interview a doctor, does he or she speak to you in a manner you understand? Typically, avoid doctors who act pompous. If they are personable, they usually are not in the business just to make money.
- Check for hands-on work. Make sure you know that your doctor will do his or her own sutures and postoperative care. If the doctor delegates the work to purses because of high volume or multiple operating rooms, watch out. “It’s perfectly legal, but you are likely not getting quality care,” Villar said.
- Find out how the doctor handles patients after a surgery. “After you pay $14,000, does he blame mistakes on the patients?” Villar said, “Will he take out his own stitches? Will he redo his own procedure if you are not satisfied?”
- Find out the surgeon’s malpractice history. Doctors who have multiple malpractice lawsuits will often swear they did nothing wrong. Check with the Office of Insurance Regulation athttp://www.fldfs.com/Data/Liability/byname.asp, and the Florida Department of Health at http://www.doh.state.fl.us to find out a doctor’s track record.
- Get a second, and third, opinion. Get several opinions on whether the surgery is truly necessary. “If a surgeon doesn’t want you to get a second opinion, that is a really bad sign,” Villar Said.