Relief for Migraine Sufferers Boosts Allergan’s Stock after Fed Crackdown

For migraine sufferers, the recent FDA approval of Botox as a migraine treatment gives them access to the only thing that might actually work—injections of Botox.

Migraine victims have long awaited a drug that would avoid migraines, not just treat them after they start. Studies prove Botox’s ability to block nerves that cause a migraine. In one study, chronic migraine sufferers getting Botox injections had 9 fewer days of headaches per month compared with those receiving a placebo, who reported 6.7 fewer.

In another study that was funded by Allergan, Botox users reported 7.8 fewer days per month of any headaches (including migraines) compared with 6.4 days’ fewer headaches reported by those receiving the placebo injections.

Guilty Plea

Allergan had previously been ordered by the Justice Department to pay $375 million in fines for unauthorized promotion of Botox for headaches and cerebral palsy from 2000 to 2005. The fine was lowered to $350 million upon Allergan’s willingness to plead guilty to the charges. Allergan was also ordered to forfeit $25 million in assets and to stick to a 5-year mandated plan to disclose any payments to doctors and annually certify that their various divisions meet federal health care requirements.

Who can use it?

Men and women who have a migraine headache at least 15 days a month with pain lasting at least four hours qualify for treatment. It is assumed that health insurance carriers will approve this as a covered expense, since no other treatment has provided similar results. Treatment includes multiple injections around the neck and head every 3 months.

Allergan spokesperson, Caroline Van Hove, believes that insurers are unlikely to fight coverage of the drug since “this is a population that hasn’t responded to any of the conventional treatments.” Botox was cleared for migraine treatment earlier this summer in the UK and the company anticipates approvals in the rest of Europe and Canada yet this year.

Stock Market Reaction

Allergan (AGN) is running around $72 per share this month (Oct 2010). A month ago it was averaging $66 per share. The company, which generated $1.3 billion in 2009 sales, may earn $1 billion more in annual revenue with the migraine approval, said Aaron Gal, a Sanford C. Bernstein & Co. analyst in New York, in a May 2010 report.

Cranberry Juice Can Stop Staph in its Tracks!

For many years, cranberry juice has been recommended to help prevent and treat urinary tract infections. Researchers have now discovered how cranberry juice works to avoid bacterial infections, such as Staphylococcus aureus (S. aureus). In urine samples collected from those who drank cranberry juice, the bacteria were not able to link together and form a film or stick to the wall of the container. This process is calld “biofilm formation.” When bacteria cannot stick together, they are more likely to be flushed out during urination instead of creating an environment for the bacteria to thrive.

The bottom line? Future studies may lead to attempts to engineer invasive medical tools such as catheters, cannulae and others to make them more bacteria-resistant.

AAFPRS: Non-Invasive Procedures Continue to Rise

A recent article from the Examiner analyzed the latest plastic surgery statistics released by the American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS). Not unlike last year, the AAFPRS survey reported a significant increase in non-invasive treatments amongst their 2009 plastic surgery trends.

According to the AAFPRS, non-invasive cosmetic treatments rose 47% in 2009. The Examiner sites the current economic standing as an influencer in consumer behaviors. Dermal fillers and botulinum toxin A injections are growing in popularity because, even though their results are temporary, they are much more cost effective compared to invasive surgery.

Of the physicians surveyed, another 80% reported that patients were seeking non-invasive treatments as means to staying competitive in the workplace. The procedures with the largest amount of growth were as follows:
• Poly-l-lactic acid (Sculptra®)-up 71%
• Chemical peels-up 52%
• Hyaluronic acid (Juvederm®, Restylane®)-up 48%
• Botulinum toxin type A (Botox®, Dysport®)-up 45%

The majority of surgeons surveyed (77%) reported that patients are also more educated about their plastic surgery options. Patients are spending more time researching different procedures, costs, recovery time and physician qualifications before even stepping into a surgeon’s office.

The survey also found that women continue to be the majority of facial plastic surgery candidates, accounting for 84% of all non-invasive and surgical procedures.

The surgical procedures with the increases and decreases were:
• Ablative skin resurfacing (up 57%)
• Revision surgery (up 18%)
• Facelifts (up 14%)
• Lip augmentation (DOWN 52%)
• Rhinoplasty (DOWN 13%)

As we continue to see FDA approval for new products such as Xeomin and PurTox, the number of non-invasive procedures performed will surely continue to rise. New non-invasive technologies are continually being developed and put on the market.

Aesthetic Surgery Market Expected to Double by 2017

The cosmetics industry is growing, but by just how much? According to iData Research, a Vancouver-based pharmaceutical market research firm, the market for facial aesthetics, lasers and cosmetic surgery is expected to double—exceeding $3 billion by 2017.

The U.S. market for facial injectables is currently worth almost $860 million. The expected introduction of new injectables—such as Mentor’s PurTox and Merz's Xeomin—as well as their increasing therapeutic uses will contribute to market growth.

“A growing number of doctors are looking at the therapeutic potential of botulinum A. There are more cosmetic procedures performed using botulinum A than therapeutic; however, therapeutic procedures use higher doses of the drug, therefore these two markets are similar in value,” says Kamran Zamanian, Ph.D., iData CEO.

The iData report predicts that the value of the botulinum toxin A market segment alone will reach $543 million within seven years. Cosmetic Surgery Times also cited laser skin resurfacing, hair removal and lipolysis as the fastest-growing market segments.

Perhaps the FDA approval of new devices, such as Zeltiq, (and hopefully Ultrashape and Liposonix) will help the market meet or even exceed these predictions. I supposed we will have to wait seven years to see!

In UK, Regaining Pre-Baby Body Is A Priority

Immediately following childbirth, it is hard for a woman to regain her pre-baby body. Child bearing can lead to sagging skin, stretch marks, weight gain, cellulite and drooping breast. A new survey conducted by British TV show My Face My Body reveals that 39% of UK women would consider a ‘mommy makeover’ procedure after having children.

The researchers interviewed 326 women and found the top body concerns for women post-pregnancy to be:

Weight-34%
Stretch Marks-24%
Loose Skin-21%
Cellulite-14%
Sagging Breasts-7%


An overwhelming 93% of women admitted that reclaiming their pre-baby body was a priority to them, regardless of whether or not their partner shared their concerns. Of the men interviewed, 71% said they didn’t care about their partner gaining weight after childbirth. On the contrary, 67% of women feared their partners would not find them attractive post-baby.

"While most women enjoy being pregnant and the changes it brings to their bodies, many are concerned about these changes, such as weight gain and stretch marks, becoming permanent,” said My Face My Body presenter Stephen Handisides.

The survey also found that 57% of women would undergo a cosmetic procedure while they were still in the hospital following labor. For a mother who is considering plastic surgery, I urge you to wait at least six months following childbirth to allow the body to heal properly.

For women who are considering plastic surgery as a way to regain their body following pregnancy, the ‘mommy makeover’ is a popular option. The ‘mommy makeover’ can be any combination of procedures including liposuction, abdominoplasty, breast lift, reduction or augmentation.

In our Florida office we see many 'mommy makeovers', with breast surgery, especially breast lifts with implants, being the most popular. The difference in the popularity of aesthetic breast surgery in the U.S. and U.K. may be due to national trends, or even regional trends for South Florida.

Allergan to Pay Over $600 Million Settlement

Allergan, the maker of Botox®, is being forced to pay over $600 million following a civil settlement and charges that marketed the popular drug for off-label purposes. According to the New York Times, Allergan was marketing Botox®—which is currently used to treat wrinkles and hyperhidrosis—for the off-label treatment of migraines.

Botox® is currently not approved by the Food and Drug Administration for the treatment of migraines. The issue was not that Botox® was being used to treat migraines; it was that doctors were receiving incentives from Allergan if they actively promoted the headache treatment to their patients. The Justice Department issued this statement:

“In 2003, Allergan doubled the size of its reimbursement team to assist doctors in obtaining payment for off-label Botox® injections. Allergan held workshops to teach doctors and their office staffs how to bill for off-label uses, conducted detailed audits of doctors’ billing records to demonstrate how they could make money by injecting Botox®, and operated the Botox® Reimbursement Hotline, which provided a wide array of free on-demand services to doctors for off-label uses. Allergan also lobbied government health care programs to expand coverage for off-label uses, directed physician workshops and dinners focused on off-label uses, paid doctors to attend “advisory boards” promoting off-label uses, and created a purportedly independent online neurotoxin education organization to stimulate increased use of Botox® for off-label indications.”

Allergan, based in Irvine, CA, admitted to marketing unapproved uses of Botox®—including treatment of headaches and blepharospasm—between 2000 and 2005. The company agreed to pay $225 million to resolve civil charges that it endorsed falls Medicare and Medicaid claims, however, they denied liability. The company is schedule to pay between $610-$615 million in the third quarter of 2010, nearly half of Botox®’s $1.3 billion from last year.

Botox® was originally approved by the FDA in 1989 for the treatment in hyperhidrosis and then again in 2002 for wrinkle reduction. There is still concern as to whether or not the settlement will have an effect on the FDA’s decision on whether or not to approve Botox® for migraine treatment. The FDA’s decision is due to be announced at the end of October.

Could Invisible Bra Set Off New Trend?

Cosmetically, women can achieve the appearance of perkier breasts through breast augmentation or breast lifts. A new product, which guarantees a long-term boost, may be something to watch out for.

Breform™ surgical breast support is a new system termed as the “invisible bra”. A polyester mesh material is inserted through surgically under the skin. Breform™ is placed under the epidermis of the breast and stitched to the layer of fat above the breast tissue.

The material, which is cone-shaped, looks like a bra and can enhance the shape of the breast without undergoing surgery. Reportedly, Breform™ feels completely natural and cannot be felt through the breast skin.

Breform™ is inserted under the skin via an incision around the nipple with the assistance of general anesthesia. Just as with any surgery around the nipple, there is the possibility of loss of sensation. Breform™ claims that any lost nipple sensation, however, should return within six months following insertion.

TopNews.co.uk reports that a Breform™ procedure, which is manufactured by Aspide Médical in St Etienne, France, costs and average of 5,900GPD—or $9,100. While Breform™ can be used as an alternative to breast reduction in certain patients; the benefits of the product can also be reaped if used in conjunction with augmentation and reduction.

So what is our take on the invisible bra? Breform™ may be beneficial to ensure optimum results and prevent future sagging in patients who have undergone breast augmentation or reduction. By itself, however, Breform™ does not seem to be worth the investment. Breform™ is currently only available in parts of Europe and Asia, however, it has already received national media attention in the U.S.

Botox® Efficacy Enhanced By Oral Supplements

According to recent research conducted by Charles Soparkar, M.D., Ph.D., F.A.C.S., a dietary supplement that combines zinc and phytase increases the effectiveness of Botox® Cosmetic on patients. Plastic Surgery Practice reports that the supplement, trademarked as ZYTAZE™, is patent-pending and may be available to patients as early as this month.

The study analyzed 44 patients who had taken the oral supplements prior to being injected with botulinum toxin (Botox®, Dysport®, or Myobloc®). Forty-one of the 44 patients showed noticeable results. Multiple subjects were being treated for blepharospasm, or eyelid spasms, and had previously responded poorly to the injections.

Soparkar and his team will present the findings at the American Society of Ophthalmic Plastic & Reconstructive Surgery’s 41st Annual Fall Scientific Symposium in Chicago on October 14, 2010.

"Surprisingly, the results showed that in over 90% of the patients studied, the zinc/phytase combination resulted in a remarkable improved responsiveness to treatment of blepharospasm using the same amount of botulinum toxin as previously used," Soparkar told Plastic Surgery Practice.

"The toxins seemed to have greater effect and last longer. Potentially, this could mean using less toxin, offering patients financial savings, greater safety, and more consistent results."

Perhaps future findings will prove that the natural inclusion of diets rich in phytase and zinc can also improve the results of botulinum toxin injections. Pythase can currently be found in many grains and oil seeds, while foods like oysters and wheat germ are great sources of zinc.

Zeltiq Gets FDA Approval for Fat Reduction

Today, CoolSculpting by Zeltiq received FDA approval for non-invasive fat reduction. CoolSculpting uses cryolipolysis technology to virtually freeze fat away.

According to the company, CoolSculpting by Zeltiq results in a 20% fat reduction in the treated areas on patients. Results can typically be first seen three weeks following the treatment with maximum results seen over the course of two to four months. The treatment usually takes 1-2 hours and can be repeated over time for more pronounced results.

Prior to the approval of CoolSculpting, there had been a gap in the body sculpting market for a non-invasive fat reduction method that involves no needles and no downtime. By targeting the underlying fat, CoolSculpting leaves the skin tissue intact and unaffected.

The Skin Laser & Surgery Specialists of New York and New Jersey and the Sanctuary Medical Aesthetic Center in Boca Raton, FL, are home to CoolSculpting by Zeltiq. For more information, feel free to contact our offices with any questions or concerns you may have about CoolSculpting by Zeltiq.


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

Can Your Diet Prevent Skin Cancer?

Using sunscreen and avoiding sun exposure are two things we stress at our office in Boca Raton. However, living under the hot Florida sun doesn’t make it easy to avoid UVB rays. The good news is that a recent study has found a diet that can help protect against skin cancer.

Dr. Niva Shapira of Tal Aviv University’s School of Health Professions recently contributed to a study published in Nutrition Reviews that found a diet rich in omega-3 fatty acids and anti-oxidants can prevent sun cancer. By penetrating the skin and causing photo-oxidation, sun exposure damages both the immune system and the skin. The Mediterranean diet—which contains foods such as yogurt, fish, and olive oil—is said to fight the oxidizing effects of the sun.

During the study, Dr. Shapira dn Professor Bodo Kuklinski of Rostock University gave two groups of subjects two different beverages to drink: soda and a drink high in antioxidants. The two groups were then exposed to the sun 5-6 hours daily for a period of two weeks.

At the end of the two weeks, the group who drank the antioxidant beverage had fifty percent few oxidation products in the blood than the group who drank soda. The study also found that antioxidants such as carotenoids delay tissue damage that can lead to skin cancer.

According to Dr. Shapira, this information is imperative as free radicals and other environmental factors are now limiting the effects of sunscreen. While avoiding sun exposure is the best advice, it is impossible to do. By combining the use of sunscreen, an antioxidant diet and protective clothing you are promoting skin health.

While omega-3 fatty acids and antioxidants can be found as supplements, altering your diet to naturally contain these nutrients is the most effective way to reap the benefits.

"In foods, many vitamins and various antioxidants and bioactive ingredients work to support one another and the body's natural protective mechanisms. Synergies between the nutrients in your food, which make a significant contribution to health, may contrast with the relative isolation of a vitamin supplement,” says Dr. Shapira

Following this study, the Israeli Cancer Association included nutritional information as part of the “Smart in the Sun” advisories for the first time this year.

Some foods to avoid include red meat, alcohol, and processed food. Photosensitizing foods, which include parsley, cilantro, figs, dill and celery, can increase the damage done by the sun. Visit the Mayo Clinic’s webpage dedicated to the Mediterranean diet for more information on what suggested foods to eat.

Appointment-Booking Site Gets Big Investments, Has Drawbacks

CNET recently reported some new information about a New York-based start-up called ZocDoc. ZocDoc is an online doctor and dentist appointment-booking site that allows consumers to schedule visits based on time, specialty, location, and insurance coverage—at not extra charge. ZocDoc is looking to expand its service area with a $15 million Series B venture round led by the Founders Fund along with
contributions from Khosla Ventures.

Currently, ZocDoc only services the New York, San Francisco, Washington, D.C., and Chicago metropolitan areas. The website is currently promoting a user vote to choose what their fifth city should be from different options including Boston, Philadelphia, Seattle and Los Angeles.

Expanding won’t be easy, however. The staff at ZocDoc will have to aggregate new doctors and advertisers, set up medical profiles that are customized to the existing search criteria and enable users to book appointments online. Considering this service is free for patients, positive feedback from doctors and advertisers is required to make the expansion a success.

ZocDoc’s ambitions have grabbed the attention of some big names in eCommerce. Their first round of investors included Salesforce CEO Mark Benioff as well as Bezos Expeditions—the firm run by Amazon.com CEO Jeff Bezos. Khosla Ventures, who is investing for their second time
around, is run by Sun Microsystems founder Vinod Khosla. Khosla has been focusing a lot of attention lately on health care and clean technology.

The Founders Fund is another heavy hitter, with its principals including PayPal co-founder Peter Thiel and Napster co-founder, as well as Facebook, Inc. president, Sean Parker.

ZocDoc certainly has its benefits: book appointments from home, see doctor reviews, weeding out doctors by insurance plans accepted. However, how will this affect the plastic surgery industry if ever implemented? The ease of online booking might supersede the importance of having the patient discuss with with a patient coordinator prior to an in-office consultation. Deciding to undergo plastic surgery is a very personal decision, and taking the first step by book a consultation online is not the ideal way to go about it.

Body Contouring Market Trends 2009-2013

With rising rates of obesity, particularly in the U.S., North America will see a surge of interest in the body contouring market over the next few years. As the demand for body contouring devices increases, more plastic surgeons will adopt these technologies into their offices.

BusinessWire.com predicted the upcoming trends in the body contouring market from 2009 until 2013. With new and existing companies delving into new innovations, such as laser-assisted liposuction (LAL) and cryolipolysis, there will be a higher frequency of body contouring devices available to consumers.

The recession will, however, have a slight impact on the body contouring market growth. With a reduction in disposable incomes, patients will forego or postpone these elective procedures as a way to conserve cash. This will cause many surgeons to have a limited amount of revenue to invest these new devices that can cost upwards of $100,000.

While there was a decline in device sales from 2008 to 2009, Millennium Research Group assumes there will be an economic revival recorded for early 2010.

Cynosure launched SmartLipo MPX in the U.S. and Canada during the second quarter of 2008. SmartLipo MPX was the first dual-wavelength LAL device available in the market. Another big launch in the end of 2009 was CoolTouch’s CoolLipo, Palomar Medical Technologies' SlimLipo, Syneron's LipoLite, Elem Medical’s SmoothLipo and Sciton's ProLipo PLUS.

In addition, UltraShape’s Contour 1 was the first transdermal ultrasound device available in Canada. In 2009, Medicis received Health Canada approval for LipoSonix, which has had difficulty getting FDA approval. When transdermal ultrasound devices become available in the U.S., perhaps they will grab a hold of the body contouring market. Zeltiq cryolipolysis device has been available for off label fat removal since last summer. In many practices (including ours) it has taken off and provides consistent, safe non-surgical fat removal.


Furthermore, growing obesity rates and the more desirable results from body contouring devices suggest that there will be considerable market growth over the next few years.

A Forecast For the North American Facial Injectable Market

Cosmetic injectables are hands down the most popular aesthetic treatment in North America. The North American facial injectable market consists of four different types of fillers: collagen, Hyaluronic acid (HA) dermal fillers, botulinum toxin (BTX), and particle and polymer filler (PPF). There is a modest growth projected for facial fillers between 2010 and 2014 based on their rising popularity and the approval of new products.

According to BusinessWire.com, the more facial filler products that are available in the future, the greater the competition will be. Companies will have to spend more time and money on creating brand awareness. This will lead to a more informed audience, which can create a whole new set of challenges for the companies who make the injectables. While the recession may hinder the growth of filler companies slightly, it is predicted that they will still remain profitable over the next few years.

The introduction of Sculptra Aesthetic and Dysport® in 2009 into the PPF and BTX markets created new competition for Botox® Cosmetic. While Botox® remains the king of the throne, the “Dysport® Challenge” helped increase the popularity of the new injectable.

It is also projected that the collagen filler market will shrink excessively in 2011 following Allergan and ColBar LifeScience’s withdraw from the market in 2010. With new products expected to gain Canadian and U.S. approval, it will be interesting to see how the market responds. New facial injectables, which can be introduced into any product segment, could theoretically affect average selling prices and heighten competition within the market.

Patients Need Less Botox® Over Time for Same Results

A recent study performed by Oregon Health & Science University shows that patients can decrease the frequency of Botox® injections after approximately two years and still see similar cosmetic benefits.

The study was run by Roger A. Dailey, M.D., F.A.C.S., professor and Lester Jones Endowed Chair of oculofacial plastic surgery in the OHSU School of Medicine. "After two years of treatment at recommended intervals, patients can potentially cut the frequency, and thus the cost, of their Botox® treatments by half," said Dailey.

Dailey’s study was presented at the American Society for Aesthetic Plastic Surgery conference in Washington, D.C., on April 24. Allergan, Inc., the maker of Botox® Cosmetic, sponsored the study with an unrestricted educational grant.

The study also found Botox® to have a wrinkle-preventing—or prophylactic—effect. Patients who were administered injections between their 30s and 50s not only eliminated existing wrinkles, but also prevent new wrinkles from forming.

Previous studies suggested that patients should be injected with Botox® every three months in the glabellar region—the area between the eyebrows—to maintain a wrinkle-free appearance. According to Dailey, the frequency and cost of the treatment deterred some patients from starting or continuing a Botox® regimen.

The study monitored 50 women between the ages of 30 and 50. The women were injected regularly with Botox® over the course of two years. "We found that after the patient receives Botox© Cosmetic injections every four months for two years, the frequency of the injections can be changed to every six months and still achieve good results," said Dailey. "This demonstrates patients have the ability to achieve good results with broader treatment schedules and ultimately at a lower overall treatment cost.”

According to the American Society for Aesthetic Plastic Surgery, 2,557,068 patients underwent Botox® treatments in 2009 (257,786 of which were men). Botox® was approved by the FDA for cosmetic purposes in 2002.

Botox® Competitor Approved by FDA For Medical Use

Earlier this month Merz Pharmaceuticals, a North Carolina-based company, announced the FDA approval of Xeomin® (incobotulinumtoxinA). Xeomin® is a botulinum toxin type A-based drug that is used to treat patients with blepharospasm (eye spasms) or cervical dystonia (neck spasms).

A recent epidemiology study conducted in Rochester, MN, found that focal dystonia, which includes both named conditions, affects 295 million people in the United States.

Two significant studies that were conducted on patients with cervical dystonia and blepharospasm were imperative to the FDA’s decision to approve Xeomin®. Findings from additional European studies comparing Xeomin® to Botox® were also included in the data that was submitted to the FDA.

Similar to Botox® and Dysport®, Xeomin® is injected into the muscle to control spasms from the nerve. The advantage of Xeomin® is that is allows more biological activity and it doesn’t require refrigeration to preserve its integrity.

As for right now, Xeomin® is only FDA approved for medical purposes and not cosmetic. Merz Pharmaceuticals is optimistic, however, that the drug will be approved for its secondary purposed in the future.

Hyperoxia Shown To Reduce UVB Wrinkles, Skin Thickening

According to Cosmetic Surgery Times, a new study suggests that oxygen treatments (hyperoxia) could prospectively battle skin damage and wrinkles caused by ultraviolet light.

Performed by researchers at the University of Tokyo, mice were place in oxygen chambers after extensive exposure to UVB radiation. The mice who showed who were treated with hyperoxia had fewer wrinkles and less thickening of the skin than those who were not treated.

The researchers split 24 hairless mice into three groups: the control group (no UVB exposure), UVB exposure (three times a week for five weeks) without treatment, and UVB exposure (three times a week for five weeks) followed by two hours of hyperoxia after each treatment. Researchers found that both the UVB and UVB-plus-oxygen groups showed changes to their skin, however, the wrinkling and thickening in the latter group’s skin was less severe.

“Although hyperoxia may be used for humans to prevent acute UVB-induced skin damage, potential oxidative damage should be considered. … Further studies to determine the possible oxidative side effects of hyperoxia are needed before it can be applied in humans,” the researchers wrote.

These finding are critical in developing new anti-aging treatments, however, more research is needed to analyze any side effects.

Advances in Reconstructive Technology Said to Improve Function, Aesthetics

Patients who have suffered facial trauma or bone loss are often faced with difficulties chewing, speaking, swallowing, or even breathing. While the aesthetics of facial reconstruction are important, the ability to restore adequate function to the face is imperative. Researchers at the University of Illinois and the Ohio State University Medical center have applied a new technique to create custom-made implants for both form and function.

Based on its design and composition, the face is by far the most complicated part of the human skeleton. According to Glaucio Paulino, the Donald Biggar Willett Professor of Engineering at University of Illinois, mid-face reconstruction is difficult due to the unique shape and functions of the bones, as well as its high exposure to bacteria through the mouth and sinuses.

Reconstructive surgeons traditionally graft bones from other parts of a patient’s body to sculpt the skull portion. Considering bone density and shape differs greatly throughout other parts of the body, patients also suffer cosmetically as well and functionally following facial reconstruction. The two universities applied an extensive type of 3-D modeling, called topology optimization, to design the custom implants. Topology optimization is primarily used to engineer skyscrapers and automobile parts, however, may become advantageous to the medical industry.

The technology helps engineers to create pieces that meet high aesthetic standards while performing at optimal levels. Topology optimization is ideal when paired with facial reconstruction, allowing engineers to develop patient-specific bone replacements with precision. The engineering process calculates different variables including blood flow, chewing forces, soft tissue support and sinus cavities.

The researchers aspire to adopt topology optimization in the future for the purpose of tissue engineering. If successful, tissue and bone can be recreated for different parts of the body that require reconstruction. Such progression in medical technology could prospectively supersede the necessity for bone grafting from a patient or cadaver.

Don't Get Mad, Get Botox®

Getting rid of wrinkles is a reason for anyone to smile. A recent study found that Botox® could also improve someone’s mood simply by limiting his or her ability to frown.

The study, which was performed by researchers at the University of Wisconsin on 40 volunteers, tested how the patients reacted to emotional statements following an injection of Botox®. The subjects were asked to read messages that ranged from “angry” to “sad” to “happy”. Researchers then gauged the patient’s mood by observing how long it took to respond to each statement.

The subjects of the trial took slightly longer to respond to the negative statements following their treatment than they had before their Botox® injections. The elongated response time indicated that the brain had a harder time processing the negative emotion following the treatment.

"There is a long-standing idea in psychology called the facial feedback hypothesis Essentially, it says, when you're smiling, the whole world smiles with you. It's an old song, but it's right," says the study’s author, David Havas.

The facial feedback hypothesis, which dates back to Charles Darwin in the late 1800s, is the idea that one’s facial expressions can have an effect on emotional experience.

According to the research leader professor Arthur Glengerg, the brain would normally send signals to the facial muscles to frown, and in return the extent of the frown would be sent back to the brain. Under the influence of Botox®, the muscles in the face are weakened and the intensity of the emotion is in turn disrupted.

Botox® can also have the same effect on happiness as well. When injected into the lower part of the face, Botox® can obstruct a normal smile and in turn effect the brain’s ability to comprehend pleasure levels.

LipoSonix Not FDA Ready

Streetinsider.com reported recently that the FDA issued a letter to Medicis, the maker of Dysport®, notifying the company that data presented in the 510(k) application to market the LipoSonix system was insufficient. According to the FDA, Medicis must file a new submission with additional information before LipoSonix can be marketed in the U.S.

The FDA's letter to Medicis offered guidance as to the additional information needed to obtain 510(k) clearance. Medicis plans to pursue a meeting with the FDA to present the additional data and to formulate the next steps. The letter from the FDA did not request nor highlight any missing safety data and acknowledged that the agreed primary endpoint of the clinical trial was achieved.

LipoSonix technology uses ultrasound energy to destroy fat cells without harming the skin. The destroyed fat tissue is transported to the liver where it is processed as energy. The treated fat is permanently removed, leaving the patient with a slimmer, more contoured body.

According to Medicis, the LipoSonix system is unlike body contouring technologies because it is highly targeted and has the ability to concentrate energy at specific depths of abdominal fat. By doing so, underlying tissues and non-targeted areas are not damaged.

Results are typically seen in about 8 to 12 weeks. LipoSonix is currently available in Canada, France, Germany, England and Spain.

Novabel® Pulled From Market

Novabel®, a dermal shaper harvested from marine algae extract, has been taken off of the market by Merz Pharmaceuticals. The decision came after numerous patients reported temporary bruising, swelling and lumps, particularly around the under eye area.

Novabel® is currently marketed as a safe and virtually pain-free treatment with minimal side effects and results that last up to twelve months. However, due to these latest patient complaints, Merz has decided to cease production on Novabel® until they are able to re-release the product without any kinks. Biocompatibles’ CellMed branch, the developers of Novabel®, are currently working with Merz to address the problem.

"I am confident that our CellMed team will have a safe and effective technique for sensitive areas ready for evaluation in the next few weeks," said Biocompatibles’ chief executive Crispin Simon.

Novabel® differs from traditional dermal fillers like Restylane® and Juvederm® as it is not made of hyaluronic acid. Traditional fillers are likely to have more pronounced side effects in sensitive areas than Novabel®. Until the latest issues are resolved, Merz will suspend the product until they can accurately market Novabel® for it’s minimal side effects.

Novabel® was released in the U.K. in February of this year and is not yet FDA approved. With promising results expected from Novabel®, we hope that Merz will have it back on the market soon.

New Topical Cream Claims to Increase Elastin, Reduce Wrinkles

For years, scientists have been researching methods to restore the skin’s elasticity, in hopes to reduce and prevent wrinkles in any skin type. Elastin, a protein in connective tissue that permits tissues in the body to resume their shape after stretching or contracting with regular movement, begins to diminish by the age of 12 or 13 when the body decreases production. As a result, the elastin fibers begin to deteriorate. This leads, over time, to the typical signs of aging, such as fine lines, wrinkles and sagging.

On Monday, Revance Therapeutics, a biopharmaceutical research company based in California, released a new product called Relastin™, the first product to clinically demonstrate an increase of elastin in the skin. It is said to restore a youthful complexion by penetrating the skin and working with the skin’s cells to promote new elastin growth.

A press release by Revance Therapeutics claims that clinical studies with Relastin™ resulted in a visible difference in 84% of studied subjects following four weeks of testing. The new topical treatment has been shown to hydrate, tighten and smooth the skin in a manner similar to cosmetic injectables and other more invasive treatments.Relastin™ is released as Eye Silk for the under-eye area and Skin Revitalizer for all-over facial use.

Niqeuette Hunt, vice president of cosmetic and OTC products for Revance Therapeutics, is excited about the product’s release. "Relastin™ works from the inside out to foster the restoration of elastin and create a healthier, more youthful appearance,” she says. “Many products have claimed to be ‘cosmetic breakthroughs,’ but Relastin’s™ clinical studies prove remarkable effectiveness.”

According to Revance Therapeutics, clinical data shows that skin treated with the patent-pending Zinc Firming Complex™ found exclusively in Relastin™ contained more elastin than untreated skin. Following two weeks of testing, users of the product noted visible differences and experienced a decrease in dark circles, a reduction in eye puffiness and minimized fine lines and wrinkles.

If Relastin™ lives up to the claims of the clinical trials, other heavy-hitters in the cosmetic industry may have a run for their money. A topical cream that boosts elastin production would have a more permanent effect than current popular treatments for wrinkles. Rather than freezing the muscles with Botox® Cosmetic, or plumping the wrinkles with dermal fillers, Relastin™ is said to address the issue at its root. While this could be the next fountain of youth, it is important to hold out on further studies and trials to prove the product’s capabilities.

Survey Shows Growing Desire for Plastic Surgery in U.S.

According to a survey done on RealSelf.com, consumer interest in plastic surgery is increasing despite the recession. The survey, which was developed by Harris Interactive®, interviewed 2,148 U.S. adults aged 18 years and older. While the American Society of Plastic Surgeons reported earlier this year that the 2009 numbers were down, the American desire to be more attractive has renewed. Harris Interactive® surveyed 2,148 adults online and 69 percent said they would choose to have cosmetic work done if money wasn't an issue. This is a 15 point ( 54%) jump from November 2009, when the survey was taken.

Of those surveyed who would get cosmetic work done, 29 percent would choose a tummy tuck, 23 percent would select liposuction, and 13 percent would opt for a face lift. According to the American Society for Aesthetic Plastic Surgery (ASAPS), the top five surgical procedures in 2009 were: liposuction, breast augmentation, blepharoplasty, rhinoplasty, and abdominoplasty. The data from both sources suggests that the desire for plastic surgery procedures is based on people preferring more sizable changes over minor nips and tucks.

The survey also reported that the three most popular cosmetic treatments desired by women are the same procedures often associated with the “Mommy Makeover”. Forty-six percent of women aged 35-44 would have an abdominoplasty if money weren't an issue. Of women aged 18-34, 34 percent would undergo a tummy tuck. Another 34% of women aged 35-44 would undergo a breast lift, and 28 percent would choose liposuction. With cosmetic surgery among men growing in popularity, 29 percent of men surveyed would undergo liposuction. The survey also recorded the cosmetic procedures people planned to undergo within the next 12 months in order to gauge future trends in plastic surgery. Of the people surveyed, 23% plan a hair removal procedure, 11% seek dermal fillers, while only 3 percent noted they will have Botox® injections in the coming year. As far as surgical cosmetic procedures, here is the top 5 lineup: blepharoplasty (27%), hair replacement (18%), face lift (13%), abdominoplasty (12%), and breast lift (12%).

It is interesting to see if this survey, taken from a small sample of subjects, will accurately predict the upcoming trends in cosmetic surgery. Will laser hair removal throw Botox® off its throne? Will breast augmentation be ousted by the tummy tuck? We will have to wait and see!

*Chart and data courtesy of MedSpaRX.com

Big Changes in the Corporate Aesthetic World

There have been big changes in the aesthetic corporate world recently. With heavy hitters from Mentor, Medicis, and Allergan all resigning within the past week, we are left to wonder what is next for aesthetic medicine.

Josh Levine, former Mentor CEO, resigned last week. Levine joined Mentor in 1996 as Vice President of Domestic Aesthetic Sales. In January 2000, Levine resigned from the company briefly to join a start-up practice management organization, the Plastic Surgery Co., where he was the Chief Development Officer. His time with the Plastic Surgery Co was short-lived, as he resigned the position in September 2000 to rejoin Mentor as Vice President of sales and marketing. Levine served in roles of increasing responsibility and was promoted to President and Chief Operating Officer of Mentor in 2003. Mr. Levine was instrumental in the sale of Mentor last year to Johnson & Johnson.

Following the January 2009 acquisition of Mentor by Johnson & Johnson, Levine had commented that the deal "allows Mentor to expand our product portfolio and significantly grow our global reach." It appears that Levine may now be dissatisfied with the new directions of Mentor, considering his resignation comes at the end of the mandatory wait period following the acquisition. Although there are no reports as to new employment, we are sure he will be inundated with offers as Mr. Levine is one of the most experienced and capable in the aesthetic industry.

Robert Grant, the former Allergan Vice President, resigned last week to take over the presidency of Bausch and Lomb Surgical Division, an Aliso Viejo-based eye surgery business. Grant has spent almost a lifetime in the aesthetics business and is quite possibly moving to maybe a safer, but surely not as exciting, endeavor. Under Grant’s leadership since 2006, Allergan Medical amassed an all-star product lineup that includes Botox Cosmetic ®, Juvéderm ®, the Lap-Band ® surgical weight loss device and Latisse ®.

Perhaps Grant made his decision to join the B & L team based on his experience as an independent board director at Acufocus, Inc., a Carlyle Group and Versant Ventures-backed clinical stage ophthalmic device company. This appears to be a lateral move for Grant, however, he has not been assigned a seat on the Board of Directors of B & L. Is his move indicative of something internally up at our leading aesthetics company Allergan, or Grant's vision of an increasingly regulated, and maybe less attractive, industry to come? Stay tuned here!

Finally, Joe Cooper, the former VP of Corporate and Product Development at Medicis, has also resigned. Similar to Levine, Cooper had been with Medicis since 1996. Cooper has served as Executive Vice President, Corporate and Product Development since July 2006. Prior to joining the Medicis executive team, he held management positions with Schein Pharmaceuticals, Inc. and G.D. Searle

According to BusinessWeek, Cooper "has decided to pursue career opportunities outside of Medicis." This is not the first time Cooper left Medicis for greener pastures. Earlier in the decade he went off to run a start up. Cooper returned to lead the way in his business development role with important strategic investments in Revance ®, Dysport ® and Liposonix ® for Medicis.

There are certainly big shoes to fill in the aesthetic industry and hopefully Allergan, Mentor, and Medicis won’t fall behind with the alterations to their corporate lineups.

Everything You Ever Needed to Know About Cellulite

Cellulite is no one’s friend. While most people are familiar with its appearance, not everyone is aware of how cellulite is caused or treated. Cellulite, or the dimpled appearance of the skin found on the hips, thighs, and buttocks, is found on 80% of women. Cellulite is a lot less common in males due to differences in the way fat, muscle and connective tissues are dispersed in men and women's skin.

What causes cellulite?

Cellulite is caused by fibrous connective cords that unite the skin to the underlying muscle. The cords secure the skin to deeper structures with the fat lying in between. As the fat cells build up, they push up against the skin, while the long, tough cords are pulling down. This creates the dimpling of the skin

Does everyone have the same cellulite?

Mild cases of cellulite can only be seen when the skin is pinched, while more severe cases create the appearance of rumpled and bumpy skin with areas of peaks and valleys. Cellulite is most common around the thighs and buttocks, however, it can also be found on the breasts, lower abdomen and upper arms.

Does weight gain cause cellulite?

While weight gain is not a direct cause of cellulite, however, heavier persons may have more pronounced dimpling. Contrary to widespread misconceptions, thinner people are susceptible to cellulite as well.

How do I get rid of my cellulite?

There is no proven ‘cure’ for cellulite, however, maintaining a healthy lifestyle can reduce it’s appearance:

Maintain a normal weight…heavier persons can have a more pronounced cellulite
Quit smoking
Reduce your intake of high-fat foods, salt, alcohol, coffee and highly processed foods
Eat plenty of fiber
Drink an adequate amount of water daily to cleanse your body of toxins
Exercise regularly

For Boca Raton residents that are still not satisfied with the appearance of their cellulite, there are numerous cosmetic treatments available. At Sanctuary Medical Aesthetic Center, we hava a number of sevices that we use to diminish cellulite including the Alma Accent Device, Elemes Smoothshapes and Synerons Velashape 2. These devices use radiofrequency and /or light energy to treat loose skin and cellulite with minimal pain and downtime. For optimal results, 6 to 8 treatments are usually performed at 2-4 week intervals.