Study Demonstrates Restylane(R) Effect Lasted 18 Months In 97% Of Patients With One Repeat Injection

Study Demonstrates Restylane(R) Effect Lasted 18 Months In 97% Of Patients With One Repeat Injection

Recent clinical data show that Restylane(R) lasted 18 months in 97% of patients with one repeat injection. Restylane(R) is the only HA filler with an 18-month FDA-approved duration claim.

These data were generated in a controlled, randomized, evaluator-blinded study that assessed the safety and effectiveness of two different retreatment schedules, 4.5 months or 9 months, after initial treatment of nasolabial folds (NLF). Patients were evaluated using the Wrinkle Severity Rating Scale (WSRS), a five-point scale to measure visual severity of wrinkles where five is the most severe rating (extreme). 92% of patients were naive to dermal fillers so had no residual effects from earlier treatment.

Key findings from the study include:

– At 18 months, 97% of patients continued to show improvement in NLF correction with one repeat injection

– Correction with Restylane(R) lasted for 18 months, regardless of retreatment schedule

– At 18 months, patients still had a 1.7 grade improvement in WSRS over baseline

– Adverse events were primarily swelling (24%) and bruising (19%); none were serious.

Safety information

Restylane(R) is indicated for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. The most commonly observed side effects are swelling, redness, pain, bruising, and tenderness at the injection site, which typically resolve in less than seven days. Avoid exposure of the treated area to excessive sun and UV lamp exposure and extreme cold weather until any initial swelling and redness have resolved. Safety has not been established for use during pregnancy, when breastfeeding, or in patients under 18 years.

Restylane is a trademark of HA North American Sales AB.

RHAMM Holds Promise For The Elimination Of Wrinkles And Skin Rejuvenation Without Surgery Or Neurotoxin Injections

RHAMM Holds Promise For The Elimination Of Wrinkles And Skin Rejuvenation Without Surgery Or Neurotoxin Injections

Hollywood stars of a certain age take note: Research at Berkeley Lab suggests that a protein linked to the spread of several major human cancers may also hold great potential for the elimination of wrinkles and the rejuvenation of the skin. If this promise bears fruit, controlling concentrations of the RHAMM protein could one day replace surgical procedures or injections with neurotoxins that carry such unpleasant side-effects as muscle paralysis and loss of facial expressions.

RHAMM stands for Receptor for Hyaluronan Mediated Motility. Mina Bissell, a cell biologist with Berkeley Lab’s Life Sciences Division and a leading authority on breast cancer, was collaborating with Eva Turley, an oncology professor at the University of Western Ontario and leading authority on tissue polysaccharides, on a study of the role that RHAMM plays in regulating the signaling of adipocytes (fat cells) during the repairing of tissue wounds from injuries such as skin cuts, heart attacks and stroke. Earlier research by Turley, who discovered RHAMM, had shown that over-expression of this protein points to a poor patient outcome for such human cancers as breast, colon, rectal and stomach.

In the course of their collaborative study, Bissell and Turley, working with mice, discovered that blocking the expression of the RHAMM protein – either by deleting its gene, or through the introduction of a blocking reagent – can be used to selectively induce the generation of fat cells to replace those lost in the aging process. At the same time blocking RHAMM expression also reduces deposits of unhealthy visceral fat.

“This technique could be developed as a means of providing a non-surgical approach for normalizing skin appearance after reconstructive surgery, for wrinkle reduction, and for face lifts and figure enhancement,” said Bissell.

Said Turley, “Unlike neurotoxin agents, which have to be injected periodically, a localized injection of a RHAMM inhibitor should produce long-lasting skin volumizing effects and would not involve muscle paralysis, which means there would be no loss of expression if it were to be injected into the face.”

There are compounds now on the market that promote the production of adipocyte cells and result in increased subcutaneous fat, however, these adipocyte-promoting factors also increase the production of visceral fat. The mouse studies led by Bissell and Turley have shown that blocking RHAMM expression significantly increases subcutaneous fat while decreasing visceral fat. This suggests that blocking RHAMM should also have a beneficial effect on patients with obesity-related diseases, cardiovascular disease or diabetes. Another unique advantage of RHAMM is that its expression in normal adult human tissues is restricted.

“Therefore, anti-RHAMM agents should have low toxicity and according to preliminary animal studies, could be beneficial to patients with a tumor or inflammation-related disease,” said Turley.

Potential applications of RHAMM modulation in addition to wrinkle reduction include normalizing skin appearance after reconstructive or cosmetic surgery, e.g., grafted tissue on burn victims. It has also been shown to have a beneficial effect on tumors and inflammatory diseases in mice.

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Article adapted by Medical News Today from original press release.
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Why Do Eyelids Sag With Age? Study Answers Mystery

Many theories have sought to explain what causes the baggy lower eyelids that come with aging, but UCLA researchers have now found that fat expansion in the eye socket is the primary culprit.

As a result, researchers say, fat excision should be a component of treatment for patients seeking to address this common complaint.

The study, published in the September issue of the peer-reviewed Journal of Plastic and Reconstructive Surgery, is the first to examine the anatomy of multiple subjects to determine what happens to the lower eyelid with age. It is also the first to measure what happens to the face with age using high-resolution magnetic resonance imaging (MRI).

“A common treatment performed in the past and present is surgical excision of fat to treat a ‘herniation of fat’ – meaning that the amount of fat in the eye socket does not change but the cover that holds the fat in place, the orbital septum, is weakened or broken and fat slips out,” said lead author Dr. Sean Darcy, a research associate in the division of plastic and reconstructive surgery at the David Geffen School of Medicine at UCLA and a plastic surgery resident at the University of California, Irvine. “This orbital septum weakening or herniation-of-fat theory is what most plastic surgeons have been taught.

“However, our study showed there is actually an increase in fat with age, and it is more likely that the fat increase causes the baggy eyelids rather than a weakened ligament,” Darcy said. “There have been no studies to show that the orbital septum weakens.”

The study looked at MRIs of 40 subjects (17 males and 23 females) between the ages of 12 and 80. The findings showed that the lower eyelid tissue increased with age and that the largest contributor to this size increase was fat increase.

According to a recent report by the American Society of Plastic Surgeons, nearly 241,000 Americans underwent eyelid surgery in 2007, making it one of the top four surgical cosmetic procedures performed.

Currently, many plastic surgeons performing procedures to treat baggy eyelids do not remove any fat at all. They reposition the fat or conduct more invasive tightening of the muscle that surrounds the eye, or they tighten the actual ligament that holds the eyeball in place. These procedures are performed despite there being no data indicating that these structures change with age.

“Our findings may change the way some plastic surgeons treat baggy eyes,” said study co-author Dr. Timothy Miller, professor and chief of plastic surgery at the Geffen School. “Our study showed that a component of a patient’s blepharoplasty procedure should almost routinely involve fat excision rather than these procedures.”

Blepharoplasty refers to surgical rejuvenation of the upper or lower eyelids, or both, depending on the extent of aging or disease. The procedure is usually performed on the lower eyelid because the most common complaint patients have is that their eyes appear tired, puffy or baggy. The surgeon makes external incisions along the natural skin lines of the eyelid to remove the excess fat and improve the contour of the lower eyelid.

“Although baggy lower eyelids are a significant result of aging and fat expansion, there are other factors that can contribute too,” Miller said. “We recommend that surgeons evaluate each component and address them accordingly in an individualized approach to blepharoplasty.”

The next phase of research will be to perform MRIs of people with baggy eyelids.

The study was supported in part by a UCLA research-enabling grant and a U.S. Public Health Service grant.

Other study authors included Dr. Robert A. Goldberg, Dr. J. Pablo Villablanca, Dr. Joseph L. Demer and senior author Dr. George H. Rudkin, all of UCLA. None of the authors have any commercial associations or financial relationships that would pose a conflict of interest.

For more information on the UCLA Cosmetic Surgery Center and the UCLA Division of Plastic and Reconstructive Surgery, visit http://www.uclaplasticsurgery.com.

From Medical News Today

Age Of Patients Seeking Cosmetic Surgery Shows 2 Year Increase In 2007 Procedural Survey

The American Academy of Cosmetic Surgery (AACS) announces the results of its 2007 Procedural Survey Data. Since 2002, the average age for patients receiving invasive cosmetic surgery has increased.

From 2002 to 2007, the mean age of patients seeking the top ten most performed invasive procedures has increased by two years. The invasive procedures that have seen the largest increase include liposuction, sclerotherapy, facelift and forehead lift. Following suit with this trend, Botox®, the most popular non-invasive procedure, has experienced a two year increase in average age.

The aging population and the baby boomers are likely to be the driving force behind these increases. Baby boomers make up approximately 28% of the national population, according to 2006 census reports. Baby boomers fall in the 42-64 age range and the average age of those receiving invasive and non-invasive procedures are 42.6 and 42.4, respectively.

“Cosmetic surgeons are seeing anywhere between a one to three year increase in our patient’s age,” said Dr. Steven Hopping, MD, President of the AACS. “It appears that as baby boomers grow older, so does our clientele.”

Of note among the findings: for the eighth year in a row, liposuction proved to be the nation’s top cosmetic surgical procedure with Botox® injections being the top non-invasive cosmetic surgery procedure.

There has been a 13.7% increase in the percentage of men from 2002 to 2007 who have had cosmetic surgery, showing a growing trend among men. Among patients treated, 80% were women and 20% were male.

The report includes data on the prevalence of various cosmetic surgery procedures, with a breakdown of men and women. The survey also showed that of all cosmetic procedures performed, 23% were surgical, with the remaining 77% being non-surgical procedures.

The report also highlights the price ranges of the procedures performed.

The top three most performed cosmetic surgical procedures in 2007 include: liposuction, sclerotherapy, blepharoplasty; while the most popular non-surgical cosmetic procedures were Botox® injections, microdermabrasion and chemical peels.

The 2007 Procedural Data is based on a survey of U.S.-based AACS members completed in December 2007. The entire report, conducted by RH Research, is available by contacting the Academy.

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Article adapted by Medical News Today from original press release.
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The American Academy of Cosmetic Surgery is a professional medical society whose members are dedicated to patient safety and physician education in cosmetic surgery. Most members of the AACS are dermatologic surgeons, facial plastic surgeons, head and neck surgeons, general surgeons, oral and maxillofacial surgeons, plastic surgeons, or ocular plastic surgeons – all of whom specialize in cosmetic surgery. AACS is an organization that represents all cosmetic surgeons in the American Medical Association through its seat in the AMA House of Delegates.

Source: Sarah Massier
American Academy of Cosmetic Surgery

Men Are Opting To Remove Spider Veins Over Replacing Hair

The American Academy of Cosmetic Surgery (AACS) is pleased to announce the results of its 2007 Procedural Data. This information is collected by polling the Academy’s U.S.-based members.

Findings conclude that sclerotherapy, the standard treatment for spider and varicose veins, is now the number two most performed cosmetic surgical procedure, due in large part to men. Sclerotherapy has seen a 226.3% increase in males over the past five years. A drastic comparison to the 3.5% increase in females since 2002.

On the opposite end, males have strayed away from hair transplants. Cost is likely to be a cause of this decline. Over five years, the price of hair transplants increased by $1,296, while sclerotherapy decreased by $103.

“Cosmetic surgeons have experienced a boost of males wishing to receive sclerotherapy,” says Dee Anna Glaser, M.D., an AACS Trustee from St. Louis. “Now, there are notably fewer stigmas associated with men receiving this procedure.”

The top three most performed cosmetic surgical procedures in 2007 include: liposuction, sclerotherapy and blepharoplasty; while the most popular non-surgical cosmetic procedures were Botox(R) injections, microdermabrasion and chemical peels.

The 2007 Procedural Data is based on a survey of U.S.-based AACS members completed in December 2007. The entire report, conducted by RH Research, is available by contacting the Academy.

The American Academy of Cosmetic Surgery is a professional medical society whose members are dedicated to patient safety and physician education in cosmetic surgery. Most members of the AACS are dermatologic surgeons, facial plastic surgeons, head and neck surgeons, general surgeons, oral and maxillofacial surgeons, plastic surgeons, or ocular plastic surgeons — all of whom specialize in cosmetic surgery. AACS is an organization that represents all cosmetic surgeons in the American Medical Association through its seat in the AMA House of Delegates.

The American Academy of Cosmetic Surgery
http://www.cosmeticsurgery.org

Cosmetic Injectables No Contest Or Party

Hot lips contests and pump parties are taking on new meaning, but cosmetic injectables should never be offered or accepted as contest prizes or in a party setting, warns the Physicians Coalition for Injectable Safety. “There continues growing popularity and interest in injectables; improving appearance is intriguing and has allure,” says Coalition leader Renato Saltz, MD, of Salt Lake City, Utah. “But despite the interest, consumers must remember these are medical treatments. It is against physician codes of ethics to offer medical treatment as a prize or winning of any kind.”

The first thought of the consumer should be the training and expertise of the treating physician, not the excitement of winning a prize. In addition to ethical violations on the part of the physician, consumers must be aware that winning a contest does not ensure the winner is an appropriate candidate for a treatment.

“In addition to contest and promotions for cosmetic injectables, we see new types of injectable parties,” said Coalition leader Roger Dailey, MD, FACS of Portland, Oregon. “Media have reported hotel parties and spa weekends in tropical and urban retreats. In smaller communities, spas and salons as well as homes have been reported as party sites.” Injectables, like any medical treatment, must be prescribed by a physician, approved by the FDA and belong only a medical setting.

The Coalition offers consumers these very simple questions to ask before considering any cosmetic injectable procedure:

– Doctor: Is the injectable recommended by a qualified doctor who regularly treats similar conditions, in an appropriately licensed and equipped medical facility? Has the doctor examined the prospective patient before recommending treatment?

– Brand: Is the injectable recommended approved by the U.S. FDA for cosmetic indications and is it appropriately labeled and packaged to reflect its authenticity and approval?

– Safety: Is the setting a proper medically-equipped office, with safety and sterilization procedures? Has the physician evaluated conditions, recommended treatment, offered alternatives and clearly defined the potential outcomes including any complications?

To learn specifically the FDA approved brands of cosmetic injectables and their benefits, and to see video of live, appropriately administered injectables as well as real patient stories from injectable parties and more visit http://www.injectablesafety.org.

About Us

The Physicians Coalition for Injectable Safety is an alliance of specialty physician organizations including the American Society for Aesthetic Plastic Surgery, American Academy of Facial Plastic and Reconstructive Surgery, and the American Society of Ophthalmic Plastic and Reconstructive Surgery. The mission of the Coalition is to provide the public with unbiased and necessary information on injectable cosmetic treatments, appropriate injectors and where to safely access cosmetic medical procedures. Our goal is to promote treatment supervised by properly qualified and trained, board-certified doctors and to promote only the use of U.S. FDA-approved, appropriately administered product. More information can be found at http://www.injectablesafety.org.

About ASAPS The 2400-member American Society for Aesthetic Plastic Surgery (ASAPS), founded in 1967, is the leading professional organization of plastic surgeons certified by the American Board of Plastic Surgery who specialize in cosmetic plastic surgery. With 2,100 members in the U.S., Canada, and many other countries, ASAPS is at the forefront of innovation in aesthetic plastic surgery around the world.

About AAFPRS The American Academy of Facial Plastic and Reconstructive Surgery is the world’s largest specialty association that represents over 2,700 facial plastic and reconstructive surgeons throughout the world. The AAFPRS is a National Medical Specialty Society of the American Medical Association (AMA), and holds an official seat in both the AMA House of Delegates and the American College of Surgeons board of governors. AAFPRS members are board certified surgeons whose focus is surgery of the face, head, and neck.

About ASOPRS The American Society of Ophthalmic Plastic and Reconstructive Surgery represent surgeons qualified in plastic surgery of the eyelids and surrounding facial structures. Fellows of the Society are board certified in ophthalmology, have completed fellowships in oculofacialplastic surgery (currently two years), and perform aesthetic, plastic, and reconstructive surgery of the face, orbits, eyelids, and lacrimal system.

Physicians Coalition for Injectable Safety
http://www.injectablesafety.org