Archive for the ‘Injectable Fillers’ Category

The Rising Popularity of Lifestyle Medications: A Cause for Concern?

Wednesday, November 9th, 2011

An article that appeared last week in HealthDay News has illuminated a somewhat controversial issue surrounding pharmaceutical companies and the marketing of “lifestyle” drugs.

These medications are not designed to be cures or treatments, but enhancements that address conditions which are quite normal, such as small eyelashes or gray hair.

The article names several popular medications:

Propecia (finasteride), which began as a stronger-dose drug to treat enlarged prostates, has been prescribed to treat men with male pattern hair loss since 1997; Botox — botulinum toxin — first used to calm spastic eye muscles, was approved to treat frown lines in 2002; and Latisse, initially used to treat glaucoma in the 1990s, became available in 2009 for cosmetic purposes after patients noticed they were also growing longer, thicker eyelashes.

Those who work in health policy are voicing concerns about whether these types of drugs are a poor use of resources or if they promote an unnecessary medicalization of normal, age-related conditions.

On an individual level, there’s little or no ethical dilemma regarding the use of medications that enhance appearance or delay the signs of aging. However, a stronger argument could be made that widespread medicalization of trivial body concerns may lead to mis-prioritization of society’s healthcare resources.

“People can do probably whatever they want, explains health policy professor Dr. Joel Lexchin, “but on a collective level, we have to think about whether producing drugs that enhance people is really the best use of our resources.”

The Food and Drug Administration treats all medications in “an identical manner,” whether they are designed for preventing heart failure or treating wrinkles. What the pharmaceutical companies end up producing depends on the market and the public’s demand for lifestyle drugs.

Read more on the HealthDay article by Maureen Salamon on Womenshealth.gov

Restylane Lip Augmentation Now FDA Approved

Tuesday, October 11th, 2011

restylane lip augmentation fdaMedicis announced today that FDA clearance has been received for Restylane injectable gel to be used in lip augmentation.

As one of the world’s most popular wrinkle fillers, Restylane has been used for years to treat moderate to severe facial wrinkles and folds. The new FDA clearance will include indications for lip enhancement in patients over 21.

New Restylane packaging will include the new indication and clinical results that studied the lip augmentation procedure. Medicis is reportedly planning to incorporate the clinical study in their training and promotional materials.

Medicis CEO Jonah Shacknai commented:

“We are pleased with the FDA’s decision to expand the Restylane label to include lip augmentation. This marks another significant milestone for Restylane, now the first and only hyaluronic acid dermal filler approved in the United States for lip augmentation. We were very encouraged by the compelling data from the robust pivotal clinical study, showing effectiveness for up to six months, with a clear majority of eligible subjects opting for retreatment at six months. We believe physicians and their patients will appreciate the unique gel particle structure of Restylane and its ability to create fullness in the lips for up to six months.”

Multi Center Study Evaluates Restylane Lip Augmentation

To evaluate Restylane for lip augmentation, researchers carried out a randomized, evaluator-blinded, no-treatment-as-a-control, multi-center study of 180 patients. Subjects randomized to Restylane treatment at the beginning of the study were retreated at six months, and subjects randomized to no treatment received their first Restylane treatment at six months.

The study measured safety through use of:

  • Adverse events that were reported during the study
  • Patient diaries kept for two weeks after Restylane lip augmentation
  • Nine lip safety assessments performed at various intervals throughout the 7-month study

The Medicis Lip Fullness Scale™

The Medicis Lip Fullness scale is an innovative, 5-point measurement tool that evaluates the effectiveness of lip augmentation. To design the scale, they collaborated closely with the FDA and clinicians during the validation process.

A blinded lip evaluator, physician and photo reviewer all measured effectiveness of Restylane lip augmentation for the upper and lower lip. They also employed the GAIS – Global Aesthetic Improvement Scale. Researchers measured effectiveness for seven months. In addition, three independent physicians performed photo evaluations after the study.

The Results: Research showed that Restylane lip augmentation is well tolerated and effective for up to 6 months. Adverse events were not serious, and included pain, swelling, tenderness, bruising and erythema. 80 percent of patients chose to be treated again after 6 months.

Courtney Thorne-Smith Talks About Her Botox Experience

Thursday, October 6th, 2011

botox courtney thorne-smithAllergan just launched a new media campaign with actress Courtney Thorne-Smith to discuss the changes in women’s perceptions about Botox Cosmetic. The actress is talking about her experience with Botox, and helping to answer some of the most common Botox questions that women still have.

According to a recent survey by HealthyWomen:

The number of women considering talking to their doctors about BOTOX® Cosmetic treatment more than quadrupled from 1.3 million in 2002 to 5.8 million in 2010.

The number of women who think that BOTOX® Cosmetic is an effective means for treating frown lines between the eyebrows has increased from 21 percent when the product was approved to 79 percent in 2010.

Still, there are many people out there that are considering treatment, but hesitating due to lack of information. “Our partnership with actress Courtney Thorne-Smith and the non-profit organization HealthyWomen is our latest initiative to address pressing questions women have about medical aesthetic injectable treatments like BOTOX® Cosmetic.”

“I’ve been treated with BOTOX® Cosmetic for nearly 10 years, said Thorne-Smith, “and while I think it’s become more mainstream, many women have the same questions I initially had.” Allergan released a brief Q&A that addresses some of the common questions, as indicated by the new HealthyWomen survey.

Botox Questions

According to the survey of 826 U.S. women ages 35 to 65, the most common BOTOX questions include:

  1. Are these products safe? Each aesthetic injectable treatment has a unique safety and efficacy profile and treatments are not interchangeable. For every injectable treatment, including BOTOX® Cosmetic, it’s important to review the Important Safety Information and Medication Guide with your physician as serious side effects can occur. The most common side effects include pain or temporary bruising at the injection site, temporary tiredness, headache and nausea.
  2. How much do these treatments cost? Cost varies across the country based on a number of factors. According to an American Society of Plastic Surgeons survey, the average cost of BOTOX® Cosmetic is approximately $400 for treatment of the glabellar lines between the brows.
  3. Will my face still have expression? Injectable treatments such as BOTOX® Cosmetic should not radically change one’s appearance. When BOTOX® Cosmetic is administered by an experienced physician, a person can still frown and look surprised without those moderate to severe lines – also known as the “11” – between the brows.
  4. How long does treatment last? Minimally invasive treatments are temporary. BOTOX® Cosmetic treatment effects can last up to four months.
  5. Is treatment painful? Discomfort associated with the injection is usually minimal and brief, and your physician may apply an ice pack or anesthetic cream.

Obagi Gets Results in New Aesthetic Surgery Study

Thursday, August 25th, 2011

A new study in the July issue of Aesthetic Surgery Journal says that certain patients report much higher rates of satisfaction when using products from the Obagi skin care line.

obagi results study woman with skincare productThe study analyzed results of patients who combined their BOTOX treatment with Obagi, versus a control group who used Botox and a placebo. A recent press release specifically reports that Obagi’s Condition and Enhance line “provides greater improvement in overall facial appearance, as well as increased patient satisfaction vs. Botox treatments with a placebo.”

The Condition and Enhance line of Obagi products, also marketed as Obagi Nu-Derm, uses a combination of 4 percent hydroquinone and tretinoin.

About the Study

The 120 day study was a multi-center, randomized, investigator-masked, parallel-group study with 61 Botox patients. Patients were randomly prescribed either a hydroquinone system (cleanser, toner, 4% hydroquinone, exfoliant, and sunscreen) combined with 0.05% tretinoin cream, or a “standard skin care regimen” with cleanser, moisturizer, and sunscreen.

Results Found With Obagi

Patients in the Obagi group reported a significant improvement in fine lines, wrinkles and hyperpigmentation. Lead investigator Joel Schlessinger MD said: “This data clearly highlights the fact that by adding Condition & Enhance to injectable patients’ treatment regimen, patients are addressing multiple aspects of aging skin for optimal results.”

Investigators and patients alike were asked to evaluate the results. They found “significantly milder fine lines/wrinkles and hyperpigmentation at days 30, 90, and 120″ in the combination group and patient surveys showed “superior overall ratings.”

Here’s a breakdown of the Obagi results and standard group’s results:

  • 89 percent of the combined group was satisfied or extremely satisfied with their results.
  • 93 percent of the Obagi group was satisfied or extremely satisfied with the treatment regimen.
  • 100 percent of the Obagi Condition and Enhance group wished to continue treatment after the study.
  • 12 percent of the “standard skincare group” was satisfied or extremely satisfied with their results and their treatment regimen.

According to ASAPS, “Patients using the hydroquinone system plus tretinoin believed that their study treatment had further enhanced the improvements attained with botulinum toxin type A compared to those using the standard skin care regimen (86% vs. 8%).”

Read more from the following sources:

Sources:

More Couples Getting Plastic Surgery Together

Monday, June 27th, 2011

With the increasing acceptance of cosmetic procedures among men, a new phenomenon among the plastic surgery clientele has been on the rise: more couples are appearing together in surgeons’ offices across the country.

According to this article in the Pittsburgh Tribune-Review, America’s recovery from the recession has seen a resurgence of plastic surgery procedures. Women account for roughly 80 percent of plastic surgery patients, but the number of men has skyrocketed 88 percent from 1997 to 2010. The most popular procedures among men include Botox, liposuction, and rhinoplasty.

The article tells the story of Marsha and Mike Gavula, a couple from Evans City, PA, who do just about everything together. Recently, the 50-year-olds both stepped into a plastic surgeon’s office. Marsha has undergone chemical peels, dermabrasion, and other minimally invasive procedures, while Mike opted for Botox and wrinkle-filling injections for the first time on his fiftieth birthday.

One medical spa with three offices in the Pittsburgh area reports that it offers cosmetic procedures for nearly 30 couples annually, compared with a half-dozen couples in the mid-2000s.

What are some of the factors driving this increase in couples’ procedures?

  • Plastic surgery no longer carries a stigma among men, particularly as the baby boomer generation ages.
  • More options are available for those who don’t want a surgical procedure, as products like Botox can produce results comparable to facelifts.
  • Many men wish to have a more youthful appearance in order to compete in a younger workplace. Injectable fillers such as Restylane and Artefill are fast, effective ways to rejuvenate your appearance.
  • Recovery times for many procedures have lessened, thanks to cutting-edge techniques like VASER LipoSelection that reduce tissue trauma.
  • Couples who have surgeries around the same time can “leapfrog” their procedures, alternating care and recovery.

Dysport Superior for Crow’s Feet Correction

Tuesday, June 21st, 2011

woman with eye wrinkles, crows feet, she may be candidate for dysportWhen targeted crow’s feet, Dysport achieves better results than Botox, according to a plastic surgeon who just published a study comparing the two botulinum toxin medications.

“Lateral orbital rhytids,” commonly called crow’s feet, are lines that travel horizontally from the eyes. Like other wrinkles, they develop gradually as a result of several factors including muscle contraction (especially squinting the eyes and moving the brow) and age-related loss of skin elasticity.

Botulinum toxin, as found in Dysport, is a product that temporarily stops facial muscle contractions to reduce or erase the appearance of wrinkles.

The comparative study was based on photographic evaluations of 90 adult patients who received Botox or Dysport injections in the crow’s feet wrinkles. As a “split-face” study, the drugs were injected on opposite sides of each patient’s face. Before and after photographs (during muscle contraction and at rest) were taken of each subject, grading their crow’s feet correction on a 5-point scale.

When patients evaluated the photos taken during muscle contraction, about two-thirds of them indicated a preference for the Dysport results. The difference was a full point higher on the wrinkle scale.

However, the authors mention several caveats about the Botox vs Dysport comparison for crow’s feet:

  • When subjects had relaxed faces (no significant muscle contraction), there was no visible difference between each product’s results.
  • Although they claim that Dysport treats crow’s feet more effectively, they can’t make any similar claims about treating wrinkles on the forehead or neck.
  • Allergan, maker of Botox, did not approve of the study methods, challenging their dosing ratio, study length and statistical analysis.
  • Medicis, maker of Dysport, provided funding for the study while Allergan declined to do so.

Although Dysport and Botox are similar in the way they correct wrinkles, the dosage is different. Both manufacturers caution that Botulinum toxin medications are “not interchangeable.” Therefore, if you’ve been treated with either product in the past, it is wise to notify your cosmetic surgeon before you decide to switch.

You can read about Dysport for crow’s feet in the latest online edition of Archives of Facial Plastic Surgery. A summary is also available from Healthday News.

Coastal Empire Plastic Surgery provides Dysport on Demand – No Appointment Necessary

Call 912-920-2090 to learn more!

FDA Advisory Panel Recommends Restylane for Lip Enhancement

Monday, May 9th, 2011

While an advisory panel to the Food and Drug Administration (FDA) has voted to recommend injectable filler Restylane for lip enhancement, it seems unlikely to make much difference even if the FDA does move to approval. Many doctors in the United States already find Restylane very effective in filling out their patients’ lips.

Restylane, like other hyaluronic acid fillers such as Juvederm and Elevess, temporarily smooths wrinkles by adding volume under the skin, and was approved for this use by the FDA in 2003. The effects of hyaluronic acid fillers typically last about six months.

Restylane is frequently used for off-label purposes, such as lip augmentation, since hyaluronic acid occurs naturally in the body and there are very few risks associated with the procedure. According to Dr. Farhad Rafizadeh, a New Jersey plastic surgeon who spoke with MyHealthNewsDaily, Restylane is the best filler for the lips because it remains in place. Other facial fillers, he says, tend to seep into other areas of the face.

This practice is not as unusual as one might think, since off-label use for a product is quite different from using a substance that has not been approved by the FDA. Experienced, conscientious doctors can legally and ethically use drugs and other products for alternative purposes, as long as these products have already been shown to be safe for human use, and the patient fully understands the nature of the use.

A move by the FDA to approve hyaluronic acid fillers for lip enhancement would most likely only impact doctors that are unaccustomed to using the products and hesitate to go off the beaten path. In the hands of an expert plastic surgeon, however, hyaluronic acid fillers can work wonders for smile lines, wrinkles, creases, lips, and hollow cheeks.

Botox or Facial Filler? How to Reduce Wrinkles Without Surgery

Thursday, April 28th, 2011

While Botox is the most popular cosmetic procedure in the world, with 5.4 million procedures performed last year in the United States alone, facial fillers have become very trendy in recent years. Products like Juvederm, Sculptra, and Artefill are continuing to redefine how we think about wrinkles. Each product has unique benefits that are worth considering.

All of these products work by being injected into the face over the course of about 15 minutes. The benefit of injectable treatments is that there is no downtime, as patients can usually return to their routine immediately after the procedure. Typically, the only side effects are what you might expect for an injection, such as redness, bruising, or stinging, which pass soon afterwards.

Botox is best suited to treating forehead lines, frown lines between the eyebrows, crow’s feet, lines between the upper lip and nose (perioral wrinkles), and wrinkles on the neck. All of these areas can be treated through targeted injections that relax certain muscles and allow others to pull the skin tighter than before.

Facial fillers are best used on smile lines and wrinkles below the mouth. However, they can often be used for other wrinkles and creases on the face, as well as for augmenting lips and filling out hollow cheeks.

Some fillers, such as Restylane, Elevess, Perlane, and Juvederm, use hyaluronic acid for striking results that last up to 6 months. All are highly effective on smile lines and other facial wrinkles, although each is formulated differently and suited to unique purposes. For example, Juvederm is especially well-suited to filling out lips, while Perlane contains no animal proteins whatsoever.

Other fillers last much longer than Botox and hyaluronic acid-based fillers. Sculptra lasts for up to two years and works by replacing lost collagen. Artefill, however, lasts longer than most (if not all) other facial fillers. It provides permanent support thanks to special microspheres that are injected along with the collagen and provide a framework for new collagen deposits. The microspheres are not absorbed into the skin, so that they may provide lasting support for a number of years.

Each product has unique benefits that are best suited to different patient needs, desires, and timeframes, so it’s always important to discuss your needs with a qualified plastic surgeon to find the injectable treatment that’s right for you.

Facial Plastic Surgery Stats Show Increase in Non Invasive Treatments

Thursday, February 24th, 2011

Statistics about facial cosmetic treatments show that in 2010, about 75 percent of the procedures performed were non-surgical, which may confirm an often discussed trend toward non-surgical cosmetic treatments.

The stats come straight from the American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS), and they show a 45 percent increase in the number of facial procedures performed over the last two years, representing a 16 percent annual increase in non-surgical facial procedures.

“Non-surgical procedures are an excellent option for some people, with the added benefits of lower costs and shorter recovery time; two things that are consistently important to those considering facial plastic surgery,” said Dr. Jonathan M. Sykes. “We have been seeing a trend over the past few years that people who want to look and feel younger and rejuvenated are turning to non-surgical, less invasive procedures to obtain the refreshed look they want.”

Based on the AAFPRS survey, the hot procedures of 2010 were non-surgical procedures like Botox and Restylane injections. Among surgical procedures, the most popular were rhinoplasty, facelift and eyelid surgery.

Females received the majority of facial procedures in 2010 (83 percent), but the most popular procedures varied by age. For women 35 to 60, the top surgical procedures were brow lift, facelift and eyelid surgery, while a nose job was the top surgical procedure performed on women under 35. Botox, injectable fillers nose jobs, and hair transplants were the most common facial procedures performed on men in 2010.

The AAFPRS survey also reported an increase in ethnic patients: two out of five surgeons said they had an increase in their Asian American and Hispanic patients last year.

You can read more of these survey results at www.aafprs.org.

Swiss Pharmaceutical Seeks to Acquire Restylane Manufacturer

Tuesday, December 14th, 2010

The latest news from Bloomberg.com say that Q-Med, the Swedish manufacturer of Restylane wrinkle filler, is likely to be acquired by the Swiss pharmaceutical company Galderma.

Galderma is known for making the popular Cetaphil products. The dermatology-focused pharmaceutical company was founded over 25 years ago, and is currently owned by L’Oreal and Nestle.

Q-Med makes the popular Restylane dermal filler, which was introduced in the mid 90s. Earlier this year, the company announced a new line of skincare products made with their patented NASHA gel, which is not currently available in the U.S.

In the United States, Medicis Pharmaceutical is licensed to distribute Restylane, along with Perlane, Dysport and other cosmetic products. According to the most recent updates from Bloomberg, Galderma’s offer to acquire Q-Med is conditional on approval from Medicis. On their corporate website, you can read about the history of Medicis and their partnership with Q-Med.

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