Aug 09 2007
Aging Gorgeously: From Hope in a Jar to Help in a Syringe
Women may be programmed from an early age to believe the best way to avoid getting lines and wrinkles is to moisturize. But at some point, you may ask yourself, “should I do more?” As your fine lines start to deepen into creases, and those folds from your nose to the corners of your mouth begin to take over your face, it may be time to consider injectables.
Anti-aging creams can work to reduce the appearance of fine lines and wrinkles. However, some women may have different needs and desire different results than those offered by creams. The main reason women are dissatisfied with their skin care is that their expectations are off the charts to begin with. Cosmetic products are designed to beautify and promote attractiveness. These products do not contain any active ingredients that affect the deeper structures of the skin.
“Clinically proven” are those two little words on a label that invoke images of Petri dishes and microscopes. Behind the claims of scientific evidence, consumers expect some degree of assurance that skin care products actually deliver the benefits they claim. Importantly, consumers should understand that pharmaceutical products or devices are required by the FDA to be studied in large-scale, controlled studies conducted under rigorously monitored conditions; these studies may last several months or even years.
Many Women Buy More Creams Than They Can Use in a Lifetime
Think about it. When was the last time you actually saw the bottom of a jar of anti-aging cream? If you’re like most women, the answer is probably never. But instead of fighting the appearance of wrinkles, most of it just ends up sitting on the shelf. The best way to look at skin care is with a regimen approach. Choose a select few products that suit your skin type, and use them on a daily, consistent basis.
At the end of the day, the real proof in skin care is still every woman’s standby — trial and error — and it has worked for centuries! Cosmetic skin care is a great place to start, to lay a foundation for your beauty future. However, some consumers may be interested in a more immediate approach to addressing the visible signs of facial aging. These individuals may opt to seek out a good doctor to discuss the available alternatives.
Restylane(R), the Number One Selling Cosmetic Dermal Filler in the United States
If you are ready to consider a clinically studied treatment for moderate to severe facial wrinkles and folds, such as those extending from the nose to the corners of the mouth, you may wish to consider an injectable solution. One injectable solution is Restylane, which will give you immediate results. In more than 4 million treatments in over 70 countries, people have experienced the fast, safe, effective, and beautifully natural results it offers. Restylane lasts as long as six months and provides natural-looking results.
The plethora of dermal fillers on the cosmetic beauty marketplace makes it hard to know which is the right one for you. If you’re suffering from filler confusion, the best way to sort through all the options is to consult with an experienced dermatologist or plastic surgeon for advice.
“Since it was introduced in the U.S. over three years ago, Restylane has become an important choice in my practice,” says Dr. Michael Kaminer, a dermatologist at SkinCare Physicians in Chestnut Hill, Mass., and Assistant Professor of Dermatology at Yale Medical School. “The treatment takes 15 minutes. Patients can visibly see the results after treatment. The results of treatment last about six months.” With each treatment, Restylane restores volume and fullness to the skin to correct facial wrinkles and folds, such as the lines running from the nose to the corners of the mouth.
Creams and Injections: Like Borrowing Time
You don’t have to throw away your supply of wrinkle creams when you decide to go with Restylane. These cosmetics serve a different purpose than Restylane. The best anti-aging creams pack a strong arsenal of antioxidants and proteins for your skin. Restylane, the top selling dermal filler, serves a different role in an individual’s anti-aging pursuits. “The appearance of a smoother, even complexion from cosmetics is the first step; softened facial lines and folds with dermal fillers can take facial beauty to the next level,” says Dr. Michael Kaminer.
Safety Information
Restylane is approved to correct moderate to severe facial wrinkles and folds. After your treatment, you might have some redness or swelling. This will normally last less than seven days. Sunbathing and cold outdoor activities should be avoided until any redness or swelling disappear. If you are pregnant, breastfeeding, or under 18, you shouldn’t use Restylane.
Restylane is available only through a licensed practitioner. Visit www.RestylaneUSA.com for complete product and safety information.
Courtesy of ARAcontent
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EDITOR’S NOTE:
1. http://www.q-med.com/DynPage.aspx?id=741&mn1=198&mn2=207 (accessed April 19,2007)
2. Narins RS, Brandt F, Leyden J, Lorenc ZP, Rubin M, Smith S. A randomized, double-blind multicenter comparison of the efficacy and tolerability of Restylane versus Zyplast for the correction of nasolabial folds. Dermatol Surg. 2003;29:588-595.
BRIEF STATEMENT (for full product information, see package insert)
RESTYLANE (R)
Caution: Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner.
Indication
Restylane(R) is indicated for mid-to-deep dermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds.
Contraindications
* Restylane(R) is contraindicated for patients with severe allergies manifested by a history of anaphylaxis, or history or presence of multiple severe allergies.
* Restylane(R) contains trace amounts of gram positive bacterial proteins, and is contraindicated for patients with a history of allergies to such material.
* Restylane(R) must not be implanted into blood vessels. Implantation of Restylane(R) into dermal vessels may cause vascular occlusion, infarction, or embolic phenomena.
Warnings
* Use of Restylane(R) at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the inflammatory process has been controlled.
* Hypersensitivity as an inflammatory reaction to Restylane(R) has been observed with swelling, redness, tenderness, induration and rarely acneform papules at the injection site.
* Injection site reaction to Restylane(R) has been observed as consisting mainly of short-term inflammatory symptoms starting early after treatment and with less than 7 days duration.
* Localized superficial necrosis may occur after injection in the glabellar area. It is thought to result from the injury, obstruction, or compromise of blood vessels.
* The safety or efficacy of Restylane(R) for the treatment of lips has not been established in controlled clinical studies.
Precautions
* Restylane(R) is packaged for single patient use. Do not resterilize. Do not use if package is opened or damaged.
* Based on US clinical studies patients should be limited to 1.5 mL per treatment site. The safety of injecting greater amounts has not been established.
* The safety or effectiveness of Restylane(R) for the treatment of anatomic regions other than nasolabial folds has not been established in controlled clinical studies.
* Long-term safety and effectiveness of Restylane(R) beyond one year have not been investigated in clinical trials.
* As with all transcutaneous procedures, Restylane(R) implantation carries a risk of infection. Standard precautions associated with injectable materials should be followed. Rare reports of delayed-onset, prolonged reactions have been reported following the use of dermal fillers that present as inflammatory papules. Treatment may consist of close observation, broad-spectrum antibiotics, intralesional or topical steroids, and/or other interventions identified as necessary by appropriate investigations.
* The safety of Restylane(R) for use during pregnancy, in breastfeeding females or in patients under 18 years has not been established.
* The safety of Restylane(R) in patients with increased susceptibility to keloid formation and hypertrophic scarring has not been studied. Restylane(R) should not be used in patients with known susceptibility to keloid formation or hypertrophic scarring.
* Restylane(R) should be used with caution in patients on immunosuppressive therapy.
* Patients who are using substances that reduce coagulation, such as aspirin and non-steroidal anti-inflammatory drugs may, as with any injection, experience increased bruising or bleeding at injection sites.
* After use, treatment syringes and needles may be potential biohazards. Handle accordingly and dispose of in accordance with accepted medical practice and applicable local, state and federal requirements.
* Restylane(R) is a clear, colorless gel without particulates. In the event that the content of a syringe shows signs of separation and/or appears cloudy, do not use the syringe and notify Medicis Aesthetics, Inc. at 1-866-222-1480.
* The patient should be informed that he or she should minimize exposure of the treated area to excessive sun and UV lamp exposure and extreme cold weather until any initial swelling and redness has resolved.
* If laser treatment, chemical peeling or any other procedure based on active dermal response is considered after treatment with Restylane(R) there is a possible risk of eliciting an inflammatory reaction at the implant site. This also applies if Restylane(R) is administered before the skin has healed completely after such a procedure.
* Restylane(R) is supplied in a syringe ready for use. Never mix Restylane (R) with other products prior to injection of the device.
* Restylane(R) is packaged in a glass syringe. Glass is subject to breakage under a variety of unavoidable conditions. Care should be taken with the handling of the glass syringe and with disposing of broken glass to avoid laceration or other injury.
Adverse Events
The most commonly reported adverse events were bruising (52.2%), redness (84.8%), swelling (87.0%), pain (57.2%), tenderness (77.5%), and itching (30.4%) which typically resolve in less than seven days.
Adverse reactions should be reported to Medicis Aesthetics Inc. (866) 222-1480
Rx only
US Patent 5,827,937
Manufactured for
Medicis Aesthetics, Inc.
8125 N. Hayden Road
Scottsdale, AZ 85258
U.S.A.
Phone: 1-866-222-1480
*Restylane(R) is a registered trademark of HA North American Sales AB.
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