DR MICHELE KOO, MD, FACS, BOARD CERTIFIED PLASTIC SURGEON, ST LOUIS, MISSOURI wants you to know that JUVEDERM and BOTOX are an extremely safe, economical way with no down time to soften your face in a significant way by smoothing and filling in the facial wrinkles that make you look tired and older than you are. Why always be asked if you are mad or tired? Take charge of your life and in 30 minutes in Dr Koo’s office rejuvenate your face with JUVEDERM AND BOTOX to lift up the frowns around your mouth, ever so subtlely plump your lips, and fill in those deep nasolabial folds.

Dr Koo wants you to know that JUVEDERM AND BOTOX are extremely safe and has been FDA approved for facial use to fill creases and smooth the dynamic lines of your face around the eyes and forehead.

The following is a continuation of an article by Dr Mary Lupo, published in the Plastic & Reconstructive Journal, January 2008. Dr Koo hopes that this is helpful information to let you understand the fillers that are available and to realize that the fillers are very safe.

One small open-label study in France treated 49 subjects with Juvéderm 30 in either one or two of four possible injection sites, the nasolabial folds (59 percent), upper lip (37 percent), glabella (16 percent), and bitterness folds (10 percent).4 Most subjects had a touch-up at 1 to 2 months after treatment, with a mean of 0.6 ml administered at each session. Wrinkle severity improvement of approximately 50 percent on a five-point scale remained stable up to 11 months after initial treatment.
Interestingly, in our study, the nasolabial folds initially treated with Zyplast returned almost to baseline after the initial 24-week period, but subsequent treatment with Juvéderm Ultra Plus resulted in the same duration of clinically significant improvement as seen in the nasolabial folds originally treated with Juvéderm Ultra Plus.

The most significant finding from our studies is the extended duration of correction for Juvéderm Ultra Plus, in particular, for severe folds. Other resorbable fillers (collagens and hyaluronic acids) have not been proven to last beyond 6 months. The most comparable product, Perlane, was developed to treat deeper folds in that it is indicated for injection into the deep dermis and has larger hyaluronic acid gel particles than its sister product Restylane, both from Medicis Aesthetics (Scottsdale, Ariz.).5 Juvéderm has a different manufacturing process that creates a homogenous gel without a granular consistency.

In a split-face study comparing Perlane to Zyplast in 68 subjects with a range of different wrinkle severities from mild to extreme, 26 percent were classified as having severe nasolabial folds before treatment, although results were not stratified by baseline nasolabial fold severity.6 At 6 months after optimal correction, 59 percent of all Perlane-treated folds maintained correction, as opposed to the 96 percent noted in the Juvéderm Ultra Plus severe folds study. Moreover, at 9 months, only 49 percent of the Perlane folds were rated as superior to Zyplast, with 37 percent showing equivalency between Perlane and Zyplast and 14 percent showing Zyplast to be superior to Perlane.

Given that Juvéderm Ultra Plus outlasts the temporary dermal fillers, perhaps it should be compared with the semipermanent fillers Radiesse (BioForm Medical, San Mateo, Calif.) and Sculptra (Dermik Aesthetics, Berwyn, Pa.). Radiesse consists of synthetic calcium hydroxylapatite microspheres suspended in a gel of glycerin, water, and sodium carboxymethylcellulose.7 Following injection, the gel dissipates, collagen production is stimulated for volumizing, and phagocytosis gradually breaks down and eliminates the microspheres.

In December of 2006, the U.S. Food and Drug Administration approved Radiesse for correction of moderate to severe facial wrinkles and folds such as nasolabial folds and for facial lipoatrophy in people with human immunodeficiency virus,8 although the product had earlier been approved for other uses such as vocal cord augmentation and was used off-label, particularly for deep creases such as severe nasolabial folds.9 The pivotal trial involved 117 subjects treated with Radiesse in one nasolabial fold and human collagen in the other nasolabial fold with up to two touch-ups allowed at 2-week intervals to attain optimal correction (mean Radiesse injection volume, 1.2 ml).8 Rated on a six-point scale using blinded photographic assessments, the mean improvement in wrinkle severity at 6 months was 1.3 (compared with 1.7 on a five-point scale for Juvéderm Ultra Plus at the same time point), and no long-term data were provided.

In a small open-label study, patient self-reports showed duration of nasolabial fold correction of 10 to 12 months for four of 18 subjects and greater than 12 months for 14 of 18 subjects.10 Another open-label study was based on surveys sent to 609 subjects who had received Radiesse injections to the nasolabial folds or other facial areas.11 Responses to the 6-month survey were received from 155 subjects, and responses to an additional survey sent between 12 and 24 months after initial treatment were received from 112 subjects. Average subject satisfaction at 6 months was 3.9 on a five-point scale (with 5 being most satisfied). In the 12- to 24-month survey, 69 percent reported satisfaction, although the most common comment was thought it would last longer. Importantly, 84 percent of subjects (n = 512) required repeated treatments to achieve or maintain optimal correction. Of those, 63 percent had touch-ups at 4 to 6 weeks and 53 percent at 5 to 9 months.

Sculptra is an injectable poly-L-lactic acid indicated for correction of lipoatrophy though, like Radiesse, it is used off-label for cosmetic wrinkle correction and volumizing. The product must be reconstituted with water at least 2 hours before injection, and the correction fades within 1 week as the fluid is absorbed. The mechanism of action is the stimulation of collagen production, which requires several injections at intervals of at least 2 weeks to generate cosmetic improvement.12 Clinical studies on Sculptra have focused on human immunodeficiency virus-positive subjects with facial lipoatrophy13; thus, the longevity of correction in facial wrinkles is unknown.

One salient point about the semipermanent fillers is that they are generally injected through larger needles than used with collagen or hyaluronic acid-based fillers to prevent the particles in the product from clogging the needle. A 25-gauge needle is preferred for Sculptra,14 and a 25- to 27-gauge needle is recommended for Radiesse,15 with a larger needle having greater propensity to generate tissue trauma and pain on injection. In contrast, Juvéderm Ultra Plus is injected through a smaller 27-gauge needle.2 Moreover, Radiesse and Sculptra are intended for placement only in the deep dermis or dermal-subcutaneous junction and do not have the flexibility to treat finer wrinkles and folds, as can Juvéderm Ultra Plus.

CONCLUSIONS
Juvéderm Ultra Plus represents an excellent combination of attributes for a dermal filler. Permanent products bear some long-term risk if the initial correction is excessive or misapplied and can result in an unnatural appearance as aging tissues shrink and make the filler visible.16 Semipermanent fillers, in contrast, are prone to the problems endemic to the particulate nature of these products, may require larger needle sizes, and have limited utility in superficial defects or wrinkles. Juvéderm Ultra Plus may have found the sweet spot of an ideal duration for wrinkle correction with a good safety profile.

Dr Michele Koo, MD, St Louis, Missouri, is a Board Certified Plastic Surgeon who treats facial wrinkles including crows feet, glabellar frowns (11’s between eyebrows), forehead creases, peri-oral (lip wrinkles), and platysmal bands (neck bands) with BOTOX. She also treats nasolabial grooves, chin creases, thin lips, and downturned lips with various fillers including JUVEDERM, RESTYLANE, AND EVOLENCE.

If you’ve been feeling tired and people keep asking you if you are sad or disinterested, then perhaps it’s time to refresh your face with some filling out of the creases and hollows to make you look softer, fuller and more alive.  

BOTOX along with filler and a simple skin care regimen can make a significant difference in the appearance of your face in very little time in the office of Dr Koo. You will have very little if any recovery time and you can do it on a Friday and be ready to go out the next night.

Dr Michele Koo feels that the following information will be helpful in educating you about BOTOX and its safety. She feels if you understand its actions and chemistry that you will feel much more comfortable and understand that BOTOX is very safe used by trained personnel such as Dr Michele Koo, MD, of St Louis, Missouri, 314-984-8331.

Inactivation of the orbicularis oculi muscle by chemodenervation with botulinum toxin type A (Botox, Allergan, Inc., Irvine, Calif.) as a sole procedure or in conjunction with blepharoplasty has proved to be a reliable method to improve the appearance of the periocular area. Botox has the unique and ideal characteristic in that, with repeated use, there is potential for a prolonged clinical effect with smaller dosages. In addition, if a complication does arise—while not aesthetically acceptable and potentially untoward—it is time-limited, and the anatomical area will eventually return to its pretreatment baseline status.

The eradication of facial wrinkles has traditionally been approached with facelifts, blepharoplasties, and various surgical interventions of soft-tissue augmentation, and resurfacing methods. Facial wrinkles are a result of a combination of basic chronologic aging compounded by sun damage and smoking.

Facial wrinkles can be categorized as dynamic (accentuated with animation) or static (present regardless of facial expression) in nature. An example of dynamic facial wrinkles are the crow’s feet wrinkles. These facial creases  are primarily a consequence of hyperkinetic activity of the orbicularis oculi muscle that encircles the eye. With animation, there is hypertrophy of the lateral muscle fibers. Treatment, therefore, should ideally be aimed at the underlying muscular component. One of the most recent advances in the aesthetic arena has been the expanded use of the botulinum type A neurotoxin (Botox, Allergan, Inc., Irvine, Calif.) to improve the appearance of dynamic facial wrinkles.

BOTOX, temporarily prevents these dynamic muscles from working by inducing chemodenervation by preventing release of acetylcholine at the neuromuscular junction of striated muscles. The result is muscle-fiber atrophy and subsequent clinical flaccid paralysis, thereby smoothing out an area that once had facial wrinkles.

This form of therapy is particularly well suited to the muscles of the upper one-third of the face: the vertical midline glabellar groove (corrugator supercilii, procerus, and medial fibers of the orbicularis oculi muscles), the horizontal forehead lines (frontalis muscle), and the crow’s feet (lateral fibers of the orbicularis oculi muscle).

Botox is received in crystallized form (25°C) in a vial containing 100 units of toxin, 0.9 mg sodium chloride, and 0.5 mg human albumin. The toxin is reconstituted with preserved or unpreserved normal saline yielding various concentrations for the obliteration of facial and neck wrinkles. Dr Koo dilutes the BOTOX depending on the location of the muscle and how deep the wrinkles are and how hypertrophied the muscles are and whether this is a first or repeat injection, and when the last injection of BOTOX was.

The toxin is reportedly quite labile and readily denatured; therefore, Dr Koo  prepares the solution immediately before use and prefers to use it within 24 hours. Contingent upon the degree of orbicularis oculi muscle hypertrophy, Dr Michele Koo, St Louis, Missouri, typically uses an average of 7.5 to 15.0 U per side. The patient is asked to perform an exaggerated smile (squint), and equal divided aliquots of 2.5 U (0.05 ml) of Botox are injected into the raised folds of the skin corresponding to the presumed muscle pattern.

Three or four injections are spaced at 1.0- to 1.5-cm intervals, beginning immediately beneath the lateral edge of the eyebrow down to the lateral infraorbital rim. Because there is an inherent spread of Botox both in between and within muscle fibers, it is injected 1.0 to 1.5 cm (a fingerbreadth) from the lateral orbital rim to prevent its migration into adjacent periocular muscles.

Dr Koo performs the injections in the office in 15 minutes and the patient is ready to return to the office or out for the day immediately afterwards. The onset of action, with the loss of muscle activity and rhytids, can be rapid in this area, and although some improvement may be noted 48 to 72 hours after injection, the full effect may take 3-5 days.

Wrinkles in the crowsfeet area can be one of the earliest signs of aging. In large part, they are the result of muscle hypertrophy of the fibers of the orbicularis oculi that encircle the eye. Consequently, blepharoplasty, soft-tissue augmentation, and resurfacing of any depth are only partially effective in reducing their appearance, and muscular inactivation would therefore be the optimal treatment modality. However, given the muscle’s size and the critical function of tightly closing the eyelid, weakening of the muscle with BOTOX is an ideal and preferable method to diminish and eradicate the creases around the eyes.

Perhaps the most common untoward event that occurs when the crow’s feet are treated is bruising which Dr Koo minimizes by holding pressure for a minutes after the injection. This can also be minimized with superficial injections, because the relatively thin orbicularis oculi muscle seems to be satisfactorily affected when the toxin is injected into the subcutaneous space overlying the muscle. This not only reduces the chance of bruising but may prevent intravascular injection and hemodilution, which can affect potency. Furthermore, injection into the subcutaneous compartment may allow for more local and even diffusion over the targeted muscle and provide an additional safety barrier to structures deep to the muscle.

Botulinum type A neurotoxin physiologically denervates mimetic muscles, thereby eliminating the pull on the skin and the appearance of superimposed wrinkles. The improvement in the appearance of crow’s feet can be profound. Botox does not, however, address other stigmata of aging of the eye, such as fat-pad herniation and excess skin, both of which require surgical intervention. Botox injections and blepharoplasty should not be viewed as mutually exclusive but rather as potentially complementary procedures. Dr Michele Koo, MD, FACS, Board Certified Plastic Surgeon, St Louis, Missouri, will advise you as to the best approach for your complaints regarding your wrinkles and the excess skin around your eyes depending on your desires and your anatomy.

Currently available injection suggestions for the periocular area are general and primarily include a safety zone of approximately 1.0 cm (one  fingerbreadth) from the orbital rim in an arclike pattern. To reduce the temporary yet disfiguring risks of periocular Botox injections alone or in concert with blepharoplasty or facial surgery, Dr Michele Koo performs  precise identification of the muscular anatomy and needle placement.

BOTOX® Cosmetic and BOTOX® (Botulinum Toxin Type A) By the Numbers

• 3,181,592: Number of BOTOX® Cosmetic treatments administered in the United States in 2006
alone

• 1,000,000s: People who received treatment with BOTOX® for medical and aesthetic purposes
around the world

• 300,000: Number of men who received treatment with BOTOX® Cosmetic in 2006

• 10,000: People in clinical trials

• 3,000: Publications on Botulinum Toxin Type A in scientific and medical journals

• 100: Years of study into botulinum neurotoxins

• 97: Percentage of people satisfied with their BOTOX® Cosmetic treatment based on a survey of
   approximately 1,000 patients

• 75: Countries around the world who have approved use of BOTOX®

• 20: BOTOX® indications approved by regulatory authorities around the world, including the aesthetic 
   indication

• 18: Years since U.S. Food and Drug Administration (FDA) approved BOTOX® to treat excessive eye 
   blinking and crossed eyes

• 11: Descriptor for the glabellar (vertical) lines between the brows which can be treated with BOTOX®
   Cosmetic, that can help improve one’s overall facial appearance

• 8: Years since FDA approval of BOTOX® for the treatment of cervical dystonia (painful neck twisting
   condition) in adults

• 6: Years since FDA approval of BOTOX® Cosmetic for the treatment of the moderate to severe
   glabellar (vertical) lines between the brows in adults 18 to 65

• 4: Years since FDA approval of BOTOX® for the treatment of severe primary hyperhidrosis (excessive
   underarm sweating) inadequately managed with topical agents

• 1: Rank of BOTOX® Cosmetic on list of “Top 5 Surgical & Nonsurgical Physician Administered
   Cosmetic Procedures,” according to American Society for Aesthetic Plastic Surgery

About BOTOX® (Botulinum Toxin Type A)

BOTOX® is a medical product that contains tiny amounts of highly purified botulinum toxin protein refined from a bacterium. The product is administered in small therapeutic doses by injection directly into the affected area, and works by blocking the release of acetylcholine (a neurotransmitter that signals the
muscles to contract) at the neuromuscular junction.

BOTOX® neurotoxin therapy was granted approval by the FDA in 1989 for the treatment of strabismus
(crossed eyes) and blepharospasm (uncontrollable eye blinking) associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age and above. The efficacy of BOTOX® treatment in deviations over 50 prism diopters, in restrictive strabismus, in Duane’s syndrome with lateral rectus weakness, and in secondary strabismus caused by prior surgical over-recession of the
antagonist has not been established. BOTOX® is ineffective in chronic paralytic strabismus except when
used in conjunction with surgical repair to reduce antagonist contracture.

BOTOX® neurotoxin has since received approval in December 2000 for the treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck pain associated with cervical dystonia.

In 2002, with dosing specific to treat frown lines between the eyebrows, the product was approved by the FDA for the temporary improvement in the appearance of moderate to severe glabellar lines (the vertical “frown lines” between the eyebrows) in adult men and women aged 65 and younger, under the name BOTOX® Cosmetic. More recently, in July 2004, BOTOX® was granted FDA approval for the treatment of
severe primary axillary hyperhidrosis (excessive underarm sweating) that is inadequately managed with
topical agents.

WELCOME TO 2010….DO YOU HAVE 1 HOUR AND 3 DAYS TO GET RID OF THE WRINKLES AND TIGHTEN THE SKIN OF YOUR FACE, EYES, AND NECK….WITHOUT SURGERY…

Then Dr. Michele Koo, MD, FACS, Board Certified Plastic Surgeon, (314) 984-8331, St Louis, Missouri, is the one for you.

Call our office, (314) 984-8331 and be one of the first 50 patients to call for this promotional discount to have your face lasered to remove those ugly brown spots and wrinkles so that you do not have to use cover up when you go out.

Why undergo surgery when Dr Koo can smooth wrinkles on your face, neck, eyes, and even chest within ONE HOUR and go to a party in ONE WEEK!!

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