The 3rd Botox: Xeomin Gains FDA Approval for Cosmetic Uses

About 11 months ago, I blogged about that...

• Botox
• Dysport

...were about to get more competition from the newest kid on the block, Xeomin.  http://www.pickartplasticsurgeryblog.com/2010/08/fda-approves-xeomin-the-3rd-botox.html

On August 2, 2010, the FDA approved Xeomin for treatment for cervical dystonia (neck spasms) and blepharospasm (excessive eyelid contractions).  Late last week, on July 21, the FDA approved Xeomin for "the temporary improvement in appearance of moderate to severe glabellar lines in adult patients."

Xeomin is thus the third botulinum neurotoxin type A (BoNT-A) to enter the marketplace.  However, it is not expected to be available to physicians in the United States until the spring of 2012.

Why the delay?  I don't know.  I have called my Merz sales representative to get the scoop....

Perhaps, You Don't Need Botox Every 3 Months

New research suggests that patients getting regular Botox treatments can eventually reduce wrinkles with half as many sessions.

The research, conducted at Oregon Health & Science University, in Portland, sought to determine whether less frequent Botox treatments could provide long-lasting reduction of the frown lines between the eyebrows.  After a patient receives Botox injections every 4 months for 2 years, the frequency of treatments can be changed to 6 months with comparable wrinkle-reducing results and with high patient satisfaction.

So, if you like the effects of Botox, but if you hate having costly injections every 3 months, maybe you should reconsider.  Try to stick with Botox 3-4 times per year for a couple of years, and then you'll probably be able to reduce your Botox treatments to just twice per year.

Oh, by the way, the study also confirmed the wrinkle-preventing effects of Botox.  The study patients' wrinkles did not worsen while they used Botox.  Since they could not create wrinkles, they never formed them in the first place.  Terrific!

FDA Approves Autologous Filler

There has been a lot of hype about stem-cell therapy for facelifting.  As a Board Certified Plastic Surgeon, I find those claims comical.  Please don't fall victim to clever advertising.

However, the biologists have tremendously improved our understanding of cellular biology, and it looks like some of that basic science will legitimately hit the plastic surgery world soon.  On June 21, 2011, the U.S. Food and Drug Administration (FDA) approved the first autologous cell therapy for purely aesthetic purposes.

The product, azficel-T (laVív), is from Fibrocell Science, Inc.  According to company records, azficel-T involves a patented technology whereby fibroblasts are extracted from behind the patient's ear (via a small biopsy); sent to the Fibrocell Science laboratory; multiplied for about 3 month;s and then frozen until needed.

Over a series of 3 treatment sessions, typically 3 to 6 weeks apart, those cells are then injected back into the patient's face.  The goal is to fill in creases--such as at the nasolabial folds, which would then reduce the appearance of smile lines.

In effect, azficel-T will provide a true biological solution for deep folds and wrinkles.  The results should be gradual and natural-looking.

My opinion is that this technology is certainly interesting, and I will definitely invest the time and effort to become proficient with azficel-T.  However, I suspect that the product will not be revolutionary.  I bet that the results will not be much better than the current crop of chemical fillers (such as Juvederm and Restylane) or the current biological/stimulatory fillers (such as Sculptra).  Almost certainly, azficel-T will, however, appeal to a niche of patients who demand "natural" and who want to use their own cells (rather than a lab-produced product).

The big negative will be that patients will have to have a biopsy, wait 3 months before they get their injections, and then undergo a series of treatments (rather than just one session).  A long, drawn-out process will not be appealing in our "fast-food culture."

Also, azficel-T will likely be pricey.  No word yet as to how it will compare with Juvederm or Restylane for ~$500-500, but I suspect that azficel-T will hurt in the wallet.

Restylane to Be the First FDA-Approved Lip Enhancer

Late last week, an FDA-advisory panel overwhelmingly voted to recommend approval for Restylane's use as a lip enhancer.  While the whole FDA still needs to make a final decision, they typically accede to the advisory panel.

Of course, using Restylane (or its competitor Juvederm) for lip enhancement is nothing new.  Lindsay Lohan, Lisa Rinna, Lara Flynn Boyle, and Meg Ryan (among others) have each demonstrated Restylane's...er...effectiveness.

Well, those are poorly chosen examples!

Lip enhancement with Restylane and Juvederm doesn't have to be overdone, unnatural, and ridiculous.  Actually, I frequently use Restylane and Juvederm to enhance lips....

• to minimize "smoker's lines"
• to accentuate pouts and pillows
• to restore fullness that has disappeared after weight loss or with age
• to create voluptuousness when God made your lips too thin

Very soon, expect to see a lot of appropriate examples of lip enhancement on television and magazines.  FDA approval will allow the distributors of Restylane to advertise their product!

6 International Consensus Statements on Plastic Surgery Controversies

The International Confederation for Plastic, Reconstructive, & Aesthetic Surgery (IQUAM) recently published consensus statement regarding controversies in plastic surgery.  I thought that my readers might find this list interesting...

• Multiple "medical studies have not demonstrated any association between silicone-gel filled breast implants and carcinoma or any metabolic, immune, or allergic disorder."

Translation:  Silicone breast implants are safe.  They do not cause breast cancer.  They do not cause lupus, rheumatoid arthritis, psoriasis, etc.

• "Silicone-gel filled breast implants do not adversely affect pregnancy, fetal development, breast-feeding or the health of breast-fed children."

Translation:  If you have had silicone implants, feel free to breast feed your babies.

• "Phosphatidylcholine has been used for prevention and treatment of fat embolism for many years, but it is currently being used 'off label' for dissolving fat in aesthetic applications.  Data concerning the efficacy, outcome, and the safety of its use for aesthetic indications in subcutaneous tissue have not yet been established. Further basic science and clinical trials are needed."

Translation:  "Lipodissolve" and "LipoZap" injections have not been shown to be either effective or safe.  While I know that everybody wouldn't mind getting rid of a "love handle" or two, don't submit to any unproven injection technique.  Liposuction remains the gold standard.

• "Botulinum toxins (BTxA's) have been used extensively for aesthetic purposes. BTxA's in high dosages have been used in various therapeutic clinical applications with minimal reported significant adverse effects. Current clinical data confirm the safety of BTxA’s for aesthetic indications when used by experienced doctors under sterile office environment. Patients should be provided with detailed information, and a signed informed consent should be obtained prior to performing the procedure."

Translation:  Botox and Dysport kick ass!

• Regarding injectable fillers...  "Today, more than 35% of the procedures performed by plastic surgeons are no longer purely surgical.  The use of resorbable substances is preferable to the use of nonresorbable fillers, as recommended by many national health authorities or academic societies....Permanent fillers (excluding autogenous tissue) can give a definitive correction, but have been reported to be associated with long-term, irreversible complications and should be used with extreme caution."

Translation:  Fillers are increasingly popular.  Choose one of the common resorbable fillers (such as Restylane, Juvederm, and Radiesse) rather than a permanent filler (such as Artefill or liquid silicone) because the temporary fillers are safer.

• "IQUAM urges governments to pass legislation to prohibit the use of non-certified products and to protect patients from untrained physicians and nonmedical personnel injecting or implanting materials for various indications."

Translation:  Board Certified Plastic Surgeons wish that patients were protected from poorly trained injectors.  However, there are few laws that limit the practices of doctors and nurses, many of whom suck.  Make sure that your injector is certified by an appropriate specialty board.

(By the way, the only board recognized by the American Board of Medical Specialties to certify phyisicians in the practice of plastic surgery is the American Board of Plastic Surgery.)

Osteoporosis of the Face

When you think of facial aging, wrinkles and sagging skin come to mind, but new research finds that skin isn't the only thing that ages.

Over time, so do the facial bones, which lose volume and recede, making you look even older.

And if crow's feet and jowly cheeks weren't enough, the bones of the eye socket gradually widen, the brow bone recedes, and the jawbone becomes less defined.

If you think of the facial bones as "scaffolding" for facial tissue and skin, the bone loss can contribute to that drooping, deflated look.

And sorry, ladies. While the most pronounced bone loss happened for men when they were 65 and older, the process starts earlier in women. Women's facial skeletons between 41 and 64 look much different than their facial bones did between the ages of 20 and 40.

The bone loss helps explain why getting a simple facelift (or skin tightening) won't ever make you look like your 20-year-old self.

In the 20th century, plastic surgeons assumed that facial aging was primarily due to skin aging and to gravity.  Hence, we focused on skin tightening and lifting.  But a lot of faces never looked like they did when they were younger.  Facelifts never completely achieved a natural, youthful look.

Over the past 10 years, we have increasingly recognized that facial fat loss is major issue.  Hence, substances that mimic the fullness of fat (such as Restylane, Juvederm, Radiesse, and Sculptra) have become wildly popular.  And results have correspondingly improved.  The results from comprehensive plastic surgery (surgery + filling + laser resurfacing) are starting to look pretty good.  But they still fall far short of true rejuvenation.

Now, we are understanding more of what's missing:  bone.

In the January issue of Plastic and Reconstructive Surgery, researchers from Rochester, New York, published their comparisons of facial CT scans of faces of differing ages.

With age, the scans showed that the bones that make up the eye sockets recede, enlarging the sockets.  This contributes to the appearance of excess or droopy skin around the eyes.

Similar losses of volume happen in the bones of the middle face, including the brow bone, nose, and upper jaw.  The loss of bone can also reduce the angle of the lower jaw, which is why those with a strong jawline in their youth may not be so well-defined in old age.

For those seeking facial rejuvenation, plastic surgeons should start considering how they can mimic the fullness of youthful facial bones.  Options might include more fillers, or even facial implants.

While it may never be possible to return a patient to looking 20 years old, adding volume to mimic lost fat and bones will improve results for most patients.

The study makes sense.  We know that bone densities in the back, hips, and legs decrease with age, why wouldn't osteoporosis also set in at the face?

Clearly, aging is multi-factorial.  "Quick lifts" and other gimmicks are certainly not going to treat all of the issues.  A comprehensive plan will be necessary to rejuvenate different issues at different decades.

Decreasing Enthusiasm for Lower Eyelid Blepharoplasties

A new understanding of lower eyelid aging is decreasing plastic surgeons' enthusiasm for lower eyelid surgery.

Based upon the latest research, we have a better understanding of what makes lower eyelids look old....

• Skin wrinkles, including crow's feet
• Pigment deposition
• Bulging fat bags
• Flat cheeks

Huh?  Flat cheeks?  Yes, you read right.  Flat cheeks.

As we age, we gain fat in some places (such as our tummies and buttocks), and we lose it in others (such as our breasts and cheeks).  In aging faces, the lower eyelids frequently demonstrate bulging fat bags.

• Possibly, this could be the result of true fat accumulation (as occurs in the abdomen and buttocks).
• But, more likely, the bags result from an age-related laxity of the tissues holding the fat in the orbit, where the fat is supposed to cushion the eyeballs.
• Most important of all is that the bulging orbital fat looks more prominent next to the flatness of the upper cheeks.  The contrast between the bulging of the eyelid fat and the flatness of the adjacent cheek tissue renders the fat more visible and more unsatisfactory.

Regardless, lower eyelid blepharoplasties have, for decades, been the treatment of choice.  The surgery involves the removal of orbital fat through small incisions, along with the trimming of excess muscle and skin.

However, the results can look hollow.  Excessive fat removal makes the eyeball "sink" into the globes.  Moreover, persistently flat cheeks worsen the skeletal appearance of an aging face.

The solution is twofold....

• very conservative lower eyelid blepharoplasties, with only judicious removal of...
  • lower eyelid orbital fat 
  • lower eyelid skin
  • lower eyelid orbicularis oculi muscle
• filling the upper cheeks, with
  • an off-the-shelf filler, such as Restylane, Juvederm, Radiesse, or Sculptra
  • fat grafting
  • cheek implants

In other words, diminish the bulge but elevate the depression.  A hill doesn’t look so high when you fill the adjacent valley!

In my practice, I will usually treat the upper cheeks first with an off-the-shelf injectable, such as Restylane or Sculptra.  If the lower eyelid/upper cheek improvement is satisfactory, then the patient and I are done.  We have achieved rejuvenation without surgery!  Blepharoplasty surgery can be delayed for a few more years--or decades.

On the other hand, if the lower eyelids still look too baggy, then we proceed to the operating room for a conservative blepharoplasty.  After 2-3 months of healing, we reassess.  If the patient is happy, then that's it.  However, if the lower-eyelid/upper cheek area still looks too tired or too old, then I fine-tune the results of the blepharoplasties with more of the injectable--in the office, under local anesthesia, without cutting.

With this step-wise approach, not only are the results more anatomically accurate and thus more pleasing, but also the patient can take a more active role in her outcome.  By taking charge, she can make sure that she is not "over done."

My goal is always less surgery for a more subtle, more natural result.  Just say, "NO!" to the Beverly Hills look!!

The Vampire Facelift - More Nonsense

Dubbed the "Vampire Facelift" by the news media, the Selphyl System is a technique marketed as increasing the volume of the face.

• A sample of blood is drawn from the patient.
• It is placed into a centrifuge to separate the liquid from the cells and proteins.
• Then, the platelets, fibrin, and growth factors are reinjected into the face in areas that are particularly hollow.

The treatment is performed in the office, similar to fat grafting and Sculptra.

• Like fat transfer, the Selphyl System employs your own tissue.  Unlike fat grafting, however, drawing blood itself involves little morbidity (while harvesting fat from your tummy or hips via liposuction can really hurt!)
• Like Sculptra, the Selphyl System entails minimal downtime.  Frankly, both are pretty easy for the patient; expect to return to work that afternoon or the next day.  The big difference between the Vampire Facelift and Sculptra is that Sculptra is an off-the-shelf product rather than an autogenous technique.  Sculptra is not your own tissue.

Are you thinking, "Sign me up!  I wouldn't mind looking as young as Robert Pattinson"?

The problem with the Vampire Facelift is that there is little to no proof that it actually works.  While fat grafting and Sculptra have been extensively studied, the Selphyl System has been heavily advertised but poorly researched!  The photos on the web site might look great, but I have yet to read a single, high-quality, scientific analysis proving the efficacy of the Selphyl System.

Until I seem some proof, I am going to continue to recommend...

• Sculptra for in-office facial filling
• fat grafting for filling in the operating room

And, oh yeah, to look young, stay out of the sun.  The vampires have got that right.

The Newest Untested Fad: Stem-Cell Facelifts

When I first started to see advertisements for "stem cell" facelifts, I thought, "Am I missing out on a powerful new technology?  By not offering this therapy, am I not offering the latest and greatest to my patients?"

With a little research, I have unequivocally concluded, NO and NO!

Stem-cell facelifts are more about marketing and less about science.  The actual procedure is nothing revolutionary.  It involves facial injections of stem cell-enriched fat grafts, which is hardly any different from regular fat grafting--which, for the past decade, plastic surgeons have used to re-volumize the face, especially around the mouth and at the cheeks.

The addition of the stem cells has no proven efficacy and may even be dangerous.  While stem cell techonology has incredible potential, nobody in 2010 really knows how stem cells work or whether they will work consistently.

The American Society of Plastic Surgeons has advised patients considering facial rejuvenation to avoid stem-cell facelifts, as well as other “fad procedures” that lack clinical evidence demonstrating their effectiveness.  The U.S. FDA has not approved stem-cell-enriched fat grafting for any purpose.

While I hope that stem cells will improve medical care and aesthetics, as of today, it's more science fiction than science fact.

FDA Approves Xeomin - The 3rd "Botox"

Botox has even more competition.

Developed in Britain, Dysport hit American shores in July 2009, and has taken a sizable chunk of the botulinum neurotoxin-type A (BoNT-A) business from Botox.  On August 2, 2010, the FDA approved a third BoNT-A, Xeomin.

Xeomin is from Germany, and it appears to be very similar to Botox and Dysport.  The FDA approval is for treatment for cervical dystonia (neck spasms) and blepharospasm (excessive eyelid contractions), and NOT for cosmetic treatments.  However, cosmetic approvals are likely on their way.

Forget the fact that all three are terrible names.

• Botox?  Short for botulinum toxin?  Do you really want to advertise that the medication was derived from a poison??
• Dysport is even worse.  It sounds too much like dysfunctional, which connotes a lot of negativity.
• Xeomin?  How do you pronounce that?

Names aside, all three appear to be effective muscle relaxants, which are great for wrinkles on the forehead, around the eyes, and between the eyebrows.  While any differences between Botox and Dysport have been very subtle, Xeomin may be significantly dissimilar.

• The active protein (the toxin itself) has no complexing proteins.  That means that Xeomin is actually more pure than Botox or Dysport.
• As such, Xeomin does not need refrigeration.  When it is injected, it won't be cold, and it may, therefore, be more comfortable.

For physicians, Xeomin will probably be packaged like Botox (in 50-unit and 100-unit vials), and it has been said that a Xeomin unit is very similar in efficacy to a Botox unit, so dosing should be very straightforward.

(On the contrary, it takes 2 1/2 units of Dysport to equal a single unit of Botox.  So, we plastic surgeons have had to perform quick calculations to convert our Botox patients to Dysport users.  No big deal, but an extra nuisance.)

Looking forward to trying Xeomin!