June 23, 2011

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.


January 25, 2011

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.


December 27, 2010

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.


October 30, 2010

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.


May 03, 2010

Being Consistent with Botox Prevents Wrinkles Even with Less Frequent Dosing

According to recent research from Oregon Health Sciences University, consistent treatments with Botox or Dysport have a wrinkle preventing—or prophylactic—effect.  Patients who begin receiving injections every 3-4 months while in their 30's, 40's, and 50's are able to prevent wrinkles from forming and eliminate many existing wrinkles.

Moreover, after 2 years of treatment at 3-4-month intervals, patients can potentially cut the frequency of their Botox or Dysport treatments by half.  After patients receive Botox or Dysport every 3-4 months for 2 years, the frequency of the the injections can be changed to every 6 months and still achieve good results.

So what should the average person think about this study?

  • Younger patients, even in their 30s, should consider starting Botox or Dysport to prevent hyperdynamic wrinkles.
  • Patients should try to be consistent (every 3-4 months) for the first 2 years when using either Botox or Dysport.  While such frequent treatment may deter some patients from starting a regimen, eventually they should be able to achieve good results with broader treatment schedules and ultimately at a lower overall treatment cost.


April 22, 2010

Botox for Marionette Lines? Nope. Choose a Filler Instead

Hi, Dr. Pickart.  I was talking with someone about getting rid of marionette lines, and she was given Botox for that area.  Does that sound right to you?

Anyway, I was going to tell her about Sculptra.  Do you think that 1 vial may be enough for that area?

-Janet F.

Dear Janet,

Actually, the best treatment for marionette lines is NOT Botox.  I do sometimes use Botox to turn up the corners of the mouth, but Botox has NO EFFECT on the marionette lines themselves.
I would recommend a filler for marionette lines.  Sculptra is my favorite because it lasts the longest (at least 2-4 years).
Regarding how much Sculptra, it depends upon...

  • the depth of the marionette lines - Shallow will obviously require less than deep.
  • the patient's response to Sculptra - Younger patients respond more vigorously, with more collagen production, compared to older patients.

So, how many vials?  A young patient with mild folds and with a vigorous response to Sculptra might need just 1 vial.  However, an older patient with deeper lines and with less brisk collagen production might need 3-6 vials.  Make sense?
Mike Pickart


January 15, 2010

Tissue Glue Rather Than Drains (?!)

There is an old surgical adage:

If a surgeon thinks that the patient might benefit from a drain, he should put it in.  A surgeon never regrets placing a drain.

Patients, however, hate drains.  They are a post-operative nuisance.  Most patients grudgingly accept drains because they minimize fluid collections (called seromata) and infections.

Since drains are so uncomfortable, there have been a number of products and techniques developed to obviate the need for drains....

  • Quilting sutures beneath tissue flaps to minimize "dead space"
  • Tissue glues

Biological tissues glues are particularly exciting because they are quick, effective, and precise.  Unfortunately, there have been no specific research studies which have rigorously documented the safety and efficacy of biological glues for plastic surgery.  A study published in Plastic and Reconstructive Surgery in 2008 proved the success of tissue glues in a canine abdominoplasty ("tummy tuck") model; however, dog and human tissues do respond differently, and the results of an animal model can not necessarily be generalized to human beings.

To investigate human plastic surgery patients' response to biological glues, Cohera Medical, Inc., has just enrolled its first few patients in a study of its TissuGlu.  The clinical investigation is a prospective, open-label, randomized study to investigate the safety of TissuGlu, its effect on wound drainage, and its relationship to complications.  The study will compare 40 abdominoplasty patients in Bonn, Frankfurt, and Freiburg, Germany, who will undergo...

standard wound closure techniques versus

standard wound closure techniques plus the application of TissuGlu

Currently, patients who undergo abdominoplasties require the insertion of one or more drains to remove fluids that accumulate under the skin at the surgical site.  (The old surgical adage remains true in tummy tucks!)  However, TissuGlu will hopefully adhere the flaps created during the procedure to reduce fluid accumulation, and, ultimately, the duration of use of surgical drains.  With the use of TissuGlu, patients may experience a reduction in fluid accumulation, a more comfortable recovery, and a quicker return to normal activity.

If the European trial goes favorably, Cohera will apply for a larger U.S.-based trial later this year.  Let's say our prayers that TissuGlu works!...


January 07, 2010

The Nefertiti Lift with Sculptra Aesthetic Rather than Botox

About one year ago, I reviewed a published article considering the "Nefertiti Lift" (http://www.pickartplasticsurgeryblog.com/2008/12/the-nefertiti-lift-can-botox-tighten-an-aging-jaw-line.html).  The Nefertiti Lift is a technique for using Botox to rejuvenate the aging jawline and neck.

  • My immediate conclusion was...  "I'm skeptical."
  • My conclusion one year later, after having tried the Nefertiti Lift on a number of patients:  "Bogus."

However, I have since discovered that Nefertiti Lifts are possible with certain non-surgical techniques.  Botox just isn't the right product.  Sculptra Aesthetic can--non-surgically--rejuvenate some poorly defined jawlines, baggy jowls, and loose neck skin.

Sculptra works by stimulating a patient's body to make collagen.  The manufactured collagen provides volume.  The subsequent inflation helps the patient's tissues stand up at attention.  To some degree, the face and neck are, therefore, lifted.

I have grown more and more pleased with the results from Sculptra.  Nevertheless, I am not throwing out my scalpel.  For most "waddles," the surgical face/neck lift is still the gold standard.


January 01, 2010

Dr. Pickart To Host More Training Sessions for Sculptra Aesthetic

Dr. Pickart is the only Board Certified Plastic Surgeon in Southern California who trains other physicians on the appropriate techniques for Sculptra Aesthetic.  He has recently returned from...

  • Denver, Colorado
  • Lawrence, Kansas
  • Oklahoma City, Oklahoma
  • Houston, Texas
  • Galveston, Texas
  • Lake Charles, Louisiana
  • Lafayette, Louisiana
  • Los Angeles, California
  • Beverly Hills, California
  • Burbank, California
  • Encino, California
  • Rancho Mirage, California
  • Newport Beach, California
  • Huntington Beach, California
  • Pasadena, California

He will be hosting additional training sessions for physicians in his office in Ventura, California.  Please call if you would like to be included:  (805) 648-4567.


September 18, 2009

Is Artefill Back?

Artefill is the only permanent soft-tissue filler approved by the FDA.  Owing to corporate over-expansion and to the recession, Artefill's parent company, Artes Medical, filed for bankruptcy in December 2008.  So, Artefill has been unavailable for the past 9 months.

I am not a business person, and I certainly don't understand corporate finances and accounting.  Nevertheless, it appears clear that Artes Medical's problems were not a result of a bad product.  On the contrary, Artefill had been safely and effectively used in thousand of patients.

It's therefore exciting that Suneva Medical will soon re-launch Artefill.  Its competition is...

  • Juvederm Ultra/Juvederm Ultra Plus:  6-9 month duration
  • Restylane/Perlane:  6-9 month duration
  • Elevess/Hydrelle:  6-9 month duration
  • Prevelle Silk:  3-6 month duration
  • Evolence/Evolence Breeze:  6-9 month duration
  • Radiesse:  8-16 month duration
  • Sculptra Aesthetic:  > 2-3 year duration

All of the above fillers are eventually absorbed.  (Sculptra is the lone exception.  Because the collagen produced by Sculptra is a patient's own, perhaps some of Sculptra's effects will be permanent too.)

Artefill stands out because it will not be degraded.  The FDA will allow it to be marketed as the only permanent device for correction of nasolabial folds--the creases between the nostrils and the corners of the mouth.

Of course, patients will continue to age, so even Artefill's smoothing effects will not truly be permanent.  At least, perhaps, Artefill injections can be limited to once every 5-10 years.

I think that Artefill will have a place in my armamentarium.  There certainly are patients who have "injection fatigue."  While the procedure for Juvederm or Restylane is not painful, the bruising and swelling are never fun.

Cost may be an issue.  An Artefill treatment will likely cost twice as much as the other products' treatments.  Of course, in the long run, Artefill should be cheaper, but it remains to be seen whether patients in our difficult economy will be willing to spend $2000 for a single session of injectables.


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