The Nefertiti Lift with Sculptra Aesthetic Rather than Botox

About one year ago, I reviewed a published article promoting 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:  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 products.  Botox just isn't the right product.  Sculptra Aesthetic can--non-surgically--rejuvenate some poorly defined jawlines, baggy jowls, and loose neck skin.

The surgical face/neck lift is still the gold standard.

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
• Burbank, California

He will be hosting additional training sessions for physicians in...

ATX-101

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KYTHERA BIOPHARMACEUTICALS ANNOUNCES INITIATION OF

PHASE I/II CLINICAL TRIAL FOR LEAD PRODUCT CANDIDATE

LOS ANGELES, January 8, 2007 – Kythera Biopharmaceuticals, Inc. (“Kythera”)

announced today that it has commenced the Company’s first human clinical trial, a

Phase I/II study of ATX-101 for the reduction of localized fat deposits.

“This important milestone not only substantiates our belief in the potential of ATX-101,

but also validates our scientifically and medically rigorous approach to developing

prescription therapeutics in aesthetic and restorative dermatology,” said Keith Leonard,

Kythera’s President and CEO. “We hope ATX-101 will prove to be a new treatment

option for patients, and we are truly excited about the potential of ATX-101 in all

possible medical and aesthetic applications.”

ATX-101 is initially being investigated for the treatment of superficial lipomas, a type of

benign musculoskeletal fatty tumor that may occur in up to 2% of the population.

Lipomas are generally found on the torso, shoulder, arms and legs, and, while generally

asymptomatic, can cause local pain, tenderness or nerve compression. Individuals

seek to have their lipomas removed in order to reduce pain, for aesthetic reasons, or

both.

This ATX-101 clinical trial is being conducted in the United States and is intended to

identify the pharmacokinetics, safety and potential efficacy of ATX-101 in the treatment

of superficial lipomas. The Phase I/II randomized, double blind, placebo-controlled

study is the first of several planned trials to investigate the medical and aesthetic uses

of ATX-101. Kythera licensed the compound from Los Angeles Biomedical Institute at

Harbor-UCLA Medical Center.

“Until now, standard lipoma treatment has been surgical excision, which many patients

opt not to undergo due to the invasiveness and potential for scarring,” said Jay

Birnbaum, Kythera’s Chief Medical Officer. “We are hopeful that treatment with ATX-

101 can significantly reduce the size of, or eliminate, lipomas and thereby provide an

effective non-surgical, minimally invasive treatment option for patients.”

Evolence Discontinued

The economic downturn continues to particularly hurt "cosmoceutical" companies.  Evolence is the latest victim.  Ortho Dermatologics (a division of Ortho-McNeil-Janssen Pharmaceuticals, which is itself a division of Johnson & Johnson) has discontinued Evolence.

What is (was) Evolence?

• A soft-tissue filler based upon porcine collagen (from a pig)
• Excellent safety record:  Unlike bovine collagen (from a cow) which caused multiple allergies, Evolence was never associated with a single allergy.
• FDA approved on June 30, 2008:  The federal government was satisfied with its safety and efficacy.
• It has been used similarly to Juvederm and Restylane, especially at the nasolabial folds (connecting the nostrils to the corners of the mouth).
• Less swelling and bruising than Juvederm and Restylane
• Similar longevity as Juvederm and Restylane

If Evolence was similar to Juvederm and Restylane (and with less bruising), why wasn't it more popular?

Lumpiness.  A number of my patients noted that Evolence was not as soft or smooth at its competitors.  While the lumps were never visible, they were palpable (and apparently annoying).

My mother loved Evolence.  Women in their 60s and 70s have thinner skin, which tends to bruise significantly (with all of the injectable products).  When my mother had requested Juvederm, Restylane, Elevess/Hydrelle, or Radiesse, the subsequent bruising had persisted as long as two weeks.  However, with Evolence, the black-and-blue marks were smaller and resolved within a few days.

Evolence has filled a niche in my practice:  It is useful in patients who would like to minimize bruising...

• because they have a big event tonight!
• because they are older.
• because they naturally have thin blood.
• because they are on blood thinners (like Coumadin, Plavix, or aspirin).

What will be the new anti-bruising injectable filler?  In this economy, I don't know.  I certainly hope that Evolence is soon replaced.

The Boob Jab: Enlarging Breasts Via Injections Rather Than Implants

In Ventura, and elsewhere in Southern California, breast augmentations are the most popular cosmetic surgery.  Placing a prosthesis (filled either with saline/salt water or with silicone) beneath the breast increases its size and improves its shape.

Despite the relative safety of breast surgery, many patients fear "going under the knife."  Others are not looking for a pneumatic change in their silhouette; just enough to fill up B cups, please!  What to do if you fear operating rooms, or if you're after a more discreet enhancement?

Enter the boob jab.

Yes, you read right.  Jab, not job.  Some of the injectable products, which have revolutionized the way plastic surgeons treat aging faces, may be good not only for filling in sunken cheeks but also for subtle breast enhancement...

• in the office
• not in the operating room
• with local anesthesia
• no IV
• no general anesthesia

Macrolane injections--the boob jab--are currently available in Europe.  A few thousand women have now undergone treatments, and they can expect their results to last for 18 months.

It is unlikely that boob jabs will be available in the US in 2009 or 2010.  We can only hope that Macrolane (manufactured by the same people who have brought us the wildly popular Restylane and Perlane) makes it to our shores soon.  It could be another option for women seeking breast enhancement.

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.

Belotero Balance: Another Hyaluronic Acid Filler on the Way?

The FDA will review Merz Pharmaceuticals' premarket approval application for Belotero Balance.

Belotero Balance is another hyaluronic-acid-based dermal filler that will likely be FDA approved for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds.

There are already a truckload of popular, non-animal-stabilized hyaluronic acid fillers in the USA:

• Restylane
• Perlane
• Juvederm Ultra
• Juvederm Ultra Plus
• Hydrelle (formerly, Elevess)
• Prevelle Silk
• Captique

How will Belotero be different?

• Restylane, Perlane, and Juvederm last about 6-9 months.  Will Belotero stick around that long?
• (By the way, don't believe the marketing that Restylane, Perlane, and Juvederm last 12 months or longer.  Exaggerations!  These products NEVER last 1 year.)
• Will Belotero be as easy to use as Restylane, Perlane, Juvederm, and Hydrelle?  These are easily administered in the office without the needs for pre-treatment allergy testing and extensive post-treatment care.
• Safety?  I have never had a major complication with Restylane, Perlane, Juvederm, or Hydrelle.  Zero complications is a pretty high standard!
• Price?  Might Merz distinguish Belotero by offering it at a more competitive price point?

I'll keep you informed!

Under Eye Bags Caused by Muscle Hypertrophy

Hi, This has been a problem since I was a little girl.  Now I'm 40 and want to improve the appearance of my under-eye bags, whether it is with surgery or fillers.

I look tired all the time and my bags just keep getting bigger as I age. I went to another consultation for blepharoplasty (eyelid surgery).

The doctor told me there's nothing that can be done, because it's all muscle and not fat. Could I have hypertrophy?  What can I do?  I can't stand to look at myself or have others look at me.  If there is surgery for this, what is it called?

-Shellee

 

Dear Shellee,

Find an experienced Botox injector.  Ask for 1 unit of Botox in the roll under each eyelid.  This might solve your problem without surgery.

(If your plastic surgeon is up on the latest treatments, 2.5 units of Dysport would also work.  Dysport is probably equivalent to Botox.)

Do be aware that this is a tricky use of Botox/Dysport.  There are a few potential (albeit unlikely) risks...

• Lowering the lower eyelid margin (so that you see white beneath your green irises)
• Loosening the tension on the fat beneath the eyes, such that bags really do become apparent (I agree with your current analysis.  You do not have fat bags, just excess muscle.)
• Causing your eyes to become dry and scratchy

I highly doubt that you will have problems, but other plastic surgeons might be hesitant to give my suggestion a try.  This is definitely a Botox/Dysport use for experienced injectors only.

If the Botox/Dysport is unsuccessful, the injector could try more.  Or, a little filler in the upper cheeks (at the infraorbital rims--the bony rim beneath the eyes) can smooth the area out.  My favorite is Sculptra.

(By the way, the world's 2nd most beautiful woman--Angelina Jolie--also has muscular rolls beneath her lower eyelids.  Shellee, you're in good company.)

(Who's the world's most beautiful lady?  My wife, of course!!)

Sincerely,

Mike Pickart

Hydrelle: Elevess Has Been Re-Named

A promising dermal filler has been re-named.  Elevess has been re-christened as Hydrelle.

• Like Restylane and Juvederm, Hydrelle is a hyaluronic acid-based product.  This is a type of dermal filler that has a long track record of safety and success.
• Like Restylane and Juvederm, Hydrelle should last between 6 and 12 months.
• What makes Hydrelle different (and potentially superior) is that it contains a local anesthetic (specifically, lidocaine).  (Restylane and Juvederm do not.)
• Even with numbing creams and dental-type anesthetic shots, injecting certain areas of the face can still be uncomfortable.  With lidocaine, Hydrelle should have even less pain and discomfort at the point of injections.
• Could Hydrelle became the injectable of choice for needle-averse patients?!

Breast Augmentation Through the Belly Button? Don't Be Fooled

Many women would like breast implants, but they are turned off by the thought of visible scars...

• around the areola, or
• in the fold beneath the breast, or
• in the arm pit

So, some surgeons offer breast implants through the bellybutton.  Termed the TUBA (Trans-Umbilical Breast Augmentation), I have seen more disasters with this technique than any other....

• How can the surgeon expect to do finesse work from a foot away?  The belly button is too far away from the breasts.
• Hence, the implants are never placed 100% correctly.
• And the breasts are frequently asymmetric.
• How do you control operative bleeding from a distance?
• Hence, there are more bleeding complications with the TUBA.
• The long-term complication of bleeding around an implant is capsular contracture (hardening and disfigurement of the prosthesis).
• Surgeons cannot use silicone implants for TUBAs.  They are limited to saline, which are suboptimal for most patients.

I try to dissuade patients from undergoing TUBAs.  Los Angeles and Beverly Hills are filled with TUBA practitioners who have no intention of correcting their own mistakes.  So, in my practice in Ventura, California, I have to revise the breast implants on at least 5-10 TUBA patients each year.

On the other hand, non-surgical, "scarless" breast augmentations may be available soon....

• Commercially available fillers, similar to Restylane and Juvederm, have been trialled in Europe.  These products are injected into the breasts to produce small augmentations (maybe 1/2 of a cup).  While the fillers might last only 6-12 months, their placement involves no general anesthesia, no cutting, and no down-time--just a few needle pokes.
• Fat grafting may have efficacy.  Imagine liposuctioning fat from your tummy or hips, and then injecting it into your breasts.  It's a two-fer!  The big problem is the issue of cancer.  Will the fat cause breast cancer?  Will scarring from the fat transplant obscure tumors on mammograms?
• Vacuum?  Could you apply a vacuum to your existing breasts to stimulate their growth?  Sustained tension on your teeth allows your orthodontist to correct your smile.  Little people have been stretched to increase their height.  Why not suck the breasts bigger?!  This is an awfully compelling area of research which I hope pans out.