Dr. Fiala now has an iPhone app

Yes, it's true - we're entering the age of the iPhone.

My friend, Dave Tessitore, has programmed an iPhone app for us, and it's now available through the Apple app store. Look for "Plastic Surgery with Dr. Fiala", or just click here (link). Currently, it's a free download. We're one of the first plastic surgery practices in the country with this new feature!

In addition to making it easy to make and keep track of your appointments with us, the app also helps you to remember any medications / supplements that you take, your physician contact list, allows direct email access to us, has links to our website and blog, and a number of other cool features.

An FAQ section will be added in an upcoming version. If people have suggestions for improving the app, let me know, and we'll see if we can add them in!

A Big "Thank you" to Dave Tess and Dashy Apps for their work on this project.

Zeltiq: a new technology worth watching

Developed at Massachusetts General Hospital, Zeltiq is a novel fat melting device, which uses the application of controlled cooling to melt fat non-surgically. The idea, known as cryolipolysis, takes advantage of the finding that fat cells freeze before skin cells do. Thus, if the temperature of the tissues can be lowered to just the right point, the fat cells will be lysed, but the overlying skin will be OK.

The gadget that does this is known as "Zeltiq". And it does seem to work. Each outpatient treatment takes about an hour, and the results take about 3 months to appear. So far, it seems to work best on the abdomen and flank ("love handle") areas. While the results are not nearly as dramatic as those of liposuction, there are clear improvements seen in the pre and post-procedure treatment photos.

A recent pilot study by Coleman and associates found that Zeltiq treatment gave a reduction of 20.4% at 2 months and 25.5% at 6 months in the thickness of the subcutaneous fat layer, which was measured by ultrasound. Although 9 of 10 patients in this small pilot study complained of temporary numbness in the treated areas, this normalized after 3-4 weeks. Biopsies showed no damage to the nerve fibers, which is an important consideration in any fat reduction treatment, as the insulating membranes around nerve fibers have a high fat content. None of the patients had any skin damage or pigment changes.

While the Zeltiq is not FDA approved as yet for fat reduction, it has received the European "CE" mark.

I give this new technology a "looks promising" rating!

Gentlewaves LED: no better than placebo

About a year or two ago, a new type of LED device started appearing at the various plastic surgery meetings. It was suggested that certain frequencies (colors) of light could have beneficial properties on the skin, through a theory known as photomodulation. There was no heat, no pain, no downtime, no complications... Sitting under a bank of pulsing colored LED's for a short treatment was supposed to improve your skin.

Well, longtime readers of this blog will begin to notice their noses twitching. We've often commented "when you do less, you get less". So how could this low-power, non-thermal photomodulation thing work?

A group of investigators from the Massachusetts Eye and Ear Infirmary tried to confirm some previously published good results on the GentleWaves LED system, which uses an amber LED bank for facial skin treatments. Good scientists regularly do this - confirming earlier experiments. But something surprising happened. I'll let their abstract published earlier this year in Dermatologic Surgery tell the story.....

"METHODS AND MATERIALS: Facial skin was exposed to pulses of 588+/-10-nm-wavelength light from a photomodulation device for 40 seconds once a week for 8 weeks. Photographs, clinical assessment, and a subjective questionnaire were taken at baseline, at the last follow-up, and 1 month after that. Thirty-six patients' pre- and post-treatment photos were arbitrarily scrambled, and 30 independent blinded observers were asked to pick the post-treatment photo. Two time-point comparisons were evaluated.

RESULTS: For every facial characteristic studied and for both time-point comparisons, patients reported highly statistically significant improvements. In extremely sharp contrast, neither the physician's assessment nor the independent observers' evaluation indicated any improvement.

CONCLUSION: Patients genuinely believed that several of their facial features had improved, even though there was no detectable objective change. Our data therefore suggest that the LED photomodulation treatment from the device tested is a placebo."


Take-home lesson: This device was FDA approved. This means it is safe, as in non-damaging. FDA approval of devices, unlike FDA approval of drugs, does not imply that the device is effective. Gentlewaves LED photomodulation device appears to be hype. Don't waste your money.

Lesson #2: when reading scientific studies, look for objective evidence of improvement - rather than just the subjective opinions of the patients' themselves.

Xarelto: a new drug to reduce surgical risks

One of the most worrisome problems for surgeons is known as venous thromboembolism (VTE) - blood clots such as deep vein thrombosis and pulmonary embolism. These can occur after long operations, even in seemingly healthy people - and can be a life-threatening problem. In the past, we've used compression stockings, pneumatic sequential compression devices, or injectable blood thinners, like heparin and lovenox, to successfully reduce, but not completely eliminate, the risk of VTE's. However, these therapies have been awkward to use, especially for outpatient surgery.

Now, the FDA is looking at approving a new medication that may be very helpful with this problem. Called Xarelto, it's a once a day tablet. Technically speaking, it is classified as a direct Factor Xa inhibitor. According to the studies, it works as well or better than its injectable cousins (like lovenox) at preventing VTE. And unlike Coumadin, xarelto doesn't require frequent blood tests to get the dose right. As an oral medication, it would be easy to patients to continue on this therapy at home, while they are recovering from surgery.

Barring side effects, Xarelto could be a real breakthrough for patient safety. In the field of Plastic Surgery, the obvious application would be for abdominoplasty (tummy tucks), where the risk of VTE is significant. The optimal dosing schedule for plastic surgery patients hasn't yet been worked out.

The drug is approved in Europe. We're hoping for FDA approval soon.

Q-Med announces Restylane with lidocaine

This week, Q-Med, the Swedish pharmceutical company that is the home to Restylane and Perlane, announced Restylane® Lidocaine and Restylane Perlane™ Lidocaine as the latest additions to their Restylane family of dermal fillers. These products have the familiar Restylane and Perlane hyaluronic gel fillers, together with a small amount (0.3 %) of lidocaine, a commonly used local anesthetic, to help minimize the discomfort of the procedure.

According to the studies, the fill effect of the products is unchanged, but 90% of the patients tested said the new products made the treatments more comfortable than the standard formulation.

This allows the company to catch up with Allergan's Juvederm Ultra with Lidocaine product, which has been available in Canada and Europe for several months.

Availability of these products in the USA has not been announced. Hopefully, we'll see these later in 2009. It should be a pretty straightforward approval path with the FDA.

Here in the USA, Prevelle Silk has the combination of lidocaine and HA gel filler - but it is a much less concentrated product than either Restylane or Juvederm. I don't use Prevelle Silk often, as I don't find it is as long lasting around the mouth or smile lines.

Thread Lifts Don't Work

For those of you who are unfamiliar with the term, the Thread Lift was a much-hyped procedure in which a special type of barbed suture would be placed under the skin, to draw the loose facial tissue upward. The idea was to get a facelift-like lift, without actually doing a real facelift. It sounded so promising - just have a few of these magic threads inserted into your cheeks during your lunch break - and voila! - a younger looking you. A number of companies make and promote these barbed sutures, under a variety of trade names.

Well, as we've said before - when you do less, you get less.
Here's some more evidence: in this month's issue of Archives of Facial Plastic Surgery, a study looked at how well the thread lift procedure held up over a two year follow-up period. The answer: not good.

The authors evaluated the results of 33 patients who underwent a thread-lift procedure alone or in combination with other facial rejuvenation procedures to the brow, midface, jowl, and neck. Long-term aesthetic results were evaluated by 4 independent, blinded surgeons.

The thread lift group had a much smaller degree of improvement than the groups that were treated with standard procedures. Furthermore, any early improvement from the thread lift had vanished by the end of the two year study period.

The authors concluded that the short-term improvement of the threat lift was largely attributed to "post-procedural edema and inflammation" (swelling). After evaluating the thread lift extensively, they've decided to abandon it, stating "Given these findings, as well as the measurable risk of adverse events and patient discomfort, we cannot justify further use of this procedure for facial rejuvenation."

Take home lesson: there is no substitute for a properly-performed facelift for facial rejuvenation. Don't waste your time & money on thread lifts.

Saline Lip Implants

I noticed a new (to me) product at the 2009 ASAPS meeting: a saline-filled lip implant. I kid you not.

Known as VeraFIl, it has actually been FDA approved for about a year. Essentially, it is a tapered tubular implant with a silicone shell and a gore-tex outer coating. A tunnel is made in the substance of the lip under anesthesia, and the device is placed and filled - like some sort of miniature saline breast implant.

Theoretical advantages:
- permanent lip enhancement

Possible problems:
- encapsulation and firmness, with possible distortion of lip
- migration of implant (shifting)
- exposure of implant
- infection of implant
- difficulty of removal, with possible irreversible tissue changes / thinning of lip
- less shaping control than with injectable products
- deflation

We've tried lip implants before, with various companies that made Gore-tex tubes for lip augmentation. They felt, in my opinion, like "shoe leather" inside the lip, and thus were not realistically soft, like a lip should be. I didn't use the product.

I have serious doubts that this generation of lip implants will be significantly different.

The company claims that their new design fixes many of the problems with previous types of lip implants. As you can probably tell, I remain unconvinced.

Time will tell.

ASAPS 2009: new technologies in body contouring

At the recent ASAPS meeting, a number of breakthrough new technologies were presented, as potential alternatives / improvements on the standard liposuction technique. Bear in mind that most of these wonder gadgets are still in the developmental phase, and do not yet have FDA approval.

But some of the before & after photos looked pretty exciting! Definitely something to watch for over the next few years!

The techniques presented included:

Focused external ultrasound for fat reduction: "Liposonix", "UltraShape"
Radio-frequency assisted liposuction: "BodyTite"
Water-assisted liposuction: "BodyJet" - which is FDA approved.

The BodyTite before and afters seemed to show some clinically significant skin shrinkage effects. Their built-in skin temperature monitoring system may offer a better degree of protection and higher effectiveness than competiting laser lipo machines. But the UltraShape and Liposonix machines have the advantage of being external, non-surgical treatments with minimal "downtime", even though the results are more subtle than traditional liposuction surgery.

It's too early to tell which horse will win this race....

ASAPS 2009: breast implants & biofilms

One of the big topics of discussion at ASAPS this year was biofilms. Biofilms are a type of bacterial contamination that loves to form on solid, implanted devices like man-made heart valves, contact lenses, orthopedic implants, and yes...breast implants. There is a growing body of research that suggests that these biofilms are linked to the #1 unsolved problem of breast implants - capsular contracture.

Implant-associated biofilms don't cause fevers, redness or typical infection issues. They are difficult to detect without specialized testing. They are resistant to standard antibiotic treatment, and are virtually impossible to clean off from the implanted device. But when the sepcialized tests are done, there is a much higher incidence of these bacterial biofilms in women who have capsular contracture, compared to the tissue around soft, "normal" breast implants. Most commonly, the bacteria involved is Staph. epidermidis - the common bacteria that lives on our skin, and is also found inside the normal breast gland.

So, what does this mean? Well, taking this concept to its logical conclusion would suggest:

1. At the time of the initial surgery, take steps to reduce the chance of implant contamination. This can be done through technical measures such as using an antibiotic irrigation (or betadine) to rinse the implant and the implant pocket. Consider using the infra-mammary incision (more direct) rather than the peri-areolar incision (more contact with breast tissue).

2. At the time of a capsulectomy operation, consider using a brand-new implant (no biofilm), rather than re-using the old implant. Perform total capsulectomy (removing all of the capsule) rather than capsulotomy (cutting the capsule, but leaving it in place.)

3. After surgery, treat the breast implant just like a artificial heart valve, and take antibiotics whenever you have a procedure that might cause bacteria in the bloodstream, like dental cleanings, endoscopy, or minor surgery.

4. Researchers are investigating anti-bacterial coatings for implants, and other longer-lasting antibacterial delivery systems. One promising method involves a compound called Ageliferin, which disperses biofilm, and re-sensitizes the bacteria to antibiotics.

So far, most of the research is lab stuff. There haven't yet been large clinical studies giving us the answers that we need to make day-to-day decisions. But, it's hopeful that we're getting closer to finding an answer for the problem of capsular contracture.

Best new concept at ASAPS 2009 - Revance therapeutics

Sounds like science fiction, right? - a wrinkle-fighter that works without needles...

One of the coolest products in development that I heard about at the ASAPS meeting belongs to a company called Revance therapeutics, based in Palo Alto, California. They seem to be the first ones to have cracked the problem of getting large molecules into the skin. Usually, large molecules can not be absorbed transdermally, so relatively few medications can be compounded in a gel or patch formula.

While there are countless applications for this drug-delivery technology, their first commercial application using this technology is with botulinum toxin (aka Botox), creating a gel that you put on the surface of the skin, in the area of the animation wrinkles, and presto! - you get the expected Botox-like relaxation effect - no needles involved.

It's still in clinical testing, and is not yet FDA approved, but the presentation I saw of their phase I results for wrinkles in the lateral canthal (crow's feet) area were impressive. The stuff works! Applying the gel in the armpit area also works to reduce excessive sweating, again without the multiple injections we currently use.

Besides working for Botox, the same technology could be applied to a number of other drugs. Imagine, for example, using this idea with insulin - diabetics wouldn't need to use needles.

This could be a real game changer, folks.