More consolidation in the laser industry

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Big laser companies just keep getting bigger....

This week, Cutera, the California based laser company, announced that it had acquired laser competitor Iridex for $5+ million, adding Iridex and Laserscope-branded devices to their stable of lasers.

Just a few months ago, Solta Medical, the makers of Thermage radiofrequency units and Fraxel lasers, purchased Liposonix, the new FDA-approved fat melting technology, for $35 million.

No wonder those darn lasers are so expensive!

photo credit:  laserfest.org

Ulthera is under-whelming

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Ulthera is a new non-invasive skin tightening device.  The idea seems promising:  use intense focused ultrasonic energy to target tissue deep to the skin, heat and coagulate the tissue, thereby getting some tissue shrinkage and tightening.  It's had great press on the various TV talk shows.  It is FDA approved - so we know it's safe.  The question is:  does it work?

This week, at the famous Baker-Gordon plastic surgery symposium in Miami, Dr. Jeff Kenkel from Dallas reviewed his experience with the machine.  It wasn't good.  The treatments were painful for the patients.  The results, using the standard protocol, were hard to see in the neck and face, even comparing side-by-side before and after photos.  The Ulthera treatment, however, did seem to work to give a subtle lift of the eyebrow area.(average lift :1.7 mm).  It was, in my opinion, underwhelming.

Nevertheless, Dr. Kenkel and his group are going to press on, and are in the process of developing a new treatment protocol to see if they can get some improved results in the face and neck...   Honestly, I'm glad I didn't purchase that machine - I think I would have been very disappointed with the subtle results that were presented.  I suspect that many of my patients would feel the same way:  they expect more results for their money.

Updated guidelines on DVT prevention

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This month, an expert group of physicians and surgeons has published their latest guidelines on preventing, diagnosing and treating blood clots - DVT's and pulmonary emboli.  It's a massive report, known as AT9 - even the executive summary runs 39 pages.  It can be found here.

Why do we, as plastic surgeons, need to know this stuff?  Because DVT's and PE's are serious, even lethal, problems that can happen after any long surgery.  So we take this stuff very seriously.  Patient safety, to steal a line from Ford Motor company, is job one.

Here are the latest recommendations for healthy plastic surgery patients:
1.  Pretty much everyone who goes to the operating room needs to be wearing sequential compression stockings (SCD's), unless they are less than 40 years old, and having a operation less than 45 minutes long.  We already do this.

2.  Most of the bigger cases (tummy tuck, lower body lift, etc.) should receive low molecular weight heparin - also known as "Lovenox".  We already do this too.

3.  People that are at very high risk should get both the SCD's and the Lovenox.  The way this" high risk" label is sorted out is based on a scale called the Caprini score.  My friends from the University of Michigan have done a lot of work, researching the use of this scale in plastic surgery patients (link to study).  You can see the details of the Caprini score there - it's a one page, easy to use system.

What's not totally settled in this latest report is the best timing for administering the Lovenox - 12 hours before surgery, at surgery, or sometime after surgery.  Currently, we follow the recommendations initially developed in by Orthopedic surgeons - who get a lot of DVT issues after hip and knee replacement surgery - and give it 10-12 hours post-op.  I'll be digging through the full report to see if I can find out more about this important detail.

This is one of those basic issues in plastic surgery that, although not as exciting as discussing celebrity surgery or the latest gee-whiz gadget, makes things safer for everybody.  If you are planning a big surgery, ask your surgeon about the methods he or she is going to use to prevent you from getting a DVT.

US adult obesity figures released, 1999-2010

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The latest numbers in the American obesity epidemic were released in this month's issue of  JAMA.

Here's the one bit of good news:
-  American women, overall, aren't getting any bigger than they were during the last study, which looked at the 1999-2008 data, but 35.8% of US women still fit the BMI-derived definitions for obesity.  The average age-adjusted BMI was 27.3

The bad news:
-  More American men are obese than before, with 35.5% nationwide (more than one-third) being obese.  Average age-adjusted BMI was 28.7.

By comparison, in England, the prevalence of obesity is considerably less:  22.1% for men, and 23.9% for women.

photocredit: cslacker.com

Cellulaze - a new laser treatment for cellulite?

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Just this week, the FDA has given their approval to the marketing of a new laser from Cynosure called Cellulaze.  Like the name suggests, it's a surgical laser treatment for cellulite.  Here's how it works:

With the help of local anesthesia, several small incisions are made near the area of cellulite.  A laser fibre is inserted under the skin, and a 1440 nm wavelength side-firing laser is used to treat the area of cellulite.  The laser helps by both melting the excess fat, and releasing the tethering bands that give cellulite its indentations.  And it seems to work, with a high degree of patient approval in preliminary studies.  Before and after pictures (shown above) seem to show a nice improvement - but of course, these are on the corporate website, so one would only expect to see their best results!

Nevertheless, this is the first laser treatment specifically proven to improve cellulite, with at least a one year follow-up study showing positive results and minimal side effects.  Dr. Barry diBernardo, fellow ASAPS member and plastic surgeon, presented his experience with this device at last year's scientific meeting, and he seemed impressed with the technology.

So, it looks intriuging...time will tell if it's really as good as the marketing hype suggests, and whether it is better than our current selection of skin tightening devices.  For now, we're seeing nice improvements in cellulite with our Venus Freeze RF device - no incisions required!

More data on Brava-assisted fat grafting for breast augmentation

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New meaning to the term "drug bust"

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According to the Daily Mail newspaper (London), a 33-year-old woman was charged in December with international drug trafficking, after she was found carrying more than five and a half pounds of cocaine - with an estimated value of £250,000 - that had been molded inside some artificial breast and buttocks inserts ("falsies").

The woman, a model identified only as MFM, was detained by security personnel at Rome's Fiumicino Airport after a flight from Buenos Aires, Argentina.  "She tried to distract them with a plunging neckline and tight outfit, but they (security personnel) stopped her for questioning because she was so alluring," Fiumicino Airport Police Chief Antonio DiGreco said.

Botox versus Dysport

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This month, in the ASJ, comes another study looking at the Botox versus Dysport battle.  Patients are always wondering - "which one is best?".  Some patients swear they do better with one medication compared to the other.

In this paper, a randomized, controlled study, 53 patients had Botox on one side of the face, and Dysport on the other.  They were then followed for 150 days to see how they did.  The usual conversion ratio of 2.5 units of Dysport to 1 unit of Botox was used, in equal volumes of solution.

Results:  no difference - in this trial, both sides were totally comparable and equal, from day 2 out to 150 days post-injection.

As I've  said before, it's a bit of the "Coke versus Pepsi" situation... pick your favorite, as both Botox and Dysport are both equally effective.  And of course, we offer both here at our Orlando office.

Want smoother, firmer skin? And less cellulite?

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There's a lot of machines in the medical marketplace that claim to be "the answer" for non-surgical skin tightening.  Many of them work...a little bit.  But I wanted something that would give my patients real and measurable results.

In addition, it had to be painless, have no side effects, and be FDA cleared.

Now, I'm pleased to tell you that following a lot of comparison shopping, it's now here, sitting shiny and new, in my Orlando office.  Although you've probably never heard of the "Venus Freeze" before, I think it's going to be a name that you'll want to know.  It's proven to firm and tighten skin, reduce fat, and improve cellulite.  And it's painless - unlike the Thermage, the Accent, and a number of previously hyped gadgets.

You'd guess, with a name that has "Freeze" in the title, that the machine would work by cooling the tissue, much like the Zeltiq machine does.  Nope.  It actually works by heating the dermis and subcutaneous tissue, using something called radiofrequency energy, or RF for short.

Turns out this RF heating process activates the production of new collagen and elastic fibers in the skin, which is a good thing.  It also activates a lipase enzyme - a fat melter - and so it can be used for modest contouring improvements, too.

Now this RF technology has been around for a number of years.  There are couple of unique things that make this machine better than previous efforts, like the design of the handpiece.  Instead of only 1 or 2 electrodes (as in earlier designs), the Venus Freeze uses an 8 electrode design.  This divides up the treatment energy more evenly, achieving uniform heating (good!) and avoiding painful heat spikes.  This makes the treatment safe, painless and pleasant.  The new design and higher power output allows the RF energy to go about an inch into the tissues - much more than previous designs on other machines.

Also, unlike laser or IPL, this kind of treatment can be safely used whether you are tanned or not, and on skin of all shades and types.  Almost all areas of the face and body can be treated.  Typically, treatments are done once a week, 6-8 times for the face and 8-10 times for areas on the body.  Depending on the area, treatments take about 25-45 minutes.

Our test patients have commented on smoother, firmer feeling skin, an improvement in their cellulite, and even a loss of about an inch around the waist and bra fat area....and that's after 3 or 4 treatments, not even the whole series.  Three benefits in one!

Of course, this isn't a magic wand.  It doesn't compare to what can be done with surgery, such as a facelift, tummy tuck or liposuction.  But it very favorably compares with any other non-surgical machine currently on the market.  I predict that it will become very popular in our Orlando office - already, all my staff have told me they want a treatment!

Come on in and give it a try.  We've got a special introductory package available for the next 3 months.

Timing of surgery doesn't affect complication rates

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Did you ever wonder whether a surgery on Monday or Friday was riskier than one during the rest of the week, or whether surgery in July, when there are new interns on the wards in teaching hospitals, was riskier than a surgery in May? Well, a new study has analyzed this...and there's no difference in the rates of post-surgery death.  So, while you might not buy a car made on a Monday, it's perfectly fine to have elective surgery then!

Here's the rest of the story, from Cosmetic Surgery times....

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Cleveland — Results of a recent study suggest that the timing of surgical procedures — afternoon versus morning, Friday versus Monday — has no effect on the risk of post-surgery death.

Researchers from the Cleveland Clinic analyzed the outcomes of 32,001 elective surgeries performed from 2005 to 2010. The risk of death within 30 days after surgery was analyzed according to time of day (6 a.m. to 7 p.m.), day of the week and month of the year. As much as possible, emergency and urgent surgeries were eliminated from the study.

Researchers found that the overall risk of death within 30 days after surgery was 0.43 percent, and that after adjustment for other factors, mortality risk was not significantly different for patients operated on at different times of day. The same was true for operations performed later in the workweek. The study also shows no increase in mortality in July and August, when new residents begin work.

According to a report in Medical News Today, the findings help to alleviate concerns that fatigue may contribute to higher rates of safety problems for operations performed later in the workday or workweek.

The study appears in the December issue of the journal, Anesthesia & Analgesia.

Tightening up Florida liposuction requirements - it's about time!

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According to the Sun-Sentinel, there is a bill working its way through Tallahassee which will make some improvements to safety standards for office-based liposuction.  Honestly, it's about time!

The bill would require liposuction of more than 1000 cc of fat to be done in surgery suites inspected by the state, and would require doctors to have life-support training.  Currently, many low-cost providers perform liposuction in unregulated physician offices, and lack ACLS training.

I think this is definitely a step in the right direction!  All surgery, in my opinion, should be performed in an accredited setting, with appropriate anesthesia, monitoring, and emergency equipment.  For example, we are inspected and certified by AAAASF.  In addition to myself, an MD anesthesiologist, two registered nurses and a surgical tech are present for all surgeries.  Everyone has an up-to-date ACLS certification.  We have hospital-grade anesthesia monitors and a crash cart with an AED and emergency medications.  Thank goodness, we've never had to use all of this emergency equipment - but we sure are prepared, "just in case".

Happy Holidays!

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I'd like to wish our friends, family, patients and staff every happiness this holiday season and throughout the coming year.

The best part of this season is remembering those people who make the holidays meaningful. May your holidays be filled with joy and peace.

All the best,
Dr. Fiala

More trouble with PIP, the French implant company

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Although this doesn't apply to us here in the U.S., you might remember hearing about some troubles with the French implant maker PIP.  The news initially broke last year that PIP had been using a cheaper industrial grade silicone in their silicone gel breast implants, rather than medical grade silicone.  They were promptly shut down by French regulators.  Now, there's some more news...

This week, the French health ministry said that these PIP brand implants were much more prone to rupture and leakage than normal, and recommended implant removal (and replacement with new, better implants) as a precautionary measure.  They stated there was no evidence of a cancer link due to these implants.  The French government says it will cover part of this cost for patients under their healthcare plan.  (They'll pay to have the implant removed - but not to replace it.)

It is thought that some 30,000 French women, and even more in other parts of Europe and South America have these PIP brand implants.  That's a lot of patients who are potentially going to need surgery.  PIP, now bankrupt, was once the world's #3 manufacturer of breast implants.

The implants we use in our practice, made by Allergan and Mentor, are FDA-approved, and have an excellent track record.  I've been to the Mentor manufacturing facility in Texas, and it is a top-notch facility run using ultra-sterile "clean rooms" with the employees in those "Intel-inside" type sterility suits.

Fortunately, PIP implants were not used in the United States.  However, if you happen to have had your breast implants done in Europe or South America, check to see if you have PIP brand silicone implants.  If you do have them, please come and talk to us about an implant exchange.

Valeant Pharmaceuticals buys Sculptra

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In a $425 million deal, Valeant Pharmaceuticals has purchased the dermatology unit of Sanofi-Adventis.  For us, this means that Valeant will now be in charge of marketing Sculptra, the facial injectable filler agent.

Sculptra is different than other dermal injectable fillers, like Restylane or Juvederm. It stimulates your body to produce some lost collagen, which can gradually improve the quality of the skin and reduce wrinkling and deep hollows. It also lasts up to two years. It's been quite helpful in restoring hollow cheeks and temples, as well as improving deep naso-labial folds. It's quite popular here at our Orlando office.

According to our Sculptra rep, we may be seeing more direct-to-consumer marketing of Sculptra with the new owners, but little else will change.  So far, we haven't heard about any pricing changes, either.

Sanofi, apparently decided to divest its dermatology business with the intention to further concentrate on its core products.

How can we get upper pole fullness without using breast implants?

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Upper pole fullness is the term plastic surgeons use to describe the desired shape of the upper part of a breast.  Many women like the look of some upper pole fullness.  The challenge for us is how to make this shape during surgery, and have it stay there.

Certainly, breast implants are a proven way to get upper pole fullness.  Moderate and high profile implants, whether they are saline or silicone gel filled, clearly create that fullness and roundness.  I  call this "the implant look".

Fact is, it is a real challenge to get the uplifted "implant look" without using breast implants.  Not that surgeons haven't tried:  if you look at the literature on breast lifts and breast reductions, there are literally dozens of strategies that have been tried.  There are the "internal bra" methods, the internal suture methods, internal tissue re-arrangments, and many more.  These may very well work for the first month or two, especially while the breast is still swollen from surgery - but the real question is, do they last once the swelling has gone?

Dr. Elizabeth Hall-Findlay, the talented plastic surgeon from Canada and author of a textbook on surgery of the breast, did her own experiment on this problem.  She tried virtually every sensible method during breast lift surgery to try to solve the mystery of how to get persistent upper pole fullness without an implant.  She presented her results at a recent plastic surgery conference.  She found that, although the results looked promising initially, by 6-12 months after surgery, the shape of the breast returned to what it was pre-operatively, and that the fullness was lost.  Nothing really worked; all of the methods she tried failed to give lasting upper pole fullness.

This month, in PRS, comes a new study reviewing 82 major previous publications in breast lift surgery.  Careful photometric analysis was done of the techniques.  Once again, it's a disappoinitment.  With the possible exception of fat-grafting to the breast, the author found that  upper pole fullness "was not increased by any of the mastopexy / reduction techniques, or by the use of fascial sutures or autoaugmentation techniques".

In other words, all the methods touted for upper pole fullness failed to work.  So put internal lifting sutures, auto-augmentation, and the "internal bra" on the scrap-heap of discredited methods.

What does this mean for patients?  Simple:  if you want the "implant look", you have to have an implant.  Fat grafting might be an option, too - but we're still waiting for the studies on that one.