A new laser treatment for stretch marks? Maybe.

When patients come in with stretch marks, we've traditionally had little to offer them. Retin-A cream helps somewhat. IPL and vascular lasers can be used if the stretch marks are red or purple in color. But that was about it, unless the stretch marks were on the lower portion of the abdomen - and the patient wanted a tummy tuck, which would surgically remove the entire zone of stretch-mark laden skin.

Well, guess what. Just this month, Palomar Medical Technologies announced that their Lux1540 laser handpiece has received clearance by the FDA for the treatment of stretch marks. As you might expect, the company, their accountants and their stockholders are all very excited about this, as now they can market this laser to the millions of women worldwide who have unwanted stretch marks.

As we've discussed before, FDA approval for devices doesn't necessarily imply that the gadget is effective - just that it is reasonably safe. So does this laser really do what it claims?

The Lux 1540 isn't that new - it's a fractional, non-ablative "erbium-glass" laser that's been previously used for skin resurfacing and the treatment of scars. What's new here is the official indication for use in stretch mark therapy. According to the data submitted to the FDA, clinical studies with the Lux1540 achieved an average improvement of between 51% and 75% in the appearance of stretch marks, over a three month time period. Of course, that's corporate-sponsored research. I haven't seen any peer-reviewed, independent studies as yet.

So, the stretch marks got better with the treatment, but did not vanish. Nevertheless, this could represent an improvement over the previous non-surgical therapies we've had for striae....we'll have to see how it pans out in independent trials.

Bottom line: cautiously optimistic.

Juvederm XC announced - more comfortable injections

Allergan, Inc. announced today it has received approval from the U.S. Food and Drug Administration (FDA) for JUVÉDERM® XC, which is JUVÉDERM with a little xylocaine added in. Xylocaine, known in the U.S. as lidocaine, is a local anesthestic agent used for numbing the skin, and this should make the injection process significantly more comfortable for our patients.

JUVÉDERM® also received their "one year indication" from the FDA, which means they are now permitted to advertise as having "the first and only hyaluronic acid dermal filler approved by the FDA to last up to one year from initial treatment".

In the clinical study comparing JUVÉDERM XC (with lidocaine) to regular non-lidocaine JUVÉDERM, 93 percent of patients reported less pain when treated with the new formulation of JUVÉDERM, while maintaining a similar safety and effectiveness profile to the non-lidocaine formulation of JUVÉDERM®.

Of course, don't use this product if you have a lidocaine allergy.

FDA approves Cytori's PureGraft fat grafting device

This week, the FDA approved the PureGraft device, made by Cytori Therapeutics. This device greatly simplifies the collection, processing and re-injection of fat. It could be a major "game-changer" for both cosmetic and reconstructive plastic surgery.

Until now, one of the major issues with fat grafting has been that it is a slow and tedious procedure with an unpredictable outcome: it's hard to know how much of the transferred fat will actually survive the move to the new location, even with the use of the specialized techniques developed by Dr. Sidney Coleman and others. We liposuction out the fat with specialized instruments, centrifuge it, reload the good quality fat into small syringes, then inject it slowly and carefully, just a little bit at a time, into the desired area. Then we hope and pray that the injected fat will survive in its new location. Sometimes, we watch as it melts away almost totally in several months - and that's so frustrating for both patient and surgeon!

The Cytori device should allow more predictable, less laborious fat fat grafting procedures. The PureGraft device not only purifies the fat, but increases the number of the patient's own stem cells in the material to be re-injected. This "turbo-charging" effect of the stem cells seems to lead to better outcomes, in recent research studies, with a higher rate of fat survival and less fat necrosis.

I'm very excited by this new technology. I think it's the next big thing.

Dr. Fiala tests the "Keller Funnel"

Ever see a product and go, "I wish I had thought of that"? Today, I tested a new surgical product called the Keller funnel, named after its inventor, also a plastic surgeon - and I had that very same sentiment.

Essentially, the Keller funnel looks like a high-tech cake decorator's funnel, the triangular bag with which cake icing would be squeezed onto a cake - except that this one is made of fancy materials, is sterile, and has an inner surface which is coated with a slippery space-age coating. Dr. Keller devised it to help plastic surgeons place silicone gel breast implants more easily during surgery, through smaller incisions, and with potentially less contamination or chance of implant damage.

While these other possible benefits haven't yet been scientifically proven, the gadget certainly does work for its primary purpose - the implant slides into the surgical pocket, easy as can be.

If the company can produce these at a reasonable price, I think they'll have a winner.

A new device to improve mastopexy results?

One of the frustrating problems of breast surgery, particularly breast lift surgery, is the nature of the skin. It stretches out - frequently more quickly than either the patient or the surgeon would like, leading to a loss of the uplift or shaping effect of the mastopexy (breast lift).

Surgeons have been trying various methods for years to overcome this problem, with varying success. Literally dozens of different methodologies have been published - with varying results and acceptance.

One new idea, developed in South Africa, is the "breform" internal bra system. This is a soft, polypropylene fabric material, which is shaped much like the cup of a bra. At the time of breast lift surgery, it is implanted into the breast, about one-half inch beneath the skin, and secured to various fixed locations around the breast. Supposedly, it acts as an internal support system, reducing the problem with recurrent stretching out of the skin. This concept has been described in a similar way previously, by the South American Surgeon, JCS Goes. The Breform system uses a different mesh material, and features pre-sized, pre-formed implant shapes - making it an easier-to-use modification of Goes' original idea.

And the early results reported seem promising. The breast shape seems to maintain itself much better than traditional mastopexy surgery.

Before you all get excited, though, let me state that the Breform system is not yet FDA approved - but has been used for a number of years in the U.K., Europe, and South Africa.

Concerns about this technique include:
- higher possibility of infection
- interference with mammography
- subcutaneous scarring / capsule formation around the mesh
- palpability of the mesh
- mesh exposure
- mesh malposition / asymmetry
- interference with subsequent breast surgery / breast biopsy

The proponents of this technique claim that the issues are not a significant problem with this product, but currently, their follow-up is only 4-5 years in length.

We'll have to watch this technique with interest. The surgical results certainly look attractive, and the quoted complication rates appear low. Hopefully, one day it will become an option for American women as well.

The Lipo-laser: does it work?

We are now starting to see ads in Orlando for a new fat-melting treatment, a laser beam that melts fat after shining the beam on the the skin. Known as the "lipo-laser", or more properly, the Zerona, the manufacturer claims that its use can result in the loss of inches of fat - without surgery, injections or other invasive procedures.

The laser used in this machine, is a 635 nm wavelength diode - the very same laser that is commonly used in many hand-held battery-powered laser pointers. According to the manufacturer's website, the laser power is listed variably in different parts of the webpage, between 7.5 milliwatts and 14 milliwatts, which again is only slightly more than the typical 5 milliwatt laser pointer. (By way of comparison, most lasers used for ablative skin resurfacing treatments are in the neighborhood of 30 watts or more, or four-thousand times more powerful.) Thus, this new machine falls into the category of "low-level laser therapy".

The FDA has approved this device - in the same category as an infra-red heating lamp - according to the FDA's own 510(k) document posted on the laser manufacturer's website. N.B: it's not currently approved as a fat melter.

Neira and associates have been enthusiastically promoting the use of low level lasers to help with liposuction for several years. They claim that use of this type of laser leads to a deflation effect on the individual fat cells, resulting in the contouring effect.

This claim is certainly controversial. A study published in the Plastic and Reconstructive Surgery Journal, performed by the well-respected Plastic Surgery & laser group of Brown, Rohrich, Kenkel, Young and associates at UTSW, carefully duplicated the Neira protocol for laser fat treatment. However, they found no appreciable difference with this laser treatment, comparing the fat before and after treatment under a scanning electron microscope. Zip. Zilch. Nada. There was no effect whatsoever on the fat in the treated area, and certainly no evidence of any fat-cell deflation.

I have no personal experience with the new Zerona machine, and while I would love to have a non-invasive method to treat fat, the physics of the device make it hard to believe that the beam could possibly penetrate through the skin down to the underlying fat with enough energy to do anything.

I'll need to see better evidence from independent researchers before I can accept and recommend this treatment. To me, it seems like waving a laser pointer over the skin, and somehow expecting the fat to magically disappear. Caveat emptor.

Dysport - now here

Dysport - the recently approved competitor to Botox Cosmetic - is now being shipped to U.S. physicians. We have both products in our office now, and are testing Dysport, seeing how it compares to Botox, the market leader. So far, there are some subtle differences, but both seem to work well in relaxing dynamic wrinkles of the face.

It will take a little education for patients to get used to the fact that the drug doses are measured differently. Botox units are not the same as Dysport units, even though they sound similar. It's a bit like measuring someone's height in feet, compared to measuring it in yards. Same height, just different numbers. Dysport comes in a 300 unit bottle, Botox comes in a 100 unit bottle - but the clinical effect is approximately the same, as far as we can see, with a 3:1 ratio.

Dysport is priced so that it is a little less expensive than Botox (at the 3:1 conversion ratio), so patients who wish to save a little money while they are fighting their wrinkles may want to give Dysport a try.