There are several very popular non-surgical methods of fat reduction using external devices based on a variety of penetrating energies. One example is the Zerona device which uses a form of light known as a ‘cold laser’. While it is a fat reduction device that is associated with some level of controversy, it has generally been effective in my two practice locations over the past two years. By our own experience and post-treatment evaluations, we have an approximate 70% satisfaction rate.

However, this satisfaction rate is based on a patient population that is almost exclusively women. When asked by a husband of a patient that I was treating for another plastic surgery problem about how well the Zerona would work for him and his big belly, my answer was both hesitant and reserved. It was at this point that I launched into an explanation of the anatomy of abdominal fat.

Fat in the abdominal area is comprised of several very distinct anatomic locations or layers. When most people think of abdominal fat they are thinking of what exists in the subcutaneous layer, that fat that lies between the skin and the abdominal muscle wall. I would call this superficial abdominal fat. But deep to this on the other side of the abdominal muscles lies intra-abdominal or the deep fat. Technically, intra-abdominal fat is divided into either intraperitoneal and retroperitoneal sites. The more relevant intraperitoneal fat is distributed in the mesentery of the intestines and an abdominal organ known as the omentum. Depending on the size of the person, intra-abdominal fat can make up as much as 10% of one’s total body fat mass and high amounts of it are associated with increased risks of cardiovascular and metabolic diseases.

When men ask about methods to reduce the size of the stomachs, the issue of intraperitoneal fat becomes very relevant. In andromorphs, fat is commonly stored intraperitoneal. So men with a big ‘beer belly’ have a considerable amount of intraperitoneal fat and much less, by comparison, of fat in the superficial or subcutaneous layer. This can be felt by examination in how the belly feels to the touch. The big belly in a man will usually feel very firm and hard like a watermelon. This is the intraperitoneal fat underneath the muscle pushing the abdomen out and explains why it feels so firm. In contrast, women have a much higher percentage of their belly fat in the subcutaneous layer. This is why a woman’s big abdominal area will feel much softer and jelly-like. (although this is not true for every big-bellied woman)

So for most men, whether it is a non-surgical device or even liposuction, much of the target fat is too deeply located for them to be effective. This can led to disappointing results. An examination is needed of a man’s belly to determine if there is any significant thickness to the subcutaneous layer. If there is some softness and compressibility and a handful of skin and fat can be pulled off of the underlying muscle layer, then there is enough target fat that may justify non-surgical or surgical fat reduction treatment. Otherwise, only weight loss through diet and exercise will be effective.

Dr. Barry Eppley

www.eppleyplasticsurgery.com

Indianapolis, Indiana

An internet story reports:

‘Dr. Oz calls Zerona the miracle procedure that removes fat without surgery. On his Monday May 16^th TV show, Zerona laser treatments were featured as one of the ways to get rid of fat in order to slim down and get swimsuit ready for the summer. Given that Zerona does not kill the fat cells and there is no pain, swelling, bruising or downtime, it was an excellent topic to be covered in the show.’

The company marketing statement to this internet story/TV trailer was:

‘Zerona is the most researched medical procedure on the market. Our goal is to provide safe and effective health and wellness products to our physician partners. With this goal in mind all of our products are backed by the highest quality of clinical research. The low-level laser technology utilized by Zerona has been researched by Erchonia and published in numerous peer reviewed journals for cosmetic and health benefits.

Zerona is the only device that contours the waist, hips and thighs simultaneously with no side effects, pain, bruising or surgery and you can see the results in weeks not months. Our Zerona physicians have treated in excess of 40,000 patients, with an average reduction of 4.1 inches in just two weeks.’

While this all sounds wonderful, what is the results and experience from an unbiased source? My Ology spa facilities have had two Zerona machines in two separate locations for over six months. We have treated in excess of 50 patients who have completed Zerona series of either 6, 9 or 12 treatment sessions. The vast majority of been on the typical protocol of water intake and the Curva (niacin) supplement during their treatment period. More recently, we have placed some patients on HCG (human chorionic gonadotropin) sublingual drops instead of the Curva supplements.

Admittedly, I was very skeptical from the beginning of how such a non-surgical treatment would work. How is it possible that low energy laser light could cause fat cells to shed some of their contents? By then again, I don’t profess to know how I can be on an elevator and be watching a video on my iPhone either. Both concepts seem to defy my understanding of energy transmission.

Our patients results parallel fairly closely that which the manufacturer reports. In short, we have found about a 70% positive response rate with an average circumferential loss of just over 6 inches. This response rate means that 7 out of 10 patients treated saw significant results and were happy they had the treatment. About 20% saw some improvement which was not as much as they had hoped, averaging about 2.5 inch circumferential loss, but they were unhappy that they did the treatment. This left about 10% of the patients who saw no improvement at all including one who actually gained circumferential inches. All ‘failed’ patients did go on to have either liposuction and/or tummy tuck surgery.

One important thing to understand about the inches lost is that does not represent a single circumferential body area. Most patients would understandably think that this is how much was lost from the waistline…and that would be really impressive for a non-surgical treatment which takes just a few weeks to complete. However it refers to a collection of circumferential measurements from four different areas combined. The results are still quite good but don’t be misled into thinking that is all from one area.

Dr. Barry Eppley

www.eppleyplasticsurgery.com

Indianapolis, Indiana

Zerona is a body contouring device that uses low energy (cold laser) technology to effect spot fat reduction. Through a photochemical effect, fat cells in the path of the light energy become temporarily leaky and shed some of their lipid contents. These free fatty acids are removed from the release sites by a natural clearance process and eliminated through the liver. The manufacturer of the Zerona device suggests taking a supplement called Curva, which is a combination niacin and ginko, which allegedly aids in the lipid clearance process.

In weight loss management, there are numerous medications and supplements that have variable amounts of effectiveness. Adding a weight loss component to a Zerona treatment series is a logical application of known fat management and pharmacology. Patients should get an enhanced result with a more comprehensive approach. One of the intriguing hormonal supplements with a long history in weight loss is HCG. Once popular in the 1970s it fell into disuse until recently. It has now resurfaced as a weight loss medication and is gaining renewed interest.

HCG or Human Chorionic Gonadotropin is a hormone produced in pregnancy that is made initially by the developing embryo after conception (hence the positive pregnancy test) and later by the placenta. Its primary role in pregnancy is to help nourish the growing fetus by releasing the nutrients in fat from the mother’s body. This hormonal role has lead to a lot of research that has looked at its potential role in adult weight loss and obesity. While its exact role in fat metabolism can be debated, it is currently thought that it likely exerts its effect by stimulating testosterone, an anabolic hormone that causes weight loss in both men and women.

Taking small daily doses of HCG (approx. 125 IU to 200 IU) can help in the weight loss process, particularly when combined with other treatments such as Zerona and a calorie-restricted diet. When accompanied by a low calorie diet of approximately 1000 calories, HCG has emerged as a very useful adjunct. People fear dietary restriction because they know they will feel hungry or deprived. However, on HCG people do not feel the same as with the usual diets. This occurs because the HCG instructs the body to utilize fat reserves through the hypothalamus. Thus the body becomes flooded with 2000 to 3000 calories from these reserves, which along with the calorie intake, is more than sufficient to take care of your daily nourishment. As a result, not only will you not feel hungry but your energy levels stay high.

The combination of HCG with by your Zerona treatments creates a combination fat reducing effect. Zerona targets problem areas with its cold laser technology for spot reduction, HCG helps the body with overall fat and weight reduction. Your Zerona treatments will last only several weeks but your HCG supplement should be taken for 40 days.

ZERONA/HCG Treatment Protocol

1)  Administer 250 IU HCG per day for 40 days.

2)  Calorie restricted diet (1000 calories per day)

Breakfast: An apple, orange, one-half grapefruit or 1 cup non-fat yogurt

Lunch/Dinner:

One type of meat - 100 grams of beef, chicken, fish or seafood.

One type of vegetable - spinach, tomatoes, celery, beet-greens, chard, chicory, green salad, onions, red radishes, cucumbers, asparagus, cabbage.

One type of bread: One breadstick or melba toast

One type of fruit: apple, orange, half-grapefuit or a handful of strawberries.

Disclaimer: These statements have not been approved by the FDA and are not intended to diagnose, treat, cure, or prevent any disease.

Dr. Barry Eppley

www.eppleyplasticsurgery.com

Indianapolis, Indiana

In August 2010, the Erchonia Corporation was granted market clearance by the U.S. Food and Drug Administration for the non-invasive body contouring device known as Zerona. This is a brand name and in and of itself conveys nothing about what it does or how it works. Zerona is the first non-invasive device to receive FDA approval for circumferential reduction of the waist, hips, and thighs.

The Zerona works by emitting a low-level energy (hence the name ‘cold laser’) that effects fat cells through a photochemical process. It generates no heat in exerting its effects and thus is both safe and painless to undergo a treatment. Zerona has been clinically proven to target fat cells causing their immediate collapse thereby significantly reducing body volume. Through a natural process of fat removal, the laser-released fat is safely removed and broken down, providing patients with a truly non-invasive procedure without side effects or downtime. 

 As many patients may not know, the FDA grants approval based on the completion of a placebo-controlled, randomized, double-blind, multi-site clinical investigation. Zerona performed and submitted such a study which included 67 patients. The results from the study demonstrated an average inch loss reduction of 3.65 inches across patient’s waist, hips, and thighs in as little as two weeks. This study was done without diet restrictions or specific exercise requirements.

While this study data is compelling, it almost seems too good to be true. Can one really lose that much fat and that many inches without surgery in such a short time? As a plastic surgeon, it is initially hard to believe. Since it was approved by the FDA, I decided in my Indianapolis plastic surgery practice to see if such similar results could be replicated. Seeing is believing so to speak. I wanted to know if such clinical results could be produced in a study in which the investigator had no bias or motivation to see good outcomes.

Therefore, we studied our first 10 patients who underwent a full series of Zerona body slimming treatments. These were all women who completed 6 treatments over a two or three period, with treatments spaced anywhere from one to three days apart based on their availability and schedule. These patients were completed between September and December 2010 with the average age of the women being 46 years old. (range between 31 and 62 years of age) They took a daily supplement, Curva (niacin and ginko), and drank as much water per day as they could. Otherwise, there was no dietary restriction or exercise routinues or requirements.

In our Indianapolis Zerona study, the average circumferential measurement reduction was 6.74 inches at study completion. (range 1.7 to 12.65 inches) On a patient satisfaction scale, seven (70%) were extremely satisfied and saw significant improvement, two (20%) were satisfied as they saw improvement but had hoped for more, and one (10%) saw little change or improvement and was not satisfied.

While initially a skeptic, our first Indianapolis results were better than expected. While numbers are one thing, the most important barometer of any treatment is patient satisfaction. If a patient states they are satisfied or very satisfied, then the results have met their criteria for improvement regardless of the measurement numbers. When it comes to the measurement numbers, it is important to point how what they really mean. When you have an average number of inches lost of 6.74 inches, this does not mean it comes from the waistline or from one single body area measurement. Rather it is the collective number of inches lost from a combined number of cirumcumferential measurements including the waist, hips and thighs.

What do I conclude from our own study? First, Zerona is not magic nor is it equivalent to liposuction surgery. And it does not work well for everyone. But it appears to offer a non-surgical treatment for those patients who want to see if they can avoid liposuction surgery or need some help with their own diet and exercise program. While no guarantees can be made about results, most patients do end up see some visible body changes and were happy that they had the treatments.  

Dr. Barry Eppley

www.eppleyplasticsurgery.com

Indianapolis, Indiana

Recently the Erchonia Corporation, a producer of low-energy laser devices, was given granted FDA approval for the body contouring device known as Zerona . It is used as a noninvasive device to treat fat circumferential reduction of the waist, hips, and thighs. With this approval comes a lot of enthusiasm on the part of patients and skepticism on the part of numerous physicians. Patients are willing to grasp at anything short of liposuction and surgery to help them lose some fat. Physicians are understandably skiddish about touting something that has always been elusive plus the financial risk of a capital equipment purchase.

Hype and marketing aside, what are the actual study results which the FDA reviewed? The approval was based on a placebo-controlled, randomized, double-blind, multi-site clinical study evaluating 67 patients that went through the treatment protocol. The results showed an average inch loss reduction of 3.65 inches across the patient’s waist, hips, and thighs in two to three weeks. This clinical trial did not require the patients to be on a special diet or do a certain amount of exercise. What is particularly noteworthy about this study and approval is that it was done on a PMA application, not  a 510K. Since there were no previous devices commercially available that performed non-surgical fat reduction on which to compare, Zerona had to undergo the review process from scratch. This type of review is a lot more critical and rigorous than if a comparative device was already FDA-approved. Review of the documents show Erchonia submitted the study results in the summer of 2008 and it took two years (and a lot of questions in between) before it was granted approval for safety and effectiveness.

One of the main reasons that skepticism exists with Zerona is that its mechanism of action is below the human threshold for perception. It emits a low-level, or cold, laser energy that causes no heat to build up and be felt on the skin. Because the laser light causes no visible effect on the skin and no pain, it appears incongruent with how we perceive lasers to work. After all, aren’t lasers bright streams of concentrated light that vaporize anything it hits? I don’t understand how cell phones work either, and I have tried to grasp the physics of them, but I have proof on a regular basis that they do.

Through a photochemical (not photoelectric or acoustic) process that is specific to fat cell walls, the laser energy make them leaky. With this very temporary leakiness, the lipids (fatty acids) come out making some fat cells completely collapse. If enough of that occurs, fat volume will be reduced to a modest degree. These loose fatty acids are picked up by the lymphatic system and passed through the liver, the body’s phenomenal filter system which breaks them down and eliminates them. (they are not recycled) This entire process can obviously be enhanced by conventional methods of weight loss including diet and exercise.

Very interestingly, in a completely different and independent study from last year, Erchnoia reported that Zerona had been shown to reduce the levels of the hunger-hormone, leptin, and lipoprotein (LDL). In a 22 patient pilot study. Zerona not only reduced circumferential inches following a two week treatment phase but also lowered patients’ leptin levels and reduced low-density lipoprotein numbers in over half of the participants in the study period. It should be noted that this was a pilot study and was not conducted in a more formal study fashion so these results should be viewed as interesting and promising but not as a scientific fact.

Dr. Barry Eppley

http://www.eppleyplasticsurgery.com

Indianapolis, Indiana

The concept of non-surgical fat loss remains the holy grail of body slimming. Any alternative to liposuction surgery for body contouring will always have significant appeal. The first real promise of that approach was several years ago with the previously popular, and now largely defunct, use of lipodissolve injection therapy. Using an emulsifying combination of chemicals, injections were placed into selected areas for fat reduction. While this injection approach was able to remove some fat, it was not pain-free and caused a fair amount of swelling afterwards. Because these injections had to be repeated numerous times with the same amount of discomfort and swelling, their use have largely faded in popularity.

The newest approach to non-invasive fat reduction is Zerona. This is a treatment approach that uses cold laser fat reduction technology and is FDA-approved. A low-level laser is used in the office to spot areas of desired fat reduction. Each complete session takes about 40 minutes. The laser is applied to the targeted areas such as that of the waist, hips, and thighs, for 20 minutes. Then the same treatment is applied to the opposite side. Multiple sessions are required every two to three days for several weeks. At least six treatment sessions are required. Further treatment sessions may be needed based on results and desired improvements.

Unlike lipodissolve injection therapy, Zerona treatment sessions can be accurately described as non-painful and even relaxing. You simply lay in a comfortable position for twenty minutes at a time while the cold laser does all of the work. Some patients describe  feelings of being a bit different or lighter immediately afterwards, presumably due to the bio-stimulation that has been caused by the laser.

One key element that separates Zeroma from lipodissolve is the accompanying recommendations/therapies that should be used during the treatment program. Increasing your fiber and water intake helps to both improve and speed up the treatment results. Lymphatic drainage massages can also be very helpful after each treatment session. The use of a combination niacin and ginko baloba supplement is suggested to also supplement the cold laser treatments. Another prescription aide that can also be used is Adipex, a well known weight loss medication based on phenteramine phatrmacology.

Fat reduction or body slimming with the Zerona laser is a stark contrast to the use of injectcable lipodissolve treatments. Not only is it non-painful with no recovery but it uses well known fat reduction lifestyle changes that are proven to be helpful. Given that the treatments are compressed into weeks and not months, results can be seen much sooner.

The crucial question is whether Zerona produces results that are comparable or better than lipodissolve injections. The clinical documentation on Zerona to date is far better than what has been previously reported with lipodissolve. The very fact that Zerona has FDA approval indicates the superiority of its clinical results.

Is Zerona superior to liposuction? The answer is likely no. One could argue that Zerona treatments are intended to avoid the need for liposuction. Does it produce enough of a result to avoid liposuction? That will undoubtably depend on the patient. Some patients will but others won’t. But the potential that one may could be enough for many patients to give this non-invasive and non-painful method of fat reduction a try.

Dr. Barry Eppley

http://www.eppleyplasticsurgery.com

Indianapolis, Indiana