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Lilly Fowler/ FairWarning.org
The RevecoMED International offices in Fullerton, Calif.
For several years, doctors and medical spas around the country have touted a fat-melting device called the LipoTron 3000, or Lipo-Ex, as a revolutionary way for people to slim down.
Signature Medical Spa in Tampa, Fla., in an online pitch for its “Lipo-Ex Spring Fling Fat-Off!,” described the technology as “truly the only non-invasive way to reduce fat.”
Praise also came from Sculpt Medical Spa in Chicago, which called the procedure “the most innovative, effective, and technologically advanced” non-surgical method of removing fat.
Doctors have appeared on TV news shows in Houston, Phoenix and Miami to promote LipoTron treatments.
These testimonials have translated into millions of dollars in sales for physicians, med spas, and the device’s manufacturer, RevecoMED International of Fullerton, Calif.
But there’s a problem: The LipoTron, which targets fat with radiofrequency waves, has never been cleared or approved by the U.S. Food and Drug Administration, which would make it illegal under federal law to sell or promote it for weight loss.
The FDA is aware of the activity. But an investigation by FairWarning found that the agency has not taken enforcement action — even though it has known about the situation at least since January, 2010. At that time, two whistleblowers, one a former LipoTron distributor, provided sales records and a trove of other documents to an FDA criminal investigator.
The case spotlights the booming, multi-billion-dollar business of aesthetic medicine—and the willingness of some doctors and med spas to use unapproved devices as they vie to be first with the latest technologies to smooth wrinkles, tighten skin and sculpt the body.
The FDA won’t say if it is investigating Reveco, citing a policy not to discuss investigations or acknowledge if there is one.
For his part, RevecoMED President James S. Rosen said the agency hasn’t contacted the company. He asserted that, “As of today, we are compliant with the FDA.”
Still, for observers such as Dr. Patricia K. Farris, a clinical associate professor of medicine at Tulane University and a spokesperson for the American Academy of Dermatology, the situation is baffling.
Told of the unauthorized sales, Farris responded: “It shocks me the FDA would not have cracked down on them.”
“I mean, radiofrequency is an electrical device, and you can’t just be throwing these things in the marketplace without doing the right studies to make sure that, A, the device is safe and, B, that the thing does something and has some benefit.”
Dr. Suzanne Yee, a Little Rock, Ark., plastic surgeon whom Reveco asked several years ago to take part in a LipoTron study, said she was surprised to learn that the company already was selling the device.
She noted that some medical spas have falsely stated on their websites that the LipoTron is FDA-approved. “It’s not FDA-approved,” Yee said. “I think that’s dishonest.”
There have been scattered incidents of patients receiving minor shocks and burns from LipoTron treatments, but no known reports of serious injury.
While the FDA has failed to act, the Texas Department of State Health Services issued a warning letter last September to a Fort Worth distributor for marketing the LipoTron without FDA clearance. According to an agency report, Mark Durante, managing partner of Advanced Aesthetic Concepts, told state investigators that the LipoTron had been cleared by the FDA, but later corrected himself to say paperwork had been filed but no clearance yet given.
Durante told FairWarning that, in response to the warning, his company changed some language on its website. However, a spokeswoman for the Texas agency said it recently opened a second complaint investigation of Advanced Aesthetic Concepts.
Selling for as much as $85,000, the LipoTron passes radiofrequency waves through the body to heat, and destroy, fat cells. According to Reveco, the procedure targets subcutaneous fat, which is just below the skin, as well as visceral fat surrounding the vital organs, but without harming adjacent tissues. Spas typically recommend six to eight treatments for about $400 each.
According to interviews and records, Reveco first sought a green light from the FDA in 2007. It chose the FDA’s market clearance procedure, which is less demanding than the formal approval process.
To get a new device cleared this way, the manufacturer must show it is similar in safety and effectiveness to products that are already on the market.
However, Reveco’s bid failed. The company’s initial application “wasn’t in-depth enough,” Rosen said, and the FDA repeatedly sought additional data. Finally, according to Rosen, “We said, ‘You know what, it’s not worth it.”
According to interviews and a document reviewed by FairWarning, the FDA then told Reveco that the device could not be marketed.
LipoTron sales continued, however. Rosen wouldn’t disclose how many of the devices have been sold, but the number is believed to be in the low hundreds.
In 2011, Reveco took another tack with the FDA. It classified the LipoTron as a massager used for relief of minor pain. That would make it, in FDA parlance, a Class 1 device — a category that includes such simple, low-risk items as elastic bandages and examination gloves.
The advantage for Reveco is that massagers can be sold without a green light from the FDA. They automatically are exempt from FDA review and can be put on the market once a notice is filed.
Yet doctors and med spas have been promoting the device on the Internet not for massages but for removing fat.
Rosen said that was not Reveco’s responsibility, stating that the company can’t dictate what doctors do or “police everything out on the Internet.”
Asked who would pay $85,000 for a massager, Rosen replied: “Anybody that wants to buy it.”
Physicians are free under federal law to prescribe unapproved, or “off-label,” uses of drugs or medical devices — but only if the products have been cleared or approved for another purpose, according to the FDA.
FDA spokeswoman Sarah Clark-Lynn said in an email that if a device is not legally on the market, “a physician should not have been able to obtain it, much less use it on a patient.”
Dr. Sherwood Baxt, a New Jersey plastic surgeon who advertised the procedure in a promotional video, said that when he bought the LipoTron he wasn’t troubled by its lack of FDA clearance. He explained that he had used unapproved devices before and, while he considered the agency’s green light a marketing advantage, he didn’t consider it necessary.
Besides, Baxt said, “We were told FDA approval was imminent.” It didn’t work out that way, however, and, he said, “After two years, I just stopped asking.”
He continues to use the device for skin tightening on certain patients but quit using it for fat reduction. For fat reduction, Baxt said, “It wasn’t as effective as I thought it was going to be.”
The FDA was informed of the unauthorized sales through an anonymous call. Paige Peterson, a former LipoTron distributor, and Belinda W. Worley, a marketing consultant who worked with her, told FairWarning they dialed in from a hospital phone in hopes the call could not be traced.
But they agreed to meet with criminal investigator Evan Rae a few days later at a Hilton inn in Waco, mid-way between Rae’s office in Austin and Dallas, where Peterson and Worley lived.
They found a quiet spot in the lobby bar, which was closed in the morning, and talked for a couple of hours. Peterson said she gave Rae a detailed statement, a computer flash drive and copies of records, including emails, memos and invoices. Rae taped the conversation and snapped photos of the LipoTron 3000 the women had brought along. Rae declined to be interviewed.
Peterson told FairWarning she had made 39 LipoTron sales, even though she was aware the device had not been cleared by the FDA. The evidence she gave Rae “was just as damning of me as everybody else. I have zero assurances that the FDA is not going to arrest me.”
Peterson admitted there was no love lost between her and Reveco. She said she had paid out-of-pocket for some research costs aimed at getting FDA approval, but had not been reimbursed. And she said the company dumped her as a distributor in favor of another sales group.
But Peterson also said Reveco had misled her with repeated assurances it was taking all proper steps and FDA approval was imminent—and spread this misinformation to some anxious customers.
“I had run out of acceptable answers to give the doctors that had purchased the LipoTron,” she said. “I needed to fall on my sword and tell the truth.” Better to come clean, Peterson decided, than to wait for the FDA “to come knocking on my door.”
While declining to comment on Peterson’s statements, Rosen said she had gone over to “the dark side.”
“She’s a person that’s vindictive,” he said. “She’s doing it out of spite.”
For her part, Peterson says that after 2½ years she is surprised and frustrated by the apparent lack of action.
“Why do we have an FDA?” she asked.
“I tried to do what I thought was right, and nobody’s doing anything about it. Everybody gets to thumb their nose at the law.”
FairWarning.org is an online, nonprofit publication that seeks to provide robust, public interest journalism on issues of health, safety and corporate conduct.
Leave a Comment:
"For fat reduction," Baxt said, “It wasn’t as effective as I thought it was going to be.”
Oh. It doesn't work. That's why they don't care if it gets approval or not. Makes sense now.
Of course, they never expected it to get approved in the first place.
there's a sucker born every minute, and the "doctors" (and I use that term loosely) are not the only suckers, they've made their patients into suckers too.
But in the end, I dont feel sorry for ANYONE in this entire story.
exercise, eat healthy and you'll loes the weight. end of story. yeah, it's hard work...it's not NEARLY as easy to take it off as it was to put on. SHOCK! DISMAY!
i fully support surgeries that remove excess skin after someone has lost the weight, as it's medically necessary (chaffing, infection, irritation, inability to fully exercise due to the flapping skin)...and but a machine that "melts your fat" or "tightens your skin" with no adverse side affects? thats for the lazy, the greedy and the delusional...let them reap what they sow.
Who cares about the FDA's worthless rubber stamp of approval. The best way to lose weight is eat better and get off your fat ass.
Obviously you ave no clue what it takes to get FDA approval. Your talking out of your ass.
Yeah, a whole lot of money and insider connections. The FDA is an incredably corrupt bureaucracy who answers to the higest bidders. Keep in mind these imbeciles say there is no medicinal value in marijuana even after numerous studies have proven otherwise. I'm sure that has nothing to do with the possibility of big pharma losing out big time if it were to be approved and compete with their dangerous and less effective pharmaceuticals. But go ahead, keep buying into big government's lies like a good little sheep.
The FDA has its value. Unfortunately, it's also proven to ignore those lofty intentions from time to time.
Consider: If people would practice "buyer beware" half as often as they preach it, we wouldn't need the FDA--whose functions include ensuring that prescription drugs were safe, reliable and advertised accurately--to delve into such nonsense as banning caffeine/alcohol drinks.
But back to the LipoTron 3000: I agree with NoScope1337. The best way to lose weight is through diet and exercise.
Which means, of course, it takes discipline and hard work...as well as an acceptance of basic body shape as unique aspect of who you are as an individual.
Which means, of course, some Americans will look for short-cuts and supermodel-induced fantasies that may prove dangerous.
You know an agency is bought when it refuses to approve of a relativly harmless plant with numerous medicinal uses while permitting little children to be prescribed to stimulant narcotics.
I am really sick of fat lazy people looking for an easy fix for their obesity. They don't want to eat healthy, they don't want to exercise, they just want Genie to cross her arms and blink her eyes and make all the fat go away so they can go back to eating like a pig while sitting on their butts watching American Idol. I have worked my ass off, literally to stay in shape. I don't diet, I just don't eat garbage. I have the same waist size I did in college, 31, and I am 50 years old now.
We have wasted billions of dollars trying to find a way for Americans to stay slim while they continue to consume 5 times as much food as other nations. If we would have put one tenth that money into nutrition education for young children we would not have an obesity problem, but of course the corporations who market sugary junk to our kids would have to find a new line of work.
Another major problem is the fact that the federal government is continuing to give corn subsidies making it easy to produce cheap high fructose corn syrup products. Then there's the issue with food stamps being used to buy junk food, candy, and soda. As usual when you get to the root of the problem you find it's linked with big government.
NoScope, you may not know this so I'm not gonna blast you. There is ABSOLUTELY NOTHING WRONG with HFCS. Its just a mixture of glucose and fructose sugars typically in similar quantities. Both of those sugars are natural with glucose being the body's primary source of energy, often found in bread / pasta and other starchy foods. Table sugar, also known as cane sugar is just sucrose which is another carbohydrate. HFCS can be made from any source of fructose mixed with common glucose, corn sugar just happens to be the most economical source of it.
The reason manufacturers use HFCS is that it allows them to reach a level of sweetness while using less sugar overall. Fructose has a sweeter taste then sucrose, much sweeter. If anything it's too sweet and must be blended with a non-sweet sugar (glucose) to lower it's sweetness. Its cheaper to use HFCS as a sweetener then use a ton of sucrose (cane sugar).
What your arguing against isn't the use of HFCS but the use of sugars in general. That's not going away anytime in the next century or three. People need to eat less, our portion sizes are simply too large.
Onto weight gain. This may come as a shock to people, but sweets are not what make you fat. They don't exactly help, but non-glucose carbohydrates (all sugars are carbs) don't convert to glycogen very well and thus can't be stored as fat. The two primary source of glucose (and thus fat) is starchy food (starch is basically plant fat). Grain's are nothing but plant fat, same with rice. The problem with non-glucose sugars is that your body will always consume them before converting glycogen back into glucose (burning fat). Each calorie of sugar you eat is a calorie of fat your not going to use. And the glucose in HFCS can actually be converted into sugar, thought there isn't enough of it to matter.
When you look at that hamburger from BK, it's not the greasy meat or the cheese that's going to give you the biggest weight boost (though those aren't good for you), it's the bread buns. If your looking to lose weight, cut the carbs down dramatically and run ... lots of running (or other aerobic exercise). Do that for a few months and the fat will melt off your body. Co-worker of mine was pushing 300 (5'9) and decided to fix himself one day. His lunch every day consisted of a BK double whooper, without cheese and without bunns (he removed them). He ate it with a knife and fork. Dude was down to 200 lbs in less then a year.
Damn internet being crazy on me. Meant to put in that the other source of carbohydrates is glucose stored in animal fat. Though your body can also metabolize protein into energy for use, it does this only when there is no other sugar nearby.
RF causes brain cancer (cell phones) bad for you
RF melts away fat good for you
MAKE UP YOUR MIND!
It would really depend upon amplitude and frequency of the RF. UV frequency will cause skin cancer, but visible light won't. X ray RF is far more destructive than AM band RF.
You are pelted all day by X, KU, C, L, KA, DBS band really the list goes on and on. We will all start growing arms out of our heads at some point or just die of cancer if the radiowave fear is true.
That said WE KNOW stuff like this can be dangerous. Concentrating radio waves on a section of cells can be destructive. Some studies are linking sonograms to autism because you are heating up the cells of the child.
I've had ultrasound therapy on my knee to break up fluid, can't tell me that successive and prolonged ultrasounds on a child are totally cool!
All a microwave is, is RF in a concentrated environment... we ALL KNOW THAT COOKS RIGHT!
While I am against most ultrasounds, I really don't care about this fat burning craze, it's no worse than getting MRSA from a tummy tuck.
I have a very tough time believing this. I did a quick search on it and the only articles I could find disproved that ill concieved hypothesis
You do know Sonograms use sound waves, right? That's why they are Sonograms. No RF involved.
So even if this thing did what they say it does (which I doubt) my bet is that close to 100% of people who have their fat "melted away" would be right back to where they were - or even fatter within 12 months.
Losing bodyfat really isn't the hard part - the really hard part is keeping it off.
STOP EATING CRAP. The end.
This device has been around for something like 5 years. Have there been any reported adverse effects from its use? Apparently not, or this article would have sensationalized it.
The mentioned burns in the "minor shocks and burns" sentence were simply a reddening of the skin, something that passed within a few hours.
you missed the quote from the "doctor" indicating it never really produced any successful results, didnt you?
it's kind of dumb that we live in a "christian nation" but our operation method is "cheat, swindle, dupe" as a method of "growing wealth"...the financial sector bears this out, the medical sector bears this out, pretty much all sectors bear this out...wait, a new iphone doing the one thing the last one didnt do? GENIUS! suckers born every minute...but really, are we proud that we are nation of suckers and suckees?
Vainity can be costly.
Jessica 5.1
Reading challenged, are we? The doctor never said any such thing. For your benefit, the following quote is what was actually said;
This was only one doctor and he didn't indicate it didn't work, but for fat reduction, he would have liked to have seen better results.
Wow, something else we don't need.
It's called EXERCISE and it is free.
Dont worry if Romoney is elected the FDA will be closed....
The FDA is the problem - corrupt, misguided and driven by the corporate money
that is the lfie's blood of the American government. If the public had any sense
or even a modest degree of intelligence, neither the FDA or the equally useless and
wothless Congress would be replaced with honest and dedicated public servants.
hahahahah - it is supposed to just heat and melt the fat cells but leave your normal organ cells alone.
and if this has been around for 5 years I don't see the evidence, these people are huge - fat, not just obese, but morbidly so.
if a 10 year old weighs 180 pounds - it ain't baby fat
if your fingers remind you of morning sausage links - best diet
if your bathroom scale moans whenever you walk near it - best exercise
if you gain weight by just breathing in air - you're in trouble...
For all this BS, we get ONE statement that it "didn't work as well as I expected." Well...does the damn thing work or not??? Does it sculpt, reduce, tighten, obliterate, liquify, gelatinize, eradicate, burn or somehow magically shrink fat cells? Read the whole frickin' story and there's ONE mention of "Gee, maybe it wasn't the super-duper, wonder wand of instant wealth I wanted it to be so I could use it on a few thousand people, at $400 to $600 a pop, and then sell the machine and retire."
What does it take to get a STORY out of these people? Aren't they supposed to go look for facts, figures, evidence and real information? Nah...highlight that someone has gone over to the "dark side." Well, at least we know ONE fan of Star Wars is interested in the machine.
Obviously, the reporter couldn't be bothered to go find patients, practioneers or ANYONE who really knew a frickin' THING about the device! Go back to journalism school, slick! It's "Who, what, when, where, why and how." THOSE are the elements of a real news story. Anything else is "Entertainment Tonight."
Be talkin' to you....................Web Rydr
Newtonian theory noted that Mass and Weight or related by gravity. F = mg. Since the Higgs Boson is what gives us mass and thus weight, Dr. Smirk developed the Higgs Boson Dispersal ointment that you rub on your body at those unseemly places to remove body mass. Now available in a 2 oz. tube for the low price of $59.95 by mail at P.O. Box 98765432125789, Atlantic City, Old Jersey. If the product fails to work, just send in any Higgs Bosons found in the ointed area along with the tube and if we haven't already gone out of business, you will get a prompt refund.
The FDA is one of the most corrupt bureaucracies in modern history. The behind the scene shenanigans of this bloated bureaucracy would find more kick backs and fraud than anything Jimmy Hoffa could have dreamed about.
I was wondering about all those diet pill the FDA approves & yet we tell our children to say no to drugs.
Unless I'm misinformed, the FDA is 60 % funded by fees paid by the industries they regulate. How that conflict of interest escaped the architect of that arrangement, I'll never know.
Maybe they can get approval from TSA if not FDA.
Let's see - it zaps you with radio frequency waves and melts the fat away. Isn't that pretty much what you do with a roast in your Microwave? So, here's my alternative and less expensive solution: crawl inside your microwave, set it on Low power for 6 minutes - be sure and turn before you burn. Voila! Saved a $400 trip to the 'spa' - you can send me your checks now, thank you very much.
Legal Disclaimer: I am not a doctor, my recommendation is not FDA approved and is pretty much condemned by the SPCA and PETA (so you'll have to keep your fat dogs and cats as is) --- but, darn I do like $$, so send those checks right away!
Let's see, previously they jailed the inventor of the Orgone Generator, even though it did nothing harmful, and now we have a device that "melts" fat inside your body and they aren't doing anything. Hmmm, cognitive dissonance anyone?
The idea that anyone believes you can purchase a "fat-melting device" just proves the old line that there is a sucker born every day. I have spent over 2 years watching what I eat, working out 3 times a week, walking and running for miles and have been fortunate enough to lose 319 pounds through common sense - no surgery.
As hard as it is for anyone to believe, common sense is really the only way that works. But common sense doesn't sell, the quick fix does.
No one died from it - so who cares? The minor injuries were probably because the person using it was poorly trained. Sounds like a harmless product. I think the FDA has more important things to do with its time than investigate this stupid product.
I have been in business for thirty-five years. The one resounding truth I have seen time and time again is that business and commerce in general function under the process of obfuscation. The idea is to BS someone who is ignorant about the true value of your product or service, so that you can charge someone way more than the product or service is actually worth. That's why simpler services, like dishwasher can't command as much as a weight loss doctor. Some products get labels like FDA Approved, and that does often keep you from purchasing worthless (or worse yet harmful) junk. But there are NO guarantees. Caviat Emptor!
The FDA had too many fat cells in their brains so they tried the device.
Alas it worked and melted (fried) their brains which is why they are doing nothing.
Ganey, good job. Too bad that doesn't work for those fighting certain diseases or medical conditions nor those who must take the types of medications which, while saving a life cause severe weight gain. I have a dear friend on a number of medications, which over the years despite switching around have caused her to gain a lot of weight.She had no weight problems until suffering two heart attacks, then problems with her kidneys and liver.Recently her doctor has tried switching to a new drug which allowed her to lose some weight, but not much and she doesn't have your options. It isn't always about common sense fixing a problem someone created themselves simply choosing to over eat.. It turns out also she has a very abnorrnal slow metablism highly efficient needing under 900 cal.
Diana, I care along with a great many others. Obviously people got injured, so this is not some harmless product. I agree it's a foolish item, but that doesn't make it any less potentially harmful because it hasn't been tested to find out all the possible negative consequences. We know people under electrical towers get cancer. The human body has an electrical field as well. If this were used on babies would that make a difference? Absolutely. You prove my point.Because the victims are overweight individuals who cares? Unfortunately fatism is alive and well in this country. Studies have found people would rather lose a limb, be deaf or even blind then overweight. Those who happen to be, are viewed as weak-willed, incompetent and lacking in self control. Deserving of whatever negative things happen to them in life and their lives are of less value. Yet the average normal weight person, if they started drinking two 12 oz. cans of soda a day, in the course of a year would add between 24-36 pounds if they didn't change anything else in their normal routine.We are so quick to judge and condemn others different because of weight. The real crime is once more, preying on people who have true needs and fears. When the greedy person comes up with a scheme to make money off the eternal misery of man, there is rarely found honest person to stand up for justice. How sad it's so lacking as well in that our FDA would turn a blind eye to this on going practice. Yes buyer beware. There is also this agency which needs to do a better job.
Windancersong - Your friend's situation is very unfortunate, and also quite uncommon.The vast majority of people who are obese are obese because they fail to employ self discipline. For ease of speech, it is not possible every time the subject of obesity comes up to make a disclaimer for the miniscule percentage of fat people who eat like an anorexic and exercise like an athlete and are still fat due to an unusual health anomaly, so I feel there is no need to come back at Ganey. We now live in a coddling society. Instead of "No Pain, No Gain" we have sparkles, rainbows and gold stars just for being You!!! Now kids sports can't have "winners" and "losers" and everyone gets some award just for showing up. No one learns in the early, critical part of their lives that life is tough, you must be tough and that nothing worth having comes easy. I get up at 4:30am to jog/power walk, adhere strictly to healthy eating, and am mildly underweight. I have a severe medical condition, work full-time, and have kids to care for. I am very busy, and very stressed. I don't like to say "if I can do it, anyone can" in an absolute sense, but I think that well over half the fat people out there could do it too, but the biggest hurdle is the will and the discipline.
Ok ... there is absolutely no such thing as a medicine that cause's "weight gain" through fatty tissue, possibly water bloat but that's not real weight. Fatty tissue does not materialize out of thin air, there is no extra-planer dimension that fatty tissues are created in before being sucked into someone's body.
There are medications that screw with your appetite due to hormone imbalances. This merely means the individual involved with have a higher desire to eat more, and thus gain weight. If you (or anyone) practices ration control then you can not get fat. The only people who have anything remotely related to an excuse are type I diabetics. Though they need to practice even greater ration control and maintain a steady blood sugar.
And before the typical belligerent responses happen I'll shut them all down instantly. Show me one fat starving person and I'll rest my case. Show me one person who's starved to death while being fat. If this fat is somehow being materialized out of an as-of-yet undiscovered dimension and into people's body's, then there should be fat people who died of starvation.
Or heck, if this fat is being created outside of the human body and being shoved into the body by an as-of-yet-unseen force. Then we can solve our energy dependency problem right now. Line up thousands of treadmills and have fat people take 8hr shifts running on them to generate electricity. Since their fat is being created outside of their bodys and being shoved into them through an inter-dimensional hole, they have infinite energy capacity. The perfect renewable source of power. They run off 2000 calories, and overnight it reappears inside their body, all without them doing a thing.
Why are people so worked up about others looking for an easy way to lose weight? What's it to you?
Healthy eating habits and exercise are all good, who says these people are not doing that? Nothing wrong with speeding up the process a little IMO.
That said, this device does seem pretty BS..
PS: before anyone accuses me of being a lazy fat cow - I am not. I am healthy weight, excersize daily and try my best to at least not eat junk food everyday. But if I were terribly overweight, I would definitely look into more than just eating right and excersize. why would anyone care??
If this thing actually worked as claimed - zapping away fat cells without harming other cells - then it would be revolutionary, and everyone would be using, driving down its cost. That there are fat people all around, proves this thing does not work, or else if it, we'ld all be flocking to the nearest fat zap shop.
PublicCitizen (www.citizen.org) goes beyond the FDA to report to state medical licensing boards, state health agencies, and state legislatures’ medical oversight committees, pointing to the need for immediate and urgent action regarding LipoTron / Lipo-EX, their maker RevecoMED, and distributor ProfitSolutionsMD (aka Advanced Aesthetic Concepts). Here are the links:
No question about it, those Google banner ads by ProfitSolutionsMD (aka Advanced Aesthetic Concepts) will get you noticed.
PublicCitizen (www.citizen.org) goes beyond the FDA to report to state medical licensing boards, state health agencies, and state legislatures’ medical oversight committees, pointing to the need for immediate and urgent action regarding LipoTron / Lipo-EX, their maker RevecoMED, and distributor ProfitSolutionsMD (aka Advanced Aesthetic Concepts). Here are the links:
No question about it, those Google banner ads by ProfitSolutionsMD (aka Advanced Aesthetic Concepts) will get you noticed.
Oh, how the internet loves a good public hanging :P For anyone who is interested in facts, here are a few:
The manufacturer is an FDA registered manufacturer. You can see that here:
The product is registered with the FDA. You can see that here:
On that page, you can also see there that the product is registered under Federal Regulation Code 21CFR890.5660. You can see that code here:
This is an “exempt” category. Products listed here work in relatively simple ways and are assumed to do the thing they are supposed to do (e.g., “improve circulation”).
However, therapeutically "simple” doesn’t necessarily mean technologically simple. The category is called, “Massager, therapeutic, electric”, which might make someone think of a vibrating thing you buy at the drugstore. But, this FDA category was a wider reach than that. Products registered under this category use all kinds of technology - radiofrequency energy, ultrasound, electric currents, etc. - to do their jobs. Examples of such products include IDT Prestige, BellaContour, UniForm Handpiece, CEYA, Nue Fusion, SE35, VitaLift, etc). You can search for those devices here:
The LipoTron works by using radiofrequency to heat up tissue. Tissue heating is a simple well established way to improve circulation. Radiofrequency is just the way this device does that as do some other advanced “massagers” registered with the FDA.
Being so registered just means that the manufacturer can legally market it for that purpose. The FDA doesn’t approve how a device (or drug) is used by doctors, just how the manufacturer can advertise it. When a physician uses a product in a way other than the manufacturer has been approved to promote it, that’s called “off-label use”. It’s totally legal and ethical and up to half of all medical care is done that way. You can read more about that here:
Other ways a manufacturer can market a product is to have the FDA review it and “approve” or “clear” it for a purpose. A company does when the want to promote a product for a more complex use. This is a more involved process, but the end result is the same; it just determines how a company can advertise a product.
An previous distributor for this product marketed the device for ways beyond what it was registered for, which is not allowed. However, as noted above, physicians use it for other kinds of treatment if they want. One thing has nothing to do with the other. Since there are dozens of medical articles showing that radiofrequency tissue heating (how t his device works) reduces fat and tightens skin, many doctors have been using for that purpose. It’s a completely reasonable judgment based on published medical literature. You can find numerous peer-reviewed medical studies about that if you visit and search the terms “radiofrequency cosmetic”.
Now, some people have complained about the marketing, particularly the old distributor, who was sued by the new distributor to try and recover over $60,000 she misappropriated (see Advanced Aesthetic Solutions v. P2, LLC, Tarrant District Court, Fort Worth TX, ). Considering that she was let go as a rep, was sued and lost by summary judgment, and ultimately her company declared bankruptcy, you can make your own assessment about her motivation. Btw, her company was one doing the improper marketing she complains about.
The new distributor who took over selling the machine got a reprimand from Texas for possibly continuing to market the machine the way the previous distributor did. So, they cleaned up the old marketing and there’s no longer a problem there.
But, seeing a good scare story, a group called Public Citizen sent out letters to lots of state medical and health boards and the FDA complaining about the marketing. But, maybe because a story about advertising isn't scary enough, they also said they were terribly worried about how how dangerous the device may be.
But, this machine isn't new. It's been used for years and years with tens if not hundreds of thousands of treatments. There is no evidence it's dangerous at all and even the complainers admit there's been only a few minor issues common with other similar treatments. No actual patients have complained, just the ex-sales rep a former consultant and Public Citizen. Why the ex-rep has been on the warpath might be understood from perhaps a touch of bitterness. As for Public Citizen, scaring people isn't a bad way to get some publicity and increase donations. But, whatever their motivations, hopefully there are a few people interested in finding out the actual truth rather than relying hyperbole and fear-mongering on the internet.