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Thursday
Jul122012

Fairwarning: The LipoTron 3000 FDA UnApproved $85k Massager

Lipotron Medical Spa MD

According to a new story on Fairwarning.org, RevecoMED claims that their LipoTron device is really being marketed and sold as an $85,000 massager.

I just got off the phone with Myron Levin or Fairwarning.org who contacted me about Advanced Aesthetic Concepts attempts to have comments and reviews about the Lipotron 3000 and their business removed from Medical Spa MD claiming that some negative comments were costing them sales. It was an intersting discussion and Myron filled me in on some of the background that went into the story which has some interesting twists including anonymous calls to the FDA and secretive meetings with criminal investigators.

Read the entire article here: Fat-Melting Device a Weighty Matter for FDA on Fairwarning.org

From the Fairwarning.org article: 

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.”

Wow. It would take some really big cajones to claim that you're selling an $80k+ device named LipoTron to cosmetic clinics from a company named RevecoMED but you're only marketing it as "a massager for minor pain" and that it's the doctors who are running around uncontrolled promoting it for fat-melting. I'm actually somewhat impressed. I guess the real lesson is that if you can't get your device approved by the FDA as a medical device the first time, reclassify it as a band-aid and declare yourself in full compliance. That seems simple enough. 

Of course it also seems fairly clear from the article that if you have one of these devices and you're promoting it as FDA approved or as a treatment for anything other than a 'massager' you might not be in lock-step with the FDA, a fact that might be exacerbated by the fact that this story has been picked up by major media outlets like MSN.com.

I'm curious; Does anyone have one of these Lipotron devices that they're using as a massager for minor pain? You might want to see if it works on yourself because I'm guessing you have a headache about now.

Reader Comments (70)

"The discipline of the written word punishes both stupidity and dishonesty."
John Steinbeck

Thank you, FairWarning. Thank you, Public Citizen.

You didn't stake your considerable reputations on me, Paige, anyone. You staked it on the facts in the vetted documents. You staked it on the law.

You didn't write the stories nor the letters to help us. You did it because you have a mandate to public service.

No court anywhere will be able to undo what those documents and those laws say.

09.4 | Unregistered Commenterjquinn

Specific reasons for dropping the news groups are not given, however, it is a practical reality that libel suits against news organizations can be an extremely complex and expensive proposition even though the plaintiff may have good cause.

It can be a more efficient legal strategy to go directly the source of libelous, false and misleading statements. AAC is continuing action against Paige Peterson, Belinda Worley, and Susie Quinn in regard to that.

09.5 | Unregistered CommenterJillD

Letters to state medical licensing boards and other regulatory state agencies in Arizona, Illinois, Indiana, Louisiana, Massachusetts, Missouri, North Carolina, Ohio, and South Carolina have been posted this week urging immediate action regarding apparently illegal Lipo-EX equipment aka Lipotron.

Arkansas State Medical Board acknowledges Public Citizen's letter and informed PC that their requests for investigation would be presented to the board at its October 4-5, 2012 meeting. Here's the link:
http://www.citizen.org/documents/preliminary_response_from_arkansas_state_medical_board.pdf

In a blog posting by one of Public Citizen’s attorneys regarding the lawsuit you can click through several court documents that support the Public Citizen and FairWarning letters and media campaign to bring awareness to the public and regulators.
Here's the link:

http://pubcit.typepad.com/clpblog/2012/08/distributor-of-magic-machine-that-melts-away-your-fat-threatens-libel-claims.html)

09.6 | Unregistered Commenterbworley

Latest story September 24, 2012 from California Watch:
http://www.news10.net/news/local/article/210879/2/Calif-doctor-at-center-of-fat-reduction-device-controversy-

These physicians who claim their right to “off-label” use of this device apparently don’t know FDA regulations. For a medical device to be used “off-label” it has to be legally in this country, legally marketed and legally sold, none of which are true of the Lipotron or AAC/PSMD’s Lipo-EX.

The Lipotron’s current status as “exempted” and “registered” was fraudulently obtained by re-naming the same device and claiming it as a class I “therapeutic massager” only after it failed two 510k submissions in 2007 and 2009 when it was classified as a class II or class III device.

Not at any point in time, from its first appearance in this country as early as 2005 to the present date, has the Lipotron, Lipo-Ex, Recuderm, VitalRF, or any other name it has been known by, been legal to market, promote, sell, or use.

As to its safety, there are no peer reviewed published clinical scientific studies showing exactly how vital organs are affected with targeted radio frequency at the power levels, intensity, depth, frequency, and duration being used on patients with the Lipotron / Lipo-Ex.

Anecdotal results, before and afters, and ct scans from South Korea which are from undisclosed sources and unknown details or protocols that are from more than seven years ago are not clinical results from a scientifically sound, objectively sourced / IRB monitored and managed study.

If everything that the manufacturer, distributors, physician users, and other "true believers" in the blogs and in story postings say is true, accurate, and confirmable and verifiable, why didn't the 2007 or the 2009 510k get approved?

Why can't anyone show the proofs and findings, the current ct scans and blood panels (not anecdotal subjective pics and comments from patients and their physicians who have a profit motivation) from any objective, scientifically sound, IRB monitored and managed, peer reviewed published documents specific to this device--this Lipotron--this Lipo-Ex?

Just produce one white paper specific to the Lipotron/Lipo-Ex giving quantitative data and verifiable results from a scientist who has not bought the device and has not been paid (that includes airline tickets and meals and hotels to conferences, etc....), and I'll shut up.

09.25 | Unregistered Commenterbworley

For those of you posting comments in outrage and castigation regarding the whys and wherefores of the whistleblowers in this story, their motives, culpability, trustworthiness, and their past, here's an article that may be of interest to you.

I'll start with the excellent admonishment from the author (you'll see it again in the article): "To all the outraged commentators, please have a glass of Pinot and unwad your knickers. Go ahead, I’ll wait. OK, on to the undeniable truths about corporate whistleblowers".

http://www.whistleblowersblog.org/2012/09/articles/tax-whistleblowers/the-undeniable-truth-about-corporate-misconduct-and-whistleblowers/index.html

And, no, to answer your obvious question. There is no payout by the FDA for revealing a huge hole in their system. But thanks for asking.

09.25 | Unregistered Commenterbworley

It's a little frustrating that accusations are so easy to make but informed rebuttals take work, sometimes substantial. Posters infusing misinformation throughout their argument aggravates the problem since the false foundations then have to be corrected. But, in the spirit of keeping truth out there, I'll continue the effort.

Regarding whistleblowers, there is a difference between the general principle of whistleblowing, which can be good, and making misleading or false accusations, which is bad. No post I've read suggests anyone's "knickers" are in any "wad" over the idea of whistleblowing. What is being pointed out in this situation are possible - in some cases definite - misrepresentations being made and some obviously dubious motivations. Trying to put a halo around that by appealing to the genuine, righteous sacrifices of others is disgusting (this last sentence being just imo).

Now, as for physicians' off-label use, we need to sort out the errors in BWorley's last post to see where she's off track......yet again. She often refers the reader to FDA regulations, implying they support her position. They do not. But, unfortunately, it it can be hard for a layperson to recognize that, so there's a very good possibility that she's relying on regulatory complexity to bamboozle people who read her posts. Or, perhaps, she just doesn't understand what she's reading herself. In either case, her expository writings must be dismisses as either deliberate propaganda or simply misinformed.

First, let's address the term, "legally marketed", which she uses liberally but does not seem to understand. For FDA regulatory purposes, this phrase has a specific, particular, and legalistic statutory meaning that has nothing to do with any claims or advertisements made by a distributor or manufacturer. Statutorily, the phrase, "legally marketed", just means that a product is registered or approved by the FDA to be on the market for any purpose. Period. That's all. A product being advertised in a way outside the scope of its registration is referred to as "misbranding". Misbranded advertising in no way whatsoever negates an FDA registration or approval for that product's intended use and is utterly irrelevant to a physician's off-label use being legal. BWorley either doesn't know this, or is choosing to propagandize. In either case, she's factually wrong.

Next, BWorlely claims the Lipotron is "fraudently" registered - that it "failed two 510k submissions in 2007 and 2009 when it was classified as a class II or class III device". For clarity's sake, I'll point out that while the manufacturer was trying to get an approval as a Class II device, it was never actually classified that way by the FDA. We next have to delve a little into some bureaucracy (sorry) to understand what then happened. The FDA classifies a device based on 1) how it works PLUS 2) its intended use. A product could work in a very simple way but have an intended use that could have significant health ramifications (say, to cure cancer). In that case, the FDA would require very thorough study data to be presented before the product could be marketed for that purpose. Or, that exact same product could have an intended use that fairly benign (say, to relieve minor muscle aches), in which case no study data may be required at all. Just because the FDA wouldn't approve the product for the first purpose without data doesn't mean it couldn't be registered for another purpose without it.

Okay, so, the Lipotron wasn't able to get 510(k) clearance as a Class II device. That doesn't necessarily mean it's not effective for an FDA Class II indication, just that the level of evidence required by the FDA for that purpose wasn't met. However, it may still be registered as a physical medicine device to improve circulation with radiofrequency heating. That is because radiofrequency is a well established modality for that indication with numerous other similar devices already registered for that physical medicine purpose. There's no "fraud" in that at all. Zero. Zilch. Nada. It's completely legal.

Now, the regulatory requirements used by the FDA to approve marketing of a device are totally separate from the standards physicians have for using a device. (Think about this carefully for just a second; this is EXACTLY why off-label use is legal and ethical in the first place.) A device may not meet the bureaucratic standards of the FDA to be approved for marketing for some particular purpose, but so long as it is registered by the FDA for ANY purpose, a doctor may still use it for any other purpose, including one it failed to get approval for. They would do this if, upon evaluation of how the device works, particularly in light of extensive peer-reviewed studies supporting the modality of the product, they felt they could make a reasonable judgment that it would have benefits sufficient to offset potential risks.

There are numerous studies showing that the modality used by the Lipotron, radiofrequency tissue heating, is safe effective for reducing fat levels and tightening skin. Radiofrequency heating is nothing new and the Lipotron is not novel. It's primary advantage as a particular device is the range of application probe sizes which makes it easier to treat various anatomical regions (for example, a stomach versus a neck). The actual technology of the machine is well understood from extensive research that exists regarding it's mechanism of action. Also, there is no argument that physicians gain economically from using the Lipotron versus other similar devices that do have FDA marketing approval. The cost of all such equipment is comparable, one to the other. A doctor who chooses the Lipotron does so based solely their medical judgement that there is a clinical benefit to their patients.

finally, not every product - in fact not even most medical products - have "IRB monitored and managed" studies as apparently insisted upon by BWorley to support every use that evolves in clinical practice. This is, in fact, a major part of the philosophy of why the FDA has authority over how products, devices and drugs, may be advertised but has no power over how doctors may use those products. It is a deliberate balance meant to allow medicine to advance most efficiently by physicians, who treat patients and see the results daily, to freely finding ways to use medical products that may help patients while minimizing promotional abuses from manufacturers and distributors who most profit from the sale of such devices. These two issues are held separate, which is why, as previously mentioned, misbranded marketing by a manufacturer or distributor in no way precludes how a doctor uses a product.

I hope that was helpful and clear. I would be happy to answer any specific questions anyone may have.

09.26 | Unregistered CommenterJillD

A quote from the FairWarning story--http://www.fairwarning.org/2012/07/fat-melting-device-a-weighty-matter-for-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.'

Guess JillD just didn't read the story she is commenting on.

But I'm thinking it's more a matter of JillD and her compatriots at AAC/ProfitSolutionsMD and RevecoMed believing they are, like the Enron guys, "the smartest guys in the room".

You gotta be smart to get educated physicians spending upwards of $100k for a massager.

And hoodwinking the FDA is "having your cake and eating it too"!

Nonetheless, JillD's post has made my day. It's a great day when the opposition makes your case for you.

09.27 | Unregistered Commenterbworley

bworley, I was responding to you, not to the fairwarning story.

But, um, yeah, the quote from the FDA spokeswoman was:

"....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.'

See that word, "if"? That's an important word. Putting up this quote as though it supports you, when in fact it does just the opposite, is the kind of sly misrepresentation to which I was referring.

Regardless of your personal opinion about the Lipotron, it is registered with the FDA as a physical medicine device. So it is "legally on the market".

And, I explained why some physicians would want this machine. As for cost, I've seen $25,000 exam tables. Medical equipment is expensive across the board but this device is in the range of similar devices (again, if you read my post before replying, your responses will be more cogent).

09.27 | Unregistered CommenterJillD

Finally the truth-telling begins:

“RevecoMED’s attorney admits there is a federal investigation.”

From a story posted September 25, 2012, by KTVU.com in Oakland, CA, and picked up by numerous other outlets:
http://www.ktvu.com/news/news/health-med-fit-science/critics-weight-loss-device-warn-prospective-users-/nSMBg/s

As you may recall, FairWarning, Public Citizen, Belinda Worley, Susie Quinn, and I have been publically denounced, shamed, attacked, and accused of lying for saying that there is a federal investigation about the Lipotron and its marketing.

I believe I said in follow up stories that the "proof is in the pudding.....it will all come out".

But an even better quote in light of today's admission by RevecoMED, the late great Gore Vidal, when asked what were his favorite four most beautiful words in our common language, he responded “I told you so.”

And, because it’s just too fitting to leave unsaid, Vidal also quipped:
“Write something, even if it’s just a suicide note."

So go ahead, JillD, illuminate us some more.

09.27 | Unregistered CommenterPaige

Hold on just as long as you can to that "registration" line like it's your "free" ticket to pass "Go"....because it just may take you some place you really don't want to go.

Lying to federal agents, including submitting fraudulent information to get an FDA "registration" is a serious federal offense.

Not to mention putting physicians' licenses in jeopardy.

09.27 | Unregistered Commenterbworley

WATCH DOG GROUP WARNS DIETERS ABOUT WEIGHT-LOSS…

TV stations in California (KTVU and KICU) have this week broadcast a video in their am, noon, and evening newscasts concerning the controversy engulfing the Lipotron / Lipo-Ex. This link will take you to the page where you can click to run the video:
http://www.ktvu.com/videos/news/special-report-watchdog-group-warns-dieters-about/vfLKF/

While the physician in this clip says she has done her "own research", what she claims is merely the marketing "spin" provided by RevecoMed and AAC / PSMD.

RevecoMed, AAC / PSMD, the physician in this video clip nor any other physicians we know of, have done the requisite ct scans, blood panels, urinalysis, stool analysis, nor any other type of lymphatic screenings or other biologic metrics before, after, and during Lipotron/Lipo-Ex treatments. So making these claims is in the realm of pure fiction.

There simply is no proof, no research, nothing but anecdotes from subjective sources. Those CT scans pictured in RevecoMed and AAC / PSMD promotional materials are over seven years old, from South Korea of unknown origin and unknown treatment protocol.

Remember fen-phen? People took the pills, lost the weight. It was months, even years in some cases, before the damage was discovered and people were horrified--they didn't hurt or feel bad when they were taking the pills and losing the weight. But now their heart is critically impaired or some other unexplained malady crops up.

I bring up fen-phen because I personally know someone very close to me who was $300k richer from the fen-phen class action settlement. It wasn’t her health so much as her infant son’s malady that bumped her award so high.

Here's a worse case hypothetical: It’s now four years since the young female patient in this video had her Lipotron treatments. She gets pregnant and her infant is born with some birth defect. She goes through an extensive medical history for what might have caused this terrible anomaly. Nothing seems to point to a genetic or other obvious cause. But she remembers that she had a series of 10-12 radiofrequency (microwave) treatments that were specifically targeted at her stomach and lower abdomen. Her Lipotron doctor told her that she had done her own research and assured her it was safe and effective. But now the patient finds out this device, this Lipotron/Lipo-Ex, used on her never was approved by the FDA and was fraudulently marketed, sold, and used for over seven years.

What do you think this young mother is going to do now?

Since the Lipotron’s / Lipo-Ex’ s effects on vital organs has never been scientifically tested, no one knows what the long-term effects are.

No one.

09.28 | Unregistered Commenterbworley

The depth of ignorance regarding biology, medicine, and medical care demonstrated in BWorley’s messages can be breath-taking. To help counter the possibility that the misinformation she last posted may propagate through the web as “truth”, I feel compelled to continue to provide actual facts so that people may at least be exposed to them.

Regarding her statement on “…no proof, no research, nothing but anecdotes…”, I’ll simply refer readers to my previous messages regarding the extensive body of literature on the safety and effectiveness of radiofrequency heating in general. The are also other radiofrequency devices in use which have hurdled the FDA bureaucracy and obtained specific clearance to be marketed for fat reduction and skin tightening. The mechanism by which they operate and the treatment protocols they utilize are equivalent to the Lipotron. If you do not fear them, then you have no special reason to fear the Lipotron.

The fen-phen analogy is amusingly ironic because fenfluramine was approved by the FDA to be marketed for weight loss. Did you catch that? It had the very clearance that BWorley is making so much noise about. How does this help her argument? (Just curious.)

The birth defect scenario would be hysterically funny in its utter wrongness if only if there wasn’t someone reading it who might believe it. One day, BWorley may do some research and stop posting nonsense. Radiation exposure of mothers does not cause them to have transmissible DNA errors. Exhaustive studies on this topic prove this medical fact. Birth defects are caused by inherited errors in DNA being passed on to children or by fetuses being exposed to radiation during the first few weeks of development. Higher rates of birth defects have never been found in children of patients exposed even to very high dose ionizing radiation, such as that used in treatment of cancer. In fact, the surviving populations of Hiroshima and Nagasaki did not have higher than normal birth defect rates after exposure to atomic bomb radiation.

So, BWorley asks, “What do you think this young mother is going to do now?”. Unfortunately, if she reads BWorley’s post, she may waste her time blaming RF lipolysis rather than having the genetic studies she actually needs. Such is the shame of ignorant fear mongering.

10.2 | Unregistered CommenterJillD

Comments and blog postings regarding the recent “buyer beware” story from The Orange County Register in late August 2012, about the LipoTron 3000 get to the heart of key issues:

1. proof of safety and efficacy of this specific medical device Lipotron 3000, not of the general technology of radio frequency, and,
2. The entities responsible for the device being available and in use in the marketplace, not the messengers/writers of the stories.

The Orange County Register article, as with the myriad of other respected media articles in print and throughout cyber space, is about the questionable marketing of an expensive device whose legality is in question. It’s not about the technology, Public Citizen, the merits of off-label uses of medical devices or any of the other things that some commenters' continue desperately to argue about.

If anyone has something to share about these specific issue– that is, about the Lipotron 3000 or the entities responsible for having it on the market – by all means, share it.

If anyone is still unsure about the issues about this matter with all that has been written, tweeted, blogged, emailed--essentially ubiquitous now--continuing these desperate and senseless arguments not related to the relevant issues will not serve any purpose other than defending one’s turf.

All that is left is for the proverbial "Fat Lady to Sing".

The FDA, DOJ, state medical boards, state health agencies, the end-user physicians and their Lipotron patients, albeit, slowly but surely, all will have the final say.

I'll reserve any further comment until federal and state agencies weigh in.

10.3 | Unregistered Commenterbworley

That's very cute, bworley. Alarm people with posts about invented dangers of harm from the technology (Watch out!!..."Birth defects!!! lol) and repeatedly bash physicians for off-label use across multiple forums. Then post, "It’s not about the technology....the merits of off-label uses...". Nice. (Do you also play tennis without a net?) In any case, expect messages containing errors or misleading information to be replied to by messages containing facts. Sorry if that may upset you.

Oh, and the "...myriad of other respected media articles in print and throughout cyber space," to which you refer as though that were some substantial support for your case? I invite everyone to search them out. They will find reprints or derivatives of the original fairwarning article; independent research is conspicuously absent.

10.3 | Unregistered CommenterJillD

Nice. BWorley posts messages about scary dangers of the technology (Watch Out!!!, "Birth defects"!!!) and bashing doctors for off-label use across multiple forums. Then, when someone points out that she's dead wrong, she says, well, "It’s not about the technology...(or)...off-label uses of medical devices...". Not that I don't appreciate her negating her own posts, but that's called, 'playing tennis without the net'.

Oddly. she also complains that it's not about those issues or "...any of the other things that some commenters’ continue desperately to argue about". It's odd because, apparently, she's completely forgotten that it was she and her compatriots that brought these issues up in the first place. So, sorry, no, I'm not going to roll over and let misleading and incorrect information be posted without making the actual facts available in rebuttal.

And it's disingenuous to try and make it seem as though her position strengthened by "...the myriad of other respected media articles in print and throughout cyber space...". The "myriad" she speaks of is just a collection of reposts and derivations of the original OC Register and Fairwarning article with independent reporting decidedly lacking. Watch the KTVU report she linked; it is just a re-hashing of the same story with no substantive research or corroboration offered. Repeating something over and over may make a meme, but it doesn't make a fact.

However, I do commend her for saying that she'll, "...reserve any further comment until federal and state agencies weigh in." If only she and other muckrakers had adopted that attitude before posting their first messages this entire thread would never have existed.

10.4 | Unregistered CommenterJillD

Arkansas State Medical Board replies to Public Citizen by calling two Lipo-Ex/Lipotron physicians before their December 6-7, 2012, meeting to answer personally and specifically their involvement in Lipo-Ex/Lipotron.

Here's the link to the letter:
http://www.citizen.org/documents/2052_second_response_from_arkansas_state_medical_board.pdf

10.23 | Unregistered Commenterjquinn

To be specific, the Arkansas board states, “This will not be a hearing. It is a request for the doctors to appear before the Board in order for the Board members to personally question them….”

In other words, it's a voluntary meeting to acquire more information. I hope the physicians do attend to correct the factual errors and grossly misleading claims of the Public Citizen letter.

10.25 | Unregistered CommenterJillD

The exemption and "registration" of the Lipotron (device used in the Lipo-Ex program) was rescinded by the FDA last month, November 2012.

RevecoMed continues to "register" various RF devices under several different names with the FDA.

Federal and various state investigations of RevecoMed, Advanced Aesthetic Concepts/ProfitSolutionsMD, and the users of the device are still open and active.

In addition, the FCC has been notified of users advertising the Lipotron/Lipo-Ex device online and in other media for weight loss/body contouring.

12.28 | Unregistered CommenterJQuinn

JQuinn's last post is, as usual, wrong. The Lipotron is currently registered with the FDA as can be seen here:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=304916&lpcd=ISA

And the state "investigations", automatic bureaucratic responses to the filling of a complaint rather than indications of wrongdoing, are one by one closing in favor of the physicians, as expected.

01.7 | Unregistered CommenterJIllD

Just followed the above link posted by JillD.
No Lipotron to be found in the acceptable names for a class 1 exempted therapeutic massager registered to RevecoMED today, Feb 18, 2013.

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