Fat-Melting Device a Weighty Matter for FDA

iStockphoto/LipoTron

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.

Paige Peterson

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.

RevecoMED office in Fullerton, Calif. (Lilly Fowler)

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.

LipoTron 3000, sometimes called the Lipo-Ex.

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.”

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40 comments to “Fat-Melting Device a Weighty Matter for FDA”

  1. Anonymous

    Thanks for finally writing about >Fat-Melting Device a Weighty Matter for FDA : FairWarning | FairWarning <Loved it!

  2. FLGIRL

    I’m concerned about a local medspa hawking this here…is this the same thing? They say it is for weight loss and the system is FDA approved. Also, aren’t these things just the same as Tens Units?

    Thank you.

  3. BWorley

    The Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, March 20, 2013, editorial regarding FDA warning letter begins:

    “A new warning letter sent by the US Food and Drug Administration (FDA) to medical device manufacturer RevecoMED regarding the sale and use of its “LipoTRON 3000″ device is bringing both praise and scorn from some industry watchers, who say the device and its manufacturer have long flaunted federal regulations without consequence.

    “Regulatory Focus has reached out to RevecoMED for comment but did not hear back by the time of this articles publication.”

    Link to full article: http://www.raps.org/focus-online/news/tag/5302/lipotron.aspx

  4. BWorley

    Here’s the link to the FDA web page where the warning letter is posted:

    http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm342765.htm

  5. BWorley

    The FDA has issued a warning letter dated March 1, 2013, regarding the Lipotron, Lipo-Ex, RevecoMed the manufacturer, and Advanced Aesthetic Concepts the distributor.

    In addition to the update posted today at FAIRWARNING.org, Public Citizen yesterday issued a press release. Here’s the link to their update: http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=3842

  6. Jill Dandy

    Regarding BWorley’s most recent posts:

    1) If you contact the FDA and ask if “Lipo-Ex” has a valid registration, you will indeed be told, “no”. But, that is because Lipo-Ex is a program of treatment and not a device and programs are not registered with the FDA. You must specifically inquire about the registration status of the “Lipotron”, which is the device name, and you will be told that has been, and continues to be, registered with the FDA.

    2) The “substantive” action of the Oklahoma medical board was to….wait for it….give NO reprimand, NO censure, and take ZERO action against the licenses of any of the doctors. And, the Board gave their blessing to those doctors to continue to use the Lipotron in any manner supported by the medical judgement of those physicians, including fat loss and body contouring, so long as they obtain the patient’s informed consent, just as they would with any other treatment.

    BWorley resorting to abusing name confusion shows just how desperate she is to keep her vindictive but dying anti-Lipotron campaign alive. Her hyperbolic misrepresentation of the Oklahoma Board’s response is just more evidence of her willingness to twist reality to confuse the public. Do your own research. She cannot be trusted.

  7. BWorley

    LipoAdvisor on Lipo-Ex / Lipotron–posted mid-January 2013:
    http://www.lipoadvisor.com/is-lipo-ex-fda-approved/

    …here’s what it says, in case the link above doesn’t work:

    Is Lipo Ex FDA Approved?

    While conducting our research on Lipo Ex (more info here) we tried to figure out whether this system has got FDA Approval. Actually the online information about it was conflicting while some sources mentioned that it received FDA Approval on January 2012 and other were insisting that Lipo Ex didn’t receive FDA Approval. What’s the truth?
    Lipo EX’s manufacturers attempted to gain FDA approval on 2010 but their request was rejected! Then they asked FDA to approve LipoTron as a massager (while its not necessary to get FDA approval to sell a massager). The thing is that doctors and aesthetic institutions promote Lipo Ex as a fat removal device (and not as a massager) which is illegal!
    Several doctors claim that its FDA Approval was imminent and this is why we contacted FDA in order to find the real truth! Here is their answer:

    Your interest in contacting the US Food and Drug Administration (FDA) through your recent email is appreciated.
    My research into the FDA medical device databases does not show any clearance documents for the Lipo Ex. I checked into the premarket notification 510(k) database at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm to no avail, typing the name of the device into the Device Name blank. I also searched the Registration and Listing database at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm, also with no results for such a device.
    Hopefully, this response will be of assistance. You are wished the best in your website endeavor and also in the management of your own health care!
    Cynthia Benson
    Public Health Advisor
    Communication and Education Programs
    Center for Devices and Radiological Health
    U.S. Food and Drug Administration
    1-800-638-2041

  8. BWorley

    Oklahoma Medical Board took substantive action regarding three physicians promoting use of the LipoTron / Lipo-Ex device for weight loss/fat removal/body contouring. This latest action has been forwarded to the OCI/FDA and the state medical licensing entities previously contacted by Public Citizen and by the whistleblowers.

    Since the actions in OK in late 2012, the registration and exemption of the Lipotron / Lipo-EX device has been rescinded by the FDA, which has also been reported to these state medical licensing entities.

    There had been some initial confusion since the FDA web pages are not updated real-time to reflect current status. However when you call / email FDA compliance, you will be able to confirm the rescindment:

    http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm081992.htm

    Office of Compliance
    10903 New Hampshire Avenue
    Bldg. 51, Rm 5271
    Silver Spring, MD 20993-0002

    Phone: (301) 796-3100
    Fax: (301) 847-8747

  9. BWorley

    FDA compliance office now responding to questions about Lipotron / Lipo-Ex—it’s illegal.

    Here’s what I heard yesterday from a distraught Utah practice administrator: “I need to know exactly what is illegal. I was told by an FDA rep today, that using this machine (Lipotron aka Lipo-Ex) is illegal. We obviously cannot tell patients it is for fat loss, and then afterward say it was a ‘massage.’ ”

    By telephone conversation today, investigator for Missouri Board of Registration for the Healing Arts (their medical licensing entity) says when he contacted the FDA compliance office last week, the compliance officer confirmed that the Lipotron’s registration / exemption has been rescinded. Using this device is illegal.

    Here’s the link to FDA compliance contact information:
    http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm081992.htm#ContactUs

    Here’s why you may still see out-of-date information on the FDA web site. Our FDA contacts tell us it takes weeks, and, in some cases, months for current / real-time information to post. So this is why you may still see a device listed as registered / exempted after it has been, in fact, rescinded.

    Have questions? Do what the Utah practice administrator and investigator for Missouri’s licensing board did—call an FDA compliance officer.

    By-the-way, the practice administrator and Missouri investigator told us that Lipotron / Lipo-Ex distributor Advanced Aesthetic Concepts / Profit Solutions MD (AAC/PSMD) is calling their customers weekly assuring them that the device is “approved, cleared, registered, etc.” One customer said that three different AAC/PSMD reps had called telling them three different stories.

    Don’t listen to anybody. Call the FDA.

  10. BWorley

    The exemption and “registration” of the Lipotron was rescinded by the FDA last month, November 2012.

    RevecoMed continues to “register” various RF devices under several names at the FDA.
    However, federal and various state agencies’ investigations of RevecoMed, Advanced Aesthetic Concepts/ProfitSolutionsMD, and users of the device are still ongoing, 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.

  11. dano

    Why do you act as if FDA clearance is a good thing?
    The FDA is nothing more than a gateway agency to Drug Company dependency.
    Nothing More.

    Drug Companies do not want Wellness. They want Customers.

    END OF STORY.

  12. Marketing News

    I was wondering if you ever thought of changing the layout of your site?
    Its very well written; I love what youve got to say. But maybe
    you could a little more in the way of content so people could connect with it better.
    Youve got an awful lot of text for only having 1 or
    two pictures. Maybe you could space it out better?

  13. George K.

    I am confused! I found in different places that Lipo Ex received FDA approval on 06/01/2012:

    http://molipoex.com/FAQ_s.html
    http://www.lipoadvisor.com/lipo-ex
    http://www.simplyblissdayspa.com/services/lipo-x-advanced/faq/

    Is this wrong?

  14. JillD

    To clarify BWorley’s most recent post, the Arkansas Board has only requested that physicians provide additional information regarding erroneous and misleading allegations made in the Public Citizen letter. This is totally voluntary on the part of of those docs. And, of all the medical boards spammed by Public Citizen’s letters, only a couple have responded, and those responses have been perfunctory at best. This reflects the weakness of the Public Citizen complaints and gives us all at least some confidence in the occasional ability of bureaucracies to see through biased, ignorant, promotional acts of self-proclaimed “watchdogs” who may, perhaps, be more interested in publicity that truth.

  15. BWorley

    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

  16. JillD

    BarryK says,

    “My personal opinion is that the FDA should be regulating everything that businesses market to the American consumer to be ingested, applied to the body or used for some kind of health benefit.”

    Good idea, Barry Now, watch carefully…..Hocus Pocus! Abracadabra! annnnnd Presto!! …….. http://www.fda.gov/aboutfda/transparency/basics/ucm194879.htm

    Ta-Dah! ;)

  17. Barry K

    I am a layman, and all of the technical things posted above, mostly by
    JillD and BWorley, are meaningless to me.

    What is important to me, and should be to all consumers, is that products offered to them are safe, and will provide whatever benefit their manufacturers’ claim for them.

    My personal opinion is that the FDA should be regulating everything that businesses market to the American consumer to be ingested, applied to the body or used for some kind of health benefit.
    Certainly all food items (I think they are, but there may be some exemptions), and most definitely every pill, lotion, potion, cream, machine or whatever else, no matter where it is produced, or how it is marketed.
    This should include every over the counter product from aspirin to weight loss.
    I will repeat; it must be proven safe, and to have some benefit as claimed. Otherwise, it should not be allowed on the market.

  18. JillD

    Correction; the stock price of Abbott was about $68 before 10/2/2012 (not 2002). Sorry for the typo.

  19. JillD

    One of the more poisonous characteristics of some posts is the way the author presents genuine facts in an effort to create the illusion they support their case. Unfortunately, it sometimes takes a certain amount of industry knowledge to know when this is happening, so the average reader may be duped by the post.

    For example, let’s take a look at the last message from BWorley. First, she posts a link that she says is intended to “clarify the issues”. What is that link? Well, it’s a story about the judgment against Abbott Labs, including a multi-hundred million dollar fine, for misbranded promotion of Depakote. Mmmmmm…well….okay, yeah; the FDA enforces regulations against off-label promotion. We all knew that. I have no idea what is being “clarified” with this link.

    Perhaps she thinks the dollar amount is super scary and shows just how serious the FDA is about this stuff? It is a ton of money, after all. But, then, Abbott does pretty well for itself:

    http://seekingalpha.com/article/717761-earnings-preview-abbott-laboratories

    As you can see, they made about thirty thousand million dollars (that’s right, 30,000 million = 30 BILLION) in 2008 and grew to about 39,000 million (39 BILLION) in 2011. So, that fine was about one week of total revenue. Their net income on those sales is around five thousand million, so the fine was about six or seven weeks of net income.

    Well, that’s gotta hurt a little, I suppose, but it’s just a hiccup for them. That’s still true even when we take into account that they actually paid more than that in other penalties, about 1.6 Billion total. But, they sold 13 Billion dollars worth of just that one drug during the period the penalties are for:

    http://articles.cnn.com/2012-05-07/justice/justice_abbott-fine-drug_1_abbott-laboratories-abbott-s-ceo-pfizer-settlement?_s=PM:JUSTICE

    Well, okay, but can we somehow figure out just much damage these penalties actually did to Abbott? I have an idea; let’s take a look at their stock price:

    https://www.google.com/finance?client=ob&q=NYSE:ABT

    Their stock price was about $68/share before 10/2/2002. Immediately after the judgment was announced, the price started climbing, going up about 5% to around $71/share over just a few days. Why? Because the case is now settled and investors are very happy with how SMALL the award was relative to the company’s earnings. As much money as the fine was, it’s trivial to Abbott; a slap on the wrist.

    The Abbott case is also uncommon. Few companies are actually fined for unapproved promotion. Most the time, a company just gets a letter telling them to knock it off and they do. You can see a few hundred such FDA letters over the past few years here:

    http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/default.htm

    The rest of her message parsing out the regulations of approved versus registered products and off-label versus unintended use is old news (most of which I already posted in response to her posts in this and other forums) and really just a bunch of filler. The cogent point is that a product may not be marketed by a manufacturer for a use not covered by it’s FDA registration or approval. Okay. No one has debated this.

    However, the conclusion of her post is this:

    “All that is at stake is your business, livelihood, medical license, and reputation.”

    I have tried, ad nauseum, to get her to understand why these warnings of hers are totally wrong, but she clearly either doesn’t get it or she’s trolling. Nothing in her post supports her conclusion.

    The Abbott story? That’s about a manufacturer misbranding their product. No medical providers have been fined for using that product in the misbranded manner. None. Zero. As I type this, doctors STILL advocate and use Depakote for the very purposes Abbott is being fined for promoting it for. They haven’t been punished for it and they never, ever will be. Because the process of reaching a clinical decision to use a product for a purpose is completely disconnected from the FDA process regarding marketing of a product for a purpose. They have nothing whatsoever to do with each other. I’ve posted it previously, but a good source for better understanding this is here:

    http://www.aei.org/files/2008/05/21/20080522_Herrmannpaper.pdf

    Hope that helps REALLY “clarify” things :)

  20. BWorley

    Department of Justice press release regarding off-label promotion, dated Tuesday October 2, 2012, that may help clarify the issues in these postings:

    http://www.justice.gov/opa/pr/2012/October/12-civ-1195.html

    FDA contacts tell me that the rules are the same for devices as for drugs.

    We’ve been corrected by these FDA/OCI/DOJ contacts about the following important distinctions:

    1. FDA registration refers to a company, not a device. Once a device is exempted, cleared, or approved, it is listed under its registered company and there are annual fees and requirements associated with a registration.

    2. Exempted devices do not have a “label”, only an “intended use”.

    3. Only “cleared” (by successful 510(k) process) and “approved” (by successful PMA process) devices have a “label”.

    3. If an exempted device is promoted outside its narrowly defined “intended use”, its manufacturer must go through either the 510(k) or PMA process so the device may be properly and adequately classified and appropriately “labeled”.

    4. There is no “off-label” promotion nor use allowed for “exempted” devices because, by definition, they do not have a “label”. An exempted device can be promoted and used only for its “intended use” as specifically defined in its exemption.

    5. If you are marketing, selling, and training end-users on an exempted device outside its narrowly defined “intended use” it is “misbranding” and illegal to do so.

    As we’ve encouraged many times, please don’t take our word, or anyone else’s.

    Please do your own reading and research.

    All that is at stake is your business, livelihood, medical license, and reputation.

  21. JillD

    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…”. Lol….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 is 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.

  22. BWorley

    Corrected copy:

    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 and writers of the stories.

    This FairWarning story, the Orange County Register article, as with the myriad of other respected media articles in print and throughout cyber space, are 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 issues– 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 that are 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.

  23. JillD

    The depth of ignorance regarding biology, medicine, and medical care demonstrated in BWorley’s messages is often breath-taking. To help counter her misinformation propagating through the web as “truth”, I feel compelled to continue to provide actual facts so that readers 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. There are also other radiofrequency devices on the market 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 hysterical in its utter wrongness if only if there wasn’t someone reading it who might believe it. Birth defects are caused by inherited errors in DNA being passed on to children or by fetuses in the first few weeks of development being exposed to radiation. Radiation exposure of mothers does not cause them to have transmissible DNA errors. There are exhaustive studies on this topic. One day, BWorley may do some research and stop posting nonsense. 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, that mom may waste her time blaming RF lipolysis rather than having the genetic studies she actually needs. Such is the shame of ignorant fear mongering.

  24. BWorley

    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.

  25. Paige Peterson

    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.

  26. BWorley

    From the story above: “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 your opposition makes your case for you.

  27. JillD

    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 generalized principle of whistleblowing, which can be good, and making misleading or false accusations, which is bad. No post I’ve read suggests knickers being 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, 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 don’t, but 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 freely but does not seem to understand. For FDA regulatory purposes, this phrase has a specific statutory meaning that is distinct from any claims or advertisements made by a distributor or manufacturer. Statutorily, the phrase, “legally marketed”, means that a product is registered or approved by the FDA to be on the market for any purpose. A product being advertised in a way outside the scope of its registration is referred to as “misbranded”. Misbranded advertising does not negate a registration or approval for a product’s intended use and is irrelevant to physician’s off-label use being legal. She either doesn’t know this, or is choosing to propagandize.

    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 classified that way by the FDA. We next have to delve a little into FDA 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 will probably 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.

    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 a well established modality for that indication and numerous other radiofrequency devices are also 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 is totally separate from the standards physicians have for using a device. (Think about it for just a second; that’s 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 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.

    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 approval over how products, devices and drugs, may be advertised but has no power to control how doctors may use those products. It is a deliberate balance meant to allow medicine to advance most efficiently by allowing physicians, who treat patients and see the results daily, to freely use medical products in ways that may help patients while minimizing promotional abuses from manufacturers and distributors who most profit from the sale of such devices. These 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.

  28. BWorley

    First a correction and apology: The correct link to the CaliforniaWatch news article is
    http://www.news10.net/news/local/article/210879/2/Calif-doctor-at-center-of-fat-reduction-device-controversy-

    The link previously posted took you to the “Comments” section where you had to click on another link to take you to the story.

    Now the reason for this post.

    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.

  29. BWorley

    Latest story September 24, 2012 from California Watch:

    http://www.news10.net/comments/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.

    As to its safety, there are no peer reviewed published clinical 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 that are from more than seven years ago are not clinical results from a scientifically sound, objectively sourced / IRB monitored and managed study.

  30. JillD

    I agree with you, BWorley; an informed, knowledgeable public is important. Your post is disingenuous, though, since it implies that if people do the research you suggest that they will believe your claims when you know almost no one will do the work, so they won’t find that the references you cite actually don’t support you.

    Because, as you say, it is “tedious to get through” all that, let me help those who might have a genuine interest in facts and truth.

    The manufacturer is an FDA registered manufacturer. You can see that here:
    http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?rid=133135

    The product is registered with the FDA. You can see that here: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=304916&lpcd=ISA

    On that same page, you can see there that the product is registered under Federal Regulation Code 21CFR890.5660. You can see that code that here: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRsearch.cfm?FR=890.5660

    This is an “exempt” category, meaning that products listed here work in relatively simple ways and are presumed to do the thing that such products are suppose to do (e.g., “improve circulation”).

    “Simple” doesn’t necessarily mean technologically simple, though. The category is called, “Massager, therapeutic, electric”, which may call up images of some vibrating thing you buy at the store. But, from the FDA’s perspective, it can be much more than that. Many products using radiofrequency, ultrasound, electric currents, etc. are registered under this category (such as IDT Prestige, BellaContour, UniForm Handpiece, CEYA, Nue Fusion, SE35, VitaLift, etc). You can search for those examples here: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

    The LipoTron works using radiofrequency to heat tissues up. Tissue heating is a simple well established way to improve circulation. Radiofrequency is just the way this device does that, which, as noted, do other advanced “massagers” listed by the FDA.

    Being so registered just means that manufacturer can legally market it for that purpose. The FDA doesn’t involve itself in how a device (or drug) is actually used by physicians, just how the company can sell it. When a doctor uses a product in a way other the FDA has approved the manufacturer to market it, that’s called “off-label use”. It’s totally legal and ethical and there’s probably not a single doctor who doesn’t do it. You can read more about that here: http://www.aei.org/files/2008/05/21/20080522_Herrmannpaper.pdf

    Other ways a manufacturer can market a product is to have it “approved” or “cleared” for a purpose. This is a more involved process, but the end result is the same; the company can only promote the product for the approved purpose, but doctors can use it for anything they find it effective for.

    An old distributor for this product promoted the device for ways beyond what it was registered for, which is not allowed. But, even so, doctors can still use it for anything they want. One thing has nothing to do with the other. Since there are dozens of medical articles showing that the way the device works (heating tissue with radiofrequency) reduces fat and tightens skin, many doctors have been using for that purpose. It’s a completely reasonable judgment based on the evidence. To see many peer-reviewed medical articles about how this works, go to http://www.ncbi.nlm.nih.gov/pubmed and search “radiofrequency cosmetic”.

    Now, some people, particularly the old distributor, who had to be sued by the new distributor to get back over $60,000 she misappropriated (the court case is Advanced Aesthetic Solutions v. P2, LLC, Tarrant District Court, Fort Worth TX, ), are unhappy about the marketing of the device and are trying to make huge issue out of it. Considering that she was dropped and sued, you can take your best guess about her motivation. Next, seeing a good scare story, a group called Public Citizen started sending out letters all over the place complainng about it, too. But, the new distributor has cleaned up the old marketing, so there’s not really a problem there. And despite all the hand-wringing over “danger”, the machine has been used for years and years with tens if not hundreds of thousands of treatments and Public Citizen, which is a huge, very rich group, can’t find a single patient who’s had any serious or even significant injury. Some think they just seem be trying to get attention with hype; maybe to increase donations?

    So, there are some real facts but I too hope a few people will do their own research and learn the truth. Maybe the above will help them get started :)

  31. BWorley

    Here’s the good news. I trust when someone really wants to know the facts, they will read the letters, the FDA statutes, the US Attorneys’ Criminal Resource Manual, and avail themselves of other objective resources to make an informed decision, not dependent on statements from anyone with a subjective opinion.

    All these resources are online and available to anyone.

    So, don’t believe me. Read the most objective information you can find and then make up your own mind.

    Please follow the links to the letters.

    Please read the statutes on the http://www.fda.gov web site.

    Please read the parts of the statutes that describe the differences in the terms “registered”, “exempted”, “cleared”, and “approved”. There is a real difference in all these terms and what you can and cannot do when you have one or the other.

    Please read the parts of the statutes that describe when it is legal and when it is not legal to treat “off-label”. There is a real difference in what is allowed and what is not allowed.

    Yes, it’s complicated and it’s tedious to get through all the legal language of the statutes.

    But, it is the law. And the law says that ignorance of the law is not an excuse for not doing what the statutes say.

    And whether or not you agree with the law or what the letters say or what someone else is doing or what someone else says is okay, the final decision rests with the law.

    An informed, knowledgeable public is what is important.

  32. JillD

    No, the response from Florida’s device regulatory board wasn’t “partial”. They found no actionable issues regarding registration of the device which is the full extent of their authority. That’s the end of that issue as far at they are concerned.

    The Florida licensing board is a totally different entity. As noted in my previous message, the probability is that they will response in a similar fashion. The fact that an “investigation” is opened, in Florida or California or anywhere else, is utterly meaningless. Anybody can make a complaint about almost anything and there will often be an “investigation” to resolve the complaint whether its valid or not.

  33. BWorley

    Florida Department of Health’s “partial response” applauds and encourages Public Citizen efforts with the appropriate jurisdiction–the Florida Board of Medicine. Here’s the link to the complete letter: http://www.citizen.org/documents/2050_florida_department_of_health_response_to_lipotron_letter.pdf

    Medical Board of California responds with opening an investigation–control #12 2012225530. Here’s the link to the complete letter: http://www.citizen.org/documents/2056_second_response_from_the_medical_board_of_california.pdf

    Texas Department of State Health Services thanks Public Citizen for providing information which supplements their ongoing investigations (complaint numbers 1525120415 and 1525120590 . Here’s the link to the complete letter: http://www.citizen.org/documents/preliminary_response_from_texas_dept_of_state_health_s

  34. JillD

    Florida rejects Public Citizen’s complaint regarding the LipoTron, pointing out the obvious, that the device is registered with the FDA:

    http://www.citizen.org/documents/2050_florida_department_of_health_response_to_lipotron_letter.pdf

    Now, it’s up the medical licensing board to respond regarding physician use. Considering the extensive legal, professional, and regulatory precedents in support of physicians using registered devices off-label, and the large body of medical studies showing that the modality of this device is safe and effective for body contouring, hopefully we’ll see Public Citizen’s effort to use their resources and bully pulpit to harass doctors fail.

  35. JillD

    Sorry you haven’t had much result, Angel. However, there are dozens of peer-reviewed medical articles showing the technology is safe and effective (go to PubMed and do a little research for yourself). There’s a range of results, of course, so some people are inevitably at the low end. As for the machine, it is registered with the FDA and complaints on the web originated with a disgruntled ex-distributor who is the one who produced most of the off-label marketing that she complains about. The new distributor was perhaps too slow in revising the marketing, but has done so. The machine itself has been in use for years and is very similar to other devices in use that work the same way. Complications have been been few and minor and comparable to other such non-invasive treatments. Doctors who use the machine for body contouring are using it off-label but, unlike manufacturers, physicians are totally free to do so (up to half of all medical care is off-label; it’s legal and ethical). Basically, a bitter ex-rep combined with an attention seeking “advocacy” group that appears to many to be using hyperbolic fear-mongering to grow its contribution base are creating a lot of noise over very little.

  36. Angel

    I have had 8 treatments with this equipment and really do not notice any difference other then I have budges in my belly area. Did not get shocked but did bruse on hip bone area. I was hoping for more results but it is not the cheapest possibility and the area located is completely out of my area.

  37. Freelance MD

    There are lots of angry comments and back and forth between the physicians who have this device over on Medical Spa MDs post about this article: http://medicalspamd.com/the-blog/2012/7/12/fairwarning-the-lipotron-3000-lipo-ex-fda-unapproved-85k-mas.html

  38. Arnold William Klein MD

    Integrity and honesty are not things one finds at the FDA. In reality from the discussion below it is very obvious to this day dishonest forged data is employed with the use of drugs and devices that are even FDA approved.While the use of forged data and employing unlicensed illegal aliens as consultants would seem cause for legal action it is obvious the FDA and drug companies because of their wealth sit far above this a fray.

    ,December 22, 2010

    Sally Quillian Yates
    Richard B. Russell Federal Building
    75 Spring Street, S.W. Suite 600
    Atlanta, GA 30303-33
    December 22, 2010

    Dear Ms. Yates:

    I read through the Justice department settlement with Allergan and there are factors that upset me. Before he meet with me Randy Chardash was not aware of the promotional courses given by Allergan for the spasticity associated with Botox. As I indicated to him these courses provided a dangerous manner in which to treat Cerebral Palsy. Additionally the data I provided him as well as the FBI and INS concerning the unlicensed Canadian physicians Alastair and Jean Carruthers who worked for Allergan, practiced throughout the USA and did not have a green card is not even mentioned in the settlement.. Nor is the fact that these doctors privded false and dangerous data regarding Botox dilution that was published in the medical literature and still used today. I met with the FBI three times and INS two times. I was promised inclusion in the whistleblower suite if filed. Furthermore when I revealed to you the forged data on Botox dilution, David Pyott the CEO of Allergan fired me as a consultant, took my teaching grant, and prevented me from teaching additional CME courses. This is just another example where one gets penalized for revealing the truth to the FDA. Is the FDA interested in the welfare of patients or the profits of drug companies?
    Sincerely

    Arnold William Klein, MD
    Professor of Medicine and Dermatology
    The David Geffen School of Medicine at UCLA

  39. Lawrence F Muscarela PhD

    This article states that: “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.”

    This sounds all too familiar, and it brings to the fore an important check and balance – the U.S. press – that has remissly and inexplicably been overlooked and ignored. The public needs either a FDA that regulates the safety of medical devices or that recuses itself of all such regulation, freeing up funding that could be better spent on protecting our cities from crime, sponsoring job creation, and funding health care.

    I have written on this topic in a peer-reviewed medical journal at:

    http://www.myendosite.com/articles/WJCID2012.pdf

    Medical devices need to be treated and regulated, not as an unwanted adopted child or as a vitamin, but more like drugs. The patient’s safety is at risk. We need to expose this topic, talk about it, and provide sound corrective actions.

  40. Steven Grossman

    I have no knowledge of the specifics of this case.

    Assuming the allegations are correct, there is an answer to the larger question: why hasn’t FDA done anything? Simply put, there are hundreds of unapproved products on the market and FDA has a limited amount of funds to investigate and go after these products and their manufacturers.

    For more information about FDA’s need for better funding, I suggest readers go to http://www.StrengthenFDA.org. This is a multi-stakeholder group (patients, consumers, industry, others) working for increased appropriated resources for the agency.

    I have also addressed the funding question in a blog column: ” A Well-Funded FDA: Only If Congress Stands Behind Its Words.” The column can be found at: http://www.fdamatters.com/?p=1944.

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