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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)

Just read the article. It's amazing to me that they're selling the device as 'fully compliant with the FDA" after failing to get approval. I guess that the real losers are the physicians who paid for this massage device for minor pain.

"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."

I don't know who is still selling these but there seems to be some very serious questions about how ethical (or legal) it is to use something that the FDA didn't approve. I'm not conversant in FDA regs but it seems very odd that these guys could do this. Anyone have more insight?

07.13 | Unregistered CommenterLrgo

Thank you, MedicalSpaMD, for posting this story front page. I am the person who has been posting about this federal criminal investigation on this site for about 30+ months. Mark Durante of Advanced Aesthetic Concepts, the exclusive distributor for RevecoMED and the LipoTron, threatened to sue me unless I deleted my posts about the investigation and contacted you to do the same. Thank you for staying strong for free speech.

Just to be clear, Lipo-EX is LipoTron, just in case anyone is confused. The whole purpose for calling the LipoTron by another name (Lipo-EX) was to stay under the radar of the FDA and make it look like something "legal".

You will be seeing more national coverage of this story in the weeks to come.

07.14 | Unregistered CommenterJQuinn

Regarding Jim Rosen's comment about not being able to police the Internet, the link below will take you to Rosen's / RevecoMED's web site for their medical clinic which features the LipoTron for fat reduction. So looks like he could police his own site, but chose otherwise.

http://www.trinitymedclinic.com/aboutus.htm

07.14 | Unregistered CommenterJQuinn

I took a look at that link and it's very clear that this clinic, (which the CEO of of RevecoMED, Jim Rosen, appears to own) is promoting this treatment specifically as what it is, a RF fat melting medical device. http://www.trinitymedclinic.com/services.html

Copied and pasted from that page:

"How does it Work?
LipoTron uses radio frequency to specifically target fat cells. The treatment increases your body's core temperature to a point of dissolving fat cells, without causing damage to other internal organs. It is the first technology to melt the unhealthy and dangerous fat linked to heart disease and diabetes. CT scans; body circumference and weight measurements have confirmed that LipoTron results in the loss of 2-3 inches and 10 lbs of weight in just 6 weeks for most patients. It causes the disruption of fat cell membranes, thus causing the fatty content to leak out into the interstial tissue...

Question & Answer

Q. What is LipoTron?
A. The LipoTron is a non-invasive aesthetic device that tightens skin, recon tours the face and body, reduces cellulite. This safe treatment works for all the skin types and colors, and offers solutions to the inevitable problems of weigh gain and aging skin.

Q. What is different between Thermage or Aluma Skin Renewal and LipoTron?
A. Their devices use high heat ( 65˚ C or more) for contraction of collagen but LipoTron uses low tissue heat between 39-42. Their application is limited to skin tightening.

Q. What is LipoTron Application?
A. Tighten the jaw line, reduce jowls, recontours chin line, and reduce eyes under bag. Smooth the orange peel look, tighten loosen skin and recontours body measurement. Firm the breast, tighten loosen skin under the arms or on stomach.

Q. What is LipoTron Radio Frequency- Assisted Lipoplasty (RFAL)?
A. Conventional liposuction is the invasive cosmetic plastic surgical procedure to remove pockets of fat that has not responded to diet and exercise. Also, Invasive liposuction was not intended as a means for weight loss or obesity treatment. LipoTron Noninvasive RFAL system provides all the advantages of a deep thermal increase to remove subcutaneous fat (cellulite) , visceral fat at the same time including weigh loss and obesity treatment. This procedure has no downtime, side effect and maintenance."

I have no dog in this fight but it's obvious that this is both a medical device that should have FDA approval, and that they're promoting it as such.

07.14 | Unregistered CommenterCHIMD

Let’s connect the dots…
Dot 1
"State examining claims about LipoTRON device" was a story
printed in the Austin Statesman on June 24th.
http://www.statesman.com/news/texas/state-examining-claims-about-lipotron-device-2403609.html

An early quote from Mark Durante (Advanced Aesthetic Concepts) from the Statesman article…

Durante said “that although the firm still distributes the LipoTRON, the website does not tout it for fat removal.”

www.lipoexprograms.com is Advanced Aesthetic Concepts / Durante’s website touting the Lipo-Ex program for fat removal. Later in the Statesman article, he admits Lipo-Ex contains the Lipotron RF device.

How can you conclude the site belongs to Durante?
1. Advanced Aesthetic Concepts website is www.fromstarttoperfection.com.
2. Contact info on www.lipoexprograms.com is info@fromstarttoperfection.com
3. Physical address listed on lipoexprograms.com is the same address provided for Advanced Aesthetic Concepts.
4. Call the phone number listed on the Lipo-Ex site the website 800-337-0745. It is the same contact phone number on Advanced Aesthetic Concepts website.
5. Ask for Mark, Sommer, Shannon, Cindy, Webster, Jane or Samethi, all names under the about us tab as Team Leaders.

Dot 2

More quotes from the Statesman article spoken by Durante.

“The LipoTRON is used "as a therapeutic massager for increased circulation," Durante said in an interview last week.

"The state did not understand there is a difference between the Lipo-Ex program and the LipoTRON," he said, adding that the company never promoted LipoTRON for weight loss. The Lipo-Ex program includes other medical devices, including the Celluderm System and Lightwave LED, but the LipoTRON is the only one that uses radiofrequency to heat body fat, Durante said.”

As of early 2012 LipoTRON and Celluderm share the same exempted status under Regulation section 890.5660 Therapeutic Massager to relieve minor aches and pains.

The LiopTRON is a class 1 exempted massaging device registered to RevecoMED
The Celluderm is a class 1 exempted massaging device registered to Innovative Med Inc.

As of January 2010 Lightwave LED was cleared K082586 for 5 indications:
1. The LIGHTWAVE Deluxe Red light is indicated for use in dermatology for treatment of superficial, benign vascular, and pigmented lesions.
2. The LIGHTWAVE Deluxe Red and Blue light combination is intended to emit energy in the red and blue region of the spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.
3. THE LIGHTWAVE Deluxe Blue light is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
4. THE LIGHTWAVE Deluxe Red and Blue light combination is intended to emit energy in the red and infra-red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
5. THE LIGHTWAVE Deluxe Infrared Light is intended to emit energy in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

The below is quoted from www.lipoexprograms.com under the Technology tab, but you won’t see it unless you click on “read more” toward the end of the page.

“How does Lipo-Ex work and what kind of patient results can I expect?
Out of the synergy of technology and extensive research, a revolutionary formula for fat reduction, skin rejuvenation and body sculpting has emerged. Using a patented radio frequency (RF) technology, the benefits of RF are no longer limited to superficial conditions, but can now therapeutically extend to the visceral areas of the body. These technological advancements, unique to the Lipo-Ex program, are then blended with proprietary clinical techniques and education to help your patients reach their goals for fat reduction, skin tightening and body sculpting for the entire body. In international studies, the technology in the Lipo-Ex program became the first of its kind to demonstrate with CT scans the reduction of both visceral and subcutaneous fat. The studies also showed a total reduction of fat of approximately 0.8-1 quart per session with a total of 4-5 quarts after 5 sessions. Currently, our physicians nationwide are documenting an average circumference loss of 2 ½ to 4 inches in eight weeks with some patients reaching as much as 8” in a single circumference reduction.”

In the FDA market exemption of Therapeutic Massager or the Clearance for marketing indications did you see visceral fat reduction? Subcutaneous fat reduction? Skin tightening? Body sculpting for the entire body? Up to 1 quart per session fat reduction? Or Average circumference loss of 2.5 to 4 inches in 8 weeks listed as acceptable marketing claims?

Doctors can make these claims if they choose but only on the Lightwave LED because it is a “FDA 510K cleared device”, making these claims “off label”. Distributors cannot. Manufacturers cannot.

The other two devices are FDA Class I exempted devices. Any marketing claim other than therapeutic massage or minor ache and pain relief subject to FDA approval for marketing through the 510K or PreMarket Approval process.

Dot 3
Continued Mark Durante quotes from the Statesman article:
"All they are doing is they are asking us to respond to a complaint," Durante said. "We don't believe the complaint is justified. We handled everything the state asked."

He (Durante) would not say how many LipoTRON devices his company distributes or how much they cost.
Then according to the FairWarning.org story link in the article above, Jim Rosen the CEO and President of RevecoMED International. “ Rosen wouldn’t disclose how many of the devices have been sold, but the number is believed to be in the low hundreds.”
Rosen and Durante won’t say how many LipoTRON devices have been sold by their companies in the US because all sales are illegal.

A repost of FairWarning’s story on Medical Device and Diagnostic Industry Blog was correctly titled,
“Medical Device Offers Alternative to Liposuction...and a Middle Finger to FDA”
http://www.mddionline.com/blog/devicetalk/medical-device-offers-alternative-liposuctionand-middle-finger-fda

Here's how I found these details, using google.com search and the keywords Reveco, Advanced Aesthetic Concepts, Lipotron, and Lipo-EX.

Today FDA urged to seize LipoTrons / Lipo-EXs, stop RevecoMED / AAC, and protect the public by Washington DC PublicCitizen.

Here's the link to the press release, transcript of the letter to the FDA, and supporting documentation:

http://www.citizen.org/hrg2044

07.18 | Unregistered CommenterJQuinn

Just received your MEMBER ALERT email about FDA urged to seize LipoTrons. One clarification: the PublicCitizen letter to the FDA calls for the seizure of all RevecoMED LipoTron devices. There are a number of models besides the 3000, including LipoTron 500, LipoTron 1000, LipoTron 2000, VitalRF, RecuDerm, FollicieStimulator, Lipo-EX, Lipo-EX Advanced, and a few others.

Distributors of these devices have included Advanced Aesthetic Concepts of Fort Worth, TX, DermaVista of Birmingham, AL, Onyx Medical of Novato, CA, and, of course, the whistleblowers themselves.

07.18 | Unregistered Commenterjquinn

J Quinn otherwise known as Paige Pederson has failed to disclose the fact that she stole $65K from a subcontractor. The subcontractor filed civil case against her and the subcontractor WON. She then declared bankruptcy to avoid paying back the monies and avoid criminal activity. This is not an honest person.

07.18 | Unregistered CommenterLoisLane

Whether jquinn is this person or not, or even if this person is "honest" is entirely beside the point. The real losers here are the docs that have been suckered in by these people with empty promises and what could very well put them at risk on multiple fronts, not to mention the money they'll lose as a result. Who cares which snake raised it's head first.

07.18 | Unregistered CommenterRangle

Since i own a machine i'm interested in what develops from all this finger pointing. does this watchdog group have a vandetta, do they really care about patients, do they know if any harm or good has come from these treatments with lipo-ex?
I have not been using the machine for some time, but we did get fair results. It was markerted to me as a fat reduction tool.
Advanced concepts may have promoted this product off label but was it illegal? we use alot of medications with good results off label. Just playing the devils advocate here, trying to get both sides of the story. Does anyone know if any independent legal action is planned against advanced concepts or M. durante?

@antiagingmd,
I think it's too early to tell if there will be any individual lawsuits that come out of this but I would bet that there may be a few. (I would guess that you would want some money back if the FDA comes in and takes your unit.) From what I'm reading the stories that are going up are not vendettas against any of the companies involved but are really pushing the FDA for what they feel are lax enforcement. However, just as with anything else, the US has an abundance of lawyers. If I were you I would contact one and get their take. I would also make absolutely sure that I wasn't promoting this device as FDA approved and I would be somewhat hesitant about even using the device. These guys got caught with their hand in the cookie jar and the FDA is going to be forced to sit on them. (jut my 2 bits)

07.18 | Unregistered CommenterRangle

See below for statute language concerning "off label". What I understand is it is okay for a medical practitioner to use off label as long as the device is/was "legally marketed". If it was not "legally marketed", off-label is a problem.

Here's the actual FDCA language along with a link to a really useful document written by Ellen J. Flannery of Covington & Burlington LLP, an FDA expert law firm in DC

"A health care practitioner can prescribe or administer a
legally marketed device to a patient for an off-label use, but
a manufacturer cannot promote unapproved uses of a
device". FDCA § 906.
http://www.aipla.org/learningcenter/library/papers/am/AM08Materials/Documents/Flannery-paper.pdf

07.18 | Unregistered CommenterJQuinn

I found this article very interesting. Thank you for writing and publishing it. I believe the FDA has a role to play in making sure devices are safe and effective. When it comes to medical devices, the FDA focuses more on safety then efficacy. But either I am a bit confused or I find this article a bit hypocritical given its context on this webpage. What I mean is that you are writing about a device being used without proper FDA clearance, but right next to this article, you are offering to sell re-imported Botox. Isn't that illegal and against FDA mandates??????? Seems a bit strange to me. Perhaps you can clarify my confusion on this subject. Or if I am correct, you should reconsider your illegal sale of re-imported Botox.

Brian Stolley, MD.

@Brian Stolley, MD
From your question I'm guessing that you may have just stumbled upon the site. Not wanting to speak for anyone but you'll find physicians and authors from outside the US all over the site and the header/footer state that. I don't think that there's any representation to purchase anything that's illegal or unethical and that is an advertisement. (Ok, I think I"m done with this thread.)

07.18 | Unregistered CommenterRangle

I also agree with Dr. Stolley, but this is the true nature of the unregulated "spa" business. We have spa owners without any type of medical background owning and performing treatments on patients. Also, machines being sold by sales reps who know full and well their machines do not yet have medical clearance, but fail to tell the physicians buying them. Then, when they get fired, elect themselves "whistleblowers" and pretend they care about safety and the public, after taking hundreds of thousands in commissions from unsuspecting physicians. The worst part is knowing the same whistleblowers are currently out there selling their snake oil with other non-cleared devices.

I haven't heard of any real issues with this device or any 'horror stories'. Is this device capable of real damage and have there been patients who have been harmed? Is this really more about FDA enforcing their approval process or are patients really at risk if this is being handled capably through real medical clinics? There is always a scale and from what little I've read there shouldn't be anything hear (by way of complications) that couldn't be said of something like Thermage. Are there risks above burns or localized lipolysis?

07.18 | Unregistered CommenterEmeryD

If these LipoTron guys are smart, they'll take all necessary steps to swallow hard and try and fix this. Threatening the messenger is a no-win tactic as a business and sometimes you just have to admit your mistakes.

07.19 | Unregistered CommenterChabela106

Thanks but I WILL NOT buy this equipment. This country is doomed.

07.19 | Unregistered CommenterMBaracaldo

People should get their facts straight before they make statements which could harm others. There is nothing worse in this country than irresponsible reporting. The court case against Paige Pederson and the outcome are public record in Tarrant County, Texas, as is her bankruptcy filing to avoid jail and paying back monies she stole. Just as the fact the device is FDA approved. Why anyone would not take the proper steps to verify such information before making such a libelous statement is beyond the rational mind. Both, the bashing and the lost court case are related to Paige Pederson, who is nothing more than an angry, disgruntled ex-seller of the Lipotron device. There are no two snakes involved here...only a snake and a bunny...with Ms. Pederson being the two headed snake.

07.19 | Unregistered CommenterLoisLane

@LoisLane,
It's clear that you are one of the players in this case and have no fondness for Paige Pederson, but I don't see what her history has to do with the FDA approval issue. (She admitted to much wrongdoing in the story already but that's how 'whistleblowing' works.) While everything you say to disparage this person may be true, the real topic is the representation/marketing of a medical device as being FDA approved when it apparently was not.

However, from your comment above It appears that you're claiming that the Lipotron device actually is FDA approved. Is that so? Are you claiming that the LipoTron actually is FDA approved? If the device actually has FDA approval (and not this hocus-pocus 'massager' Type 1 non-approval BS) then I would think that it would be provided to the media tout de suite. If not, I don't see how you can be mad at Fairwarning or others for reporting this. If I had one of these devices, which I do not, I would want to know about this.

@MBracaldo,
Like the comment.

07.19 | Unregistered CommenterChabela106

@MBracaldo,

I think Lois Lane is angry that Fairwarning as well as other news outlets published articles based on only what Paige Peterson was saying without bothering to check all the facts. I am an owner of a Lipotron, but have not used this machine for a few years. Never did Reveco tell me that the machine was FDA approved. They applied for clearance to get FDA approval and FDA came back and needed more information. I think at this point Reveco did not have the money to pursue FDA clearance. Was I a fool for buying this machine when it was not FDA approved? Yes!, but I was so excited and happy with the results. Also, I don't agree that Paige "admitted to much wrong doing". I never once received an apology as she states she gave to the doctors she sold the Lipotron to in the fair warning article, even though she had my office, cell and email. Further, I have received numerous other email suggestions from Paige over the last few years to buy other pieces of equipment that are not currently FDA approved. Is she sorry about that too? Not to lay all the blame on Paige, because I think both her and Reveco are a bunch of snakes. It's no wonder that she was fired from this company. Their personalities are probably too similar to get along!

The bottom line is negative press is not always a bad thing…in fact it’s part of being successful. When you have a great product there will always be those who want to tear you down, protect their own interests, or try exploiting you for mere recognition. Advanced Aesthetic Concepts has always known that the forefront of any industry is as dangerous as it is rewarding. Fortunately, our desire to improve health with less risk, downtime and help physicians improve their economic situations in uncertain times had been the passion for continuing with non-invasive technologies that are near miraculous advancements in this decade. As old school surgical procedures make way to non-surgical procedures that were merely science fiction 20 years ago in movies like Star Trek, I know there will be those that will attempt to tear down the success of valuable programs, like Lipo-Ex for their own gain.

The fact of the matter is that the source and initiator of these attacks on Advanced Aesthetic Concepts and Revecomed is a disgruntled former distributor, who has been bitter and maliciously attacking both companies for three years ever since she lost her distributorship for both unethical and possible criminal behavior. The fact of the matter is that Paige Peterson, who initially contacted Fairwarning.com and is the person, mentioned above who anonymously called the FDA and held secret meetings with criminal investigators, was also proven in court to have misappropriated $60,000 from Advanced Aesthetic Concepts. She is a vengeful person out to destroy anyone associated with Lipotron 3000 merely because she lost her opportunity to work with a great product because of unethical practices. Her attacks are merely the result of her anger about losing out on a great opportunity. If not, why would she be so diligent with her attack strategies for three years? In fact, according to a post on this page all comments posted here from jquinn, who is so adamant about bashing Lipotron technology and the Lipo-Ex program are on a hacked email account. So it can be assumed that jquinn, who refuses to be identified, is probably associated in some way with (or actually is) Paige Peterson.

In addition, from a factual standpoint neither Lipo-Ex and or Lipotron 3000 one of the devices used in the Lipo-Ex program is under investigation by the FDA or anyone else. The Lipotron 3000 was in the FDA approval process in the final stages until the FDA asked for more information last Fall. It was at that point that Revecomed decided to get the class 1 FDA clearance, so that in the interim the safety and therapeutic value of the technology was at least made certain to the public. However, the manufacturer is in diligent pursuit of other indications of use.

Another fact to consider is that most non-invasive fat reduction and skin tightening technologies on the market today, no matter how well they work or how safe they are, is currently approved or registered with the FDA for uses other than what doctors are promoting all over the nation. The majority of technology being use for fat reduction is actually cleared for increased circulation and or muscle relief, skin tightening, etc. So why the attack on Lipotron, other than the bitter root in Paige Peterson, who is only interested in attacking the people who work with the Lipotron? She is not at all concerned with the patients, who benefit from the treatments, or the good for the medical community and the future of medicine.

Who is jquinn and I why does she continue to attack this technology? Jquinn has the same email address as a mysterious Susie Quinn, who started a Facebook page yesterday to post exaggerated claims about the device all over Lipo-Ex providers’ Facebook pages. And why are respectable news sources dealing with someone as shady as a Paige Peterson or jquinn, whose identity is hidden in hacked email account for what they are calling news?

Medical Spa MD, instead of asking those who offer Lipotron services as part of their Lipo-Ex program if they have a headache, the article above should those same physicians how happy their patients are and what kind of great results they are getting. I guess, unfortunately as always bad news just sells better than good news especially for a publication like Fair Warning. In reality, the good news is that most Lipo-Ex program providers have gotten rid of the headache of managed care by providing a service that makes their patients happy.

Jane Wilks, Marketing Director, Advanced Aesthetic Concepts, exclusive distributor of Lipo-EX / LipoTron.

My apologies Jayne for misspelling your name...previous post facts stand Jayne Wilks, Marketing Director, Advanced Aesthetic Concepts, exclusive distributor of Lipo-Ex / LipoTron.

Dot Connector,

Thank you for identifying me by title. The fact that I used my name surely indicates that I had no desire to hide my identity as a an employee of Advanced Aesthetic Concepts. My only objection is the slash you used between Lipo-Ex and LipoTron, since LipoTron is only one of the devices used in a program that includes other protocol. Please stop indicating that they are one in the same in your posts.

A better question that might be answered than what is Jayne Wilk's exact title is who is Dot Connector and who is jquinn for those answers would certainly help everyone CONNECT THE DOTS!

Sincerely,
Jayne Wilks

Dot Connector,

Thank you for identifying me by title. The fact that I used my name surely indicates that I had no desire to hide my identity as a an employee of Advanced Aesthetic Concepts. My only objection is the slash you used between Lipo-Ex and LipoTron, since LipoTron is only one of the devices used in a program that includes other protocol. Please stop indicating that they are one in the same in your posts.

A better question that might be answered than what is Jayne Wilk's exact title is who is Dot Connector and who is jquinn for those answers would certainly help everyone CONNECT THE DOTS!

Sincerely,
Jayne Wilks

@DotConnector, Seriously? I guess you think we should be grateful that we have some one like you, with your uncanny ability to connect the dots, to point out the obvious to those of us who are not as sharp as you. Perhaps you think everyone else here is stupid and needs your help? Connect this: She, (Jayne Wilks) obviously is not afraid and does not need to hide behind a fake name like some people. Funny thing; When you speak the truth, there is no need to hide.

07.20 | Unregistered CommenterButchQuinn

Even without knowing all the details and facts, this intriguing Lipotron story is intriguing, not that anyone ever knows all the facts; it appears that numerous libelous statements have been made and continue to be allowed to be posted. Either the manufacturer is being investigated or it is not. The FDA documents everything it does and sends extremely detailed warning letters to manufacturers when they find issues that require correction. In my humble opinion, for the editors of this website to post an alert or update on this story stating “FDA urged to seize all Lipotrons” based on a letter supposedly sent to the FDA by some consumer watchdog group is extremely reckless and seriously erodes the credibility of this site as an objective, unbiased source of information. This group that supposedly sent a letter to the FDA is not a government agency; it has no official capacity or authority. So now the question becomes: How and why did this watchdog group become involved? I wonder who contacted them? It is one thing to allow others to comment, but now the editors are posting these articles? Have you picked up the phone and called and spoken with anyone to verify any of this information? Here’s a good question to ask someone, “Could Paige Peterson possibly be out there peddling other Non FDA Approved devices to physicians right now?
To the editors of this organ I would say, You seem to have forgotten that when you have the right to Freedom of Speech, it carries great responsibility. Whether the editors of this site know it or not, Medical Spa MD may have just become another pawn in this insidious game. Shame on you J.B.

Major national news media story in development. If you have been injured, had adverse events related to Lipo-EX / LipoTron, media producers have interest in talking with patients, physicians, medspa owners, technicians. You may be contacted directly by the producers of the show--not me. tweet to jquinn@gw55sq.

07.20 | Unregistered CommenterJQuinn

Legal media weighing in on the story:
AboutLawsuits.com
News and Information about Personal Injury Lawsuits
http://www.aboutlawsuits.com/lipotron-lipo-ex-weight-loss-machine-marketed-illegally-30710/

an excerpt:

Public Citizen, a prominent consumer advocacy group, sent a letter (PDF) to the FDA July 18, encouraging the agency to “[e]xpeditiously complete its criminal investigation of the distribution, sale, and promotion of the LipoTron device and take appropriate legal action against those individuals, companies, and user facilities that are found by the agency to have engaged in any illegal marketing or promotion of this device.”

07.20 | Unregistered CommenterJQuinn

Largo – agree-- serious ethical and legal issues are at hand

JQuinn – give’em hell…wish I could say I am JQuinn, but she is in Vancouver in her ivory tower… god help us…she’s relentless…

ChiMD – way to check things out on your own and report back…verified fact are hard to fight

DotConnector – the logic is killing us, but “thanks” for the 101 course on FDA regs & internet sleuthing

Lois Lane – think you still have some issues with the “sub-contractor” case, but thanks for the reference…loved the bunny

Rangle – thanks for getting back to the issue at hand and not continuing the whistleblower bashing – “hand in the cookie jar” IS the big issue

AntiagingMD – from what I read and understand, physicians can only promote “off label” IF the device is “legally marketed”

Karma believer – “snake oil”, now watch out…. you are aligning yourself…and remember what goes around comes around…

Emery D – Stick around, there are several law groups soliciting on the internet for patients that had treatments…”if you build it, they will come”

MBaracaldo – “I wish no one else ever did”

Chabela106 – Thanks for sticking with the facts

Karma (again) – Obviously you missed some of the story published by FairWarning. AAC, RevecoMED, and Paige Peterson contributed, not to mention the FDA and American Academy of Dermatology!

Jayne – bullet points for you
• If the device is not FDA cleared/approved/exempted to market for the claims you are marketing it for in 2007, 2008, 2009, 2010, 2011…IT IS NOT OK TO PROMOTE IT to physicians, med-spas, or patients in the United States of America.
• But, BOY, didn’t it make “A LOT” of money!?,
• What happened to “First do no harm?”
• Lipo-Ex, LipoTRON, LipoTron 3000, Vital RF, Recuderm…all the same
• Your “program” contains 3 devices being promoted for non-indicated uses
• A distributor, consultant, manufacturer or ANYONE “soliciting” for business benefit CANNOT provide this info to the public, to physicians, to medical spas….Just ask Glaxo-Klein, I’m sure they have the MOST current position on this type of marketing…and they budgeted for the “hit” they are taking, so hope you are as well…

Butch – interesting you are joining the AAC group in asking for the names of only a few in a strand of more than 30 comments….what happened to “free speech”?

Shannon – at least some here (who have bothered to read), know what you and AAC have done – with and without Paige Peterson – so really Shannon, “turnabout is fair play”….

Wonder what your company name will be on Monday? (you have the whole weekend to morph into yet another identity to elude the law)…

07.20 | Unregistered CommenterPaige

I was just recently told to look at this thread of comments in relationship to news in healthcare. After reading this entire thread, and seeing the last post, my only commment is to be careful!!! This reads like a battle between a past distributor with legal issues and two companies that have no love loss for this distributor. If anything comes out of these articles as defamatory and there is legal action, as posted by jquinn earlier, you don't want to be caught in the middle by participating in any of those media outlets. Especially when that material is out there forever on the internet to be used by either sides discretion. Defamations is becoming a very big legal issue in today's society with social media giving voice to irresponsible comments. With that said, I only suggest that anyone who is thinking of tweeting jquinn to be part of a news media story, "Be careful!!!"

07.20 | Unregistered CommenterBe Careful

Paige, brave soul that you are... Don't they know the most dangerous person in the room is the one who has nothing left to lose?

FDA Office of Criminal Investigation, Texas Department of Health, Public Citizen (Citizen.com), FairWarning, and over 500 twitter follows have been notified of PROFIT SOLUTIONS MD as just another morph of AAC.

I will never quit, will you?

07.20 | Unregistered CommenterJQuinn

JQuinn, looks like your very bitter and obviously have no life.. Quit spamming everybody with your nonsense and get a job.

07.23 | Unregistered Commenterunknown

As part of the team working on the name change for Advanced Aesthetics Concepts for nine months, I feel compelled to set everyone at ease as to the thought that AAC is trying to hide behind a name change to Profit Solutions MD. Frankly, the negativity towards AAC only reared its ugly head in the last few weeks. Anyone who has ever launched a name change knows the time it takes to prepare for such a launch, such as web development, logo designs, trademarks, etc. We only wish we could have done it in a few weeks! Please don’t insult those who have worked on it this long and hard.

07.23 | Unregistered CommenterBG

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. Here are the links:

http://www.citizen.org/hrg2051
http://www.citizen.org/hrg2050
http://www.citizen.org/hrg2049
http://www.citizen.org/hrg2046

No question about it, those Google banner ads by ProfitSolutionsMD (aka Advanced Aesthetic Concepts) will get you noticed.

07.26 | Unregistered CommenterJQuinn

Today Arkansas medical board & health dept urged to act immediately on apparently illegal Lipo-EX / Lipotron
www.citizen.org/hrg2052
www.citizen.org/hrg2053

07.30 | Unregistered Commenterjquinn

State of Texas today opens yet another investigation case for AAC--this time targeting their "new" business Profit Solutions MD. Here's what the Compliance Office says:

I have entered a new complaint for Profit Solutions MD. For your reference, the complaint number is 1525120590. The investigation for complaint #1525120415 for Advanced Aesthetic Concepts is still ongoing.

Compliance Officer
State of Texas DSHS
Drugs and Medical Devices Group
Policy Standards and Quality Assurance Unit
Environmental and Consumer Safety Section
Division of Regulatory Services

07.31 | Unregistered Commenterjquinn

Jquinn, don't you think it is important to tell the full truth about investigations filed with the State of Texas. When you contact the state, you will learn that an investigation is not always an investigation like you would have everyone believe. It is also a term used by the state to say they are looking into a complaint filed, whether it has any substance to it or not. If you had a business in the State of Texas, someone could file a complaint on you and then tell the world that you are being investigated. It doesn't necessarily mean you are under investigation. You need to be careful of how you present your information because it could be misunderstood. I hope that is not your intent. That could bring question to your credibility in future posts.

Today Texas Medical Board & Texas Department of State Health urged to act immediately on apparently illegal Lipo-EX / Lipotron. Here are the links to the letters and attachments:

http://www.citizen.org/documents/2054.pdf
http://www.citizen.org/documents/2055.pdf
http://www.citizen.org/documents/2044_attachments.pdf

08.1 | Unregistered CommenterJQuinn

Friday 03Aug2012 Oklahoma Board of Medical Licensure & Supervision, Oklahoma Board of Osteopathic Examiners, and Oklahoma State Board of Health urged to act immediately on apparently illegal Lipo-EX / Lipotron. Here are the links to the letters and attachments:

http://www.citizen.org/documents/2059.pdf
http://www.citizen.org/documents/2060.pdf
http://www.citizen.org/documents/2061.pdf
http://www.citizen.org/documents/2044_attachments.pdf

08.4 | Unregistered Commenterjquinn

PublicCitizen continues its campaign regarding the apparently illegal Lipo-EX / Lipotron by contacting California and Alabama medical boards and public health agencies. Links to the letters and attachments:

http://www.citizen.org/documents/2056.pdf CALIFORNIA MEDICAL BOARD
http://www.citizen.org/documents/2057.pdf ALABAMA BOARD OF MEDICAL EXAMINERS
http://www.citizen.org/documents/2058.pdf ALABAMA DEPT OF PUBLIC HEALTH
http://www.citizen.org/documents/2044_attachments.pdf

08.4 | Unregistered Commenterjquinn

This is little more than a witch-hunt. This equipment has been used throughout the world for several years. At least many tens of thousands but more probably hundreds of thousands of treatments have been performed but the only complaint they can come up with is some "scattered' reports of "minor" burns and shocks? These minimal side effects occur with other medical devices and specifically with other "approved" devices used for non-surgical fat reduction. So, why is this suddenly some terrible public emergency? It's looks like a bitter former distributor making a lot of noise and a grandstanding "advocacy" group trying to get attention and pull in more contribution $$$$ by scaring people.

08.23 | Unregistered CommenterJillD

August 3, 2012 letter from an attorney representing Advanced Aesthetic Concepts (AAC) — the distributor of the LipoTron device — demanding that Public Citizen cease and desist all communications about AAC’s activities involving the marketing and promotion of the LipoTron device and threatening to file a lawsuit against Public Citizen unless it complied with this demand. Here's the link: http://www.citizen.org/documents/aac_response.pdf

August 22, 2012 letter from Public Citizen rejecting the demand from AAC’s attorney. Here's the link:
http://www.citizen.org/documents/pc_response_to_aac.pdf

08.23 | Unregistered CommenterJQuinn

JennD you are so right about this “public advocacy” group acting like they are doing good merely to get donations. Look at this jquinn twitter that went out to hundreds of her contacts eliciting money for Public Citizen as well as the group involved in this attack on Lipotron: @prn_radio It's NAT'L WHISTLEBLOWER DAY-234th anni 1st US whstlblwr law--celebrte by donating to http://www.citizen.org & http://www.fairwarning.org.

Funny thing, jquinn’s twitter is also eliciting funds for Fairwarning.org the publication that started all the articles on this ridiculous topic. I guess the media and “public advocacy” organizations will do anything for money today.

08.24 | Unregistered CommenterPeterQ

Florida rejects Public Citizen's complaint regarding the device, 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.

08.29 | Unregistered CommenterJillD

Update....

Worley, Quinn, Public Citizen, and others, sued for false and misleading public statements against the LipoTron:

http://pubcit.typepad.com/files/aac-v-peterson-amended-petition-and-application-for-tro.pdf

09.3 | Unregistered CommenterJillD

Here's the latest...
AAC dismissed the suit against MedicalSpaMD, FairWarning, and Public Citizen Friday, August 31, 2012.
http://www.fairwarning.org/2012/09/defamation-case-against-fairwarning-public-citizen-is-dropped/

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