Has anyone had any experience with the Lipotron 3000 - a radio frequency device..? It has claims to rid the body of even visceral fat... How effective is a RF device on deep, even visceral, fat?

There is complete information about it on www.fromstarttoperfection.com. I attended an info-course and saw a demonstration performed. As of November, it is not FDA approved for anything yet. The price is around $70,000 currently. I think it is too much for an unproven technology. Until it gets FDA approval and there are more studies confirming results I would wait. It may be an option in the future, but let someone else take the bait for now.

We have been using this technology in our clinic since July. The patient satisfaction has been at 100%. I also have friends and physicians that are using this at their clinic with great feedback and success.

FDA approval is coming soon, and this will be highly-discussed and sought after once studies are released.

This manufacturer and equipment are represented by "beauty shop" distributors in N. Calif and Alabama. Anonomously I talked with the distributors from these areas and you would not want to sully your practice by dealing with them...looks, sounds, and "feels" like "med spa / beauty shop" cashing in on the ground swell in medical aesthetics.

Careful....these guys are suspect and NOT FDA approved. Stick with the research and respected medical entities you know.

sq55gw@gmail.com

If you do any basic reading on the basic scientific principles of RF, you will quickly learn that fat is a very poor conductor of RF current. None of the papers done by reputable researchers make any claims about heating fat. I wouldn't buy any claims for helping reduce subcutaneous fat with RF.

The only product that REALLY true is SMART LIPO.

This class II / III "medical" device has been shown at aesthetician and beauty shows by sales people selling "lotions and potions"--it was in Florida and a couple of other "spa" shows late last year. I've yet to see it at any reputable medical conference nor seen it offered by a reputable medical distributor--just these beauty sales people.

I don't want a patient I'm treating with a device to walk down the street and see it in a beauty shop. But that's what is happening--no doctors in sight for medical direction--just a beautician.

They don't have FDA approval and they're already out there acting like they do.

J. Quinn,

I am sorry you have a poor view of this technology. I have seen some of what you see, but we have also seen steps to get this in the right hands, keeping it with physicians only.

I agree with you that too many salespeople could care less about regulations and ethics. But I can assure you that, not all companies are adding to the noise.

Interesting comment from Live from Tokyo. But isn't the Accent from Alma lasers and VelaShape from Syneron using Rf for fat?

W.Lodge,

Don't have a poor view of RF. I do have a problem with the "misinformation" from the manufacturers and distributors who "promise" the physician that the device is "medical" and then you see what i've seen both on web sites and out on the street.

Have you viewed the info out on the Internet...you'll see what I mean in less than 10 minutes--it's "beauty shop" not medical.

You'd think the FDA would find this out and investigate what it's allowing.

One last point. Thank goodness for these blogs where physicians can openly and honestly warn other doctors and professionals about these abuses.

I have done much more "due diligence" before purchasing and this is a direct result of the posts I've read here.

What I read on this site saved me the $55-60K on this device--despite the hard push by the "beauty shop" rep.

If there is anyone else out there who can tell me otherwise, I'd like to hear from you.

Here's an entry when you google LIPOTRON in your browser:

Shear Bliss Salon and Day Spa - Services
The Lipotron RF uses radio frequency dermal technology for FAT REDUCTION in ... This Lipotron Cellulite reduction treatment is for a longer session time to ...
http://frontdesk.appointments123.com/suites/service.asp?salo...

I sure want to have my $65K LIPOTRON sitting in my office down the street from this beauty shop.

And below from the web site of the "beauty" distributor in Alabama-- Lipotron is right up there with the TEETH WHITING and HAIR GROWTH and MICRODERM systems:


AESTHETIC EQUIPMENT SKIN CARE PRODUCTS APPLICATIONS Microdermabrasion Vascutouch LED Mask Lipotron Teeth Whitening MediLift Contour Ultra Active Optical IPL OxyVital Crystal (Turbo) Crystal (Non-Turbo) Crystal Free Solutions to Hormone
Dependent Symptoms -- Aknof -- Follon -- H.Ogel -- Regenesis Sun Protection ATACHE Professional
Products Professional Facial
Treatments Leorex Retrocaine DermaChic Skin Care www.dermachic.com Acne Hair Removal Gel Hair Removal IPL Veins Cherries Angiomas Exfoliation Muscle Lifting (Medilift) Skin Tightness Cellulite Fat Reduction (MediLift) Hair Restoration Wrinkle Filling Teeth Whitening Skin Resurfacing Sun Damage Microcurrent Face/Neck Tightening

Results from the First Treatment

See results from the first treatment and know that each treatment brings better results. Impressive results seen by the fifth session. Most conditions for the body require ten sessions and six sessions for the face and neck.

Why buy it when your local beauty shop and teeth whitening center has it?

And results in 1 session....I should buy 2!

It's these kinds of things (easily researched on the web) that kept me from buying -- I don't think it's a medical device.

J. Quinn,

I will respond quickly. You obviously have lots of time on your hands. Until you see anything first hand, it is not polite to pretend like you have all the answers. There are two different versions of this device. We only work with the physician model. I can only relate the results that we have achieved and that of several physician friends.

If you want to miss out on something special, that is fine. But please don't talk poorly about a technology when you yourself aren't using, or do not have all the facts.

Have a great day.

Now I understand--there are 2 models for 2 different markets.

I stand corrected. Perhaps the manufacturer should consider having 2 different names so as not to confuse which device is for which market.

I look forward to learning more about the medical grade device--I've obviously seen/heard about the aesthetician model...and the manufacturers web site doesn't distinquish between the two.

I am currently using the Lipotron at our medical clinic and we are seeing results. My first patient has had 8 treatmetns over 5 weeks and went from a size 18/20 to a 14. She bought 4 more treatmetns!

I tried to check on it via google but could not find much on the Revecomed site. There was no information on how to contact them for more info. Does anyone know how we can be directed to some company's site, how about white papers??

Unknown:
Thanks for the heads-up. I guess I would ask for a rain check on it

Unknown, you can go to www.fromstarttoperfection.com, and ask for more information.

i have had 16 treatments and wasted 3000.00 with no results. i just kept hoping maybe next time it will work or i would see a difference but i did not. while it heated my abs (very hot) no melted fat or waste left my body. IT DOES NOT WORK!!!

I know it sounds too good to be true...after much deliberation "I took the bait" I could not start pushing this device in my husband's practice until I was sure it would work. After 8 weeks and 9 subjects ( I treated my staff and friends free for 6 weeks), I can now without apprehension introduce it to his patients. I know it is a tough market out there, physicians are being "sucked in" by unscrupulous vendors, they are easy targets, they "have money". No one has money to invest in worthless nonsense...Anyway, everyone has lost one dress size, some two. It is a slow process, it is not a magic wand, but it does work. I agree that the technician has a great deal on impact with the results. One setback is the cream, it is expensive.

We are using the Lipotron 3000 in our practice and are seeing great results. Our clients are happy with the procedure and the lack of down time. It is working very well for skin tightening as well as fat reduction. I will say that the machine must be used properly to get the best results, so make sure that whoever you are using has had proper training.

Agape, please email me as I too have been having good results with the Lipotron 3000. I would like to discuss technique and training, as maybe we can each share some tips. Thanks. valley_laser@msn.com

This “Hair Salon”in question is 6000 square feet, and has 4 back office treatment rooms, and 5 full office treatments rooms upstairs. There are at least 2 doctors that come in at various times to offer services, and they also have a doctor on call doing liposuction at his facility. They have the required paperwork not only to have the LipoTron, but also to do Laser Hair Removal, which they also do. They are located in Florida
The LipoTron 3000 is the one that is exclusive to Medical offices, and the "hair salon" in question actually use the LipoTron 2000 which is not as invasive, but amazing in its effects anyway.

There are individual reps in various territories can give references of many medical offices that are local, that are all getting very good results. This technology can also be paired with mesotherapy and Lipodissolve for better effect, as well as before and after Liposuction for better fat dispursement, and healing.
This technology is very effective, but no aesthetic service is 100 %. I believe with this technology 9 out of 10 patients would be more than satified, and various users around the state have verified these numbers to me.

This treatment is popular with dermatologists in Korea and Japan. I am afraid of liposuction's dangers and expense so I am giving this a try. It's a slow process from the description I received from the doctor. Also unlike Liposuction it does not destroy fat cells, so the fat can return, whereas it's less likely to do so from the surgery.

However, the doctor here is using a three pronged approach. First he starts you on a diet using an apetite supressant called Silkramine. A few days later he begins abdominal injections at 20 points aimed at breaking up fat cells. The injections are comprised of placenta, lidocaine, vitamins C and B complex and other agents I don't understand as a layperson. And 15-20 minutes on the machine. Revecomed recommends 40 minutes on their site, but the doctor says the machine he has is stronger than that model and can cause skin irritation if used over 15 minutes. I've only done this once but I understand this to be the routine each time I visit the doctor's office, shots and machine. This is twice a week at about $50. I was told I would require about 8 sessions for a total cost of anywhere from $400 to $500. I was told with my ponch it would be around $400 roughly.

Actually I don't feel any smaller after the first treatment, but I was told that is common until a few treatments are "under your belt." In fact the two series of shots left me feeling bloated and blobbish.

The process is accepted here and only in the hands of dermatologists who perform all sorts of laser and neat cosmetic tricks, very cheaply and safely I might add. But so far I've had better treatment on the national health program here then I've ever had in the USA. I have unlimited visits to doctors that cost $2 and specialists that cost me $4 with tests. I've never had a month's supply of prescriptions cost more than $15 and that's usually quite high. No deductibles or limits.

Last month I had a checkup, with a Hemoglobin A1C test and cholesterol etc, the whole lot which cost $8 including the checkup. In the USA that would have cost me at least $330.

Maybe we have something to learn from our Asian neighbors...at least Korea. Maybe you can learn about their use of the machine as well. They aren't beauty shop equipment, but powerful machines from what I can see. I'm only a layperson.

Here is a website of a Korean physician. http://www.clinictheview.com/02/02_menu_1.html . It's not in English. You can use google translation tools to read it or employ the help of a Korean friend.

I had smartlipo and then Lipotron to get rid of whatever stubborn fat was left and I was extremely impressed with it. It dimished the look of that "pouch" on my lower abs, and I believe it works. Youre not supposed to eat for 2 hours afterwards, and drink plenty of water as well. I had the biggest bowel movement ever afterwards, TMI. And the first treatment I had, I lost 2lbs, the second treatment I lost 1/2 lb but I still lost something.

i am currently operating the lipotron and i have seen wonderful results, but i have also seen poor results. It all depends on how the patient commits. Larger people tend to have a very hard time because they do not diet, but my smaller pts have awesome results. i use it to get rid of any lumps from lipo and i also use it to shape women who have a boyish figure. i would rccommend anyone who had smart-lipo to consider this procedure it really does work.

MissRenee,
Shouldn't the smartlipo work to reduce the fat and tighten skin and us not have to use another device? I have been skeptical of both technologies the lipotron and the smartlipo. I think that there are better technologies out there

In reply to TMM, who asked shouldn't the smartlipo work for reducing fat and tightening skin... The Lipotron will reduce BOTH subcutanous and visceral fat, whereas the smartlipo, as well as any other type of lyposuction, only reduces your subcutanous fat (the fat directly under the skin). Some patients natually have more visceral fat than subcutanous, so when they go in for liposuction, they can still be left with a bit of a pooch. Also, you can only safely take out so much fat with liposuction. If the patient were to do a some sessions of Lipotron before the procedure, we can get rid of a few inches of fat before the liposuction and then take out even more with the liposuction. In addition, the lipotron loosens and liquifies the fat, so it is much easier for the surgeon to suck out with the cannula. I totally agree with you about the smartlipo. I am no fan of that machine either. We use the Coollipo in our surgery center, and the surgeon is able to tighten up skin with excellent results. What better technologies to do think are out there? I am a natural born skeptic as well but have you tried any sessions of the lipotron? I had my doupts, until we had a demo machine in our office for a while. Now, I love it and I am very happy we purchased this machine. I don't know where you are located, but come on down to South Texas. I will give you a session and you can make your own conclusions about how well this machine works.

Would you recomend that I use this treatment in my office?

Tom,

I highly recommend the LipoTRON in your office. I hear that the Manufacture will be attending the EMAA in Paris Oct 2-3. They will have a guest speaker that will speak about their Medical Device to the whole Congress.

In reply to TMM, who asked shouldn't the smartlipo work for reducing fat and tightening skin... The Lipotron will reduce BOTH subcutanous and visceral fat, whereas the smartlipo, as well as any other type of lyposuction, only reduces your subcutanous fat (the fat directly under the skin). Some patients natually have more visceral fat than subcutanous, so when they go in for liposuction, they can still be left with a bit of a pooch. Also, you can only safely take out so much fat with liposuction. If the patient were to do a some sessions of Lipotron before the procedure, we can get rid of a few inches of fat before the liposuction and then take out even more with the liposuction. In addition, the lipotron loosens and liquifies the fat, so it is much easier for the surgeon to suck out with the cannula. I totally agree with you about the smartlipo. I am no fan of that machine either. We use the Coollipo in our surgery center, and the surgeon is able to tighten up skin with excellent results. What better technologies to do think are out there? I am a natural born skeptic as well but have you tried any sessions of the lipotron? I had my doupts, until we had a demo machine in our office for a while. Now, I love it and I am very happy we purchased this machine. I don't know where you are located, but come on down to South Texas. I will give you a session and you can make your own conclusions about how well this machine works.

careful...you get what you pay for by way of "free" advice here--too many of the posts/responses here are from salespeople selling this device who are not objective and are not running clinics as they profess.

it's a scam...

Hi,

Is anyone interested in purchasing a lipotron machine? I have a practically new one that the company purchased in 2008, but we haven't used since 2008. Please let me know if anyone is interested. thanks

Is it the Lipotron 3000? For how much?

The manufacturer and distributors of Lipo-EX, aka LIPOTRON are currently under federal criminal investigation for marketing and selling without FDA approval. Investigators from the Office of Criminal Investigations are, as I post this, conducting interviews with LIPOTRON/LIPO-EX buyers/users throughout the US.
If you are currently using this device or have been approached to purchase this device, I urge you to read the FDCA and US CODE OF FEDERAL REGULATIONS from the FDA web site (link listed below along with the specific sections regarding why this device is being investigated).
http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/default.htm
• SEC. 301. [21 USC §331] Prohibited acts
• SEC. 302. [21 USC §332] Injunction proceedings
• SEC. 303. [21 USC §333] Penalties
• SEC. 304. [21 USC §334] Seizure
• SEC. 501. [21 USC §351] Adulterated Drugs and Devices
• SEC. 502. [21 USC §352] Misbranded Drugs and Devices

CODE OF FEDERAL REGULATIONS
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 892 RADIOLOGY DEVICES

This is a very serious matter for which the FDA is prosecuting to the maximum extent of the law.

Jquinn,

First, your facts are incorrect. No one is under any type of "criminal investigation" by the FDA. Therefore your statements are libelous. Secondly, that you would make such a statement on a public forum indicates that you are a person lacking good judgement. Obviously, you are a person with a vested interest in the untruth that you are perputating, thereby corrupting any chance of gaining the respect you so desperately seek. Just looking at the venomous nature of your previous comments, a picture of a very bitter little person starts to develop and emerge.

Hi jquinn-

I have been interested in Liprotron for a while, but wanted to wait until it had finally received FDA approval, which I had believed was pending as they were in their 3rd FDA trials

It had been used in Asian and South America for the last decade, and has been in FDA clinical trials since 2006. I have heard both positive and negatives about it, but when reading through your postings it seems as though your biggest complaint is that is has been marketed to “beauty shops” that also offer teeth whitening and micros.

Well my Med spa offers BriteSmile teeth whitening and I pay a dentist some serious money to oversee it. We also offer micros as well as laser hair removal, fotofacials, scleratherapy, Velashape etc.. and all of the injectibles. So how and where this device is sold and marketed to really doesn’t concern me.

However, your claims of federal criminal investigation concern me greatly. Yet when I’ve followed the links that you’ve provided I don’t see anything pending by the FDA or by the FDA’s Office of Criminal Investigations.

I am confused by the drama and the controversy-what’s your issue with this device and/or it’s manufacturer other than marketing and sales tactics?

You can sign up for the FDA Law Blog at fdablog@hpm.com, FDA NEWS at enewsletters@fdanews.com. In addition, the FDA and DOJ web sites post press releases concerning these matters once the OCI, DOJ, and other federal investigative agencies have completed their findings. Active FDA / OCI / FBI criminal investigations are not a matter of public record until they are ready to prosecute. Interested and vested parties can get objective information directly from these government web sites.

The OCI of the FDA is now currently interviewing Lipo-Ex / Lipotron purchasers and other interested parties. I know this because I am an interested party and have been interviewed and several purchasers and end users have called me concerning their talks with FDA / OCI investigators.

Here’s a link where you can read an actual press release and access other pertinent information directly from the DOJ about similar cases: http://www.justice.gov/usao/cas/press/cas90219-Folsom.pdf

If you haven’t done anything wrong by actively manufacturing, marketing and selling a device that is not FDA approved, you have nothing to worry about. But the FDCA & USC 21 say otherwise.

We'll very shortly know the outcome of these issues.

In my previous Aug 06 posting, I inadvertently left out USC 18, Section 371 which is usually cited (see DOJ case referenced above where Count 1 was USC 18) in these types of medical device cases, along with the FDCA and USC 21:

Search 18 U.S.C. § 371 : US Code - Section 371: Conspiracy to commit offense or to defraud United States

If two or more persons conspire either to commit any offense
against the United States, or to defraud the United States, or any
agency thereof in any manner or for any purpose, and one or more of
such persons do any act to effect the object of the conspiracy,
each shall be fined under this title or imprisoned not more than
five years, or both.
If, however, the offense, the commission of which is the object
of the conspiracy, is a misdemeanor only, the punishment for such
conspiracy shall not exceed the maximum punishment provided for
such misdemeanor.

Link: http://codes.lp.findlaw.com/uscode/18/I/19/371

I’m not worried.

I am concerned however, because this looked like it was a promising technology.

Ok- so I read through the press releases that you referred to and again I am confused.

Maybe someone more intelligent than myself can explain how this relates to Lipotron?

Or maybe SW is correct in stating that your statements are libelous.

“NEWS RELEASE SUMMARY - February 17, 2009
United States Attorney Karen P. Hewitt announced that James Folsom was found guilty by a federal jury earlier today in United States District Court in San Diego of twenty-six felony counts relating to his sale of an unapproved medical device.
The verdict follows a two-week trial before the Honorable John A. Houston, United States District Judge. According to evidence presented at trial, from 1997 through August 11, 2008, James Folsom conspired with others to ship adulterated and misbranded Rife-type biofrequency devices in interstate commerce.
The device, sold under the names “NatureTronics,” “AstroPulse,” “BioSolutions,” “Energy Wellness,” and “Global Wellness,” consisted of a micro-current frequency generator with a digital readout, two stainless steel cylinders, two personal application plates with connectors and lead wires connecting the device to the cylinders and the plates.
Users were provided with an operating manual that set forth hundreds of digital settings for the device, directed to specific conditions from AIDS, diabetes, stroke, and ulcers to worms. Users were advised to connect the cylinders or plates to the machine and touch them to the body for a recommended run time to treat each condition.
According to testimony at trial, the defendant purchased over 9,000 units, which he sold to distributors for approximately $1000-1200 and to retail customers for $1995, with sales of over $8 million. The devices were manufactured by the defendant and others in a San Diego location, which he failed to register with the Food and Drug Administration (FDA) as a device manufacturing establishment. The defendant used the false name “Jim Anderson” when selling the device and used post office boxes, self-storage units, and bank accounts opened in the names of others to conduct his business, all in an effort to avoid detection by the FDA. The defendant also marketed his device “for investigational purposes,” deceiving consumers into the false belief that he possessed a valid investigational device exemption from the FDA.
According to Assistant U.S. Attorney Melanie K. Pierson, who prosecuted the case, the devices were adulterated in that they were marketed without a valid investigational device exemption, without pre-market approval, and in violation of an electrical performance standard set by the FDA prohibiting lead wires that come into contact with patients from being able to come in contact with potentially hazardous voltages. The devices were also misbranded in that they were marketed without valid clearance from the FDA, did not bear the name and address of the manufacturer on the labeling, and were produced in an unregistered manufacturing establishment. “

Okay JQuinn. Your previous post did not make a whole lot of sense to me when I read them and when I tried to look at your multiple web address "proof" nothing came up except what BetterOffNow posted. I'm a little baffled. I guess this is supposed to be some kind of scare tactic for the purchasers of Lipotron, such as myself, to not use the machine or get a lawyer or something. The thing is, when I called the FDA's toll-free line at 1-800-463-6332, I was told there was nothing on file and nothing pending. My question to you is why are you writing that you are "an interested party" to the supposed OCI and FDA interviews? Why are you interested? Did you file a complaint against Revecomed? All the posts you have written on here pertain only to Lipotron/Lipo-Ex and are negative in nature. Are you a disgruntled employee? Umm the plot thickens...

My guess from what you have posted is that you most likely have filed a complaint with the FDA and you believe that RevecoMed is going to get into serious trouble based on your complaint. Good luck with that. Anyone can report to the FDA about any adverse reactions, false advertising, etc. I'm sure they get thousands of complaints and have to spend countless hours looking into them only to toss them out if their is no evidence. Judging from the lack of evidence provided by yourself, I am quite sure you provided no supporting facts to prove your claim.

As for Lipotron not getting FDA approval yet, I think where Revecomed went wrong was not getting FDA approval for a side effect such as pain reduction. Correct me if I am wrong, but there is no non-invasive "fat melting" machine on the market that is FDA approved for melting of fat. Zeltiq is FDA approved for thermal cooling and Zerona was FDA approved for "use during liposuction." Once a medical device is labeled FDA approved, then it seems like physicians feel more comfortable purchasing the equipment and patients feel better having have services performed on them even though the machine is being used "off-label".

JQuinn, you seem to be on a life-long mission to slander the makers of Lipotron for the last three years. At least if you have some honest and verifiable issues, by all means share them. Otherwise, it just seems like you are unwisely opening yourself up for future litigation.

I have used this technology at another office and it works. I do have to say thought, it works in the right hands. The user must be able to perform lymphatic drainage correctly so that on ce the treatment is over, the lymphatic system doesnt get blocked. The body must be heated to the necessary temp for there to be results. PLUS the patient must do their homework and go work out - walk briskly for 30 minutes afterward and avoid alcohol. It works, but like any other piece of equipment, the user must know how to do it, how to educate the patient and have a commited patient. There is no magic wand...unless you are willing to do surgery, but then you have the risks. Also, like surgery or other weight loss/fat melting equipment, if you eat fat, dont work out, of course the results will not last.
The current price for the medical grade machine is around 90k. They have been trying to get it FDA approved for over 2 years that I know of.
It works and works well and practices that I have been in and other practices that i know that have it have made well over their investment. The practice that I was in purchased a second one after 9 months and it is the primary service that they do.

Wow...a lot of interesting content here. Can anyone inform me on where to buy Lipotron or who the US distributor is? I went to the Revecomed site and the email doesn't work. The phone number provided sounded like a wrong number as well. You would think that a company that wants to sell their product would have better ways to get a hold of them.

Any help would be appreciated.

From: fdablog@hpm.com
Posted: 14 Oct 2010 08:12 AM PDT

Watch Out! At FDLI Conference, Government Says More People Will Be Convicted of Crimes

By Douglas B. Farquhar –

At a trade industry conference this week, a cadre of government officials unanimously predicted a dramatic increase in the number of criminal prosecutions of individuals for violations of laws governing FDA-regulated industries. They also discussed how the types of prosecutions may be shifting away from charges based on off-label promotion of drugs and medical devices to charges based on threats to the safety and efficacy of FDA-regulated products, which include food, tobacco, medical devices, and drugs.

I was, Douglas B. Farquhar, a co-chair of the conference, which was sponsored by the Food and Drug Law Institute (“FDLI”) in Washington, D.C., along with Jennifer Bragg of the law firm Skadden, Arps, Slate, Meager & Flom. The Annual FDLI Enforcement Conference gathers together as speakers the decision-makers on enforcement and compliance from all of the major Centers at FDA (Food, Medical Devices, Advertising and Promotion, Drugs, Veterinary Drugs, and Biologics), the top enforcement officer for the agency (Eric Blumberg, FDA Deputy Chief Counsel for Litigation) and the head of the Office of Consumer Litigation, the litigating arm for FDA at the federal Department of Justice (Eugene Thirolf).

In what was probably the most concentrated collection of enforcement speakers gathered at an industry event, nearly all of the speakers predicted an increase in the number of prosecutions of individuals for violations of the Federal Food, Drug and Cosmetic Act, the statute that governs manufacture and distribution of FDA-regulated products. The Conference focused on strict-liability prosecutions under the so-called Park doctrine (also covered in an HPM-sponsored webinar last week, see blogpost here), and the officials predicted an increase of prosecutions of responsible corporate officials, even if there is no proof that they participated in, encouraged, or even had knowledge of the violations. Speakers from the government, industry, and private law firms (that would include yours truly) discussed how it is imperative that top corporate officials implement policies and procedures that effectively prevent violations from occurring, with a special emphasis on ensuring that no unapproved claims are made in promotional materials for drugs and devices, that reports of safety problems are filed with FDA promptly and accurately, that officials do not ignore problems discovered in testing of manufactured products, and that drugs and devices are manufactured in accordance with regulations setting current Good Manufacturing Practice.

The trade press has already reported that the government may especially be looking at prosecuting officials for off-label promotion because they feel that the huge monetary settlements with drug and device companies (reportedly more than $9 billion in the last ten years) are not getting the job done.

In addition:

Blumberg indicated that he expects that criminal investigations will focus on distribution of unapproved new drugs, failure to report unexpected adverse events caused by medical products, and “flagrant” off-label promotion (that is, advertising, company-sponsored programs, pitches by sales reps, and other promotional material which encourages the use of the products for conditions or treatments other than those approved in the labeling).
Each of the FDA Center compliance directors reported that they are cooperating much more closely with FDA’s Office of Criminal Investigations.
Howard Sklamberg, Director of FDA’s Office of Enforcement, noted that Class I recalls (the most serious category of recalls) will generally lead to increased FDA inspections and scrutiny of an FDA-regulated company.
Thirolf mentioned that he anticipates seeing more criminal investigations and prosecutions focused on safety issues, rather than just off-label promotions. He confirmed, in response to a particularly astute question (that would be from me) that safety issues include distribution of defective products, failure to report adverse events, and fraudulent reporting of testing data or false documentation of manufacturing processes and procedures.

One of the speakers also said that there were 70 whistleblower cases that were filed last year against device and drug companies that are currently being investigated by the federal government.

For more information about the conference, or to get a copy of a CD audio recording of the proceedings, visit www.fdli.org.

FDA is approving any garbage these days, I guess with a good $$$ tip.. Who knows for sure with the equipment will work, IT'S ALL ABOUT THE MONEY.

A korean company Lutronic is asking $89+ K for their poorly made MOSAIC, Erbium Fiber IN 2007 and today they are asking for more money..

I guess we have become a bunch of h educated** yet IGNORANT consumer.

SHAME ON US FOR ALLOW these god damn company EXPLOIT US.

Devices & Diagnostics Letter of FDANEWS online
Nov. 1, 2010 | Vol. 37 No. 43

OIG Exclusion Guidance Will Serve As Warning to Company Officials
Individual officers and managing employees at a device company can be labeled a criminal and banned from the industry because of someone else’s misconduct, according to a new guidance from HHS’ Office of Inspector General (OIG).

Lipotron is effective in circumferential reduction of fat, skin tightening and reduction of visceral fat. Problem with the visceral fat is that it comes back if the reason it's there is not addressed. Full hormonal evaluation and treatment makes it more successful and the only people I have seen with no results are those who were unwilling to exercise and unwilling to change their diets. Most effective that I have seen in noninvasive body contouring. we have had it since 2007 and are very happy with results. Works well with Velashape on treatment of cellulite, too.

I am a physician who owns a medical spa, and I have had very positive results from the 2 Lipotrons that we use in our medical spa. I would be interested in selling the second unit, however, due to downsizing. If you are interested in inquiring about it, please post a reply and I can send you my contact information.

Lipotron is a newer technology to the area in which I'm from. However, Im in the process of researching the difference between Lipo Ex, Lipotron 3000, Lipotron 2000 & Smart Lipo and any or other names it goes by. Does anyone have information on the difference between all these machines or is it just one machine with different names???
As far as I've seen, this is a medical device not all the way FDA approved. But a doctor must be overseeing the patients. As more and more doctors go towards the cosmetic world, which they are because it generates revenue... You shouldnt destinguish between medical or cosmetic... Customers & Clients want it and if they can get it more affordable without a deductable, such as at a salon... They will go-