Spa “Fat Melting” Machine Not Shown to be Safe or Effective
Via Lindsay Beyerstein, here’s another “buyer beware” story from the Orange County Register about the LipoTron 3000 – which is promoted in spas/clinics as a non-invasive way to remove stubborn fat deposits.
For several years, doctors and medical spas around the country have touted a Fullerton company’s 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., described the technology in an online pitch for its “Lipo-Ex Spring Fling Fat-Off!” 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.
There’s only one small problem… the device has never been given FDA approval for the purpose, and hasn’t been proven to be safe, let alone effective. While safety doesn’t appear to be a major issue (the article mentions only a few minor shocks and burns), the device, which uses radiofrequency waves to target subcutaneous fat, doesn’t sound like it works very well, either.
Dr. Sherwood Baxt, a New Jersey plastic surgeon who advertised the procedure in a promotional video, said that when he bought the LipoTron he wasn’t troubled by its lack of FDA clearance. He explained that he had used unapproved devices before and, while he considered the agency’s green light a marketing advantage, he didn’t consider it necessary.
Besides, Baxt said, “We were told FDA approval was imminent.”
It didn’t work out that way, however, and, he said, “After two years, I just stopped asking.”
He continues to use the device for skin tightening on certain patients but quit using it for fat reduction. For fat reduction, Baxt said, “it wasn’t as effective as I thought it was going to be.”
Considering that clients/patients are charged approx. $400/treatment, and that 6 – 8 treatments is the norm, the lack of data on efficacy or safety is pretty mind-boggling.
July 27, 2012
$400 a treatment and it isn’t proven safe or effective? Sign me up for this one! lol
August 23, 2012
Actually, do a little bit of real research (try PubMed), rather than reading 60 second internet “news” posts, and you will find at least 40 medical articles showing that the technology used by this machine works even if this particular machine it doesn’t have government approval for the specific purpose of fat loss. But, doctors use treatments all the time for things not approved by the FDA. I doubt there isn’t a single doc who hasn’t, in fact. It’s totally okay and legal. The complaints you are reading about marketing, FDA, blah, blah, blah seem like mostly noise being made by a bitter former distributor and a grandstanding “advocacy” group trying to pull in more contribution dollars by scaring people. Do your own investigation and you’ll see it’s mostly a witch-hunt.
August 24, 2012
Elissa, lol, you are the one who needs to read the article….
QUOTE: Signature Medical Spa in Tampa, Fla., described THE TECHNOLOGY [emphasis added] in an online pitch for its “Lipo-Ex Spring Fling Fat-Off!” as “truly the only non-invasive way to reduce fat.” :END QUOTE
And as for unapproved treatment, that isn’t a “red herring”, it’s the fundamental basis of the dog and pony show being put on by Public Citizen. But, I assure you, if you’ve been treated by a physician for anything, there is an excellent chance you were treated with a product (drug/device) in a way NOT “approved” for the treatment. So looks like you need to adjust your “assumption” since, statistically, between 25-50% of ALL medical care is off-label (you can do your own research, you may learn something).
Maybe the marketing was out of bounds, but that doesn’t mean THE TECHNOLOGY (lol) doesn’t work or is dangerous (which it does and isn’t) and which is why all this fear mongering is mostly just huffing and puffing out of a bloated sense of self-righteous indignation.
August 23, 2012
LOL – did you even read the article or post?
Not a word is said about the “technology,” pro or con. The article is about a specific device, and the failure of the manufacturer to do what manufacturers of medical devices are supposed to do before marketing them for specific purposes.
That “doctors use treatments all the time for things not approved by the FDA” isn’t the issue. It’s a red herring.
What IS being questioned is the propriety of marketing/promoting a medical device that hasn’t met established standards. Certainly, if I agree to a series of expensive treatments using a particular device, it’s under the assumption that said device is safe and that due diligence has been done to assure that it does what its claimed to do, safely and reliably. This is something that has apparently not been established in the case of the Lipotron 3000.
As for “witch hunts,” “bitter,” and “grandstanding,” – well, obviously your mind is made up, although how you managed to make those judgments isn’t particularly clear.
August 24, 2012
Seriously – you’re just trolling me now, right? I can’t believe you think that the quote you mined somehow negates my point, simply because it uses the word “technology.”
Wow.
Go back and read my earlier response. I used the words, “pro or con.” This implies a judgment. And no one in the article makes any sort of global judgment on the technology. Period. You’re being literal to the point of being utterly nonsensical.
Even this negative assessment of the machine:
“Dr. Sherwood Baxt, a New Jersey plastic surgeon who advertised the procedure in a promotional video, said that when he bought the LipoTron he wasn’t troubled by its lack of FDA clearance. He explained that he had used unapproved devices before and, while he considered the agency’s green light a marketing advantage, he didn’t consider it necessary.
Besides, Baxt said, “We were told FDA approval was imminent.”
It didn’t work out that way, however, and, he said, “After two years, I just stopped asking.”
He continues to use the device for skin tightening on certain patients but quit using it for fat reduction. For fat reduction, Baxt said, “it wasn’t as effective as I thought it was going to be.””
Is focused on the company and its product. It is not about the technology, per se.
The above quote is also relevant to the issue of off-label use of drugs and devices. The article does not suggest that off-label use is wrong or illegal. Nor do I. Nor does Dr. Baxt, for that matter. This is why it’s a red herring.
For the record, however, off-label use of drugs or devices may be a good thing, if – in the words of the American Academy of Orthopaedic Surgeons – the practitioner is “well-informed about the product,” bases “its use on firm scientific rationale and on sound medical evidence,” and if s/he maintains “awareness of the product’s use and effects.” Certainly not all of these conditions appear to be true in the case of the Lipotron 3000. I surely hope that you’re not arguing that – simply because it’s common – that it’s therefore correct and justifiable in all cases?
To reiterate: the article concerns the “out of bounds” (your term, not mine) marketing of an expensive machine. It’s not about the technology, Public Citizen, the merits of off-label uses of medical devices or any of the other things that you seem desperate to argue about.
And I’m not inclined to cater to that desperation any longer. If you have something to share w/respect to the specific issue addressed in the article & post – that is, about the Lipotron 3000 or the company that makes it – by all means, share it. But otherwise, this conversation, such as it is, is over.
August 29, 2012
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.
October 3, 2012
Touché, Elissa. I’m with you–this conversation is over. All that is left is for the “Fat Lady to Sing”.
The FDA and DOJ, albeit, slowly but surely, will have their say in all this very soon.
I’ll reserve any further comment until then.