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.
More bad news for LipoTron, RevecoMED (the manufacturer of LipoTron), and probably for it's resellers... as well as all the physicians and clinics who are offering LipoTron treatments.
Here is what Public Citizen is asking for; from their letter to the FDA:
Immediately seize all LipoTron devices that have been manufactured by RevecoMED and either (a) are being held in inventory by the manufacturer in the U.S. or (b) have been sold and distributed to user facilities in the U.S.
(2) Immediately order RevecoMED and any distributors of the LipoTron device to cease and desist all activities involving the distribution, sale, and promotion of the LipoTron device.
(3) Expeditiously 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
This can not be good news for any of the medical spas and clinics who already have this device.