The LipoTron 3000, also known as the Lipo-Ex, is major innovation in cosmetic surgery. The non-intrusive device passes radiowaves through the skin; heating and destroying fat cells in the body. RevecoMED, the company that produces the LipoTron, has successfully sold it to hundreds of medical spas in the U.S. To the tune of $85'000 per device. Liposuction scars can be ugly. So a device that can be just as effective without puncturing or damaging the skin should be a huge hit, right?
There's just one problem with the LipoTron: It hasn't been approved by FDA. Even after attempts to move the product forward via 510(k) and later by reclassifying the device as a massager, RevecoMED has not suceeded in getting the device FDA approved. The lack of approval, however, hasn't stopped Reveco from marketing and selling the LipoTron for the past two years and, more troubling, it hasn't sparked the FDA to take any enforcement action against the company.
In a report by MSNBC, two whistleblowers who sold the device for RevecoMED and brought this situation to light, have expressed their disappointment that FDA hasn't acted more strongly. It seems the company was able to stave off concerns from salespeople, doctors, and patients by continually promising that FDA approval was imminent. The company has since revised the language on its Web site to no longer imply FDA approval, but MSNBC reports that some medical spas still falsely state that the LipoTron is FDA approved.
While the device appears relatively safe, with only “scattered incidents of patients receiving minor shocks and burns...” reported, the troubling concern here is how easily a company has been able to put a potentially hazardous device out on the mass market without FDA approval and then, once discovered, seem to have entirely skirted FDA scrutiny and consequences. Setting aside ignorance on the part of marketers and customers, shouldn't FDA be doing a better job of policing what is essentially a black market device? Particulary with the medical device user fee signed into law, perhaps government should be looking less into how to speed up FDA approvals and more into how to regulate devices that bypass the process entirely. RevecoMED did the right thing and at least tried to go for FDA approval. But one can't help but wonder how many unscrupulous device makers are out there who have bypassed FDA entirely and are marketing their products to doctors and patients.