While I hadn’t seen anything new recently on the fuzz balling front (e.g., using mechanical methods to beat up adipose tissue for lipofilling procedures), imagine my surprise to see a press release dated July 5th with the following headline:
FDA Clears The Way: Lipogems’ Receives FDA Clearance For Microfragmented Adipose Tissue System Utilizing Body’s Own Fat To Support Tissue Repair In Orthopaedic And Arthroscopic Surgeries
Needless to say, the press release was discussed on the Blog-o-sphere by folks like Dr. Don Buford and Dr. Chris Centeno, both of whom confessed to being confused about what was going on with Lipogems and their fuzz ball making kit. And for good reason, since based on statements made in the press release you might think the FDA had completely reversed their approach to dealing with the use of fat tissue in orthopedic conditions, like osteoarthritis. After the FDA issued a final guidance last year in which they stated unequivocally that it was a non-homologous use to treat orthopedic conditions with adipose tissue, was it possible they had completely changed their minds, and announced it in a press release written by Lipogems?
Nah. It was just Lipogems playing everyone with a press release about a previous 510(k) clearance they received way back in May 2017. At least, that is what I think is going on, since after carefully reading the press release the only thing I think is new about the Lipogems fuzz ball making kit is that there is a new press release. In order to help those who remain confused after reading the press release, I will provide a few pointers on how to interpret it, so that the next time they try to play the crowd, the crowd will just yawn.
Let’s start with the most obvious giveaway in my view that nothing really new has happened to warrant putting out a Fantastic Press Release. If you search through the entire release, you will see no mention of a 510(k) number. A 510(k) number isn’t a trivial detail, so its absence from the press release means that there probably isn’t a new 510(k) clearance for a Lipogems kit. To confirm my suspicion, I went looking and as of July 17th, there were three 510(k) letters associated with Lipogems on record at the FDA, with the most recent being posted in May 2017 as mentioned above. There can be a lag in recording 510(k) letters in the database, so I will keep looking.
In order to appreciate just how cleverly written this press release is, you need to be aware of the indications for use in the most recent Lipogems 510(k) letter (with edits):
The Lipogems System is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue in medical procedures involving the harvesting, concentrating and transferring of autologous adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the transfer of harvested adipose tissue is desired: orthopedic surgery, arthroscopic surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and plastic and reconstructive surgery when aesthetic body contouring is desired. Only legally marketed accessory items, such as syringes, should be used with the system. If harvested fat is to be transferred, the harvested fat is only to be used without any additional manipulation.
What is immediately obvious is that the Lipogems press release understates the breadth of the applicability of its kit when it just lists orthopedic and arthroscopic surgeries. There are another 10 areas of surgical intervention in which you could use the Lipogems kit! One interpretation of the modesty of Lipogems is that they want the reader to think the FDA has focused its clearance on just orthopedic and arthroscopic surgeries. I am aware of at least one chiropractor who believes that since the term orthopedic is mentioned in the indications for use that healthcare professionals can do whatever they want in orthopedics with the kit.
The press release is filled to the brim with carefully selected words that seemingly are meant to convey the appropriateness of using Lipogems-generated fuzz balls to treat orthopedic conditions, without actually stating that you should do this. For example:
Lipogems is attractive to orthopaedic physicians because it is compliant with the latest FDA guidelines and is cleared for use in orthopaedics and arthroscopic surgery unlike many other technologies.
It is true that their kit is compliant with FDA guidelines, which apparently they hope you will mis-understand to be the Final Guidances the Agency issued last November. In reality, the compliance of their kit is to the FDA requirements for kits in the Product Code MUU. What kinds of devices are included in the Product Code MUU? This is the description of the MUU Product Code, as listed in the Code of Federal Register Title 21:
Sec. 878.5040 Suction lipoplasty system.
(a) Identification. A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of 1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.
(b) Classification. Class II (special controls). Consensus standards and labeling restrictions.
[63 FR 7705, Feb. 17, 1998]
That’s right, the much touted Lipogems kit is considered by the FDA to be nothing more than a lipoaspiration device. Equally as important, notice that products/devices in the MUU Product Code are to be used for aesthetic body contouring. Do orthopedic surgeons do a lot of aesthetic body contouring procedures? Don’t know, but I kind of doubt it. So, this is perhaps the best evidence that Lipogems is just playing around with words in an attempt to give orthopedic surgeons the false impression that the FDA thinks fuzz balls are just what the doctor ordered for treating orthopedic conditions like osteoarthritis. Of course, this is just wishful thinking on the part of Lipogems, and the occasional chiropractor.
There are other descriptions in the Lipogems press release that warrant reviewing, if only to show just how brilliantly misleading I think this press release really is. I will continue with my review in the next post.