Physicians in the regenerative medicine community were startled to read a press release issued on July 5th by Lipogems, which seemed to suggest that the FDA had reversed or at least modified the prohibition on using adipose tissue to treat musculoskeletal conditions the Agency just released in a Guidance on Minimal Manipulation and Homologous Use last November. While I admit the press release is very cleverly worded, and states that physicians can use the Lipogems kit to treat pathologies in orthopedic and arthroscopic surgeries, the clear implication is that physicians can use their kit for treating musculoskeletal pathologies, when in reality the Lipogems kit is limited to lipofilling in a wide variety of surgical fields (see the previous post for the excerpt taken from the 510(k) letter on the indications for use).
There are a number of statements in the press release that could contribute to physician confusion, but the portion of the Lipogems press release that comes razor close to crossing the line is the following:
“Many patients are looking for another option to major invasive surgery. Fat has many important cells and is easy to get from the patient’s body. I believe cells from their own body are the best cells that a patient can use,” said Dr. Baker. “Lipogems may be a great option for patients who have tried physical therapy, nonsteroidal anti-inflammatory drugs, or steroid injections, and other treatments that have not provided enough relief.
“If surgery is needed, Lipogems may be ideal to help provide cushion and support to facilitate the healing environment and optimize recovery,” he added.
At first glance, Lipogems’ Dr. Baker just has strung a series of non-controversial statements together:
- “Many patients are looking for another option to major invasive surgery.”
- “Fat has many important cells…”
- “[fat] is easy to get from the patient’s body”
- “I believe cells from their own body are the best cells that a patient can use…”
- “If surgery is needed, Lipogems may be ideal to help provide cushion and support to facilitate the healing environment and optimize recovery…”
What is curious about this sequence is that Dr. Baker starts with a statement that most patients don’t want to have major invasive surgery, which certainly is true. Yet, in the last statement he makes the use of Lipogems conditional: “If surgery is needed…”. Why would Dr. Baker come back to the surgical environment if patients don’t want to have surgery, as stated in the first sentence? The easy answer is that if he didn’t couch the use of the Lipogems kit within a surgical context, he would be indicating that Lipogems could be used without a surgical procedure, directly contradicting the language of the indications for use I shared in the previous post. And not sticking strictly to the indications for use of a regulated kit is a big no-no with the FDA. He further states that “…Lipogems may be ideal to help provide cushion and support…”, which is the language the FDA associates with fat grafting procedures. What that has to do with repairing a tendon is beyond me.
But there is this other statement that Dr. Baker makes:
Lipogems may be a great option for patients who have tried physical therapy, nonsteroidal anti-inflammatory drugs, or steroid injections, and other treatments that have not provided enough relief.
Here, the good doctor is reciting the conventional therapies for treating painful orthopedic conditions like osteoarthritis, without mentioning the words pain or osteoarthritis. But what I don’t understand is how Lipogems can be a solution to providing enough relief. Relief of what? Relief from deficient cushioning and supporting in a pathology? Because cushioning and supporting an orthopedic pathology is exactly all that Lipogems can talk about in terms of therapeutic benefit—just see the indications for use for the Lipogems product I showed in the last post. However, Lipogems’ objective is clear: the reader of the press release isn’t asked to think too hard, just follow the sequence laid out by Dr. Baker and you might get the wrong impression that Lipogems is FDA-compliant for treating painful conditions like osteoarthritis.
The next statement leaves me shaking my head in amazement at the sheer level of audacity of Lipogems:
In November 2017, the FDA finalized its rules guiding the use of Human Cellular and Tissue Products. The Agency reaffirmed that the Lipogems system meets the new guidelines’ criteria for minimal manipulation of the tissue, and that it is intended for homologous use.
Let me assure the reader that the FDA didn’t finalize any “…rules guiding the use of Human Cellular and Tissue Products (sic)…” in November 2017. What the Agency issued were Guidances concerning the use of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps). Guidances are not enforceable, unlike the rules the FDA has issued on HCT/Ps contained in 21 CFR 1271.
Beyond their confusion between guidances and rules, the statement indicates that the FDA “…reaffirmed that the Lipogems system meets the new guidelines’ criteria for minimal manipulation of the tissue and that it is intended for homologous use”. I have read the November Guidances and I don’t recall ever seeing Lipogems mentioned anywhere in them, so the Guidances didn’t reaffirm squat about the Lipogems system.
What is Lipogems playing at when they want the reader to get the impression that the FDA reaffirmed that the Lipogems system is compliant with the FDA to do whatever Lipogems implies docs can do with their kit? Let me be clear, the FDA would never directly comment on the status of a commercial system as Lipogems implied in their press release. Instead, I suspect that since the most recent 510(k) letter Lipogems received was issued in May 2017 that the folks at Lipogems jumped to the conclusion that the FDA must have blessed their kit in the context of the Guidances, which were still under review at the Agency. Or they just took some liberties with the timing of their 510(k) letter and the Guidances, putting two and two together and coming up with a reaffirmation by the FDA. Nice try.
There are other egregious statements that Lipogems has made in their press release, but it will all come to naught, when the FDA starts whacking the fuzz baller moles who treat orthopedic conditions with fat tissue. But I have to give the Lipogems folks credit, since there are lessons to be learned from this press release about how to confuse physicians on regulatory matters.