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FAQs about Lipo-dissolve

PC/DC Overview

What are lipo-dissolve injections?

Lipo-dissolve injections have become an increasingly popular means to remove excess fat. The procedure goes by many names (e.g., Lipostabil®, Lipodissolve, Flab-Jab, Lipojection, Lipotherapy, etc.) and involves the injection of mixtures of various chemicals into the fat through multiple microinjections administered over multiple treatment sessions. The desired end result is the gradual removal of localized fat deposits. Lipo-dissolve injections are generally not regarded by medical professionals to be as potent as liposuction, a powerful yet invasive surgical procedure in which multiple liters of fat are 'sucked' from patients in a single session. Lipo-dissolve therapy typically requires that dozens of small 'fat burning' injections of compounded phosphatidylcholine/deoxycholate (PCDC) be injected into fat and connective tissue over several sessions. These drugs are not FDA-approved.

What are the compounds/ingredients in the injectable solution?

The main compound used in lipo-dissolve is phosphatidylcholine (PC), a compound derived from soy that is a component of cell membranes in many organisms, including humans.1 Deoxycholate (DC), a naturally occurring bile salt produced by the liver, is also used in the formulation to solubilize phosphatidylcholine, thus keeping it in solution.1 Together, the main ingredients are commonly abbreviated as PCDC, however without a specific FDA-approved formulation for the injected solution, the ratio of the two compounds in a given formulation may be substantially different depending on the provider. Some providers also add small amounts of other medications, vitamins, and herbs. PCDC injections have not been approved by FDA for ANY indication and neither phosphatidylcholine nor deoxycholate are active ingredients in ANY FDA-approved drug.

Where do providers get the PCDC for lipo-dissolve injections?

The PCDC drug is obtained from compounding pharmacies, which traditionally make small quantities of unique drugs for specialized treatments (e.g., special versions of drugs for patients with allergic reactions). According to experts who discussed this issue with the Washington Post, in many situations involving compounded drugs, quality control and sterility can often be "spotty or nonexistent."2

What is the standard lipo-dissolve procedure?

There is no standard process/procedure that has been studied in controlled clinical trials or to the satisfaction of the FDA. Therefore, the procedure will differ depending on the provider. FDA-approved drugs have a standardized drug formula and method of administration. With lipo-dissolve, individual providers determine dosing and technique. The lipo-dissolve procedure "typically" involves an average of 2-4 treatment sessions spaced 4-8 weeks apart.3According to the Aesthetic Surgery Journal, the maximum safe dose of PC is 100 mL per session with approximately 0.4 mL delivered with every micro-injection. However, because studies have not concluded a standard protocol outlining specific number of sessions, number of microinjections per session, and amount of PC needed for results, this average may vary greatly.4

How is the drug cleared from the body?

There is no scientific support for theories about how the drug is cleared from the body. It is unclear exactly how the body metabolizes and excretes the drug and the broken down fat cells. The injected chemicals are believed to trigger an inflammatory response as the fat cells are broken down and are thought to be excreted in the urine and feces. Without pharmacologic studies (those that study the compound's mechanism of action and are required for FDA-approved drugs), these theories cannot be confirmed.

How long has the procedure been around? How many times has it been performed?

Cosmetic use of phosphatidylcholine injections was introduced at the First International Meeting of Mesotherapy in 1988 by Italian Physician Sergio Maggiori5. The formulation began being used for fat removal in Brazil in the 1990's yet was later banned by ANVISA (Brazilian National Agency of Health Inspection). The procedure has only more recently been introduced in the U.S., and the American Society of Non-surgical Aesthetics estimates that 50,000 to 100,000 lipo-dissolve treatments have been performed in the USA and Europe6. Despite the numbers of treatments performed, the drug's safety and efficacy cannot be confirmed without controlled clinical trials as required by the FDA.

I keep hearing different terms for the treatment (e.g., lipo-dissolve, advanced lipo-dissolve, lipotherapy, injection lipolysis, etc.), are they all the same thing?

The treatments are similar in that each typically involves the injection of an unapproved PCDC formulation.

What areas can be treated with injections?

Currently, people use PCDC in a variety of areas (chin, abdomen, thighs). However, no well-controlled studies have examined where in the body the drug may or may not work. There is no FDA-approval for this drug for any part of the body.

Does the phosphatidylcholine affect other cells in the body besides fat cells?

It is unknown whether the drug affects other cells in the body (such as muscle or nerve cells). While a "theory" has been proposed for the method by which phosphatidylcholine destroys fat cells, the scientific mechanism still is not well understood.7

Are the injections a proper treatment for weight loss?

Without FDA-approval, this answer is unknown. But according to lipo-dissolve providers, the answer is no. Lipo-dissolve is not a viable means to lose weight. The ideal candidate is at a healthy weight but possesses localized fat deposits that cannot be reduced by exercise and diet. Lipo-dissolve may be successful in reducing inches but may not show any reduction in actual weight.

Are the ingredients used for lipo-dissolve safe?

PCDC is an unapproved drug. According to physicians currently studying the procedure, "until more safety data becomes available, physicians may be placing patients at unknown risks as they become reliant upon a compounded formulation for these treatments."8 Additionally, FDA has stated that "there are no FDA approved drugs with an approved indication to dissolve fat and FDA cannot assure the safety and efficacy of these types of drugs."8

FDA Status

Is the drug approved by the FDA?

PCDC is not approved by the FDA for any use. Furthermore, neither PC nor DC alone are active ingredients in any FDA-approved drug. FDA has issued a statement warning consumers "there are no FDA-approved drugs with an approved indication to dissolve fat and FDA cannot assure the safety and efficacy of these types of drugs"9 and that this is a "buyer-beware situation."9

I understand that the compounds in PCDC are naturally occurring substances in our body. If it's natural, why is it considered a drug?

Just because something is a naturally occurring substance does not mean that it is not a drug. Take insulin, adrenaline, human growth hormone, and erythropoietin, for example. They are natural substances in our body, all are considered drugs, and all are extremely dangerous at the wrong dose. The FDA considers something a drug if it affects the structure and function of the body. PCDC providers claim that it does just that.

What does FDA-Approval mean?

In the United States, prescription drugs are required to undergo rigorous laboratory, animal, and human clinical testing before they can be put on the market. The FDA reviews results of these studies to verify the identity, potency, purity, and stability of the ingredients as well to verify that the drug is safe and effective for its intended use. PCDC has not undergone any of the necessary testing required for FDA-approval.

If PCDC is not approved, does that mean it's being legally used off-label?

No. According to FDA, "off-label" use involves using an "approved" drug for an indication not in the approved labeling at the discretion of a physician10. Since PCDC is not approved, its use cannot be considered "off-label.".

Futhermore, the FDA has stated, "We are not aware of any phosphatidylcholine injectable products or sodium deoxycholate injectable products that could be used 'off-label' in 'lipodissolve' procedures." Read more...

What data exists to demonstrate the safety and efficacy of phosphatidylcholine injections?

It is important to note that there have been numerous retrospective studies (i.e. historical observations) performed on the use of phosphatidylcholine injections for fat dissolution1,2and a few prospective non-placebo-controlled studies performed to test the efficacy of the procedure.11 However, to date there have been no prospective, placebo-controlled studies (those required for FDA approval) done on the use of PCDC for fat removal and therefore safety and efficacy cannot be confirmed. Placebo-controlled studies are those where participants are randomly assigned to receive either the placebo or the active substance. Neither the participant nor the doctor know which treatment the participant receives. The goal of this type of trial is to illustrate that it is the drug that is eliciting a response, not the placebo. With retrospective studies, one makes conclusions based on pre-existing data (i.e. you start with an answer and look backwards to selectively find data that supports your conclusion). Prospective trials, as required by the FDA, by their very structure prevent this from happening.

Footnotes

1Hexsel, D., Serra, M., Mazzuco, R. (2003). "Phosphatidylcholine in the treatment of localized fat." 2 (5): 511-8

2Boodman, Sandra G. "Can Shots Safely 'Melt Away Fat'?" Washington Post 26 June 2007.

3Duncan, D.I. (2005). "Lipodissolve for Subcutaneous Fat Reduction and Skin Retraction." Aesthetic Surg J 25 (Pt 5): 530-543

4ASDS Technology Report: Mesotherapy.

5Hexsel, D., Serra, M., Mazzuco, R. (2003). "Phosphatidylcholine in the treatment of localized fat." 2 (5): 511-8

6Boodman, Sandra G. "Can Shots Safely'Melt Away Fat'?" Washington Post 26 June 2007. URL:
LINK

7Matarasso, A. and Pfeifer, T.M. (2005). "Mesotherapy for body contouring". Plast Reconstr Surg 115 (Pt 5): 1420-4.

8Rubin, Rita. "Lipodissolve proves popular despite lack of FDA nod" USA Today 11 September 2007

9"FDA's Statement to Healthline 3 regarding lipo-dissolve"

10URL: LINK

11Rittes, P.G. (2001). "The use of phosphatidylcholine for correction of lower lid bulging due to prominent fat pads." 27 (4): 391-2

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