Inside Cosmetic Surgery Today

Lipodissolve: the facts, research, and truth: Dr Lycka & Dr Crutchfield

mesotherapyLipodissolve is claimed to be a magic injection to remove unwanted body fat. It is also the subject of some controversy in the media and medical profession with often strong emotions which are not always tied to scientific reality. So what to believe? This week on Inside Cosmetic Surgery Today, Dr Barry Lycka welcomes a re-knowned expert on Lipodissolve, Minneapolis-based Dr Charles Crutchfield, to explain his recent paper on Lipodissolve. Dr Crutchfield explains what is lipodissolve, how it works for body sculpting, and introduces the 8 years of results which have been published by himself & Dr Khalid Mahmud. He gives clear information about how the treatment should be performed, and by whom. He also explains who are ideal patients for lipodissolve, and who are not and provides important information about possible side effects and how they can be avoided.

Inside Cosmetic Surgery Today – Crutchfield

Charles Crutchfield on Webtalk RadioInterview with Dr Barry Lycka & Dr Charles Crutchfield

Dr Barry Lycka cosmetic dermatologist from Edmonton, Alberta is talking today with
Charles E. Crutchfield III, MD is a board certified dermatologist and clinical professor of dermatology at the University of Minnesota medical school, active member of the American Medical Association, National Medical Association, and American Academy of Dermatology. Dr. Crutchfield is also involved in academic medicine – with many published research papers and a textbook of dermatology. His latest is discussed today.

Talking today about Lipodissolve, an injectable procedure to reduce body fat.
So today we are talking about Lipodissolve – described as a magic injection which can improve a fatty area within days… Is it really magic?

To answer this question we have Dr Charles Crutchfield who is one of the world’s experts on this procedure. Lipodissolve is also sometimes referred to as Mesotherapy.

Well no – it’s not magic…. BUT it is a really nice tool to reduce unwanted fat in the adipose tissue.
And how long has Dr Crutchfield been involved with this? Around 7 to 9 years. Dr Lycka also has been using this procedure, after attending a course in 2003 – Dr Lycka thought this all sounded too good to be true…. but after seeing the results firsthand which were excellent, he decided to start offering it through his practise.
What have been your experience and results with Lipodissolve Dr Crutchfield?

We have been measuring patient satisfaction with this procedure, and have achieved between 75% to 80% patient satisfaction – patients were happy with the results they achieved in reducing unwanted fat. In fact Dr Crutchfield has recently published a paper on his research and findings – available through Journal of Clinical & Aesthetic Dermatology October 2012, and it can be found online on http://jcadonline.com/lipodissolve-for-body-sculpting-safety-effectiveness-and-patient-satisfaction/ the paper is entitled: ‘Lipodissolve for Body Sculpting’.

What is the difference between Mesotherapy and lipodissolve?

Mesotherapy is the general term for the injection of materials into the middle layer of the skin – and it originated in sports therapy medicine when drugs were injected into an injury to help the injured area heal faster. The process and ideas have refined over the years into different applications.

Lipodissolve is therefore a very specific type of Mesotherapy – it is an injection to dissolve unwanted fat. It uses 2 refined chemicals, derived after loads of science and research, applied with very rigorous methods, to achieve its results.

And talking of research, Dr Crutchfield would you like to tell us about the research paper you have published on Lipodissolve?
The research was to record the safety, effectiveness and patient satisfaction of lipodissolve.
It was done in conjunction with Dr Khalid Mahmud who is one of the founding fathers of this process and has been involved with this for over 20 years. A very honest doctor, this whole study has been done with no hype, with careful measurements and very honest reporting.
We followed up on 1600 patients, who received 15,000 treatments over 8 years. And we recorded a patient satisfaction rate of between 75% and 80%.

What is Lipodissolve?
There have been lots of different formulations used over the years but there was no real science behind them – one of the reasons for the study.
It is a series of injections using natural agents, phosphatidylcholine (referred to as PC) with deoxycholate (referred to as DC).
DC is a bile acid which is secreted from our bile duct to dissolve fat.
PC is an emulsifying agent (also known as lecithin) and is a major component of all of our cell membranes. The PC used in lipodissolve is actually derived from soy beans. This use of soy beans to derive PC can cause a very rare allergy to lipodissolve. In the study, 2 patients seemed to have an allergic reaction – but after further investigation, it turned out they had an allergy to soy beans.

How to create 75% to 80% patient satisfaction with lipodissolve – how is it done?

·    This is not an instant treatment – it takes a number of treatments.
·    It has to be done in a VERY precise manner – performed exactly right, with the exact preparation of PC&DC, and delivered in the right areas.
·    As a guideline, we usually treat an area about the size of a hand – so on the flank areas for example – 1 area the size of a hand on each flank.
·    It is delivered by 30 to 40 small injections, carefully placed at the correct depth.
·    It is repeated around 4 to 6 weeks, optimally, and requires between 4 to 6 treatments.
So it really isn’t a magic injection!
The injections can be spread out over 2 to 3 months, but every 4 to 6 weeks seems optimum timing.

Lipodissolve is a controversial subject; there are many ‘pros and cons’ to it. We have just discussed the basics of it… now we are going to talk about possible side effects and why there is the controversy…. keeps listening (and of course reading)!

Can all areas of the body be treated?
If someone is 300lbs, is it the right treatment for them?
NO. We tell patients that if they can point to a specific small area where the fat has accumulated and they can’t shift it – no matter what they try, and it really really bothers them, then Lipodissolve is an ideal procedure for them
One of the more common typical patients is the woman who has had several children and has a tummy pooch right under the navel that no matter what they try – it won’t go away – they are ideal for lipodissolve.
It absolutely is not for overall weight reduction programs.
It is for body shaping, body sculpting. It is not an antidote or excuse for not taking care of yourself and not keeping in shape with a great diet and exercise.
Is Lipodissolve ‘competition’ for Liposuction? No, actually it’s very complementary.
Liposuction is for treating larger body areas to remove excess unwanted fat. Lipodissolve is for small specific areas. It is typical for patients to be thrilled with their liposuction results to come back for a little extra sculpting in certain areas with lipodissolve.
Alternatively, many will start with lipodissolve as a preferred less invasive procedure than liposuction. However, if they don’t respond (which can happen), then they may progress onto liposuction. Lipodissolve is also appropriate when a patient wants some fine tuning after liposuction and don’t want to go back onto the surgery table! Patients appreciate having the choice of taking a non-surgical route first – if it’s appropriate for them of course.

And what about side-effects from lipodissolve – what are they?
People always want to know, if it’s right for them, does it hurt?
1.    There can be some swelling and discomfort. The swelling lasts a couple of days to a week, rarely longer than that. To minimise that we recommend that ultrasound massage is used before and after the lipodissolve procedure. It makes the adipose tissue a bit easier to inject into, and afterwards it also allows the injected solution to smooth out and be distributed evenly, which therefore makes the reduction in fat to be more even. It also makes it a more comfortable procedure.
2.    Patients can get nodules and dimpling. They get much less if the ultrasound massage is applied after and anyway, they do go away. It can be typical to feel them but not see them. This side effect is also common after liposuction – but remember – it does go away.
3.    Dark areas can also appear sometimes. This is from the underlying inflammation causing hyperpigmentation, it can last several months and applying a topical medicine will make that go away.

One of the biggest concerns is ulceration in the area treated. This occurs as a direct result of ‘operator error’ – incorrect placement of the solution. As we highlighted in the research paper, lipodissolve must be done precisely by a skilled person who knows what they are doing.
In the study there were 3 cases of ulceration recorded – however, one of those 3 had Lupus and didn’t report it.

There are a number of conditions / patients to avoid, if one wants to avoid side-effects with lipodissolve:
Avoid anyone who is pregnant, anyone with diseases such as heart disease, kidney disease, anyone who is diabetic, a history of infections, anyone with an auto-immune disease such as lupus. Also to avoid bruising, patients must come off any anti-inflammatory drugs or aspirin for a while before having lipodissolve. Finally, also avoid anyone with a soy allergy.
It is so important to highlight that this is a medical procedure, and everything has risks but done properly with suitable patients it records safe and effective results, as per the research results.

All doctors who are a member of ‘Doctors For The Safe And Ethical Practise Of Aesthetic Medicine’ pledge that all patients must be evaluated by a physician before any cosmetic procedure to make sure they are appropriate and healthy for the procedure. This is excellent standard practise and more information can be found at http://www.safeandethicaldoctors.org/

It’s also true that there are some doctors who are vehemently opposed to lipodissolve. There seems to be a lot of mystery surrounding the procedure, with too many unfounded strong emotions, which are not always tied to scientific reality. Another reason why Dr Crutchfield and Dr Mahmud decided to write the paper from their studies.
From their studies – they are not seeing problems – it is safe, effective and patients are satisfied with the results. It is one of the largest studies looking at safety, effectiveness, satisfaction and side effects. It is important to note that when considering the results of research studies that one looks at who is doing it, how they are doing it, why they are doing it and whether they have a vested interest or not.

Is the FDA opposed to Lipodissolve?
This is one of the biggest attacks by opponents of lipodissolve is that it is not FDA approved. HOWEVER – these solutions are based upon nutritional supplements, which can be bought everywhere, are in every candy bar, and in every cell membrane. The FDA does not regulate nutritional supplements, so Lipodissolve does not come under the regulatory influence of the FDA – so it is a highly misleading argument that Lipodissolve is not regulated by the FDA. In the past, the FDA have said that in the future they may review injectable nutritional supplements  BUT at this point, lipodissolve does not come under their regulatory influence / scope.
It is also important to note that the FDA have looked at Lipodissolve and their concerns were with the marketing of it, with people making false claims and so forth.

Any final advice for our listeners?
If you are thinking of lipodissolve…
·    go and see a doctor who is a member of  ‘Doctors For The Safe And Ethical Practise Of Aesthetic Medicine’. www.safeandethicaldoctors.org
·    Make sure you see a physician before the procedure to make sure it is appropriate for you.
·    Make sure the doctor performing Lipodissolve has the experience in doing it properly, that they know what they are doing and what has to be done very precisely for the procedure to work and give the desired results…. and avoiding the side-effects.
·    Understand all aspects of the procedure and understand that, with any medical procedure, there can be side effects and levels of risk, as well as, benefits.

Contact details for Dr Crutchfield and Dr Lycka:

Dr Crutchfield
http://www.crutchfielddermatology.com
‘Lipodissolve for Body Sculpting’ available on http://jcadonline.com/lipodissolve-for-body-sculpting-safety-effectiveness-and-patient-satisfaction/

Dr Barry Lycka
www.barrylyckamd.com
Telephone: Edmonton (780) 991 9603

Lipodissolve Safety & Satisfaction

Doctor Findings

From The Journal of Clinical and Aesthetic Dermatology

Lipodissolve for Body Sculpting: Safety, Effectiveness, and Patient Satisfaction

October 2012

Khalid Mahmud, MD, FACP; Charles E. Crutchfield III, MD

Khalid Mahmud, MD, FACP, is from Innovative Directions in Health, Edina Minnesota; Charles E. Crutchfield III, MD, is from University of Minnesota, Minneapolis, Minnesota; Crutchfield Dermatology, Eagan, Minnesota

Disclosure: The authors report no relevant conflicts of interest.

Abstract
Lipodissolve, to reduce superficial deposits of fat, has gained popularity in recent years. A simple solution of phosphatidylcholine in deoxycholate evolved around 2004 and has been used by two collaborating physicians in Minnesota. Their experience encompassing 1,616 patients receiving a total of 15,122 treatments is described. Relatively modest volumes of injections produced satisfactory and smooth results in 74.5 to 86.5 percent of the patients in the two practices. No serious complications developed. Minor and rare side effects included pain, lightheadedness, tender nodules, pigmentation, and ulceration in two patients. The authors offer useful tips to enhance safety, effectiveness, and patient satisfaction with the procedure.  (J Clin Aesthet Dermatol. 2012;5(10):16–19.)

Localized injections of phosphatidylcholine (PC) with deoxycholate (DC) to reduce superficial deposits of fat have gained popularity in the United States since the turn of the century. Initially, different practitioners added multiple other ingredients, including L-carnitine, aminophylline, collagenase, various vasodilators, and hyaluronidase. A standard formula with PC and DC as essential ingredients was then introduced in Europe and adopted by the American Society of Aesthetic LipoDissolve (ASAL) in the United States around 2004. Since then, several hundred physicians in the United States have treated thousands of patients.

The mechanism of action of the mixture is similar to that of bile, wherein DC (a bile salt) breaks down the ingested fat cells, and PC assists the digestion and drainage of released fat,[1] but mostly protects the neighboring mucosa from the corrosive action of DC.[2–4] It has been shown that when injected in subcutaneous fat, DC alone leads to adipocyte death5; however, there is less pain, bruising, and induration when combined with PC.[6] Once the fat cells are destroyed, they are slowly removed by the macrophages (foam cells) in the concomitant inflammatory response,[7] resulting in fat reduction in the treated area, while at the same time newly laid down collagen tightens the overlying skin. The techniques, efficacy, and side effects of lipodissolve have been the subject of several reports over the past five years.[8–10]

The following is a report of 1,616 patients who received 15,122 treatments of lipodissolve during the last 6 to 7 years by two Minnesota physicians who were a part of the ASAL. The results are described herein, followed by useful tips to enhance safety, efficacy, and patient satisfaction.

Areas treated
Abdomen, flanks, outer thighs (saddle bags), posterior upper thighs (banana roll), and anterior thighs (mostly cellulite) were the most common areas treated. Back, arms, and chin/jowls were less common.

Methods
The areas were marked by palpating exact outlines. For example, the abdomen was not injected as a whole, but as separate areas over the upper, lower, or periumbilical abdomen, which were marked exactly. Saddle bags were marked according to exact shape and extended to banana rolls, if necessary. Icing the area for 4 to 5 minutes seemed to reduce immediate stinging and pain and was used for most of the patients at one clinic. PC/DC injections were placed 1.5cm apart and at a depth of the middle of the fat pad and slightly more superficially in cases of cellulite to provide better skin tightening. The volume of the solution (PC 25mg/mL, DC 21mg/mL) varied from 20 to 30cc per flank or saddle bag to 40 to 60cc per abdominal area in the two different practices. A few double chins were treated with 3 to 6cc. Ultrasound, for a few minutes, was added before or after injections for the possibility of improved adipocyte lysis.[11,12]

Results
All patients had some stinging and pain during, and for 30 minutes after, the procedure, which was reduced among the patients who received 4 to 5 minutes of icing before the procedure. A variable amount of swelling and bruising developed in almost all patients, but mostly subsided within 10 days. The overall results differed somewhat depending upon the volume of solution with each treatment (Table 1).

Practice A, using higher injection volume per treatment needed fewer treatments, 3 versus 4 per area, than practice B. The satisfaction rate was slightly better among those receiving higher injection volume, 86.6 percent in practice A versus 74.4 percent in practice B. When separated for body sculpting and cellulite, in practice B, the satisfaction rates were 81 and 44 percent, respectively. When response could be easily measured, such as abdominal circumference reduction in 95 patients, it varied from 0.125 to 3 inches per treatment, with an average of 1.1 inch. The fat reduction was generally associated with some degree of skin tightening, resulting in a smooth appearance. No patient developed lumpy, bumpy, or uneven appearance, as seen in some patients after liposuction. Complications were minor and extremely rare and developed in 1 to 2 percent of the patients (Table 1). Lightheadedness from hyperventilation, pain, and prolonged tender nodules were slightly more common in patients receiving a higher volume of injections (practice A). Complications of liposuction, such as pulmonary embolism, hemorrhage, perforation, lidocaine/ epinephrine toxicity, third space fluid shifts, and fat embolism,13,14 did not occur with lipodissolve.

Discussion
These results, in conformity to others reported in the literature (cited above), reveal that lipodissolve is a highly effective procedure in reducing unwanted deposits of localized fat and that it can tighten the skin to some extent, providing smooth cosmetic results (Figures 1–4).

This is an observational report, not a prospective study, so institutional review board approval was not indicated. Because different areas of the body would show different amounts of shrinkage (e.g., abdomen vs. arm) and because the amount of fat being treated is highly variable in different individuals, the authors felt that they could not attach significance to circumferential reduction in centimeters to the entire group, but they have listed the measured reduction in 100 treated patients. In evaluating abdominal circumference reduction, the authors did see a statistically significant diminution (see Table 2). The most important parameter to the authors for this report was patient satisfaction with the procedure. The procedure should be preferred over liposuction for small-to-moderate areas of superficial fat to avoid possible complications of liposuction. Fat embolism, one of the complications of liposuction, has never been reported with lipodissolve. To the contrary, phosphatidylcholine has been used to treat fat embolism, such as with bone fractures.[15] There has been some conjecture and/or fear that lipodissolve may increase cholesterol. However, phosphatidylcholine has been shown to improve lipids and reduce cardiovascular risk factors.[16–18]

Large volumes of PC/DC injections, 100cc per area as suggested a few years ago, do not seem to be necessary. A high degree of patient satisfaction can be achieved with as little as 40 to 60cc per treatment. More treatments may be needed with lower volumes, but as the authors’ experience reveals, these treatments are better tolerated and with a lesser chance of complications.

Based on personal experience and review of the literature, the authors offer the following tips to enhance safety, effectiveness, and patient satisfaction with the procedure.

Safety
•   Avoid pregnant patients and patients with any systemic disease, such as heart disease, kidney disease, un-
controlled diabetes or hypothyroidism, infections, active or previous autoimmune disease, or active skin disorders.
•   Avoid patients on aspirin or other anti-inflammatory drugs and those with a known bleeding tendency.
•   Avoid patients with soy allergy (the usual PC/DC mixture is soy based).
•   Avoid injecting breast or axillary tail of the breast. Prolonged inflammation could possibly stimulate
malignant cells.
•   Avoid injecting around the knees (too close to ligaments) and below the knee, as these areas may be more prone to skin breakdown.
•   Inject the minimum volume necessary depending upon the area and amount of fat, usually 40 to 60cc.
•   Injections should be 1.5cm apart and in the middle of the fat pad. Avoid injecting too close to the skin or underlying muscle and fascia.
•   Avoid rubbing the area or wearing garments that are too tight.
•   Patient should avoid putting on lotions immediately after treatment to avoid infection. Wait for a few days until puncture sites have healed.

Effectiveness
•   Select patients with relatively localized areas of soft fat. Firm and fibrous fat tends not to respond as well.
•   In patients with cellulite or skin laxity, inject somewhat more superficially, but still at a depth of 5mm, at least. Avoid patients with excessive skin laxity with minimal underlying fat.
•   Palpate and mark the areas to be treated exactly. For example, some patients have a contiguous fat pad around the umbilicus, others have a large area below the umbilicus or both below and above the umbilicus, and others have multiple areas over the abdomen.
•   Ultrasound immediately before or after the procedure may help fat cell lysis.
•   Wait for 6 to 8 weeks before re-injecting the same area to have full effect of the first treatment.

Patient satisfaction
•   Avoid patients with undue expectations, such as obese or overweight patients who feel this may lead to weight loss and really thin patients who imagine they have extra fat.
•   Go over informed consent and the possibility of even rare complications. Inform them that there is a possibility of prolonged palpable nodules and pigmentation in a small number of patients, and pain that may last for three or more days.
•   Inform the patient that it may take 3 to 4 treatments per area to have the desired effect. However, if there is absolutely no effect six weeks after the first treatment, it is helpful to have a frank discussion with the patient and better to avoid further treatment if the patient is skeptical.

References
1.    Tso P, Kendrick H, Balint JA, et al. Role of biliary phosphatidylcholine in the absorption and transport of dietary triolein in the rat. Gastroenterology. 1981;80(1):60–65.
2.    Tsuboi K, Tazuma S, Nshioka T, et al. Partial characterization of cytoprotective mechanisms of lecithin against bile salt-induced bile duct damage. J Gastroenterol. 2004;39(10):955–960.
3.    Barrios JM, Lichtenberger LM. Role of biliary phosphatidylcholine in bile acid protection and NSAID injury of the ileal mucosa in rats. Gastroenterology. 2000;118(6): 1179–1186.
4.    Eros G, Kaszaki L, Czobel M, et al. Effects phos-phatidylcholine pretreatment during acute experimental biliary reflux. Magy Seb. 2005;58(6):406–414.
5.    Rotunda AM, Suzuki H, Moy RT, et al. Detergent effects of sodium deoxycholate are a major feature of an injectable phosphatidylcholine formulation used for localized fat dissolution. Dermatol Surg. 2004;30(7):1001–1008.
6.    Salti G, Ghersetich I, Tantussi F, et al. Phosphatidylcholine and sodium deoxycholate in the treatment of localized fat: a double-blind, randomized study. Dermatol Surg. 2008;34(1): 60–66.
7.    Rose PT, Morgan M. Histological changes associated with mesotherapy for fat dissolution. J Cosmet Laser Ther. 2005;7(1):17–19.
8.    Palmer M, Curran J, Bowler P. Clinical experience and safety using phosphatidylcholine injections for the localized reduction of subcutaneous fat: a multicentre, retrospective UK study. J Cosmetic Derm. 2006;5:218–226.
9.    Duncan DI, Chubaty R. Clinical safety data and standards of practice for injection lipolysis: a retrospective study. Aesthetic Surg J. 2006;26(5):1–12.
10.    Duncan DI, Palmer M. Fat reduction using phosphatidylcholine/sodium deoxycholate injections: standard of practice. Aesth Plast Surg. 2008;32:858–872.
11.    Silberg BN. The technique of external ultrasound-assisted lipoplasy. Plast Reconstr Surg. 1998;101:552.
12.    Hoefflin SM. Lipoplasty with hypotonic pharmacologic         lipo-dissolution. Aesth Surg J. 2002;22:573–576.
13.    Toledo LS, Mauad R. Complications of body sculpture: prevention and treatment. Clin Plast Surg. 2006;33(1):1–11, V.
14.    Platt MS, Kohler LJ, Ruiz R, et.al. Deaths associated with liposuction: case reports and review of the literature. J Forensic Sci. 2002;47(1):205–207.
15.    Masella L, Viscdi E, Buffardini G, et al. Polyunsaturated phosphatidylcholine in pulmonary fatty microembolism in patients with multiple fractures. Clin Ter. 1983;105(1):13–22.
16.    Klimov AN, Konstantinov VO, Lipovestsky BM, et al. Essential phospholipids versus nicotinic acid in the treatment of type 2 hyperlipoproteinemia and ischemic heart disease. Cardiovasc Drugs Ther. 1995;9(6):779–784.
17.    Jimenez MA, Scarino ML, Vignolini F. Evidence that polyunsaturated lecithin induces a reduction in plasma cholesterol and favorable changes in lipoprotein composition. J Nutr. 1990;120(7):659–667.
18.    Lombard E, Marin V, Domingo N, et al. Anionic peptide factor/phosphatidylcholine particles promote the inhibition of vascular cell adhesion molecule-1 in human umbilical vein endothelial cells. Pathobiology. 2005:72(4):213–219.