Mesotherapy, dissolving fat

This post is a compressed form of an article recently published in The Plastic Surgery News.

Lipo alternatives make impressive claims but lack long-term data
By Lynn Yoffee

Advertising campaigns for nonsurgical or less-invasive alternatives to traditional liposuction - purportedly with no down time, no surgery and no worries - dangle tantalizing claims to an eager public while plastic surgeons are often left waiting for proof of safety and efficacy "Patients are fascinated with these non-invasive ways of having fat removed," says ASPS Member Surgeon Robert Centeno, MD. "Their appetite for non-invasive treatment is insatiable. But the marketing by the manufacturers is far ahead of the clinical trial data."
More than 300,000 liposuction procedures were performed in 2007, according to ASPS statistics garnered from the National Clearinghouse of Plastic Surgery Statistics. In addition, 9.9 million minimally invasive cosmetic procedures were performed during the same period, up 81 percent since 2000. These statistics are illustrative of the growing demand for non- and minimally invasive procedures for all areas of the face and body.
The range of alternative tools and procedures for fat removal including Mesotherapy - which, according to proponents, uses micro-injections of conventional or homeopathic drugs, vitamins, minerals and amino acids to dissolve fat - seems to send up the brightest warning flares among the plastic surgical community.
"Injection lipolysis is not approved by the FDA and should be avoided," says ASPS President Richard D'Amico, MD. "There is a dire lack of clinical research demonstrating its safety and efficacy, and neither the mixtures of chemicals nor the methods used for injecting it are standardized. It's a procedure plastic surgeons - and the public - would simply do well to avoid."
For ultrasound, radio frequency and laser-assisted liposuction techniques, which work by literally melting fat cells through a variety of means for less-invasive methods of removal, Dr. D'Amico advises waiting for more research - even when a technique has FDA approval.
"If a plastic surgeon chooses to use an external method or an internal method using a tiny laser, he or she is doing so despite a lack of good scientific data for efficacy," he says. "We simply don't yet have enough data to support using these techniques."
"We tend to give a lot of these technologies credibility that they don't warrant," adds ASAPS President-elect Alan Gold, MD, Great Neck, N.Y. "Plastic surgeons who invest in these techniques too quickly may ultimately find that their patients will be extremely disappointed."
Mesotherapy: Science or sham?
Though some states have taken action against mesotherapy to limit its use to investigative trials, it is still widely offered throughout much of the country as a nonsurgical alternative to reduce fat deposits. However, mesotherapy's lack of double-blinded studies demonstrating its effectiveness (and safety) for cosmetic conditions gives many plastic surgeons serious reservations about its use.
In addition, the lack of a uniform formula for compounding agents used in mesotherapy has limited the potential for scientific research efforts. Mesotherapy compounds may include any combination of phosphatidyl choline, silicium, CRP 1000, hyaluronic acid, glutathione, ascorbic acid, glycolic acid, pyruvate, vitamins, minerals and more.
"We don't even know what's in these various potions," says Susan Kaweski, MD, chair of the ASPS Technology Assessment Committee. "I don't understand how patients can even consent to this procedure when they could be receiving an injection of any combination of plant extract, antibiotics, hormones, nutrients or vasodilators. What really concerns me are substances like isoproterinol, which is basically used for treating asthma and could be deleterious to a normal person who gets to much of it."
"None of the substances that are being put together in these cocktails and injected have individually been approved by FDA for injection," adds Dr. Centeno. "They may be approved for other modes of use, but they have never been used for subcutaneous injection. The studies done so far are typically small trials, poorly controlled and not rigorous enough to substantiate these treatments."
Despite these concerns, public interest in mesotherapy seems to remain strong.
"You would think we're in some Third World country where people wouldn't know any better, but mesotherapy is around every corner and being touted as a way to avoid surgery," says Dr. Kaweski. "The FDA hasn't approved this for injection and people are still going to these places and having it injected. I'm flabbergasted by it."
"Mesotherapy academies and associations are springing up in the United States," Dr. Centeno adds. "Most of these organizations are being put together to promote training courses and the adoption of this technique to legitimize a process that doesn't have a great deal of well-designed scientific studies proving its efficacy."
One of the biggest questions surrounding mesotherapy (and other fat-melting techniques): Following the procedure, where does the dissolved fat go if it's not suctioned out?
"The commonly explained mechanism is that the fat is excreted," says Dr. Centeno. "Some people say it's excreted in the GI tract or urine, but that doesn't make sense from a biochemical standpoint. It's possible that it's not excreted, but rather redistributed."
A grave concern is that the fat rushes into the bloodstream and collects in the circulatory system.
"Do the end products ultimately go to the heart and cause cardiovascular disease?" she says. "Beyond that, how do we control for fat destruction so that you're only going to get the middle layer of fat cells and not the superficial layer? What are the short-term effects vs. the long-term effects? None of these questions have been answered."
As an experiment, Dr. Centeno says he purchased the fat dissolving substances from a compounding pharmacy and tried it on a partner and a nurse to see if there were any clinical effects.
"The early result was that it caused a very intense inflammatory reaction and an intense amount of edema and third-space fluid shifting, but no significant abdominal circumferential reduction," he says. "It's supposed to be a no-down-time procedure - but it turned into a couple of weeks of pain. It's not a benign therapy. It's probably doing something, but is it really reducing fat?"
More research needed
LipoDissolve®, was manufactured by Fig before the company closed its doors in December 2007 and filed for bankruptcy.
LipoDissolve involves micro-injection of phosphatidylcholine deoxycholate to permanently dissolve fat. According to Fig, the hardened fat cells break down within a few weeks and are flushed out via excretions, and over the course of the treatment period, the fat cells in the targeted area are permanently eliminated from the body.
Upon first learning of the procedure, Dr. Koenig decided to attend a LipoDissolve training conference in 2004. "I went to figure out if it was worth doing," Dr. Koenig says. "I had it done on myself and explored it with some other people in the practice. It definitely did give modest results, so I incorporated it into my practice."
Going to that first meeting was also an "eye opener" for Dr. Koenig. "They truly look at the world differently from us surgeons," he says. "There is such ignorance about what surgery can do and how to approach problems - people at the meeting were volunteering to have it put in their eyelids, and that really freaked me out. They were willing to try anything. As plastic surgeons, we need evidence that it works and is safe."
In February 2005, ASPS issued a policy statement saying it does not endorse the use of mesotherapy because further research on safety and efficacy is needed. "The seemingly painless approach to body contouring will always be appealing to many, but without scientific evidence to verify mesotherapy's usefulness, practitioners and patients must be aware of the risks of the treatments and the lack of FDA approval of medications used in the injections," the statement reads.