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The Use of Phosphatidylcholine for Correction of Lower Lid Bulging Due to Prominent Fat Pads

Patrícia Guedes Rittes, MD
Clínica Patrícia Rittes, São Paulo, Brazil

Background
Patients with prominent periorbital fat pads often complain of having a persistent "tired" look and seek treatment from their dermatologist.

Objective
A non-surgical treatment of fat pads.

Methods
Thirty patients were treated for prominent lower eylid fat pads with phosphatidylcholine injection. Pre- and posttreatment photographs were taken for long-term analysis.

Results
A marked reduction of the lower eyelid fat pads was noted over the 2-year follow-up period. There were no recurrences.

Conclision
The injection of phosphatidylcholine (250 mg/5ml) into the fat pads is a simple office procedure that may postpone or even substitute for lower eyelid blepharaplasty.

INFRAORBITAL FAT PAD herniation results in a prominence of the lower eyelids, causing patients to have a tired and aged appearance . These deformities consist of skin, subcutaneous fat , orbicular muscle, and suborbicular fat. Orbital fat exerts pressure both on the orbital septum and the orbicular muscle, causing a bulge. What appers to be excess skin is often merely the conversity caused by the fat pads appearing under the skin. The precise mechanism of this herniation is controversial.

This deformity may be managed by surgical resection or reinsertion of the herniated fat into the orbital cavity . (1-4) Continuous suture of the capsular palpebral fascia maintains it in its original anatomic site. Herniation of the infraorbital fat pad entity must be distinguished from periorbital edema due to medical problems (such as angioneurotic edema or fluid imbalance).

Phosphatidylcholine has been shown to reduce the systemic levels of cholesterol and triglycerides . Bobkova et al. (7) showed that upon increasing phosphatidylcholine, the cell membranes improved their receptor properies, augmented their sensitivity to insulin, and accelerated lipolysis. Phosphatidylcholine has also been employed intravenously in patients with cardiac ischemia. (8) A marked reduction of atheromatous plaques withour a reduction in plasma cholesterol occurs. Phosphatidylcholine is a bile component and is responsible for the lipids’ emulsification from the diet. (9) This article describes the use of phosphatidylcholine injection into the infraorbital fat to reduce the size of infraorbital fat pads.

Materials and Methods
This study conformed to guidelines of th 1975 Declaration of Helsink . An informed consent was obtained from all individuals. Preoperative evaluation included examining the size and location of the fat pads. Baseline photographs were obtained. Patients were also examined for any coexisting ocular pathology. The procedure was performed in an outpatient setting with the patient seated. The skin of the lower lid was pulled downward with the forefinger. Gentle pressure was applied over the globe for better visualization of the fat pad. Using a 0.5 inch, 30-gauge needle, 0.4 ml of phosphatidylcholine (250 mg/5 ml) was injected into the infraorbital fat pad. The medication was distributed among the there bulging periorbital fat pads (central, medial, and lateral) based on the individual patient’s need.

Anesthetics were not utilized in this study.

Thirty patients with varying degrees of bulging fat pads were included in the study. The patient population included 22 women and 8 men, with ages ranging from 30 to 70 years.

Injections were given at 15-day intervals to allow for complete resolution of infraorbital swelling. Two patients received a total of four aplications, 5 patients a total of three applications, 12 patients a total of two applications, and 11 patients a total of one application. The number of additional injections administered was determined by the clinical response at the end of the 15-day period as observed by the physician and patient.

Results

Cosmetic improvement occurred in all patients. Pre-and postprocedure photographs were utilized to document the changes (Figures 1 and 2). All patients complained of mild burning following the injections, which typically lasted about 15 minutes. Immediately following the injections, infiltrative edema and local erythema were noted. Edema of the entire lower lid was noted over the initial 6 hours and persisted for approximately 72 hours.

RITTES: FHOSPHATIDYLCHOLINE FOR LOWER LID BULGE

Figure 1. A 71-year-old patient with prominent fat pads. B) Postprocedure view after three injections of phosphatidylcholine.

Figure 2. A 55-year-old patient with prominent fat pads. B) Postprocedure view after for injections of phosphatidylcholine.

Discussion
This study offers a nonsurgical alternative for improving "old-looking" eyes by reducing the prominence of bulging infraorbital fat pads through phosphatidylcholine injection. Up until now, all options for treating this entity have been surgically based. Proper patient selection is essential, as this method only treats infraorbital fat . Prominent infraorbital fat pads must be distinguished from other periocular conditions, including prominent malar folds and lax lower eyelid skin. (10)

Because phosphatidylcholine injection does not create scar tissue, ectropion is not a risk. In our experience, the postoperative results offered by phosphatidylcholine injection were as natural in appearance as those obtained from surgical procedures. Postoperative discomfort was also relative to surgery. In addition, no recurrences of protruding infraorbital fat pads were noted.

The cosmetic results observed in this study were satisfactory from both the patients’ and the dermatologists’ point of view. Patient selection is essencial for optimal results. This study provides a simple, nonsurgical office-based procedure for treating prominent infraorbital fat pads.

Acknowledgment I wish to thank Marcelo Gandelman, MD for his help in editing this article and to A.S. Noel MD, French dermatologist and pionner in the surgical excision of fat pads.

Presented at the 54th Brazilian Dermatology Congress, Belo Horizonte, Brazil, September 1999.

  1. Parsa FD, Miyashiro MJ, Elahi E, Mirzai TM. Lower eyelid hernia repair for palpebral bags: a comparative study. Plast Reconstr Surg 1998;102:7.
  2. Sachs ME, Bosnick SL. Correction of true periorbital fat herniation in cosmetic lower lid blepharoplaty. Aesthetic Plast Surg 1986;10:111.
  3. Loeb R. Fat pad sliding and fat grafting for livelimp lid depression. Clin Plast Surg 1981;8:757.
  4. Hamra ST. The role of orbital fat preservation in facial aesthetic surgery: a new concept. Clin Plast Surg 1996;23:17.
  5. Warembourg H, Jaillard J. Experimentation clinique du lipostabil dans le traitement des angiopathies diabetiques. Lille Med 1968; XIII (suppl):721-3.
  6. N avder KP, Baraona E, Lieber C. Polyenyphosphatidylcholine decreases alcoholic hyperlipemia without affecting the alcoholinduced rise of HDL cholesterol. Life Sei 1997;61:1907.
  7. Bobkova VI, Lokchina LI, Korsunsk BH, Tamamova GV. Metabolic effect of lipostabiforte. Kardiologia 1989;29:57.
  8. Pogozheva AV, Bobkova SN, Samsonov , MA, Vasilév. AV. Comparative evaluation of hypolipidemic effects of omega-3 polyunsaturated acids and lipostabil. Vopr Pitan 1996;4:31.
  9. Montgomery R, Conway T. Bioquímica, 5th ed. 1994:249.
  10. Farrior RT, Kassir RR. Management of malar folds in blepharoplasty. Laringoscope 1998;108:1659-63.

P. G. Rittes, MD has indicated no significant interest with commercial supportes.
Address correspondence and reprint requests to: Patricia Guedes Rittes, MD, Rua José do Patrocínio, 92 Aclimação, São Paulo SP – Brazil, CEP 04108-13.

2001 by the American Society for Dermatologic Surgery, Inc. – Published by Blackwell Science, Inc.

Make your cells young again to combat atherosclerosis, improve circulation, and even reverse aging

Angioplasty and coronary bypass are two of the most common surgeries performed today.

But despite the procedures' widespread use, how successful are they really? Research tells us that up to half of all angioplasty patients experience restenosis (another blockage of the same artery) within six months of the procedure. And up to 20 percent of bypass patients see their grafts close up again within a year of surgery.

According to a doctor in Switzerland, there is a better way. In fact, he says this non-invasive, organic protocol for clearing plaque from arteries has been around for decades -but got lost in the black hole of the pharmaceutical industry.

And he says this approach isn't just for heart patients-it can improve circulation in diabetics, boost male sexual performance, and even reverse the ravages of aging.

How EPLs control your overall health

The cell is the most basic unit of human life. Every organ, every bone, every bit of skin in your body is composed of cells. But if we zoom in on an individual cell, we see that it's a complex organism in its own right.

Each cell is covered in several layers of membrane. The cell membrane is made up of different kinds of phospholipids, a type of lipid molecule that contains one or more phosphate groups. There are two major types of phospholipids: phosphatidylcholine (PC), which is derived from glycerol, and sphingomylin (SM), which is derived from sphinosine. Both play critical roles in cell membrane function-and they're so important that some doctors and scientists have begun referring to PC and SM as "essential phospholipids," or "EPLs."

Phospholipids activate the enzymes that trigger protein receptors on the cell membrane to receive neurotransmitters, hormones, peptides, antigens, antibodies, and other biological messengers. They also regulate many different metabolic processes in the cell membrane, and influence the synthesis of prostaglandins from essential fatty acids.

In short, without a properly functioning phospholipids structure, your cells are in trouble. And while nearly all of us have a ready supply of high-functioning phospholipids when we are young, things can start to unravel as we age.

End the relentless assault that aging wages on your cells --and your heart

Of the two main kinds of EPLs, PC generally outnumbers SM in cell membranes as much as nine to one, although this ratio varies depending on the function of a specific cell. But as we age, a number of factors conspire to impede the body's own synthesis of PC. Years of exposure to free radicals, disease, allergens, and environmental pollutants can upset the delicate balance. Furthermore, the body's natural production of PC slows over time. The result is an inadequate supply of PC-and consequently, defective cell membranes.

When cell membranes aren't functioning properly, all sorts of things can go wrong. Nourishment can't get in effectively, and wastes can't get out. Enzyme function is disturbed. Receptors can't function properly, causing all sorts of imbalances. All of these problems contribute to a destructive cycle-each ultimately weakens cell membrane stability even more.

How does all this relate to the heart? These effects manifest themselves most vividly there, because the heart gets attacked inside and out. When phospholipids in the cell membrane become unbalanced, cholesterol synthesis is disrupted, causing an increase in circulating LDL, or the so-called "bad cholesterol." At the same time, the phospholipid imbalance impedes the function of heart muscle cells, making it harder and harder for the heart to pump blood through those ever-narrowing arteries. Both factors together contribute to atherosclerosis, a common-and potentially deadly-problem in older adults.

Doctors have known about the critical relationship between phospholipids and cell membrane function for decades. So the next logical step was to see if they could replenish the body's dwindling supply of PC somehow and reverse the destructive cycle.

Decades-old research proves you can turn back the hands of time

The research actually began back in the 1960s and 70s in Russia and Germany. Scientists discovered that soy lecithin-a byproduct created during the processing of soybeans into soybean oil-is a phyto-phosphatidylcholine, with the same molecular structure as human PC. They experimented with injecting the soy lecithin solution into animals with elevated cholesterol levels and assessing the results. Although most of those early studies weren't translated into English, the extent of work done and indexed in MEDLINE, an internet search engine specifically for medical studies, suggests that this was a promising line of research. (One study was even supported by a grant from the British Heart Foundation and the U.S. National Institutes of Health.)

Abstracts of several more recent studies support the hypothesis. One Russian study shows that an intravenous injection of soybean PC into rabbits with atherosclerosis effectively lowered cholesterol levels in red cell and platelet membranes, improved membrane permeability and reduced platelet aggregation. It also increased ATP activity in the cells, the nucleotide that serves as an energy source for many metabolic processes and is required for RNA synthesis.

Another Russian study compared the effects of EPL versus niacin on cholesterol levels in 100 patients with ischemic heart disease. After six months of treatment by injection, the scientists found that EPL was as effective as niacin in reducing total cholesterol, LDL, and triglyceride levels. Both approaches also reduced the intensity and number of angina attacks per week, but only the EPL patients demonstrated an increase in exertion capacity in a cycling test.

Treatment relieves angina and eliminates the need for medication

The early research led to the development of a product called Lipostabil, which was approved and marketed in Germany and, eventually, in 53 other countries. But over the next few decades, the product virtually disappeared. No one is quite sure why, but problems with the manufacturer and lack of funds may have had something to do with it. Research into phospholipids and their role in cell membrane health dried up for about 10 years. (In the meantime, angioplasty and bypass surgeries took off as the mainstream solution of choice.)

That is, until Dr. Sam Baxas at Baxamed Medical Center in Binningen, Switzerland resurrected it. Dr. Baxas had some experience with Lipostabil earlier in his career, but when he inquired about it again he found it was no longer available. After re-reading the EPL research from years ago, he was convinced of its viability and determined to make an EPL product available to his patients. He found a pharmaceutical company in Germany to re-create the Lipostabil formula and began using it with a small group of six patients. According to Dr. Baxas, the results in these patients were nothing short of amazing.

Two had already undergone bypass surgery; a third patient had gone through two angioplasties and still suffered with angina; and a fourth had a Thallium stress test indicating serious blood flow problems in his heart. The last two patients had serious circulation problems threatening their legs and feet.

All six received intravenous infusions of Dr. Baxas' EPL solution several times a week for several weeks for a total of 40 treatments. And according to Dr. Baxas, at the conclusion of the study all the participants were completely free of symptoms and no longer dependent on medication. The heart patients no longer had angina pain, and a follow up Thallium test showed no perfusion problems. In the patients with circulation problems, skin color, temperature and pulse rate were normalized, and pain while walking disappeared.

Not just for the heart- makes cells throughout your entire body young again

Since then, Dr. Baxas has used his treatment on many patients and seen remarkable results in relieving angina and improving circulation to the extremities. In 2001, he began making his EPL protocol available to doctors around the world. And as more and more people began to use it, he noticed some interesting things.

The heart and the circulatory system weren't the only parts of the body that benefited from EPL infusions. Sure, improved heart function and improved circulation yield wide ranging benefits in the body. But that couldn't completely explain the results Dr. Baxas was noticing. Patients who underwent EPL infusions looked and felt younger. They had more energy. They were healthier. They even reported an increase in libido, and men reported an improvement in sexual performance.

After some thought, Dr. Baxas decided that it all made sense. Phospholipids are present in the membranes of all cells, not just heart cells and blood cells. And all cells experience an imbalance of PC and SM as the body ages. Providing additional PC to the body was bound to improve the cell health of cells throughout the body, making them function again as they had in younger years.

Drug companies create obstacles for alternative approach...again

Dr. Baxas is determined not to let the EPL protocol slip into obscurity again. But he's also experiencing how difficult it can be to champion an alternative approach. Since 1995, he's called his product Plaquex. But just recently, a major pharmaceutical company launched a trademark dispute on the name, over a new drug they are introducing. So Dr. Baxas was forced to change the name of his product to X-Plaque.

Doctors across the country and around the world are beginning to offer X-Plaque treatments for their patients with atherosclerosis, circulation problems, and aging concerns. Since it is administered in intravenous infusions, X-Plaque is only available to doctors.

Contributing Editor: Health Sciences Institute, 6/1/2003 Members Alert

Lipostabil - www.dermadoctor.com
People in the know are talking about the latest (alleged) miracle fat buster gaining popularity, and it’s called Lipostabil. Plug the word Lipostabil into any internet search engine and you’ll net hundreds of hits that match what is being touted as the injectable answer to liposuction. Then it hits you; nearly all of them are penned in a language other than English and originate outside of the United States. Why?

While those seeking a sleeker waistline, less of a double chin, or an end to saddlebags may be chatting up the promise of this fat dissolving elixir, the Food and Drug Administration hasn’t made a peep. In fact, they have yet to receive an application from the maker, Aventis, the gigantic French pharmaceutical company, for approval in the United States.

It is not that the drug itself hasn’t been approved overseas. Lipostabil is phosphatidylcholine, a liquid form of lecithin, an enzyme which occurs naturally in the body. It was first used in the 1950s to dial down climbing cholesterol and triglyceride numbers and is approved for use, according to the manufacturer, in Brazil, Germany, Italy and South America.

It took Brazilian dermatologist, Patricia Rittes, widely credited with pioneering the treatment often called Lipo-Dissolve, to reincarnate the drug as a pathway to physical perfection. After experimental use as an injectable fat-dissolver by doctors overseas such as Rittes, it started to make its way stateside. Thanks to some anecdotal evidence and off label usage, a few doctors in the United States are now injecting surgery-shy but eager patients in order to send their eye bags packing, whittle pudgy upper arms and reduce other areas often too small to treat with liposuction. You may remember that wrinkle busting Retin-A was only FDA approved as an acne treatment for years before it could claim its wrinkle reducing charms. However, doctors were prescribing it to their creased and lined, albeit unblemished, patients for years before it got the FDA stamp of approval. The same is true for Botox. Doctors found it helped reduce the appearance of wrinkles and used it for that off label purpose before it got the FDA go-ahead to claim it could tame wrinkles. But, Retin-A and Botox were FDA approved drugs. Lipostabil is not approved for any use in the United States. Aventis notes that they did not develop the drug for the popular use it’s currently gaining across the globe.

So, how does Lipostabil work? Depending on the area and the desired results, a patient gets injected with the drug at the trouble site or sites spaced over the course of several weeks. A topical anesthetic is used at the injection site. One may experience some side effects like mild swelling and bruising or itching at the injection site. Then the patient waits a couple of weeks and goes back in for another round of shots. After the treatments are over and the swelling subsides, one should find a new, fat free area in its wake thanks to the fat dissolving properties of the drug. Because no official protocols have been established, how many shots you need depends upon what your doctor advises. How much of the drug to use has been determined by trial and error.

You only need a couple of shots to get rid of that stubborn slab of abdominal flab? Sounds fuss free, and it is... sort of. The snag is that we don’t know more than we do know about this treatment. Random calls to dermatologists and other doctors didn’t net a single one who is currently using the drug, although several dermatologists and other doctors have gone on record in the media that they’re performing the treatment. What’s more, testing of the procedure has been limited to just one 30 person (non-peer reviewed, without a control group) study performed in Brazil testing how the drug worked on the small amounts of fat that make up under-eye bags. Photos from the study do show an improvement, but the results have not been duplicated nor scrutinized in other studies.

The American Society for Aesthetic Plastic Surgery has gone so far as to issue a statement questioning the use of Lipostabil adding the only proven method to permanently remove fat deposits is liposuction. The ASAPS also questions how practitioners will evaluate how much fat is to be removed and raises the issues of whether the drug dissolves other tissue as well, how the body will react to the introduction of an increase in a naturally occurring substance and the potential unknown side effects.

For some, the unknown may be offset by what we do know and the promise of dissolving fat. Anecdotal evidence shows it can ditch an inch or more of fat off your waist, arms or thighs and flatten under eye bags or the chin "wattle." Lipostabil injections may also help with the curse of cellulite, the puckering orange-peel skin that plagues 9 out of 10 women. Some doctors are injecting the drug to dissolve this stubborn fat that often shows up on the back of thighs and the buttocks.

How much will the procedure cost you? Figure on $1,000 to $1,500 per session depending on the part of the body being treated (e.g.- the stomach will cost more than the arms). Also, don’t forget you’ll need several, as many as ten, sessions to get the desired results. Don´t expect to just lay out cash for a new physique. Lipostabil is best used for small areas, whereas liposuction can treat larger areas and remove more fat.

Karmen B. Saran
Contributing writer to DERMAdoctor.com.

(Any topic discussed in this article is not intended as medical advice. If you have a medical concern, please check with your doctor.)

http://www.dermadoctor.com
Copyright 2000-2003 DERMAdoctor.com, Inc., All rights reserved.

Watch the Pounds Melt Away!

From the October 07, 2002 issue of New York Magazine.

By Beth Landman Keil
Just when we’d gotten used to the idea of Botox (well, sort of), along comes a new trendy injectable. Beauty junkies and their doctors are buzzing about Lipostabil, a liquid form of lecithin that’s shot directly into fat tissue, melting it as if it were on an internal George Foreman grill. “We started using it under the eyes,” explains Dr. Soren White, medical director at Skinclinic, the Upper East Side “medispa.” “Now we use it for hips and love handles.

“Lipo dissolve, as dermatologist Steven Victor calls it, is meant for areas too small for liposuction. Only topical anesthesia is required, and bruising lasts just a few days. It’s not yet approved by the FDA, upping the frisson factor, but Victor says that “in Europe and South America, they’ve been injecting it into the arteries for fifteen years.” “The result may be subtle,” says one woman, “but it’s a huge difference to me. In just two sessions, it tightened up my jawline.

Some doctors are holding off (We want more data,” says Alan Matarasso, a plastic surgeon) despite the cash-cow appeal: Three to five sessions are recommended, at about $1,000 each for upper arms and $1,500 each for the abdomen. “With lipo, you remove fat cells permanently,” says Howard Sobel, a dermatologist. “With these shots, we don’t know if it will come back.” Adds dermatologist Pat Wexler, “You’re not talking about getting rid of a huge stomach, and it’s a lot of money. But if you have it, flaunt it

Next-Gen Liposuction "Resculpt your body for the price of a good meal"
FROM THE DEC. 16, 2002 ISSUE OF TIME MAGAZINE; POSTED SUNDAY, DEC. 8, 2002

By MICHIKO TOYAMA/Tokyo
Posted Sunday, Dec. 8, 2002; 2.02 p.m. GMT
To São Paulo beauty therapist Debora Ferreira, it sounded like a miracle cure. The way her dermatologist, Patricia Rittes, explained it, Ferreira would be able to get rid of the excess fat on her thighs without exercise or surgery — and for just $85, a fraction of the cost of liposuction. It would take just three or four sessions of injections, a fortnight apart. Ferreira, 28, signed up in Nov. 2000; two years on, she's still delighted with the results. "I never looked good in pants before," she says, "but I do now, and my jeans are an inch tighter!"

Rittes' "miracle cure" might be called the Lipo of 2003, a year that may witness the first human face transplant and, continuing the timeless quest for the perfect human, the birth of the first cloned baby. In 1995, Rittes figured a way to melt away fat by injecting patients with Lipostabil, a drug normally used to lower triglyceride and cholesterol levels. According to Rittes, it contains an enzyme called phosphatidylcholine that dissolves the fat surrounding blood vessels. She claims to have "treated" 1,300 patients and trained doctors from around the world — including the U.S., where Lipostabil has not yet received FDA approval.

As with liposuction, many doctors warn against the procedure. "There isn't enough scientific and clinical data to substantiate the safety or even the effectiveness of Lipostabil as a fat-dissolving treatment," warns Vernon Leroy Young, a spokesman for the American Society of Aesthetic Plastic Surgery. Others swear by it. "We've seen people lose fat around thighs, knees ... I did my love handles and they're gone," says New York cosmetic dermatologist Steven Victor. For plus-size people, those are magic words.

Burn Fat Away With An Injection?
BOSTON, Nov. 30, 2002

(CBS)  A recent trip to the Carribean convinced 30-year-old Misty Koons that she needed to slim down her waistline.
"I was in my two-piece and every time I'd sit down, there was a bulge that was hanging over the bottom of my bikini," says Koons. "It bothered me. I kept looking at it and became obsessed with it."
That obsession led her to New York dermatologist Dr. Soren White. He suggested Koons try Lipostabil, an injectionable form of the nutritional supplement Lecithin. The substance is widely used in Europe and South America where doctors say it may literally melt fat away.
Dr. Mallika Marshall from WBZ-TV in Boston gave The Saturday Early Show the skinny on the new technique, which might one day replace the more invasive liposuction treatment. Liposuction is the most common type of cosmetic surgery performed on women and it's number two for men.
"Most of my colleagues — primarily in South America and Europe — find or believe that it accelerates lypolysis, which is the breakdown of fat," says Dr. White.
Most women in Koons's position would have turned to liposuction. While it's an invasive surgery, doctors say tremendous advances in the past decade have made it much safer and more effective. Unlike Lipostabil there is the ability to contour or shape the area where fat is being removed.
But with Lipostabil, the situation is quite different. "You are injecting a substance and it's going to go where it wants. You may be breaking up areas unevenly and then what do you do?" says dermatologist Dr. Howard Sobel.
Despite it's unproven track record in the United States, Koons insists Lipostabil worked for her.
Dr. Marshall explains on The Saturday Early Show that doctors typically recommend between three and five sessions. Those sessions can run anywhere from $1,000 to $1,500, depending on the part of your body that gets the injections. The stomach is more expensive than the arms. She says that really begins to add up and can in fact end up being more expensive than liposuction. But the idea of liposuction scares some people, which is why they may choose the Lipostabil option.
Lipostabil does not have approval from the Food And Drug Administration. It is made up of the nutritional supplement Lecithin, which traditionally doesn't fall under the FDA's jurisdiction. Dr. Marshall says it will take new studies with proper supervision to see whether the results of the Lipostabil injections are effective and safe.

MMII, CBS Worldwide Inc. All Rights Reserved.

Fat-dissolving injections offer a scalpel-free alternative
MMII, CBS Worldwide Inc. All Rights Reserved.

Hachette Filipacchi Media U.S., Inc.

For those who prefer to fine-tune their figure in a doctor’s office rather than at the gym, new fat-dissolving injections offer a scalpel-free alternative. But are they safe? Aida Leisenring investigates whether these methods are worth a shot

What’s injected, is illicit, and can cause bruising and weight loss? Unlike the infamous narcotic that first comes to mind, mesotherapy solution and Lipostabil won’t land you in jail. While these two fat-targeting injectables are unapproved by the FDA, their use has become a hotly debated topic among doctors seeking a nonsurgical alternative to liposuction. Rampant success stories—one waistless ballerina claims she developed curves in 24 hours; models have been getting “fixed” before swimsuit shoots—are turning ordinary people into junkies. Both techniques originated in Europe and work the same way: Doctors inject “fat dissolving” blends into the subcutaneous layer of skin, which over a series of sessions allegedly cause fat cells to shrink. The difference between mesotherapy and Lipostabil is largely what doctors put in that 4mm syringe.

Inside Information
Mesotherapists create a cocktail of up to seven ingredients tailored to each patient’s goal (cellulite reduction, weight loss, or body sculpting). Components usually include lidocaine, an anesthetic; various vitamins that are said to help to tone;  and isoproterenol, a beta blocker that supposedly inhibits the fat-building receptors of cells. All are FDA-approved for other uses, but none is approved for use as a fat-reducing injection. Lipostabil—also known as lipo-dissolve—contains soy lecithin (the same antioxidant found in much lower dosages in multivitamins), which is used in Germany and Italy to treat clogged arteries via injection. Unlike mesotherapy’s ingredients, injectable soy lecithin is not approved for any use in the U.S., so doctors get their stash overseas.

The Promise
“I have a patient who lost 13 inches from her waist in 20 sessions,” says osteopathic physician Lionel Bissoon, a mesotherapist who practices in L.A., New York City, and Palm Beach. There are enough similar anecdotes to keep the roughly 20 U.S. mesotherapy doctors—only physicians can perform mesotherapy—double booked (New Jersey­based osteopathic physician Marion Shapiro treats 150 clients a week). The treatment isn’t painless, though: To ensure that weight loss is evenly distributed, mesotherapists administer multiple injections, one inch apart. The overweight may require thousands of shots over as many as 30 weekly treatments, but Shapiro reports that 20 percent of her patients find that their pants are looser after one visit of roughly 70 shots. “In general, patients drop one size after four sessions,” she says. But some doctors believe it’s mesotherapy’s requisite diet and exercise plan that makes the difference. “If you refuse to diet and exercise, I won’t treat you,” Bissoon says.

While mesotherapy has been touted as an option for treating obesity and sculpting the body, Lipostabil targets only small amounts of fat, like patches of cellulite, love handles, and fat under the eyes and chin. Manhattan-based plastic surgeon Thomas Loeb, MD, who has been administering Lipostabil shots for one year, says he smooths cellulite lumps with extreme caution: “I use a diluted formula because I still don’t know the nature of lecithin. What if it shrinks other types of cells?” New York City dermatologist Howard Sobel, MD, won’t administer Lipostabil: “What if you get Lipostabil in your thigh, then you stand up and it gravitates downward, affecting other fat cells and creating an indentation?”

Dangerous Cuves
Considering that mesotherapy has been around for more than 50 years and Lipostabil for nearly five, there’s a surprising lack of data backing either: No independent, controlled studies or published, peer-reviewed articles exist in the U.S. to prove their effectiveness (mesotherapy research has been published in France). Even Loeb, who uses Lipostabil, admits, “Liposuction is by far a better method for very obess patients.”

Lose Those Love Handles

A CBS HealthWatch Special Report
Nov 25, 2002 10:38 pm US/Eastern
NEW YORK (CBS) I don't think any exercise will get rid of these love handles,” says 30-year-old Misty Koons.
But would she be willing to jab the flab?
“I want a quick fix,” replies Misty.
So Koons, a consultant from New Jersey, who says she isn't comfortable with the way she looks chose the latest way to a svelte waistline. CBS 2’s Dr. Mike Rosen has the story.
It's called lipostabil, no, it's not liposuction. It's a cosmetic technique just being introduced in this country, that's been popular in Europe and South America for years.
Lipostabil claims to break down fat deposits with 5-10 injections over 2-3 weeks. But what's in those needles?
“It's basically a molecule that emulsifies fat, it's in everbody's body, it's a natural substance,” says Dr. Soren White.
New York dermatologist Soren White has treated 40 men and women in the last 6 months with lipostabil, “It works on fat deposits resistant to diet or exercise - love handles, abdomen, knees, chins, under the eyes. It's a great thing, works well, easy to do and there are no side effects.”
The cost of each procedure can run anywhere from $350 to $1,000 depending on which part of the body you treat.
“It was easy, painless, pinched in a few places,” adds Misty.
“It's not dramatic on the outside, but for her the way she feels in her clothes will be different,” adds Dr. White.
Just two weeks later, after some minor bruising and swelling, Misty sees results, “As you can see, I can't pinch anymore. I feel like vast improvement.”
But Park Avenue plastic surgeon, Alan Matarasso warns that lipostabil is not FDA approved and still needs to be evaluated.
“We need to know the proper dosage, side effects, how many treatments. No one can tell us now how much drug to use or the long term consequences,” says Dr. Matarasso.
"There was a study published from a dermatologist in Brazil on bulges under the eyes and there were impressive results, no recurrences and no surgery,” responds White.
But Dr. Matarasso contends that liposuction is still the safest, most effective treatment for the permanent reduction of fat, although it may not be for everyone.
“I am more comfortable with lipostabil than with having anesthesia and surgery,” says Michelyn Camen, a 40 something marketing executive who wants lipostabil to melt away her "bra bulges."
“I trained to get rid of this area, and it's resistant, so when I heard about this, I made the call,” says Michelyn.
Meanwhile, Misty is back for treatment number two, “I love it, I worked out, everything is fine. I would rave about it to everyone.”

Interested in contacting Dr. Soren White? Here's how:

Skin Klinic
800 B 5th Avenue
New York, NY 10021
Tel: 212-521-3100
Fax: 212-521-3190
E-mail: info@skinklinic.com
(MMI Viacom Internet Services Inc. All Rights Reserved.)

What Is Mesotherapy?

Story Highlights
A growing number of people are deciding to have doctors inject them with a cocktail of drugs, vitamins and supplements in hopes of reshaping their bodies.
It's a procedure called mesotherapy, and it involves undergoing hundreds of injections, once a week, for several weeks. The drugs are injected into the mesodermal — or middle — layer of the skin.
The technique was pioneered in France by Dr. Michel Pistor, and has been performed there since 1952. But it's just begun to attract practitioners and clients in the United States in the past few years.
Dr. Lionel Bissoon, who learned the technique in France five years ago, has become America's leading expert and advocate of mesotherapy.
Bissoon says mesotherapy — over the course of 10 sessions — blocks our ability to store fat and stimulates our ability to burn it up. He says a physician can target specific areas of fat by injecting a blend of medications commonly used for asthma and high blood pressure along with vitamins and supplements directly into a specific area of the body.
A single session can cost as much as $500, so a full course of treatment is a substantial investment. But it seems to be catching on. Bissoon, who has practices in New York, Florida and California, says his clients range from celebrities and CEOs to secretaries.
Bissoon claims the fat winds up in the muscle, where it's used for energy. It does sound too good to be true, especially since Bissoon says he refuses to take patients who won't exercise or follow a healthy diet.
But his patients seem to be happy with the results. Bissoon's most famous client is Roberta Flack. The superstar crooner had a long battle with weight and thought that her extra pounds were indeed killing her softly.
"When you're young and you're overweight, it's just there. After you pass a certain point in your life, well, gravity takes over. And you have a fat stomach that has rolls on top of rolls on top of rolls. And you can't breathe with that," Flack said.
Since starting mesotherapy last year — along with exercise and changing her diet — Flack has lost more than 40 pounds.
Two Patients’ Progress
20/20 followed two of Bissoon's patients for weeks to see how mesotherapy worked for them.
One patient, Josselyne Herman-Saccio, is a 35-year-old mother of two who has a full-time job. She looks fit now, but, she says she used to look much better before she had kids. Now, she says, she can't find time to work out. To see the effect of the mesotherapy alone, 20/20 asked Herman-Saccio not to exercise or change her diet.
The other patient 20/20 followed is Katie Noonan-Ewald, a 32-year-old business executive. Noonan-Ewald says she exercises regularly, but had hit a plateau and was unable to get the results she wanted. Every week she flies from her home in Detroit to New York, where she gets her mesotherapy injections.
After six weeks, we checked in with Herman-Saccio — who changed neither her eating nor her exercise habits. She was very happy with the results.
"I've lost over four and a half inches in my waist," she said, "three or four inches in my hips … I'm wearing clothes that I haven't worn in four years."
Noonan-Ewald's results were even more dramatic. We visited her after she had undergone 12 weeks of mesotherapy. She had lost 14 inches from her waist, and another 12 inches from her hips, legs, and saddlebag area, according to Bissoon's records.

Is It Safe?
While Bissoon's patients are thrilled with the results of their therapy, some physicians have voiced some serious concerns about the procedure.
Dr. Lisa Donofrio, a dermatologist who teaches at Yale University and practices cosmetic surgery with a specialty in liposuction, has been monitoring reports about mesotherapy and says she worries about its possible long-term effects.
"The problem with mesotherapy," she said, "is that it's a cocktail. The ingredients change on a whim all the time."
While Bissoon says all of the drugs he injects have been approved by the Food and Drug Administration, 20/20 discovered one that hasn't been.
In fact, that ingredient, phosphatidylcholine, is usually consumed as a dietary supplement, has just been banned by Brazil's equivalent of the FDA for cosmetic purposes in injectable form. That agency lists the known risks of phosphatidylcholine as including nausea, diarrhea, depression and arrhythmias.
Even the FDA-approved drugs that Bissoon uses haven't been approved for these sorts of cocktail injections. But Bissoon doesn't seem troubled by this. "The biggest complication I see with mesotherapy," he said, "is black and blue marks."
However, Donofrio says she's aware of reports of toxic reactions "where pieces of skin will die and slough off." A report from Belgium, for example, cited several examples of serious skin infections.
Bissoon said that those infections happened because the doctors were sloppy. "We use gloves, we use sterile needles. … Using the proper technique you should not really have that worry," he said.
20/20's investigation found no reports of bad infections in American patients.

Where Does the Fat Go?
The drug cocktail actually does seem to break down fat, as Bissoon claims.
Professor Susan Fried, an obesity expert at the Baltimore VA Medical Center, tested Bissoon's concoction on human fat cells. "The rate of fat breakdown actually increased about two to three times," Fried said.
However, Fried cautions that the fat being released may go places you don't want it to. "The question is, what happens to those fatty acids? Could they end up in another tissue? Could they end up in your artery? That's a real concern."
Bissoon said the fat should go into your bloodstream because that's how stuff is going to get excreted. "But as far as getting a large component of fat in the blood vessels," Bissoon said, "I don't think that's possible to happen because it's a very slow process."
Several other medical experts 20/20 consulted said they were skeptical about mesotherapy's claims, or they hadn't heard of it. They expressed concern about the minimal research behind the therapy.
Fried was concerned about the release of the fatty acids. She said if they are released from the fat cells, they're going to go to other tissues.
"Those tissues could possibly use them to deposit fat within them where they could cause damage to the tissues, and increase our risk of diabetes and cardiovascular disease," she said. "Just because the fat is released does not mean that it's burned. If that fat is moved from the thigh to your heart or to your liver, it can actually cause diabetes."
But Flack says she's not worried. "I do other things to protect myself," the singer said. "I see a nutritionist weekly, and I have myself checked all the time."
Still, Donofrio says she's concerned. "I think that people need to be cautious. This is their body. You get one."
But Bissoon is confident that the therapy is effective and safe. And so, this latest way to zap fat looks likely to continue. And that thrills Bissoon's patient Noonan-Ewald, who says she plans to keep up the mesotherapy and keep melting away her unwanted fat.
Lipostabil is the ® trademark of Nattermann & Cie [GmbH] and Aventis Pharma.



Injections Dissolve Fat Away
October 9, 2003, Las Vegas
Beth Fisher reporting

We're all looking for a miracle to get rid of fat. We try diets. We MIGHT exercise. And in desperate cases, we try lipo-suction. Now a Las Vegas doctor says he has a better solution: lipo-dissolve. Instead of going under the knife, you go under the needle. And he says tiny injections help the fat fade away.
Crystle hates the way one side of her back seems fatter than the other does. "On my left side, there is no fat sagging. On my right side, there is fat sagging. So I need to target one specific area. What better way than to inject it in that specific area?"
After numbing the area with gel, and marking the injection sites, Dr. Ed Hoffman begins a series of shots he says will dissolve a stubborn section of fat.
Dr. Ed Hoffman says he decided to try Lipo-dissolve on himself before giving it to patients. He is a triathalete who eats a healthy diet. But even exercise wouldn't get ride of his love handles. So Dr. Hoffman has been injecting the lipo-dissolve into one side of his body, leaving the other side for a comparison. After a few weeks, he says the difference between the two sides of his body was remarkable.
Dr. Hoffman says, "This is more for specific areas that just don't seem to go away with exercise and diet. For the whole body you need exercise and diet. But for one area like this? Lipo-Dissolve."
Lipo-Dissolve can be used for love handles, hips, thighs, or even smaller areas like under the chin or eyes. He says patients should expect a little bruising or swelling, but the procedure takes just a few minutes and patients can head right back to work. So what's in these shots? Dr. Hoffman says, "It's a natural substance. It is actually in the bowel acid in your stomach and it dissolves fat. They've been using it in Europe in patients with heart disease to dissolve plaque. If it's safe to use intravenously, it's safe enough to inject just under the skin in fat deposits."
Smaller areas usually require one treatment. But larger areas may require 4 or 5. The cost varies from $500 to $2500, but that price includes all of the necessary treatments. It's also important to note this procedure is not yet FDA approved.

New Fat Removal Technique Getting Raves: Is it Safe? Does It Work?

(New York-WABC, February 7, 2003)
— A medical technique that's just catching on in America promises to melt your fat away. It's called mesotherapy, and while some people swear by it many doctors aren't so sure.

Dr. Marion Shapiro: "OK, what I'm doing right now is I'm injecting a combination of medications that melt the fat under the skin."
And believers say it works wonders. In fact, Christine Comba says she's now lost 25 pounds of fat.
Christine Comba, Mesotherapy Patient: "My bra size went down. I was wearing a 14, I'm now wearing a 10 in jeans."
Doctor Marion Shapiro is a former emergency room doctor who now performs this procedure in West Orange, New Jersey. It's known as Mesotherapy. It's for patients who want to lose weight or just sculpt their body. It's called Mesotherapy because it involves the injections of four to seven different compounds into the mesodermal layer of the skin.
Dr. Marion Shapiro, Mesotherapist: "What happens is when you inject the medication beneath the skin, it melts the fat and helps it dissolve and be excreted by the body."
Dr. Shapiro tells us she trained for the procedure in France, where this has been done since 1952. But it has never caught on here in the states. In fact, only a handful of doctors are doing it and some of the most well-known plastic surgeons in the city strongly caution patients about it because no US studies on Mesotherapy even exist.
Dr. Norman Schulman, Lenox Hill Hospital: "Don't do it. Wait till the homework is done. It may turn out to be something OK, but certainly not now."
Stacey Sager, Eyewitness News: "And you wouldn't feel comfortable doing it now?"
Dr. Schulman: "I would not do it now."
But patients continue to rave. They say it's much less invasive than liposuction, and that Mesotherapy works all over the body.
The big question is really whether the fat can come back. Technically, yes, because the fat cells remain intact, so diet and exercise are still key.
But the skeptics continue to wonder, especially about side effects and so-called "off-label use." That is, medications that may be FDA approved, but not together for this purpose together.
Dr. Schulman: "If you do have an adverse affect from off-label use, you're going against the directives of the FDA."
Sager: "So you could be held liable?"
Dr. Schulman: "You absolutely could be."
Dr. Shapiro: "There's been no case reports of ill effects from mesotherapy. And I would assume by this time that we would know, since 1952."
So Doctor Shapiro continues to believe in a treatment her patients love, even though the test of time in this country remains to be seen.

There's a revolutionary new cosmetic procedure on the market that promises no-hassle, 'lunch-time' weight loss! Commonly known by the brand-name Lipo-Dissolve, this 'cutting edge' cosmetic procedure is an injection that dissolves body fat and promises to shift stubborn pockets of fat through a series of injections into the body. But at around L300 per session and with up to six sessions needed, do these injections work and what are the side effects?

What is Lecithin?
The active ingredient of drugs like Lipo-Dissolve is a substance called Lecithin and the actual drug name used for cosmetic treatments is Phosphatidylcholine.

Lecithin is a naturally occurring substance that is produced in the human body and can also be found in foods like soybeans, milk and egg yolks. In the body, lecithin is produced in the gall bladder and is a fatty substance that acts as an emulsifier, helping to keep the blood's cholesterol circulation flow freely. Lecithin has also been shown to reduce cholesterol levels in the body.

When extracted and used in the manufacturing of foods, like chocolate and biscuits, lecithin is used as a thinner or emulsifier and will control, say, the 'flow' properties of chocolate.

Lecithin... The New Botox? In the medical world lecithin has been used in Europe for a long time, on patients with heart conditions and/or blocked arteries and can be injected into a blocked artery to dissolve a fat clot.

Then in the early 1990s a Brazilian doctor took lecithin and began using it for cosmetic reasons, injecting it into patient’s bodies in order to dissolve fat in specific areas.

The exact mode of action of the drug still remains unclear, however published studies have shown that it does work. Although the drug is still not legally licensed in the UK, the use of lecithin is gaining popularity and manufacturers have branded the drug for cosmetic use under such names as Lipo-Dissolve, FatAway and FlabJab.

Although Lecithin is not yet licenced in the UK, it is not illigal to use. For example, Botox, is not licenced either. These drugs are allowed to be used because the law states that any doctor can use any drug for whatever use, as long as the patient is aware of why and how the drug is being used.

The Cosmetic Process.
Lecithin is administered through a series of injections in localised areas of the body, like the abdomen, the hips, the back, the neck or on the face. It's best to deal with one area at a time and for large treatment areas patients will need up to six sessions of injections before their fat has dispersed and these sessions need to be a minimum of fourteen days apart.

Side effects from the injections will include a swelling of the area (which will go down in three to four days), a tingling or burning sensation, redness and some discomfort.

Lecithin injections are prescription-only and should therefore only be administered by a qualified doctor and depending on the size of the treated area, costs will range from around L200 to L350 per session.

Lecithin is not suitable for:
* pregnant or breastfeeding women
* people with kidney, liver or thyroid problems
* people with diabetes

Dr Samantha Gammell
Dr Gammell is a Cosmetic Doctor who runs a private clinic (Wimpole Street) dealing with non-surgical cosmetic procedures, like Botox and lip fillers. She travelled to the States to be trained by the doctor who pioneered the use of lecithin for the beauty industry and is now one of the first doctors in the UK to offer this treatment and since doing so she says she has been "inundated" with calls from women (and a small amount of men) eager to spend money to have their fat dissolved away by injection. She commented, "After an article appeared in the press, I had to take on two extra secretaries to deal with all the calls!".

Dr Gammell says she believes the intense interest in the procedure lies in the fact that it's relatively quick and easy and, unlike liposuction, doesn't leave any scarring or need a huge amount of recovery time. She says: "Lecithin injections are a real 'lunch-time' procedure. There's no anaesthetic involved and so the patient can literally walk-in and walk-out of the surgery in no time at all and with little discomfort. The results also happen quite rapidly and patients are always eager for quick results."

Dr Gammell, is eager to point out that she always makes clear to her patients that their injections of lecithin have to coexist with a lifestyle change and that they still have to keep in check their diet and exercise. She says: "I am about a size ten myself and know that I am like this because I watch what I eat. My patients have to be aware that the injections won't work miracles. They will help with stubborn areas of fat, where dieting hasn't worked."

For more information on Lecithin injections please contact:

Dr Samantha Gammell
The Hadleigh Clinic
08456 44 77 11 (local call rates)
or email sgammell@doctors.org.uk

Clinic locations are : London (Wimpole Street), Hertfordshire and Middlesex.

The British Association of Cosmetic Doctors
0800 328 3613
www.cosmeticdoctors.co.uk


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