Actual publication: Plastic Surgery News Feb. 2008
Allure Magazine November 2007
NY Times, September 20
Hamilton Spectator, August 07, 2007
Wall Street JournalPopular Treatment That Aims
To Melt Fat Draws Scrutiny
By RHONDA L. RUNDLE
June 12, 2007
The rise of cosmetic fat-busting injections, called lipodissolve, is spurring warnings from doctors who are alarmed about the spread of the pricey procedures, which use concoctions that aren't approved by the Food and Drug Administration.
Lipodissolve, sometimes called medical lipolysis, is touted as a nonsurgical alternative to liposuction. It involves a series of tiny shots meant to melt fat deposits in various parts of the body, including bellies and buttocks.
The treatment, which originated in Europe decades ago, has been taking off in the U.S. on the wings of local ad campaigns. A number of medical spas -- which offer aesthetic treatments like Botox -- have begun doing lipodissolve. And specialty centers are popping up, such as a chain called fig., which operates 11 clinics in the U.S. and plans to open more this year. Fig. declined to answer questions about its business.
But as the popularity of the injections has grown, so have complaints. Last month, the American Society for Aesthetic Plastic Surgery warned that the shots are "scientifically unproven, lacking any objective data on safety and efficacy." The surgeons' group, which is sponsoring human tests to evaluate one such treatment, urged the public "to steer clear" until more data come in.
Physicians who offer lipodissolve say the injections can be effective in skilled hands. Diane Duncan, a plastic surgeon in Fort Collins, Colo., cites a 2006 retrospective study that she co-authored in the Aesthetic Surgery Journal, based on data submitted by 75 physicians in 17 countries from 17,376 patients. The study found that roughly 12% of patients expressed disappointment with the aesthetic result. The authors concluded that the treatments have a good safety record; complications included temporary hyperpigmentation, pain and allergic reactions.
Many studies have been done in Europe and Brazil, adds Dr. Duncan, who says the injections account for about 10% of her practice. However, U.S. physicians say those studies don't meet rigorous scientific standards.
One fact isn't in dispute. There are no fat-busting injectables approved by the FDA. Practitioners use different recipes that are prepared by a compounding pharmacy or in a physician's office. Such custom mixes, using ingredients approved for other uses, fall into a regulatory gray area. One combination used by many practitioners is phosphatidylcholine and sodium deoxycholate, or PCDC for short. Phosphatidylcholine is a soybean-derived ingredient in food supplements; sodium deoxycholate is an emulsifier typically derived from cattle bile. Lipodissolve is often described as a form of mesotherapy, which may use different ingredients, including herbs, in its shots.
DETAILS
The components of PCDC, a compound often used in lipodissolve injections:
• Phosphatidylcholine: derived from soybeans; a common ingredient in food supple- ments believed to improve cardiovascular health.
• Sodium deoxycholate: an emulsifier typically derived from cattle bile.
Lipodissolve clinics say their injections are legal because states regulate pharmacy practice, including compounded drugs. Some doctors, however, including Joel Schlessinger, an Omaha dermatologist and president of the American Society of Cosmetic Dermatology and Aesthetic Surgery, have written to the FDA, urging the agency to halt "the practice of unapproved medicine."
Separately, Kythera Biopharmaceuticals Inc. of Woodland Hills, Calif., wrote to the FDA to request enforcement action against businesses that market PCDC for fat reduction. Kythera says it's conducting clinical trials under an investigational new drug application with the FDA of a proprietary drug to reduce fat deposits.
The FDA says that "in virtually all cases," it "regards compounded drugs as unapproved drugs." The agency says it's evaluating lipodissolve, but "we do not discuss pending investigations or enforcement matters."
Clinics typically sell packages of three lipodissolve treatments. Spaced a month apart, the treatments cost $900 to $2,000 for each body part. "We've mostly had people sign up for two areas, but plenty have three or four," says Matt Freeman, owner of Aurora Medical Spa in St. Louis, where he says lipodissolve accounts for 20% of his business.
Aesthetic Medicine Feb/Mar 2007
Medical freedom at the crossroadsOpen letter from the Medical & Scientific Advisory Board, the Board of Representatives, the Board of Trainers of the Lipolysis NETWORK and the Directorial Board of the ISL - International Society of Lipolysis Therapy - on the situation in the UK.
Published in the February issue of Aesthetic Medicine.
What has been happening over the last two years in the UK can be considered from an international standpoint as simply bewildering, a deliberate misinformation campaign, or serious interference in the fundamental freedoms of the medical profession. It depends on the perspective from which the activities of institutions and the media are viewed, as far as injection lipolysis is concerned.
Our British colleagues' attempts to counter denunciation and polemics with scientific facts are particularly to be admired. Many thanks to the entire NETWORK for their courage and support.
We'd like to contribute some important and highly relevant information on this subject:
* Off-label use of a drug is a medically and ethically justifiable form of treatment, common in other fields of medicine, as well as in aesthetic medicine. The use of drugs at the practitioner's discretion and on their responsibility is particularly widespread in the UK, even in paediatric medicine. Practitioners concerned must, however, inform the patient comprehensively and objectively of all the risks involved, including those that are highly unlikely. The practitioner must also be medically and scientifically convinced that the treatment chosen will not do the patient any harm. Our British colleagues' statistics are one of the bases on which this is decided. The Lipolysis Network has a database of a current approximately 60,000 treatments administered by professional medical practitioners applying our protocols and the standards prescribed by our Medical Advisory Board. Our Treatment Failures Research Group has, to date, documented just four cases of improper treatment. Two of them involved injection into scarred tissue with poor blood circulation previously subjected to liposuction. One was a case in which an abscess resulted from lack of sterility and one of excessively deep injection causing temporary side effects. No other such cases are known. All four cases mentioned have nothing to do with the treatment as such but with individual errors made by individual doctors. Due to none of these circumstances can we therefore advise against this treatment.
* From our standpoint it is part of every doctor's duty of care to advise patients of ALL the treatment alternatives for their specific problem or condition. Advising a patient that liposuction is the sole remedy for fat is now, professionally, simply not acceptable. This form of treatment, although in expert hands generally very safe, does involve some serious risks and has been known to cause cases of death, injuries and deformations but is accepted without adverse comment, although treatment with phosphatidylcholine has been subjected to restrictions or even completely forbidden. To our point of view this is not justified. It is justified only by claiming that the producer of Lipostabil N includes the information in their accompanying literature that it is not suitable for subcutaneous administration. Our research has revealed that the producer is obliged to print this warning for legal reasons regardless of its veracity. It does not mean that subcutaneous administration would result in any harm to human health. If the competent authorities in the UK had informed themselves of the legal situation in Germany they would be well aware of this. These justifications might have been used to restrict doctors' independent professional decisions and to ban a form of treatment that we believe is a preferable alternative, and in the better interests of patients, in some cases, to liposuction. In our view the patient should always have the right to decide the form of treatment to be used in their specific case.
* This kind of scientifically untenable intervention on the part of the State is incomprehensible when viewed from an international perspective. However, we do not find the situation in the UK merely perplexing. The actions of the competent authorities have led to most medical practitioners administering this form of treatment having their insurance coverage abruptly and non-negotiably withdrawn by all available UK medical indemnity providers. Following this, our network needed eighteen months to obtain Europe-wide cover for its members. That cover includes our UK members if they adhere to our protocols and have undergone specialised training by our trainers. However, we are now concerned that the authorities may continue to take other unreasonable measures to try to restrict professional independence and try to block this treatment.
* The expert doctors in the Lipolysis Network are dedicated to achieving exact clarity regarding the effects, side effects and possible alternatives to this treatment. Their membership dues are, in part, now being used to fund groundbreaking research at the University of Regensburg, the full results of which will be available in eighteen months time, at the latest. Further studies and research are being undertaken at the following universities: Bochum (lipomas), Cairo (cellulite) and Rome ('buffalo hump' in HIV patients). This research by our members has the goal of further clarifying the potential and the limitations of this new form of treatment. It is already known that toxicity cannot occur, as research on this was required before the drug was authorised for use. Last year, there were a total of twelve publications on injection lipolysis in internationally respected, peer-reviewed, medical journals, two of them by British colleagues. Mr. Ninian Peckitt, FRCS, FFD, RCS, FDS, RCS, a member of our Scientific Advisory Board, has written a book containing his detailed hypothesis on how injection lipolysis works. The longer the British authorities maintain their absolute opposition, the more untenable they are making their position appear internationally. We therefore believe it essential that both the MHRA and the GMC look in detail at all the currently available data and information, in the international medical community, and carry out an informed review of their opinions regarding injection lipolysis as a matter of urgency. We are open for any kind of exchange.
* The type of campaign we have seen, that includes the police searching the practices of professional medical practitioners, in order to intimidate or attemt to incriminate them, is alien to international medical colleagues . Denunciation of disliked colleagues for competitive reasons is encouraged by such actions, despite the denounced having behaved correctly, in our view, both professionally and ethically. Every country naturally has its own laws but whether these police actions comply with current European law, in our view, needs investigation.
* Disregard for European law by UK institutions seems to have been occuring in the case of injection lipolysis. What's all behind that? According to the International Apotheke Hamburg they are permitted under EU law to export any drug approved in any EU country - such as Lipostabil - to any prescription chemist in any other EU country. What it is used for is irrelevant. The MHRA ban on such imports for prescription chemists would therefore seem to be a breach of EU law. The question is to what extent our British colleagues are prepared to put up with such seemingly unreasonable and possibly unlawful restrictions and when they will defend their professional freedoms? If the UK authorities continue to act as they have done so far, then at some point the patience of our British colleagues will surely snap. This is particularly the case here, as fundamental rights are at risk, and the question of whether injection lipolysis is to serve as a precedent for the future restriction of professional liberties must, in our view, be challenged.
* We have heard that UK journalists have been acting to denounce individual doctors. This seems to us a reversion to behaviour long since consigned to uncivilised times of the past. We welcome open discussion - dissident opinions might after all be of value to us - and are not opposed to public polemics. However, if doctors are to be unlaterally 'investigated' by journalists without any specialised knowledge, and then publicly pilloried and defamed, this seems to us to go beyond the boundaries of any ethical behaviour and we can only express our disgust towards it. British society will have to tolerate being asked whether it wishes to surrender its liberties in this way. This seems to us incredible in view of the UK's long democratic traditions. It should, in our view, be prevented - especially in the medical field. Governmental interference seems to us to have no place in the doctor-patient relationship.
We'd like to state our views on the legality of the treatment in the UK.
A doctor may inform the general public of the potential of body shaping or fat reduction, although doctors should fully respect the MHRA's warning that, in their opinion, advertising and promotion of injections to reduce fat is unlawful. During a consultation, a doctor has an ethical duty to inform his or her patients of all available treatment alternatives - including injection lipolysis. This includes those practitioners who offer only cosmetic surgery. The doctor must always inform the patient comprehensively of all possible risks and side effects of all treatments to be considered, so that the patient can come to their own conclusions. Ethical practitioners may not influence those conclusions but must stick to comprehensive information alone. Every doctor has the right to issue a patient a personal prescription for Lipostabil. Every patient has the right to order such a drug, provided it is approved in any EU country, from a prescription chemist in another EU country and to import it. Every doctor has the right, if a patient so requests, to administer this drug to the patient subcutaneously provided the doctor is certain this will not harm the patient and that the drug used is appropriate for the symptoms presented.
Medizinalrat Dr. Franz Hasengschwandtner , Austria
Medical and Scientific Director NETWORK-Lipolysis
Chairman of ISL
Dr. Diane Duncan, USA, Scientific Advisory Board NETWORK-Lipolysis
Bernhard Bieniek, MD, Germany, Medical Advisory Board NETWORK-Lipolysis
Dr. Horst Grübmeyer, Germany, Medical Advisory Board NETWORK-Lipolysis
Claus-Peter Meissner, MD, Germany, Medical Advisory Board NETWORK-Lipolysis
Dr. Patricia Ogilvie, Germany, Medical Advisory Board NETWORK-Lipolysis
Dr. Georg Popp, Germany, Medical Advisory Board NETWORK-Lipolysis
Dr. Eva Wegrostek, Austria, Medical Advisory Board NETWORK-Lipolysis
Dr. Claudia van der Lugt, Netherlands, Medical Advisory Board NETWORK-Lipolysis, Directorial Board ISL
Dr. Lucy Glancey, United Kingdom, Medical Advisory Board NETWORK-Lipolysis
Dr. Patrick Treacy, Ireland, Medical Advisory Board NETWORK-Lipolysis
Dr. Swapan Chowdhury, Australia, National Representative NETWORK-Lipolysis
Dr. Michael Zacharia, Australia, National Representative NETWORK-Lipolysis
Prof. Nor El-Din, Egypt, National Representative NETWORK-Lipolysis
Dr. Marc Nelissen, Belgium, National Representative NETWORK-Lipolysis
Dr. Rodrigo Sierra, Chile, National Representative NETWORK-Lipolysis
Dr. Bernhard Lux, Germany, National Representative NETWORK-Lipolysis
Dr. Jaako Pitkanen, Finland, National Representative NETWORK-Lipolysis
Dr. Thierry Marechal, France, National Representative NETWORK-Lipolysis
Dr. Konstantinos Gritzalas, Greece, National Representative NETWORK-Lipolysis
Dr. Spyridon Ioannides, Greece, National Representative NETWORK-Lipolysis,Directorial Board ISL
Dr. Mark Palmer, United Kingdom, National Representative NETWORK-Lipolysis
Dr. Kam Singh, United Kingdom, National Representative NETWORK-Lipolysis
Dr. Ghaus Jilani, United Kingdom, National Representative NETWORK-Lipolysis
Prof. Roy de Vita, Italy, National Representative NETWORK-Lipolysis, Directorial Board ISL
Dr. Roberto Zunica, Italy, National Representative NETWORK-Lipolysis
Dr. Hiroko Sugino, Japan, National Representative NETWORK-Lipolysis
Dr. Sinisa Glumicic, Croatia, National Representative NETWORK-Lipolysis
Dr. Roger Elkhoury, Libanon, National Representative NETWORK-Lipolysis
Dr. Hans-Nielsen Hauge, Norway, National Representative NETWORK-Lipolysis
Dr. Doris Grablowitz, Austria, National Representative NETWORK-Lipolysis
Dr. Sylvia Orasche, Austria, National Representative NETWORK-Lipolysis
Dr. Eva Kärnsby, Sweden, National Representative NETWORK-Lipolysis
Dr. Roland Voëlin, Switzerland, National Representative NETWORK-Lipolysis
Dr. Jim Wong, Singapore, National Representative NETWORK-Lipolysis
Dr. Justin Hao, Taiwan, National Representative NETWORK-Lipolysis
Dr. Setthakarn Attakonpan, Thailand, National Representative NETWORK-Lipolysis, Directorial Board ISL
Dr. Ercin Özüntürk, Turkey, National Representative NETWORK-Lipolysis, Directorial Board ISL
Dr. Maria Angelo-Khattar, Dubai, National Representative NETWORK-Lipolysis
Prof. Dr. Harryono Judodihardjo, United Kingdom, Directorial Board ISL
P.D. Dr. med. Thomas J. Galla, Germany, Directorial Board ISL
Aesthetic Medicine Dec/Jan 2006/07
Your Body, Mind & SoulDecember, 2005
Liposuction without surgery?
European methods deemed the largest discovery in aesthetic medicine since Botox.
From the American Society for Aesthetic Surgery
It is the American Society for Aesthetic Plastic Surgery's position that, currently, lipoplasty or liposuction is the only proven method of fat deposits.
Recently, however, there have been articles in popular consumer magazines and in major news channels describing the method of nonsurgical lipoplasty through two methods called lipodissolve and mesotherapy.
Just then we'd gotten used to the idea of Botox, along comes a new trendy injectable. Beauty junkies and their doctors are buzzing about lipodissolve and mesotherapy, when a cocktail of substances are used in multiple small superficial injections for body contouring.
“We started using it under the eyes” said Dr. Soren White, medical director at Skinclinic, the Upper East Side medispa in New York. “Now we use it for hips and love handles.”
“Lipodissolve,” as dermatologist Steven Victor calls it, “is meant for small medium areas of body fat.
“In France, the method of mesotherapy is applied for body-fat reduction while the patient is allowed to continue his or her binge favourite fatty foods. Obviously a suggestion that is not popularly imitated in this country where physicians use mesotherapy in conjunction with diet and exercise.
“Only topical anesthesia is required and bruising lasts just a few days. The formulas used in lipodissolve and mesotherapy are manufactured in the United States and are approved by the Food and Drug Administration, although the procedure requires they be used off-label.
“Licensed physicians may legally offer treatments involving off-label uses of many pharmacologic substances have been approved by the FDA for other uses, and there is no specific prohibition of the intended off-label use.”
Claims and European clinical research state that can dissolve fat without the need for surgical intervention. Some doctors are holding off. “We want more data,” Alan Matarasso, a plastic surgeon, said. Two to five sessions are generally recommended, at about 300 Dollars for upper arms and facial procedures and 350 to 550 Dollars each for abdomen with some clinics in Beverly Hills charging double.
“With lipo, you remove fat cells permanently.” Howard Sobel, a dermatologist said, “With these shots, we don't know if it will come back.”
But Sobel an Matarasso may see wishes fulfilled sooner than they had conceived. A European research team led by Austrian physician Dr. Franz Hasengschwandtner claims to have the clinical results to put to rest many doubts.
That evidence will be demonstrated for the first time in this country at a convention setup for medical professionals.
The meeting will include representations from the world-renowned Dr. Patricia Rittes, clinic research director Dr. Hasengschwandtner and Paris's expert on aesthetic mesotherapy, Dr. Alain Lejeunie.
Hasengschwandtner's collected data not only claims that the procedures of lipodissolve are safer than nearly all aesthetic procedures, but the results are surprising, permanent and natural looking.
eMediaWire - APRWEB.com Newswire11.11.05
New European Lipodissolve Therapy Replaces Surgical Lipoplasty Procedures
A representative for the American Society of Aesthetic Lipodissolve state, “Lipodissolve is the most effective therapy for reduction of localized fat without surgery known so far.”
London, UK (PRWEB) July 28, 2005 -- Lipodissolve, or Lipolysis as it is known in Europe, is a concept which allows physicians to inject mild substances direct into fat to initiate a process when the fat is dissolved from the fat cells without damaging the cells and without any need of surgery. This therapy was initially developed by Italian physicians to reduce cholesterol deposits of the eyelids (Xanthelasma). The idea was later introduced at the 5th International Meeting of Mesotherapy in1988. In 2001 Dr Franz Hasengschwandtner began developing the, then slow, therapy further and made it into an effective therapy aimed to replace select cases of surgical lipoplasty. Dr Hasengschwandtner is the foremost specialist on Lipodissolve today and give presentations and seminars to plastic surgeons world-wide.
The therapy, known as Lipodissolve in English, has undergone tremendous improvements since its initial introduction to the medical community in the 1980’s. “Lipodissolve has improved so much from our trials and studies in Europe that now, many patients get final results even after one single session,” says ASAL’s research director, Dr. Hasengschwandtner, “Previously the same therapy would require anywhere from 8-20 visits.”
The therapy can reduce localized fat on nearly any procedure, often only addressed by surgery. The results on facial procedures in particular are exceptional, and many of Dr Hasengschwandtner’s patients have a drastic improvement from this mild and simple therapy, taking years off the face and rejuvenating the skin and complexion. “In combination with a total makeover, alternated with Botox and Restylane, Lipodissolve can perform wonders without the risks, costs or discomforts of surgery.”
Within the European medical community, Lipodissolve has been hailed as the “most exceptional discovery in cosmetic medicine since Botox.”
Articles published in Dubai
Associated Newspapers Ltd · Terms & Conditions · Privacy ©2005August 2005
How safe is the flab jab?
by THEA JOURDAN, Daily Mail 09:41am 9th August 2005
When Debbie Oliver heard that clinics had started offering injections of a drug which would literally dissolve fat, she - like many women - jumped at the chance. The results, as the pictures in our photo gallery show, are certainly dramatic, with Debbie's double chin now gone and in its place a taut jawline.
Debbie says that she feels like a new woman. She believes that, as promised, the miracle drug really did melt the fat away. She says she has no regrets about undergoing the 'Flab Jab'. She had two injections of Lipostabil - two months apart - live on Channel 4's Richard And Judy show after her doctor was approached by the programme makers. Lipostabil contains an enzyme derived from soya beans, called phosphatidylcholine, which is claimed to break down the outer walls of fat cells.
"Before treatment, I had no neck at all and would try to hide my wobbly chin with necklaces and scarves," says Debbie, who insists that dieting and exercise did little to improve her appearance.
Dramatic effect
"Now, I have my jawline back and am much more confident. Everyone who knows me thinks that the difference is amazing.
"I have even put on a little extra weight since having the injections, but the fat has stayed away from my chin.
"The jabs had such a dramatic effect. The second time I went into the studio, Judy could hardly believe the transformation." So is the 'flab jab' too good to be true? Well, yes - because the cosmetic surgery industry is divided over the safety of the drug used in the injections.
Unlicensed drug
Lipostabil has yet to receive a licence for cosmetic use. This means that British clinics who offer the treatment are defying the medical authorities.
Some experts have concerns about the drug's long-term effects, and there are fears that it could cause nerve damage or skin complaints.
There have been no long-term trials to establish its safety, and even the company that makes it says it was never intended as a cosmetic drug.
'Cowboy surgeons'
Mel Braham, chairman of the Harley Medical Group of cosmetic surgeons, said those who continued to offer the treatment are "rogues, cowboy-type people and very unprofessional".
The concerns mean that Debbie could be one of the last people to use the so-called wonder drug. Earlier this year, the Medicine and Healthcare products Regulatory Authority (MHRA), which licenses drugs in the UK, wrote to at least 50 clinics to order them to stop advertising the treatment.
If clinics don't comply, doctors could face unlimited fines and even jail sentences. Many UK doctors, who have already trained to administer the injections, have now stopped offering the treatment to patients.
Gillian Peacock, spokesman for the MHRA, explains: "Lipostabil is not licensed and cannot be used for cosmetic purposes in the UK. The bottom line is that we do not have the safety data to justify its use for the localised reduction of fat." The company that makes the drug, Sanofi-Aventis, also says that it does not condone it for cosmetic use. While Lipostabil is licensed for use in Britain, it is only for helping to remove the fatty deposits in arteries that could lead to heart attacks.
The drug is available by prescription only, and doctors who order it have to provide the name of their patient and the details of the condition.
Until now, some doctors have got round the problem by prescribing 'off-licence'. This technical loophole means doctors can prescribe drugs for something other than their intended use as long as they take legal responsibility for anything that may go wrong.
Botox, which is now used by hundreds of thousands of people to reduce wrinkles, is also not licensed for use as a cosmetic treatment yet is routinely prescribed off-licence.
No insurance for 'flab jab'
The reason that doctors are no longer prepared to take the risk with Lipostabil is simple. The two main medical insurers, the Medical Defence Union and the Medical Practitioners Society, have refused to insure doctors who use the anti-flab injections on patients.
Many doctors believe that the MHRA and the medical insurers have been too hasty in effectively banning Lipostabil as a cosmetic treatment. There have been only three recorded adverse reactions to the treatment in the UK, all of them mild allergic reactions to soya.
Dr Hilary Allan, co-director of the Woodford Medical Clinic, used Lipostabil on patients for six months before succumbing to pressure from the MHRA and stopping the treatments.
"The irony is that this was one of the most effective fat-busting treatments we have ever used," she says. "Our patients had visible improvements, with the minimum of fuss. "It was a really sad day when I had to tell them that I could no longer provide the service." Dr Allan points out that the alternative to fat-busting injectionsis liposuction, which is a much more invasive surgical procedure.
"What we are saying is that people can no longer opt to have a safe, simple injection," she says.
"Instead, they must put themselves through a difficult and painful operation. It makes me very angry."
Dr Allan says that her patients are even going abroad to seek the treatment, which is widely available in Germany and Italy.
Dr Dai Davies, an eminent plastic surgeon and the director of the Institute of Cosmetic and Reconstructive Surgery in London, is also perplexed by the decision of the MHRA.
He no longer offers Lipostabil fat-busting treatment to his patients, but says: "In my experience, Lipostabil is pretty safe stuff. I have used it on more than 50 patients over the past three years. "The results have always been good.
"That said, it is a very brave doctor who will take the risk and inject Lipostabil at the moment. The problem is that you can't get insurance to cover you against anything going wrong."
He is worried that determined patients will find a way to get hold of Lipostabil, legally or not.
Website offers 'self-injections'
The MHRA is currently monitoring several websites which offer Lipostabil for self-injection to anyone who can pay. Buyers can also buy hypodermic syringes.
"We know that the websites are selling this drug to UK citizens, but there is not a lot that we can do because they are registered abroad," says Gillian Peacock.
Patients who self-inject run the highest risk of much more serious complications, including fatal embolisms caused when air is mistakenly injected into the bloodstream. Self-injection, which is common in Brazil, has led to the drug being banned there because it has been linked to serious skin infections and nerve damage.
Injections to change 'baggy knees'
Fifty-eight-year-old Patricia Oppizio from Cheshire, however, had no problems. Patricia, who is married to Stefano, 63, a retired businessman, and has three grown-up children, found out about a trial taking placed on the fat-melting injection through a friend who was a nurse. For years she had been paranoid about the fat above her knees, so she was happy to be 'a guinea pig' for an Austrian doctor, Dr Rita Rakus.
"I started becoming dissatisfied with my knees about 18 months ago after I saw photos of Demi Moore's 'knee lift'," she says. "My own knees looked just like Demi's 'before' pictures. The rest of my body was in good shape - I'm a size eight - but my knees looked like those of a 70-year-old. They were wrinkly, with a nasty pad of fat above each kneecap. "My husband had never noticed my baggy knees and told me to stop being so silly. But even though I knew he was right, my knees really bugged me, and I hated the thought of having to reveal them on holiday." She was amazed that the problem could be treated so easily. "I was thrilled because I didn't think there was much, short of surgery, that I could do about them.
"A surgical lift leaves terrible scars, and although liposuction would remove the fat, it also involves invasive surgery." Patricia had 12 injections into the fat pads above each knee. Knees are considered by some to be an ideal area to treat because the fat is concentrated in a small area. She suffered no immediate discomfort, other than some temporary bruising and itching.
"I looked as though I had fallen over and banged my knees, and they felt very tender for a week."
After five weeks, Patricia noticed that the fat pads were shrinking and the skin above her knees had tightened up.
"Within eight weeks, I could actually see my kneecap for the first time in years. My legs looked a good ten years younger. I was delighted. "I feel a lot better about myself now, and instead of crossing my knees so that no one notices them, I don't have to worry if my skirt rides up."
Duncan Williams, managing director of Lipomed Ltd, whose 12 clinics still offer the treatment at £350 a time, says that the injections are safer than Botox as long as they are carried out by a health professional.
Jab targets specific areas
Over the past two years, his team have treated around 1,000 patients without any serious adverse reactions.
He says: "The drug has been clinically tested and found safe to be injected intravenously for the treatment of fatty deposits.
"We are putting it into fatty tissue, which will have only a local effect. In the unlikely event of an adverse reaction, it will be limited." Doctors at his clinics can also decide if a patient is suitable for the treatment. Lipostabil is not a cure for obesity, and Lipomed clinics turn away would-be patients who are severely overweight and use it only to target stubborn fat deposits.
However, research into the area is limited. Dr Patricia Rittes, who pioneered the treatment in Brazil, claims to have treated 25,000 patients with Lipostabil fatbusting injections without problems.
Dr Rittes is considered to be the world's foremost expert in Lipostabil injections. Over the past 18 years, she has determined the amount of medication which needs to be injected, the time between treatments, and the areas which can be successfully treated.
Eighteen months ago, Justine Tassey, 38, a company director from Worcestershire, opted for a course of flab jab treatments to get rid of a stubborn roll of fat at the top of her stomach.
She says: "I am quite happy with my body generally, but I realised that over a period of about a year I had developed a roll of fat just underneath my breasts that wouldn't go away no matter what I did.
"I tried daily sit-ups to no avail, and despite going to the gym four times a week, it just wouldn't shift. "At the time, I was driving 80,000 miles a year as part of my job, and every time I sat at the steering wheel I could feel this extremely uncomfortable roll of fat. It was a horrible thought that I had all that fat just sitting there." She heard about Lipostabil injections from a friend and went to a clinic in Birmingham.
"The treatment sounded fantastic: just a few small injections and none of the risk associated with invasive procedures such as liposuction," she says.
"During my first consultation, the doctor told me she thought the treatment would work well on the area and that she could go ahead with the first treatment there and then.
"I had five injections under each breast. Each time, the doctor simply pinched an area of fat and injected straight into it. There was hardly any pain. It was actually less painful than the injections you have for holiday vaccinations." Afterwards, she suffered some swelling and bruising, but that soon faded.
Client 'amazed' by results
"In fact, I was playing golf just hours after my first appointment and I wasn't bothered by what I'd had done at all," she says.
"I was amazed when, just a few days after the first treatment, I could already see that the injections were having an effect. There was discernibly less fat.
"I went back a month later for the same number of injections again, and then back a third and final time a month after that. "A few days after the final injections, the whole area was flat. I felt - and still feel - fantastic about it. I feel much more confident and I no longer have the constant feeling that I'm carrying a spare tyre.
"I know that some people are concerned because there is no clinical research on the longterm effects of these injections. "But as far as I'm concerned, this has got to be a much safer option than liposuction, which has been linked to hundreds of deaths in America.
"Has anyone ever heard of anyone dying from this? The answer is no. It's quick, virtually painfree, and you can be back at work the next day. I would recommend it to anyone."
Long-term effects?
But only time will tell if Lipostabil is a true fat-busting miracle or a medical menace.
The jury is still out as to whether the treatment is a pain-free alternative to liposuction, or a long-term health risk. The experts agree that people who want to lose inches now have to decide for themselves if they are prepared to take that gamble.
Injection moulding: the fat dissolving debateJuly 2005
LONDON, Great Britain (July 2005: Vicky Eldridge):
Not since the introduction of botulinum toxin has a treatment caused such controversy as injection lipolysis. Otherwise known as Lipodissolve the treatment is being seen by many as the new rising star of the aesthetics industry, but is still being regarded with caution and looked on with scepticism by others.
Under the direction of Dr Franz Hasengschwandtner, the original therapy underwent further development and scientific research and workshops were set up to enable physicians to train to an internationally uniform standard.
Not an alternative to or replacement for liposuction, nor a weight loss treatment, injection lipolysis is more about sculpting the body and modifying body contours by getting rid of small to medium pacthes of fat. However it can be very effective in conjunction with surgery.
"Within the framework of our international network further on-going research, investigation and a worldwide exchange of experiences is taking place," says Dr Hasengschwandtner. "It is of importance that any kind of abuse by those who are not authorized to administer injections must be prevented at all costs. As far as the medical profession is concerned, one can already say that doctors instructed in the technique and who have been able to learn from the experiences made by their colleagues in the network, report satisfied patients."
Ideal candidates for treatment are people of slim to normal build and of stable weight who do not want or need to undergo surgery but who have spot fat resistant to diet and excercise. The combination of medications are directly injected into the fat with treatments taking about 10 to 15 minutes, depending on the size of the area being treated. The treatment then works to initiate the process during which fat is emulsified and then eliminated from the body, via the natural metabolic process.
Lipodissolve offers a mild treatment method for small to medium fat reduction and can in addition be used for positive skin retraction treatment.
The number of treatments needed differ from person to person, depending on body region, type of fat and body size. Between one and four treatments at six to eight week intervals are usually necessary to achieve the desired results.
Results are usually not apparent after the initial treatment, however the majority of patients see a good result after two to three sessions. For small areas such as the chin and jawline one treatment is often sufficient and results can be seen after as little as four weeks.
Most serious or long-term side-effects have not been documented, although these could include infection, nerve trauma and puncturing of an organ if the injection is not administered properly. In order to prevent this good knowledge of anatomy and correct injection techniques are vital. Overdose or intoxications have not been known to occur, according to the network.
Before treatment patients should be advised not to drink alcohol for at least 24 hours and should avoid waxing, laser treatment, sun beds and eletrolysis for at least 48 hours prior to treatment. They should also be advised that pain sensitivity can be increased at certain times such as if they are pre-menstrual or following excessive alcohol.
Body Language Issue 16LONDON, Great Britain (June 2005)
Addressing the critics
Injection lipolysis can produce a significant improvement in body sculpture. Yet it has been the target of criticism. Dr Franz Hasengschwandtner unveils data from a report that shows minimal side-effects and high patient satisfaction from physicians trained in the technique
Injection lipolysis is not a substitute for surgery for treating extensive body fat, nor is it therapy for weight reduction, but it is a safe and gentle method for eliminating small accumulations of fat. Like any other procedure, injection lipolysis should always be performed only by physicians who have undergone specialist training.Criticisms of injection lipolysis have been expressed in Germany, Austria and the UK, however.
To address this, a scientific study of phosphatidylcholin, the substance used in injection lipolysis by the first Network members, has been made. In Lipolysis Report 2004, data from 470 patients treated in 1061 therapy sessions showed no reports of risk to the patients, of whom 88.7 per cent were women and the rest men. The patients will continue to be invited for control examinations for the next two years after therapy for assessing long-term effects.
Important indications
The initial statistical data does not allow any final and conclusive assessment, nor can it take the place of long-term observation, as the statistical basis is too small. It can, however, provide important indications regarding two questions of concern to patients and treating physicians: are there any side-effects so severe to rule out use of the therapy, and how good are the results?
All the documented side-effects correspond to the symptoms stated in the patient information, such as redness, swelling, itching, haematoma and pain in the treated regions. There were no other previously unknown side-effects. The fears of some colleagues that the therapy may result in the formation of permanent nodosities and necrosis are unfounded. Within the work of the Network, a single case of necrosis has been documented. But this was found to be a clear case of medical malpractice, as the necrosis occurred because the substance was injected into tissue already cicatrised from previous liposuction treatment. The patient also suffered from multiple circulatory disturbances. Addressing the fear that the therapy could trigger cancer, Network Lipolysis' research board, which comprises experienced physicians with extensive experience of lipolysis, concluded this had no foundation in scientific fact but was merely scaremongering by journalists. Allergic reaction was also investigated. In thousands of treatments, no documented case of allergic shock has been established, despite the addition of B complex vitamins which makes this side-effect theoretically possible. Nevertheless, the Network's research board has established a work group to deal with this eventuality and to prepare all Network members for the action to be taken in the event of anaphylaxis. All doctors should be prepared for such emergencies, even if they occur rarely in practice.
Results
Patient satisfaction is high—all the more surprising as lipolysis therapy, unlike surgical procedures, does not produce any immediate effect, but only after two or three treatments of up to six months. Many patients say they find this slower rate of change as positive because they are not confronted with the psychological effects of an abrupt change in their physical appearance. This subjective opinion can also be confirmed by objective data. Table 4 shows the reduction as measured by the physician, whereby it must be acknowledged that the extent of the reduction may differ from region to region. In addition, difficulties exist in measuring the reduction in the facial area as, except for photo documentation, no objective and easy-to-use measuring methods are available for this part of the body. Most patients viewed the therapy as highly positive. Fat reduction was achieved in 93 per cent of all cases, with even higher success rates for more experienced members. A work group of the Network has been set up to investigate the reasons for non-response; this has already succeeded in producing further improvements in the results. Continuing its efforts to improve the technique, Network Lipolysis has requested its members to conduct standardised observation of the patients in the course of the therapy and to submit their data to the Network's research board.
Dr. Franz Hasengschwandtner, the first doctor to use lipolysis injections in Europe, is the medical director of the spa clinics Bad Leonfelden, A-4190 Bad Leonfelden, Spielau 8, www.doc1.at
Deutsche Ärzte ZeitungAug. 24, 2004
Fat Melts Away after One Prick - Injections Trigger Discussions
Study Reveals that Injections Reduce the Fat Portion in the Tissue
NEU-ISENBURG (sko). Ardent discussions about injections. People's opinions differ when it comes to one of the favourite topics of the public media, namely the flabjab injections sup-posed to dissolve fat deposits without problems. The advocates now gather credits: for the first time, a study offers the first scientific evidences for the effectiveness of the injections.
Still somewhat reserved, Prof. Johannes Huber of the University Clinic for Women in Vienna now characterizes flabjab injections as “worthy to become the subject matter of further stud-ies”. In cooperation with Prof. Silvia Kirchengast, anthropologist at the University of Vienna, he had treated 60 women for three times in intervals of two weeks each with the flabjab injec-tion. The medicament containing phosphatidylcholine has been approved as Lipostabil® for intravenous therapy in case of fat embolisms.
In each session, Huber injected 10 ml phosphatidylcholine under the skin at belly and hip, and before and after this treatment he determined the fat portion by means of DXA (dual-x-ray-absorptiometry) measurings. Result: “in the injected body regions, the body fat portion partly decreased by more than eight percent”, stated Huber when interviewed by the “Ärzte Zeitung”.
With 72 percent of the women, the local fat portion was reduced by one percentage point, “something what we assess as a success of the therapy”, says Kirchengast. In order to have this success, however, some women had to tolerate reddenings, bruising and sensations of pressure for a short time.
Now, investigators are eager to conduct studies and they already plan a new one “by means of which we want to investigate the effects of the injections upon fat metabolism and hormone state”. This because Huber supposes that it depends upon the hormone situation of an individ-ual being whether the injection has an effect or not.
BACKGROUND
The Dispute about Flabjab Injection:
Much Clamour, Still Only a Few Facts and Dubious Self-Treatments
by Swanett Koops
To come to the point at once: as a matter of fact, flabjab injections dissolving undesired fat deposits in the face, at the belly or legs has not been officially approved. It seems, however, that this does not bother the users. An off-lable use is, of course, nothing new - what's more important is that this injection fulfills an ardently longed for dream of mankind that has (up to now) been unfulfilled. Instead of all this torture with diets and sports the fat is simply injected away. It is said that this is possible with Lipostabil® containing phosphatidylcholine won from the soy bean and approved for intravenous therapy of fat embolisms.
In 1995, the Brazilian physician Dr. Patricia Rittes, however, had the idea that the medica-ment is able to do even more: the intravenous fat dissolving substance could also have an ef-fect under the skin, exactly there where fat is disturbing much more often than in the artery or vein.
Network-Lipolysis wants to approach the issue scientifically
Meanwhile, the fat-away injection enjoys great popularity in the whole world rather than only in Brazil. In Europe, it is above all the Austrian Medizinalrat (senior medical officer) Dr. Franz Hasengschwandtner, general practitioner, Kneipp-physician and graduated expert for nutrition, who gathers many active fat-dissolving colleagues round himself who joined up in Network-Lipolysis (www.netzwerk-lipolyse.de).
According to its own statements, Network-Lipolysis wants to approach the issue of lipodis-solve injections soberly and seriously. Here, Dr. Hasengschwandtner also published the Lipolysis Report 03 where the treatments of 187 patients are documented. His assessment: “ In any case, I can confirm the method's effectiveness”.
Exactly this, however, is one of the most important controversial questions: neither effective-ness nor tolerance of flabjab injections have up to now been evidenced scientifically to a suf-ficient degree. “As long as no standardized studies inclusive of monitoring have been con-ducted a responsibility for the therapy cannot be accepted according to today's standards”, this is what Dr. Gerhard Sattler, head physician of the Rosenpark-Clinic in Darmstadt be-lieves. “It's totally unclarified what happens under the skin after the injection!”, criticizes Dr. Klaus Exner, instructor and President of the Association of German Plastic Surgeons (VDPC) and head physician of the plastic surgery department at the Markus Hospital in Frank-furt/Main.
According to the opinion of the critics, it is true that some fatty tissue disappears after the application - the costs for one injection amount to approx. 300 Euros - and that the skin thightens. But first of all, animal studies were necessary in order to prove that the injection is harmless. Furthermore, the plastic surgeon does not believe in the necessary effectiveness: “At the belly and tigh, this is nonsense anyway because it's almost nothing what can be elimi-nated there.”
The outcome of a study conducted by Prof. Johannes Huber of the University Women's Clinic of Vienna and Prof. Sylvia Kirchengast, anthropologist at the University of Vienna, however, supposes something else. During Huber's study - according to his own statements his first one - the effect of the injection was scientifically investigated, namely by means of DXA (dual-X-ray absorptiometry)-measurements of the reduction of body fat, and with more than 70 per-cent of 60 treated women a reduction of the body fat portion in the treated region of one or more percentage points was measured. With some women, the fat portion decreased by more than eight percent. And Sattler, too, who also made some smaller treatments - “otherwise I could not make any statement in this respect” - could record positive results.
Who wants to be beautiful has to suffer - and this also applies to the Study of Vienna. Accord-ing to Kirchengast, skin reddenings, bruisings and slight sensations of pressure were recorded. With almost all women, however, the symptoms disappeared after two days. It seems, how-ever, as if not everyone gets off so lightly - but this can, of course, also be due to inproper applications.
Sattler, for instance, talks about reports about skin necrosis if the substance is injected too close under the skin. And the physician Dr. Mitra Hegge had to close her doctor's office for one week after a self-treatment because she was heavily deformed due to swollen lower eye-lids after injections into her tear sacs - the region where Rittes made her first injection at-tempts (Der Deutsche Dermatologe 4, 2004, p. 278).
Criticism with respect to the injection above all comes from plastic surgeons
Huber comments this uncheering result and says that he would not use the medicament in such sensitive regions like the face. He supposes that the heavy criticism that above all comes from plastic surgeons is caused by the fear that the liposuction clientele could fade away.
Disputes or not - flabjab injections seem to experience a boom. On the one hand, there are already some colleagues in Germany who accept treatments: the physicians' list of Network-Lipolysis alone contains more than 50 names. But it is also before the mirrors in the bathroom at home where phosphatidylcholine is injected into the fat without any participation of doctors and obviously in a completely carefree manner. Citation in a www forum: “Hi girls, who wants to purchase a package Lipostabil® 5x5 ml inclusive of syringes and cannulas at a low price? In a fit of enthusiasm, I have purchased too much of it and now, there is one package left. Give notice please! My self-treatment was quite successful and the result is o.k. Best re-gards, Gerhild.” And another interested woman wants to know: “How much do I have to in-ject per treatment and body region? I just need to know how much I have to order.”
Pharmaceutic Company dissociates itself from cosmetic application
It continues to be exciting how things concerning flabjab injections will go on. According to the statements of Dr. Christian Nauert, employee of the competent pharmaceutic company Casella-med, the company is dissociating itself from the application of the medicament in the cosmetic field. In the product information sheet it is explicitly pointed out that phosphatidyl-choline must not be applied subcutaneously. Sattler, however, sees an happy-end for the flab-jab injection, and this in spite of all criticism. “Lipostabil® will become great. It will rate high like Botox®.
CONCLUSION
Since a female doctor from Brazil has used the substance phosphatidylcholine to eliminate tear sacs for the first time in 1995 although it is only approved for the dissolution of fat embo-lisms a hot discussion about flabjab injections has broken out. The critics complain that nei-ther effectiveness nor tolerance have been proven. The advocates, on the other hand, regard the flabjab injection as an effective and cost-advantageous option to eliminate disturbing fat deposits. The users - in most cases women - also acquire the substance from the www and inject it themselves.
COMMENTARY
Flabjab Dispute Lags Behind Reality
by Swanett Koops
Reality has overtaken discussions: while physicians and scientists are quarreling about sense and nonsense of flabjab injections women purchase the freely available medicament Liposta-bil® in the www and inject the substance under their skin themselves.
Completely carefree or desparately looking at one single aim: as simple as never before on the way to the dream figure. And this although it does not take much phantasy to imagine conse-quences like infections and necroses which can be triggered by the fat dissolving agent if in-jections into the fatty tissue are made improperly.
The boom of the flabjab injections can no longer be stopped. For this reason, colleagues should concentrate their efforts to make a scientific approach to the issue of lipodissolve rather than quarreling. Now, the physicians of the University Clinic of Vienna made a first step with their study.
The therapy either proves its value in future during further studies or it establishes itself to a degree that it is no longer used in the bathroom at home but in the offices of trained doctors. Otherwise, an insufficient effect, a bad tolerance and dangerous side-effects must be made public to a degree that users voluntarily no longer want to apply flabjab injections.
District Court Puts an End to Untrue Statements about the New Flabjab InjectionApril 27, 2004
Temporary Injunction obtained against Association of Plastic Surgeons
Verden - For months now, the associations of plastic surgeons have disseminated untrue facts about the new treatment method associated with the “flabjab-injection”, and now massive consequences are threatening for “GDÄPC” and “VDPC” if these associations and their members continue to spread such information. By means of a temporary injunction and under penalty of an administrative fine of € 250,000, the District Court of Verden has now prohib-ited the associations from repeating all these complaints disseminated up to now via press releases and in interviews.
Again and again, the associations concerned reported about massive side-effects connected with the flabjab injection towards representatives of the media, for instance about dents, cysts or even harm to the inherited material. Instead, liposuction was praised as the only riskless and appropriate possibility to eliminate fat. Up to now, however, the responsible persons failed to offer the media precise evidences supporting these statements - not only that no in-jured patient could be found, what is more: the medical literature does not include any report about the above-mentioned side-effects. On the contrary - the general reliability of the applied substance that is also used by health practitioners has been scientifically supported for several times. Medical examinations carried out with 500 patients did not reveal any harm or injury. As a matter of fact, the treatment method existing for almost ten years now turned out to be a gentle method with positive effects experienced by some thousands of patients, also in Ger-many.
As one of the most experienced users in Germany, Dr. Gunther Steitz, general practitioner, obtained the temporary injunction in order to stop the purposive creation of insecurity among the public by the plastic surgeons and to return to a balanced and serious discussion about the topic in question. In this connection, Dr. Steitz asks all media to gain an own objective and thorough impression of the injection's mode of action, to gather the publicly available infor-mation about the active substance and to request evidences supporting the negative statements of the plastic surgeons. In this connection, he also draws the attention to an independent study of the University Clinic of Vienna which will offer additional objective scientific results about the new treatment method in a few weeks.
Noninvasive fat melting: the facts and the fantasyCosmetic Surgery Times, Jan-Feb, 2004 by Alison Palkhivala
Cosmetic Surgery Times
Focuses on the cosmetic nature of plastic and dermatologic surgery practices, covering relevant aesthetic developments, laser surgery, hair restoration, maxillofacial surgery, and ocular plastic surgery.
Please contact the publisher for further publication permission:
www.cosmeticsurgerytimes.com/cosmeticsurgerytimes/article/articleDetail.jsp
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Montreal 2004 -- As any Internet search will reveal, nonsurgical, minimally invasive procedures that claim to melt away fat beneath the skin are gaining in popularity. While the techniques have been available in Europe and other countries for decades, they are relatively new to the United States, and as yet not FDA approved*. Proponents of the techniques rave about safety and efficacy, but several experts remain skeptical. [Note: *The medications used in the United States are manufactured according to FDA pharmacy regulations in the US. The writer refers to medications popular in Europe.]
Lipostabil, one such alleged burner of fat, is the tradename for an intravenous preparation of phosphatidycholine manufactured by Aventis (Strasbourg, France).
According to V. Leroy Young, M.D., chair of the Emerging Trends taskforce for the American Society of Plastic Surgery and president of the Body Aesthetic Plastic Surgery & Skincare Center in St. Louis, Mo., "I think there is a theoretical chance that Lipostabil works. It could either activate lipase, which could break down fat and then mobilize it from a local accumulation. The other mechanism that it could work by is it's a bipolar molecule, so it could dissolve fat."
Another purported fat melter is collagenase, an enzyme that breaks down connective tissue. "There's been a clinical trial on injecting lipomas with collagenase," said Dr. Young, "and one shot resulted in about a 50 percent to 80 percent resorption of the lipoma. So, collagenase does seem to be able to locally break down fat."
Another fat melting technique that has enjoyed years of popularity in Europe and elsewhere but is only just coming to the attention of American physicians is mesotherapy. Marion Shapiro, D.O., has performed mesotherapy on more than 1,000 patients from her Madison Avenue and New Jersey offices after learning the technique in France. The procedure involves injecting various drug cocktails, including aminophylline, novocaine, as well as various plant extracts and vitamins into the mesoderm area of the skin.
Dr Leroy Young
"For overall weight loss, we inject all over the body," Dr. Shapiro said. "That causes a general dissolution of the fat all over the body week by week. Patients can expect to see anywhere from one to two dress sizes lost. For spot weight reduction, we just inject the body where the patient wants to lose the fat. We use a different kind of medication to melt the fat based on the area we're treating. For cellulite we need not only to melt the fat, but also break the banding under the skin, so we use yet a third combination of medications to help that, and then we inject where the cellulite is, sort of microcosmically in very small injections."
Several injections, up to 150, are performed at each session, and most patients require approximately 10 sessions to see the results they want. The most common adverse event is bruising, which is temporary.
Allergic reactions are another potential problem, but Dr. Shapiro uses patch testing to minimize this possibility. She has not seen any other adverse events, although some cases of skin infections were reported with mesotherapy in Europe in the 1990's. The procedure, she says, works on 95 percent of patients.
Getting rid of needles
Transdermal electroporation could make the injections associated with mesotherapy obsolete. Jeff Zeldin heads Turnwood International, a Toronto-based company that, in collaboration with Italian manufacturers, plans to bring a type of transdermal electroporation called Acthderm Pulse to North America. "It's a way of transdermally introducing product into the skin without using needles," he said.
According to Zeldin, the device includes a pointer that, when placed against the skin, delivers an electric pulse that opens the pores deeply for about two to three minutes. A rollerball device is then used to deliver a topical product under the skin surface. "The product itself is positively charged, and then you've got a positive charge running from the machine into the rollerballs, where the product goes through," he said. "So, positive and positive repel, so it's actually pushing the product into the skin."
A final form of melting fat nonsurgically is ultrasound. Two companies are marketing or planning on marketing noninvasive ultrasound fat-melting devices in the United States, Israel-founded UltraShape and Bothell, Wash.-based LipoSonix. Jens U. Quistgaard, president and chief executive officer of LipoSonix spoke about the company's technology, which he hopes to market in the United States within two years.
Are these nonsurgical fat melting technologies too good to be true? Some experts think so. One nagging question is, What happens to the fat once it has melted away? According to Dr. Young, if the patient does not exercise or eat less in order to burn it off, it will just get deposited elsewhere on the body.
"My view of these things," he said "is, let's say you have a little love-handle area or something, you might be able to treat something like that with it, and improve your contour and redistribute the fat over the rest of the body. But if you've got a lot of extra fat, then you've got to go about it the hard way--not eat and exercise."
Dr. Shapiro claims otherwise, however. She said that with mesotherapy, "we stimulate the fat cells to release fat and then our body processes it naturally as if we were losing weight, and what we find in our patients is that their cholesterols drop anywhere from 20 to 40 points, and that's because they're shedding fat from their body, and the fat is not going to their heart."
According to Quistgaard, the fat that is melted away with ultrasound, "is either taken up through the body's immune system through phagocytosis or it drains typically through the lymphatic system." Their ongoing human trials show no signs that the fat is deposited elsewhere, although he acknowledges that further study is required to confirm this.
Science must define technologies
Another problem with these technologies is the lack of good, peer-reviewed studies demonstrating their efficacy, at least in English. Proponents of the various technologies say that there is plenty of good clinical evidence for their safety and efficacy--in French, Italian, and Spanish.
William P. Coleman III, M.D., clinical professor of dermatology at Tulane University School of Medicine in New Orleans, is not convinced, however. "We always hear that [there are good studies available in foreign languages].... I've been to meetings and lectures in South America and France, and seen mesotherapy for at least a decade. So far, I have not seen anything there that's impressive at all. I think it's just a gimmick."
Study Description“Scientific Evaluation of Lipodissolve Injections”
(Flabjab Injection according to Dr. Steitz)
Place: University Clinic of Vienna
Study manager: Prof. Dr. Johannes Huber
Study start: as from February of 2004
Number of subjects: 50 patients
Orientation of the study in terms of contents:
Densiometry is a recognized method to diagnose the risk of osteoporosis. According to the same principle, the proportion of muscle and fat tissue can be documented for each body re-gion. Thus, the dexa-deniometrical measurement is the “most expensive” weighing device of the world. The University Clinic of Vienna owns such a device; it does not only display the mineral content of the bone to an objective degree but also the fat-muscle distribution. By means of this device, 50 patients are subjected to a dexa-measurement prior to the lecithin injection (flabjab injection) as well as after the third lecithin injection. If it can be assumed that the injected lecithin stimulates the “reverse transportation” of fatty acid and cholesterol to the liver an objective assessment of the therapeutic effect is possible on the basis of these measurements.
At the same time, the male hormones are being determined because they form a precondition for lipolysis. This factor is likely to get a special role in future because it can be proceeded from the assumption that a lecithin injection has the desired success if the androgen hormone situation is in good order.
Comment
on the press release of the German Association of Aesthetic-Plastic Surgery, registered association (DGÄPC), of January of 2004 and on similar statements of other representa-tives of interests of plastic surgeons.
Dr. Gunther Steitz, March 16, 2004
Claim 1:
The fat-dissolving active substance of the so-called “flabjab injection”is called phosphati-dylcholine. Said substance has been used for many years to reduce an increased cholesterol level.
Phosphatidylcholine is not only used for cholesterol disorder. It also proved to be an effective substance against arteriosclerosis, high blood pressure, liver problems, dementia as well as multiple sclerosis. The phospholides form a part of each cell membrane. The substance has been successfully used for many years without any side-effects within a wide medical spec-trum - from the general practitioner via surgeons to health practitioners.
Claim 2:
In Germany, the active substance has not been officially approved for dissolving greater quantities of fat tissue. Anyway, the treatment may only be carried out on the basis of a spe-cial informed consent to be given by the patient.
As a matter of fact, the pure active substance cannot be “approved” in this connection. It is rather the medicament Lipostabil that has been approved in Germany for many years now. As far as the special use as “flabjab injection” is concerned the approval of this recent treatment method still has to be obtained for Germany. For this reason, we have to do it with an “off-label use” here. This means that an increased quantity of information must be given by the treating doctor. This off-label use is a usual procedure in the whole world. We are already familiar with such a procedure because of the injections with Botox, an anti-wrinkle agent not yet approved for cosmetic purposes in Germany. This original neurotoxin has been used by the DGÄPC members - always provided that the respective patient explicitly gives his or her written consent - for thousands of times and the non-approval has never been regarded as an obstacle.
Claim 3:
Side-effects, dosage and tolerance of the “flabjab injection” have not yet been investigated to a sufficient degree. The active substance as “fat dissolving agent” is just being tested for less serious cases.
Since 1995, the “flabjab injection” has been used with more than 15,000 patients in the whole world, and up to date, the medical literature as a whole does not include a single case of side-effects going beyond a sensation of burning, reddenings or slight swellings in the injection area. Dr. Rittes, the inventor, also published a patient study about effectiveness and tolerance in the technical magazine Aesthetic Plastic Surgery which was already known to the public but ignored by the German associations of plastic surgeons. About 500 patients had been ob-served for more than four years - the problems suggested by the interest groups did not occur in any one case. Apart from that, the University of Vienna is conducting a scientific study about the method and mode of action. Said study began in February of 2004. For more infor-mation about studies as well as detailled reports about self-treatments made by the treating doctors please have a look at www.fett-wegspritze.de.
Claim 4:
The “flabjab injection” does not represent an alternative to liposuction.
The “flabjab injection” cannot be compared with the liposuction method; it rather represents a new and gentle possibility to have disturbing fat deposits eliminated - and all this without any side-effects. On the other hand, an article in the Medical Tribune of Febr. 13, 2004 reports about the massive risks connected with liposuction. According to current investigations of the University of Bochum, twelve persons died after liposuction only in the period from 1998 to 2002. In more than 40 further cases, severe complications occurred, and the scientists experi-enced numerous cases of effects at the belly wall, thrombosis etc. Even if the treatments were faultless the method of subcutaneous liposuction represents a much higher burden for the or-ganism than lipodissolve injections do it. This fact illuminates the intention of the associations to protect their “market” against soft and more gentle methods than liposuction when they do all this public relations work - at the expense of their patients' health. Always remember: with respect to the application of the “flabjab injection” no evidence of lasting side-effects has been published in the medical literature of the world since 1995; the medicament has been used for years now with success and without any side-effects in form of intravenous interven-tions as well as in medical science (mesotherapy). Independent studies already proved that the substance does not have any toxical effect in the body and does not trigger any mutagenic effects.
Claim 5:
The active substance decomposes the fat in the course of a chemical reaction. In contrast to liposuction, the decomposed fat remains in the body and has to be catabolized. In case of greater quantities, the body is not able to transport the “waste” away sufficiently. This may result in bad inflammations and cyst formations, and in these cases, a surgical intervention exceeding the degree of liposuction becomes necessary.
As already stated in claim 3, more than 15,000 patients have been treated with the flabjab injection in the whole world during the past nine years. Among plastic surgeons, it is again and again alleged that these injections trigger “deformations”, “cysts” or “bad inflamma-tions”. This statement is not correct. The associations and surgeons fail to produce the corre-sponding evidences to the media or the treating doctors. Currently, some doctors investigate the legal possibilities to pursue such statements representing a harm for the image of the treat-ing doctors.
Claim 6:
The physician is not able to control the fat dissolution by injections because he cannot assess the individually appropriate dosage. The deposited fat differs from human being to human being and even from body part to body part. Each person reacts differently on the substance.
For this reason, the treatment may leave ugly holes or nods only after the injection of small quantities.
Within the past nine months, about 2,000 patients have been advised informed and - in most cases - also treated by the team around Dr. Gunther Steitz in Germany. In none of these cases any lasting side-effects occurred. In almost every case, however, the fat deposits at the treated regions were reduced to a clearly visible and perceptible degree. Apart from that, the treated body regions now show a clearly visible lifting of the skin. No one of the about 2,000 treat-ments triggered any “ugly holes”, “nods” or any other big or small deformations. On an aver-age, treatments lasted 15-20 minutes only, anesthetizations were not necessary, and immedi-ately after the treatment the patients were able to start with their daily routines without any restriction. The currently available independent studies about the active substance and the medicament as well as the experience gathered over many years with the flabjab injections demonstrate that further harms cannot be expected.
Claim 7:
Serious plastic surgeons refuse to apply the so-called “injection lipolysis”.
This statement, too, is not true. Following initial attempts to manipulate the public opinion in the U.S.A. a great number of plastic surgeons now started to accompany the procedure - rather critically. Meanwhile, there even exist many reputed plastic surgeons who make use of this method as an alternative to liposuction or for small fat regions. This is also the case in Austria and Germany. During the past months, for instance, many plastic surgeons decided to attend courses about “flabjab injections” and to offer the treatment. For more information please look at www.injektions-lipolyse.de.
Claim 8:
It is only in case of liposuction that the doctor is able to control the fat quantity to be elimi-nated individually and the body contours of the patient.
The difference between liposuction and the flabjab injections is that in case of liposuction the fat is eliminated directly (with known side-effects) whereas the flabjab injection triggers a natural procedure during which the body fat is decomposed over several weeks. The pur-posive application at a certain body region is possible in both cases - the approx. 2,000 pa-tients treated with the flabjab injections according to Dr. Steitz were always treated at a cer-tain body region - and with a very exact result all down the line.
Claim 9:
Patients should only have treated themselves by an experienced plastic surgeon.
“I fully agree if the treatment consists of liposuction or other cosmetic-surgical interventions”, says Dr. Gunther Steitz. “But whenever it is a matter of influenza, gastrointestinal problems or metabolism procedures in connection with injections - and this is the case with the flabjab injection - general practitioners still are the first contact persons of their patients. They still feel committed to recommend the most gentle method for their patients”. In view of the above-mentioned statement, it is particularly interesting that there already exist numerous plastic surgeons applying the flabjab injection. In many cases, they were trained by general practitioners having gathered a high degree of knowledge about this procedure...
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