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    Lipolysis Report

    The Lipolysis Report summarises material supplied to us by the members of the NETWORK-Lipolysis who conduct out application observations on the patients treated by them. All patient data is anonymised before being statistically processed by us.

    First Considerations

    March 16, 2004: Why a follow-up study?

    Initially, the physicians of NETWORK-Lipolysis were not aware about how they could initiate a development of the therapy without violating the rules of ethics commissions which use to accompany and supervise studies etc., particularly because these commissions have been established for good reason. It was above all Dr. Hasengschwandtner who dealt with this topic very thoroughly and who finally came to the conclusion that there do not exist any important objections against a careful application of the therapy. Thus, he was one of the first European physicians who documented their treatments; furthermore, he carried out a statistical analysis. These data have now been summarized in the Lipolysis Report 2003. The members of our NETWORK intend to monitor all treated patients in the long run and to exchange these data. The first results of all participants will be published in the Lipolysis Report 2004.

    In order to ensure a uniform standard only physicians who 1. participate in the follow-up study and 2. were trained by NETWORK-Lipolysis, Dr. Hasengschwandtner qualify for membership in NETWORK-Lipolysis. The uniform therapy standards are supposed to make comparable results of the follow-up study possible. In addition, the NETWORK members make use of the same information material for their patients and said material ensures relentless information. In the beginning, Dr. Hasengschwandtner and colleagues will train medical experts practicing in the German-speaking territory. And in the second half of the year, the colleagues coming from the non-German-speaking territory will be trained and may participate in the NETWORK.

    The Editors

     

    February 21, 2004: Dear Colleagues

    After having considered the possibilities for a research into the combined effects of lipodissolve injections very thoroughly I would like to propose the following theses and the resulting conclusion as working basis for our further approach.

     

    Thesis 1

    The active substance phosphatidycholine has already been researched very well in the last decades. Due to its use as medicine, clinical studies about the burden for the body when disposing of destructed fat cells have already been conducted. In my opinion, its use for an injection into fat cells is riskless against the background of all facts already known. On careful consideration of all risks, I thus decided to carry out treatments. And I am totally aware that I share the risk as it is the case with botulinus toxin injections and anyway with any other physician’s activity. For this reason, it is very important to inform any patient prior to the treatment about all possible risks.

     

    Thesis 2

    If I were to consider the risk of liposuction on the one hand and lipodissolve injections on the other hand I would assign much more risks to liposuction.

     

    Thesis 3

    Due to the enormous costs, a clinical study in order to have the therapy officially approved would only be possible with the financial support of the manufacturer. The manufacturer, however, is in no way interested to assume the risk itself and to apply for an extended approval; and here we have another parallel to botulinus toxin. In particular, claims for damages are feared like it was the case in the U.S.A. So, we cannot expect any official approval in the years to come.

     

    Thesis 4

    If I am ready to carry out the therapy on my own risk because I proceed from the assumption that there does not exist a risk for the patient our NETWORK-Lipolysis should work as an early warning system with respect to side-effects unknown up to date in order to exclude any danger or risk for the patients. Our cooperation offers the possibility to communicate each and every risk immediately and consequently to reduce it considerably – for the treating physician and for the patients.

     

    Thesis 5

    A statistical survey of the treatments has not been made. For this reason, we are in urgent need of a validated data basis. I propose to draw up monthly assessments of all treatments – like it has been done in my Lipolysis Report 2003 – and to interrogate the patients about side-effects and results. The statistical basis is to give us the required security to present the therapy offensively as an alternative to the traditional methods of fat reduction.

     

    Thesis 6

    In order to increase our basis in terms of numbers we should make interested colleagues familiar with the correct injection techniques and dosages by means of workshops. I propose a total number of 50 physicians in Austria, Switzerland and Germany in order to have the statistical analysis, especially with a view to the therapy’s effect, validated as soon as possible. So, it should be a precondition for a workshop attendance that interested colleagues agree to take part in this platform with the follow-up study proposed by me.

     

    Conclusion

    NETWORK-Lipolysis offers us a security by means of further statistical elaborations of our common data to be analysed centrally. Thus, we are – on an international level - the only NETWORK working with figures and facts rather than with positive or negative opinions or mini-studies. So, my proposal is: immediate start of the therapy and the follow-up study with statistical analysis according to the scheme already used by me in the Lipolysis Report 2003.

    Dr. Franz Hasengschwandtner

     

    January 10, 2004: The follow-up study is to be based upon three colummns

    Prior to and after each injection, the interrogation of the patients by the treating physician with respect to their own assessment of the results, prior to each further injection, together with photo documentation, laboratory examination and histology (examination of the fine tissue) of the fatty tissue.

    General considerations

    As far as researches of phosphatidylcholine for this field of application are concerned we are just in the beginning; this situation may be compared with the situation in which the active substance botulinus toxin, a neurotoxin, was discovered for use in aethetic medicine. The substance was originally used for patients suffering from spasmodic cramps and continues to be used in this field with success. Today, this active substance is being used for more and more fields of application within the aethetic medicine. Everywhere where stress results in cramps and disturbances of perfusion the substance serves to inactivate the affected muscles for a certain period of time. When used by laymen, e.g. by cosmeticians or untrained doctors, this very dangerous neurotoxin can entail terrible consequences; in the hands of experts, however, it is rather riskless for the patient.

    Here, we find a parallel line not only with respect to the development originating in a certain field of application and moving towards aethetic medicine but also with respect to its importance for injection techniques. In case of phosphatidycholine, too, the injection technique is of utmost importance because the injection has to be made into the fat cells only and in no case into the surrounding muscles.

    We must, however, note that our research does not start at zero. The application has not revealed any side-effects always provided the injection technique is applied correctly. Although the cosmetic surgeons in the U.S.A. were up in arms against the use of phosphatidycholine in the beginning this attitude has somewhat changed in the meantime. Today, even well-known clinics in the U.S.A. offer lipodissolve injections as an alternative to liposuction.

    Manufacturers are warning about a negligible use for this treatment, and they are right from our point of view. This warning was above all expressed because in Brazil undue treatments by untrained medical experts and even self-treatments by patients were recorded.

    MD Dr. Franz Hasengschwandtner

    February 21, 2004: Dear Colleagues (copy 1)

    After having considered the possibilities for a research into the combined effects of lipodissolve injections very thoroughly I would like to propose the following theses and the resulting conclusion as working basis for our further approach.

     

    Thesis 1

    The active substance phosphatidycholine has already been researched very well in the last decades. Due to its use as medicine, clinical studies about the burden for the body when disposing of destructed fat cells have already been conducted. In my opinion, its use for an injection into fat cells is riskless against the background of all facts already known. On careful consideration of all risks, I thus decided to carry out treatments. And I am totally aware that I share the risk as it is the case with botulinus toxin injections and anyway with any other physician’s activity. For this reason, it is very important to inform any patient prior to the treatment about all possible risks.

     

    Thesis 2

    If I were to consider the risk of liposuction on the one hand and lipodissolve injections on the other hand I would assign much more risks to liposuction.

     

    Thesis 3

    Due to the enormous costs, a clinical study in order to have the therapy officially approved would only be possible with the financial support of the manufacturer. The manufacturer, however, is in no way interested to assume the risk itself and to apply for an extended approval; and here we have another parallel to botulinus toxin. In particular, claims for damages are feared like it was the case in the U.S.A. So, we cannot expect any official approval in the years to come.

     

    Thesis 4

    If I am ready to carry out the therapy on my own risk because I proceed from the assumption that there does not exist a risk for the patient our NETWORK-Lipolysis should work as an early warning system with respect to side-effects unknown up to date in order to exclude any danger or risk for the patients. Our cooperation offers the possibility to communicate each and every risk immediately and consequently to reduce it considerably – for the treating physician and for the patients.

     

    Thesis 5

    A statistical survey of the treatments has not been made. For this reason, we are in urgent need of a validated data basis. I propose to draw up monthly assessments of all treatments – like it has been done in my Lipolysis Report 2003 – and to interrogate the patients about side-effects and results. The statistical basis is to give us the required security to present the therapy offensively as an alternative to the traditional methods of fat reduction.

     

    Thesis 6

    In order to increase our basis in terms of numbers we should make interested colleagues familiar with the correct injection techniques and dosages by means of workshops. I propose a total number of 50 physicians in Austria, Switzerland and Germany in order to have the statistical analysis, especially with a view to the therapy’s effect, validated as soon as possible. So, it should be a precondition for a workshop attendance that interested colleagues agree to take part in this platform with the follow-up study proposed by me.

     

    Conclusion

    NETWORK-Lipolysis offers us a security by means of further statistical elaborations of our common data to be analysed centrally. Thus, we are – on an international level - the only NETWORK working with figures and facts rather than with positive or negative opinions or mini-studies. So, my proposal is: immediate start of the therapy and the follow-up study with statistical analysis according to the scheme already used by me in the Lipolysis Report 2003.

    Dr. Franz Hasengschwandtner

     



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