Fat Dissolution - Lipolysis
Lipolysis - Melting superfluous fat away by means of an injection......
Phosphatidylcholine (PC) - a major constituent of lecithin - was originally used “Off Label” in 1988 by Dr Sergio Maggiori in the treatment of Xanthelasma (cholesterol deposits under the eyelid skin) and was effective because of its ability to make cholesterol more soluble, which aided dispersal of the Xanthelasma deposits.
PC was later used for the cosmetic dispersal of fat deposits. Following injection, PC interferes with the cell membrane of fat cells, which burst open releasing fat. This fat is taken up by macrophage cells and removed to the liver where it is excreted in the bile, and to a lesser extent in the urine.
The technique was developed, amid some controversy, and popularised, by Dr. Patricia Guedes Rittes, a South-American dermatologist, in 1995. http://www.lipolyte.com/lectithin_eyelid.pdf
However, the lack of State regulation of the drug, and popular use of PC by the Public, (purchasing the drug without ever consulting a doctor), led to a ban on the use of the drug by the public, in Brazil, where it is now a prescription only drug.
Dr. Franz Hasengschwandtner of Austria has
significantly refined Rittes' treatment protocols and has personally carried
out several thousand treatments. He has a respected international reputation
in this field and is one of the most experienced therapists within Europe. He
has been instrumental in forming a European Network-Lipolysis
for research and development of the Lipodissolve® technique,
(a registered tradename with the American Society of Aesthetic Lipodissolve
- ASAL http://www.asal-meso.com)
and for the clinical audit and governance of this therapy. Clinical governance
is crucial with respect to the maintenance of clinical standards of patient
care for optimum outcome, and patients are strongly advised to seek lipolysis
treatment under the direction of trained members of the European Network-Lipolysis
/ American Society of Aesthetic Lipodissolve.
The Lipodissolve Process
The active substance used in these injections, phosphatidylcholine, is a natural compound produced from the soya bean. The body uses the same substance in a number of chemical pathways, including fat metabolism.
• >10,000 Treatments World-wide
• Anaesthesia is not normally required
• No Serious Side Effects recorded
• Treatment recommended under the direction of trained medical experts
• Not yet officially approved in cosmetic surgery (e.g. similar to Botox)
• Phosphatidylcholine used in medicine e.g. prevention of fat embolism
Until recently PC injections were not be regarded as a new miracle drug for weight reduction. It was advocated for fat deposits which cannot be removed by diet or exercise. The injections were thought to help the natural metabolic process during which fat is melted away and then eliminated from the body. The medication is directly injected into the area concerned.
However, at the 1st International Congress of Injection Lipolysis in Salzburg (2005) the use of PC was demonstrated by Dr. Claudia van der Lugt in conjunction with a protocol for sustained weight reduction without the need for surgery. Dr van der Lugt has been working in this area for 8 years and has amassed large numbers of patients treated for obesity with this technique. Further coordinated research is advocated in this area.
• Permanent Effect - fat cells do not return
• Reduction of circumference measurements >7yrs
• Over dosage has not been reported
• Treatment intervals depend upon the body region
• 2-4 treatment sessions between 6-8 week intervals
The number of treatments differs from person to person, depending upon body region and body size. Due to the differing structure of the connective tissue and fat cells, it has been found that men do not respond to the therapy as well as women. As a rule, 2-4 treatments in intervals of 6-8 weeks are necessary to successfully complete the treatment.
Areas suitable for treatment include the face, buttocks, abdomen, and thighs. Using different techniques Lipodissolve is also effective in the treatment of cellulite and reducing the size of lipomas (fatty lumps), without resorting to surgery.
All patients should expect the following (usually minor) symptoms for around 72 hours following injection.
• Is noticeable following Injection circa 7days
• Requires adjustment of lifestyle and social activities
• a single dose of Non-Steroidal Anti-inflammatory Drugs may help muscle ache
• Severe allergy is very rare – but may require
• Permanent Reddening of Skin
• Nodule formation – disappears after 2 months / rarely permanent
• Temporary Circulatory Problems at time of injection – fainting sickness sweating
• Temporary Diarrhoea following treatment – bowel excretes fat
• Allergy – like nettle rash
• Intermenstrual Bleeding - fat cells release oestrogen
• Patients < 18 years old
• Pregnant women and Nursing mothers
• Diabetics with complications e.g. poor circulation
• Patients with current infections
• Severe immune deficiency disorders
You must declare any of the above
to your surgeon
Lipodissolve treatment is possible for the following groups of patients, but must be carried out with additional safeguards.....:
• Autoimmune Disease
• Serious Liver / Kidney Disease
• Gross Obesity BMI > 30
• Allergies / Hypersensitivity to Phosphatidylcholine / Soya Bean
• Bleeding Disorders
• Menstrual Abnormalities
You must declare any
of the above to your surgeon
The success of Lipodissolve injections is also a permanent
one but does not occur directly but after a certain time. Patients who underwent
a follow-up examination still show a definite reduction of their circumference,
and this even after seven years. This therapy is suitable for patients who do
not want to undergo a surgical intervention. Anaesthesia is not necessary for
this treatment. Over dosage or intoxications have not become known to occur.
The intervals between the treatments are different per individual patient and
depend upon the body region; they may amount to 6-8 weeks. Again depending upon
the body region treated and other factors, the number of treatments may amount
to 2-4 sessions. It has been reported that more than 80% of the patients are
very satisfied with the results after 2-3 treatments.
It should be noted that Lipolysis injections should not be
expected to result in weight loss; they rather help to modify body contours.
The effect of Lipolysis injections must not be compared with liposuction, a
surgical method permanently removing also greater amounts of fat by means of
Although a relatively new treatment, many thousands of treatment courses all over the world have now been completed. In the UK around three complications have been reported - allegedly related to the cosmetic use of phosphatidylcholine and an allergic response.
The respective case reports remain unpublished and the diagnoses have not been confirmed, by the UK regulatory body, the MHRA.
At the time of writing (December 2005) allergy following the cosmetic use of phosphatidylcholine is a possibility in view of its origin from the soya bean, but this has not been confirmed. Injection Lipolysis should therefore only be carried out by medical experts trained in this field.
In order to obtain successful results knowledge of the anatomical distribution of fat deposits in the body, the correct injection technique and the right dosage for the treatment are of the utmost importance.
It is to be noted on the limited evidence available, that injection lipolysis appears to be much safer than other modes fat recontouring, notably liposuction, which has a significant morbidity and mortality.
This is discussed in detail by Ninian Peckitt in a definitive review of the Mode of Action of Phosphatidylcholine in Injection Lipolysis - available through Jeremy Mills Publishing Ltd
Off Label Use of Drugs http://www.off-label.com/
In order for a pharmaceutical/biotechnology company to promote and sell a medicine, the company must first obtain a license (or ‘label’) that authorises uses for which the drug has been shown to be effective without causing unacceptable side effects. It is important to emphasise that this license/label is intended to regulate the activity of the company which must market the drug strictly for those conditions that are clearly described within the license/label. This licensing process does not regulate a doctor's prescribing practice. In the UK for example, the Medicines Act 1968 specifically safeguards a doctor's clinical freedom.
When a drug is used to treat a condition or manage a symptom that is not included within the Marketing Authorisation/label, or when the administration or population to which it is administered differs from that defined, then such use is known as 'off-label'.
While it can take twenty years for a new drug to progress from discovery into clinical practice, in reality when a drug becomes available to prescribers this represents the start of a never-ending learning process. Many drugs have more than one mechanism of action and the specific targets of a drug's pharmacological activity will often be expressed in many different disease states. Such profound overlap means that virtually all drugs have important uses that are not those for which the drug was originally approved, and which only become apparent with increasing clinical use.
For many specialties that include Palliative Care, Oncology, Psychiatry, Neurology, Pain, and Gastroenterology, off-label use is an essential and necessary component of patient care. Cumulatively, the off-label use of drugs is an invaluable resource that in addition to providing prescribers with an evolving supply of new and exciting therapies, also gives researchers and manufacturers new insights for the development of future drugs.
Although phosphatidylcholine has been used for years elsewhere, these injections have not yet been officially approved as an aesthetic (cosmetic) therapy in the UK. This is in common with many other treatments, including muscle relaxing injections such as Botox, for fine lines and wrinkles, which is used world wide in aesthetic medicine. In the case of Lipolysis, the active ingredient of phosphatidylcholine has been widely used for other medical applications such as the prevention of fat embolism, without significant problems.
United Kingdom Embargo - Injection Lipolysis
In June 2005 the UK's Medical Protection Society removed indemnity cover for the use of phosphatidylcholine in the cosmetic treatment of fat deposits, following advice that the safety of subcutaneous phosphatidylcholine has not been officially demonstrated to the satisfaction of the MHRA - the government body in the UK charged with the duty to review the safety and efficacy of medicines / drugs. It was acknowledged that many practitioners offering this therapy were not in agreement with the MHRA position, but that under the circumstances, further use of PC for cosmetic purposes could not be sanctioned.
Only when the safety of subcutaneous phosphatidylcholine has been demonstrated to the satisfaction of the MHRA - can treatment practically re-commence in the UK.
Clinicians challenging this position and continuing to offer this treatment in the UK are operating within the UK Law.
However clinics and clinicians are not allowed to market the service in the UK and run the risk of criminal proceedings / disciplinary action by the General Medical Council with erasure from the Medical Register in the event of a complaint related to any illegal marketing of an off label drug.
Clinicians also risk serious censure and / or disciplinary action by the General Medical Council in realtion to any complications related to cosmetic lipolysis treatment.
The MHRA position is that the regulations pertaining to off label use of the drug phosphatidylcholine for cosmetic purposes will be strictly enforced and it is to be noted that same position has not been emphasised for hundreds of other drugs used in an off label capacity, including those currently used in cosmetic medicine. For example the marketing of the cosmetic (off label) use of Botox is widespread in the UK and as such is illegal. This situation has not resulted in any prosecution as far as the author is aware. This is especially surprising as one of the rare complications of botox is cardiac arrest.....
The cosmetic use of a drug does not constitute a special (clinical) need under SI 1999/4 and this means that, even if safety can be demonstrated to the satisfaction of the MHRA, a license for the cosmetic use of phosphatidylcholine will not be granted in the United Kingdom.
This means that even when safety issues are met, the drug will still be used in an off label manner.
The NCAFOS position is that a mechanism of the regulation of cosmetic medicine drugs is required in the interests of Public Safety in the UK, so that the organisation of clinical studies can be conducted to meet the safety requirements of the MHRA and to license a medicinal product for cosmetic use.
If clinical studies can be organised, interested patients should register with the NCAFOS by email below.
You have the opportunity of discussing the treatment with your surgeon who is accredited in the use of phosphatidylcholine as well as other treatment options. You will be encouraged to take time to make your decision.
Lipolysis represents a new cosmetic treatment and currently
unavailable UK. As it is the case in all medical /cosmetic therapies, there
is a treatment failure rate, and even when treated to the highest standard and
following existing clinical protocols, sometimes it is possible that the results
achieved may be less than anticipated.
Results cannot be absolutely guaranteed in any cosmetic procedure
by any surgeon, and in the case of Lipodissolve, the efficacy of the treatment
varies from individual to individual, and a number of treatments may be necessary
to give optimum improvement.
You must give the doctor providing the treatment all the relevant
medical details prior to treatment. Pre-treatment assessment can include body
measurement and photography.
An international platform has been created where clinicians using Lipodissolve can exchange their experience and submit an audit of cases treated.
The NETWORK presently cooperates with the Ruhr University of Bochum a team under the leadership of Dr. Hoffmann, senior physician, with respect to a trial designed to find out the mode of action and the efficacy of the therapy.
Case Studies (cases courtesy Network-Lipolysis)
Any cosmetic surgical treatment around the eyes including eyebag surgery (blepharoplasty) has a theoretical risk of producing bleeding and pressure on the optic nerve, with an association of vision problems. Whilst these complications are very rare indeed, they can have devastating consequences for the patient. It is vitally important that these treatments are carried out by surgeons experienced in surgical decompression of the orbit, to avert this theoretical complication, and to promote the interests of patient safety.
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