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Lipotherapy or Injection Lipolysis for Cellulite and Fat Reduction Information

Procedure Time: minutes, multiple sessions may be required

Recovery Time: Varies by product brand

Results Duration: Usually permanent, depending on diet and lifestyle

Cost: Varies by product brand

Anaesthesia: Local anaesthesia

For a full list of FAQs please .

Lipotherapy or Injection Lipolysis treatment involves the use of an injectable solution to break down stubborn areas of fat, which are then eliminated through the body's own system. This treatment area has been controversial at times, with much talk about safety and efficacy of the various products on the market. Lipostabil®, also marketed as Flabjab™, Lipomelt, Liposdissolve and Fat-Away, which contains phosphatidycholine has being unlawfully advertised in the UK as a cosmetic product for the reduction of fat since 2004. Lipostabil® is not licensed in the UK. AQUALYX™, to the UK in 2013, is an injectable treatment of deoxycholate which is being marketed for ‘Aqualysis’ or ‘Aquaplasty’ treatment as a means of treating localised pockets of fat underneath the surface of the skin. This is a European CE Marked Medical Device.

Lipotherapy or Injection Lipolysis for Cellulite and Fat Reduction Information FAQs

The treatment of Lipotherapy or Injection Lipolysis, whereby a substance is injected into stubborn pockets of fat in order to reduce them by causing their destruction and elimination by the body has been a highly controversial one, with much talk about safety and efficacy of the various products on the market. 

One such treatment, Lipostabil®, which was also marketed as Flabjab™, Lipomelt, Liposdissolve BBL Hero and Moxi by Sciton, visit site, Fat-Away, was being unlawfully advertised in the UK as a cosmetic product for the reduction of fat over a decade ago. Please see below for more on the issues with this product.

, introduced to the UK in 2013, is an injectable treatment of deoxycholate (containing deoxycholic acid) which is being marketed for ‘Aqualysis’ or ‘Aquaplasty’ treatment as a means of treating localised pockets of fat underneath the surface of the skin. It or liquefies fat cells once injected and the resulting fatty acids can then be excreted through the body’s lymphatic system. 

Lipostabil®, also marketed as Flabjab™, Lipomelt, Liposdissolve and Fat-Away, is being unlawfully advertised in the UK as a cosmetic product for the reduction of fat.

Lipostabil® is licensed as an intravenous medicine in Germany, for the prevention and treatment of blood vessel blockages by fat particles (fat embolism). It is not approved or licensed for use. Product safety has not been established for subcutaneous use for cosmetic purposes. Consumers should be aware of this should they be offered the product.

The Medicines and products Regulatory Agency (MHRA) has received three reports of potential adverse to cosmetic treatment with Lipostabil®. 

Lipostabil® is not licensed in the UK. Unlicensed medicines may not be advertised and Lipostabil® should not be imported for cosmetic purposes. The MHRA has concerns about the safety of this product for cosmetic use.

Press Release: Lipostabil® not licensed for cosmetic use

Lipostabil®, also marketed as Flabjab™, Lipomelt, Liposdissolve and Fat-Away, is being unlawfully advertised in the UK as a product for the reduction of fat.

Lipostabil® is licensed as an intravenous medicine in Germany, its country of origin, for the prevention and treatment of blood vessel blockages by fat (fat embolism). It is not approved or licensed for cosmetic use. Product safety has not been established for subcutaneous use for cosmetic purposes. Consumers should be aware of this should they be offered the product.

The Medicines and Healthcare products Regulatory Agency (MHRA) has received three reports of potential adverse reactions to cosmetic treatment with Lipostabil®. Some patients may experience allergic reactions or sensitivity issues to the product. The usual route of administration for cosmetic surgery is subcutaneous (injection under the skin) and this is warned against in the manufacturer’s information sheet which specifically states that Lipostabil® should not be given subcutaneously.

Lipostabil® is not licensed in the UK. However, it may be imported into the country by doctors for clinical use for the prevention and treatment of fat embolism subject to compliance with the Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations (SI 1999/4). This allows for importation from elsewhere in the EU by holders of Wholesale Dealers Licences, or from outside of the EU by holders of Wholesale Dealers Import Licences. When ordering, proof must be available from the doctor to demonstrate the existence of a special clinical need for the patient. The MHRA must be consulted about the import by the wholesaler using the notification procedure set out in SI 1999/4. The use of for cosmetic purposes does not constitute a clinical need.

Unlicensed medicines may not be advertised in the UK and Lipostabil® should not be imported for cosmetic purposes. The MHRA has concerns about the safety of this product for cosmetic use and continues to investigate a number of cases where medicines legislation may have been breached.

To Whom It May Concern,

It has come to the Agency’s attention that the product Lipostabil®, also marketed as Flabjab™, Lipomelt, Lipodissolve and Fat-Away, is being promoted as a cosmetic in the UK and is available for the reduction of fat.

Definition of a medicinal product

A relevant "medicinal product" is defined in 1 of Directive 2001/83/EC as:

"Any substance or combination of substances presented for treating or preventing disease in human beings. Any substance or combination of substances which may be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings is likewise considered a medicinal product".

Lipostabil

The product Lipostabil® is an intravenous preparation of phosphatidycholine and is for the prevention and treatment of blood vessel blockages caused by fat particles (fat embolism). It is indicated as a medication for reducing blood fat (liquid reducer). It is a licensed medicine in some European Member States but not the UK.

The Medicines and Healthcare products Regulatory Agency (MHRA) has determined that is a medicinal product and subject to the provisions of The Medicines For Human use (Marketing Authorisations Etc) Regulations 1994 as amended (Statutory Instrument 1994/3144). In accordance with section 3(1) of S.I. 1994/3144, no relevant medicinal product shall be placed on the market unless a marketing authorisation (formerly Product Licence) has been granted for it.

Circumstances in which an unlicensed medicinal product may be supplied.

In the UK, an unlicensed medicinal product (other than a herbal medicine in respect of which different rules apply) may only be supplied in accordance with the provisions of Schedule 1 to S.I. 1994/3144. This provides amongst other things, that to certain conditions, an unlicensed product may be supplied in to the order of a doctor or dentist, and on his responsibility, to meet the clinical needs of an patient.

The conditions are set out in paragraph 2 of Schedule 1. In very general terms there must be a bona fide order. The relevant medicinal product must be formulated in accordance with the requirements of a doctor or dentist registered in the UK for use by his individual patient on his /her responsibility. It must be supplied to a doctor or dentist, or for use in a registered pharmacy, hospital or health centre. The relevant medicinal must also be manufactured, assembled, imported or distributed by the holder of an authorisation.
We would draw attention, in particular, to the fact that the regulations expressly provide that such products cannot be advertised to the general public or included in any catalogue, circular or price list.

Importation

Persons who source a relevant medicinal product from another Member State of the European Economic area (EEA- all EC countries, together with Norway, Iceland and Liechtenstein) other than for personal use must hold a Wholesale Dealer’s Licence (WL). Persons importing a product from outside the EEA must hold a Wholesale Dealer’s Import Licence (WI) (Section 3 of SI 1994/3144).

A holder of a WL or WI license who imports an relevant medicinal product must comply with the provisions of 8B of Schedule 3 to the Medicines (Standard Provisions For Licences And Certificates) Regulations 1971 which provides that the holder of a WL or WI who imports an unlicensed relevant medicinal product for the purpose of sale and supply in accordance with schedule 1 of S.I. 1994/3144 must meet specified requirements. The requirements provide for notification to the Licensing Authority (LA) concerning the importation of the relevant medicinal product, record keeping and set maximum quantities for import.

The quantities permitted per importation are: 25 individual doses, or sufficient material for 25 patients in a 3 month period. Following receipt, the LA has 28 days to assess notifications.

Regulation of cosmetic products is governed by the Cosmetic Directive 76/768/EC. Lipostabil is not a cosmetic product within the meaning given to that term by the Cosmetic Directive. The recitals to the Directive state expressly that:-

"….products containing substances or preparations intended to be ingested, inhaled, injected or implanted in the human body do not come under the field of cosmetics;"

The regulations described above relating to medicinal products not those relating to cosmetic products are therefore those which are applicable to Lipostabil

Further information concerning the supply of unlicensed relevant medicinal products for individual patients and The Medicines (Standard Provisions For Licences And Certificates) Amendment Regulations 1999 (SI 1999/4) is on the MHRA web-site.

Questions and answers about Lipostabil®, also marketed as Flabjab™, Lipomelt, Lipodissolve and Fat-Away, which is being illegally promoted as a cosmetic in the UK and is for the reduction of fat. 

Synonyms: Lipodissolve, Flabjab™, Fat-Away, Lipo-melt

Active Ingredient: Phosphatidylcholine

Q Has the MHRA determined Lipostabil® to be a relevant medicinal product?
A Yes, the MHRA considers that Lipostabil is a relevant medicinal product within the meaning of the Medicines for Human Use (Marketing Authorisations Etc) Regulations 1994, as amended (S.I. 1994/3144).

Q Does the product have a Marketing Authorisation (sometimes referred to as a product licence)in the UK?
A No.

Q Can a medicinal product be imported, supplied or used in the UK  without a marketing authorisation?
A. Yes, if it is either imported for personal use (discussed below) or if it is exempt from the to have a marketing authorisation by regulation 3(2) and paragraph 1 of Schedule 1 to SI 1994/3144. The is limited to products which fulfil a clinical need. Where such a is supplied by wholesale dealing, further conditions may apply under regulation 11 of and Schedule 4 to the Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 (SI 2005/2789). In particular, importers of such products must provide MHRA with prior notification of import. Importation will only be permitted where the relevant conditions in Schedule 1 to SI 1994/3144 and Schedule 4 to SI 2005/2798 are met.

Importers from elsewhere in the European Economic Area (EEA) must be holders of Wholesale Dealers Licences (WL), those from outside the EEA must be holders of Manufacturer's Licences, (ML) (previously Wholesale Dealers Import Licences WI, now being updated to Manufacturer's Licences.
 
Q Does the product have a marketing authorisation elsewhere?
A Yes, in Germany.

Q What is Lipostabil®?
A Lipostabil® is a preparation of phosphatidycholine for intravenous use.

Q What use is Lipostabil® authorised for in its country of origin?
A For prevention (prophylaxis) and treatment (therapy) of blood vessel blockages by fat particles (fat embolism).
 
Q What about cosmetic use for fat ?
A It is not authorised for this use.

Q Is this product authorised anywhere for cosmetic use?
A No.
 
Q Has the product been assessed for safety for cosmetic use?
A The product’s safety for cosmetic use would not have been assessed as part of the application for a marketing authorisation for treatment of fat embolism. The usual route of administration for use is subcutaneous. This is contraindicated (specifically warned against) in the manufacturer’s information sheet.

Q Are there any known adverse reactions to cosmetic treatment with Lipostabil®?
A The MHRA is aware of at least three potential reactions to cosmetic with Lipostabil® in the UK.
 
Q Surely, subcutaneous use for cosmetic treatments is safer than IV use for the licensed indication?
A The product information sheet from the manufacturer specifically contra-indicates subcutaneous injection of the product (injection under the skin). Therefore, MHRA has particular concerns about its safety in cosmetic use.

Q Are there any other safety concerns with Lipostabil®?
A The product is based upon soya bean extracts and also contains benzyl alcohol. There may therefore be allergy or sensitivity issues in some patients.
 
Q What should I do if I suspect this treatment has affected meadversely?
A You should speak to your GP and ask them to complete a yellow card which will report the adverse reaction to the MHRA, or alternatively you can submit a report directly to the MHRA using the .

Q Why is this product banned by the MHRA?
A The MHRA has not banned the product. The manufacturer has not applied for a marketing authorisation in the UK.

Q Can I bring this in for my own personal use?
A The regulations do not prohibit individuals from importing Lipostabil® for their own personal use. However, you should be aware that control of the distribution network from to end user,