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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 Skin+ Packages 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™, introduced to the UK in 2013, is an injectable 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 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 as Flabjab™, Lipomelt, Liposdissolve and 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 information on the issues with this .

, introduced to the UK in 2013, is an injectable of deoxycholate solution (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 dissolves 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 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 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®. 

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 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 medicine in Germany, its country of origin, for the prevention and treatment of blood vessel blockages by fat particles (fat embolism). It is not approved or licensed for cosmetic use. Product safety has not been established for use for cosmetic purposes. Consumers should be aware of this should they be 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 allergic or sensitivity issues to the product. The usual route of administration for cosmetic surgery is (injection under the skin) and this is warned against in the manufacturer’s sheet which specifically states that Lipostabil® should not be given subcutaneously.

is not licensed in the UK. However, it may be imported into the by doctors for clinical use for the prevention and treatment of fat embolism subject to compliance with the Medicines ( 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 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 Lipostabil® for cosmetic purposes does not constitute a special 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 for cosmetic use and continues to investigate a number of cases where medicines legislation may have been .

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 "medicinal product" is defined in Article 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 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 Lipostabil® is a relevant 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 with section 3(1) of S.I. 1994/3144, no relevant medicinal product shall be placed on the market unless a authorisation (formerly Product Licence) has been granted for it.

Circumstances in which an unlicensed medicinal product may be supplied.

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

The conditions are set out in paragraph 2 of Schedule 1. In very general terms there must be a bona fide unsolicited 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 product 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 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 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 unlicensed relevant medicinal product must comply with the provisions of Paragraph 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 to the Licensing Authority (LA) concerning the of the unlicensed 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 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 not those relating to cosmetic products are therefore those which are applicable to Lipostabil

Further information 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 available 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 available for the reduction of fat. 

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

Active Ingredient: Phosphatidylcholine

Q Has the MHRA determined 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, 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 requirement to have a marketing authorisation by regulation 3(2) and paragraph 1 of Schedule 1 to SI 1994/3144. The exemption is limited to products which fulfil a clinical need. Where such a product is supplied by wholesale dealing, conditions may apply under regulation 11 of and Schedule 4 to the Medicines for Human Use (Manufacturing, Wholesale and Miscellaneous Amendments) Regulations 2005 (SI 2005/2789). In particular, importers of such 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 Economic Area (EEA) must be holders of Wholesale Dealers Licences (WL), those from outside the EEA must be holders of 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 ?
A Lipostabil® is a preparation of phosphatidycholine for intravenous use.

Q What use is Lipostabil® authorised for in its 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 reduction?
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 as part of the application for a marketing authorisation for treatment of fat embolism. The usual route of administration for cosmetic use is . 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 adverse reactions to cosmetic treatment 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 product 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 of the distribution network from manufacturer to end user, including storage by the end user, is of major importance in ensuring the quality of medicines. Recommendations concerning storage