Lipotherapy (Injection Lipolysis) In Dippin

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 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 product.

AQUALYX™, introduced to the UK in 2013, is an injectable treatment 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. 

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 cosmetic 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 particles (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 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 product for cosmetic use and continues to investigate a number of cases where medicines legislation may have been breached.

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 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 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, 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 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 assessed as part of the application for a marketing authorisation for treatment of fat embolism. The usual route of administration for cosmetic 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 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 Yellow Card Scheme website address.

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 control 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 temperatures given on product labels and in product literature are made to ensure optimum stability of products to which they relate in order to help to ensure that they remain safe and effective. For example, storage and transportation of medicines at temperatures above those recommended, can increase their rate of degradation. Failure to adhere to such requirements may result not only in reduced effectiveness, but also in increased toxicity.

MHRA considers that if a doctor is involved in, for example, recommending a supplier, assisting in ordering or storing the medicinal product, the product cannot be regarded as imported for personal use.

Q If I import this product for personal use into the UK, can I lawfully give it to anyone else?
A Someone who personally imports Lipostabil® for his own use may give it to someone else in certain limited circumstances, e.g. a family member. Determination of whether importation is for personal use will depend on the particular factual circumstances and is ultimately a matter for the courts.

Q I have seen Lipostabil® advertised in the UK - what is the situation with this?
A Unlicensed medicines may not be advertised or marketed in the UK. In addition, it is not lawful to advertise a prescription only medicine to the public. Lipostabil is a prescription only medicine. The MHRA will investigate cases where either activity appears to have taken place, and may take regulatory action.
 
Advertising includes every form of advertising, whether in a publication, or by the display of any notice, or by means of any catalogue, price list, letter (whether circular or addressed to a particular person) or other document, or by words inscribed on any article, or by the exhibition of a photograph or a cinematograph film, or by way of sound recording, sound broadcasting or television, or in any other way, and any reference to the issue of an advertisement shall be construed accordingly

Further information:

The MHRA website at www.mhra.gov.uk

To view the full PDF version of this question and answer sheet (Size 32kb) from the Medicines and Healthcare products Regulatory Agency (MHRA), please click here.