U.S. FDA slams Lipodissolve clinics for misleading consumers

Posted on the 22 April 2010 at 11:59

Lipodissolve, Flab Jab™, Lipomelt, Lipozap and Lipotherapy, amongst others, are all marketing names used to describe the treatment of injection lipolysis whereby a drug or combination of drugs and other substances are injected into the skin in the location of small fatty deposits, such as on the thighs, arms and abdomen with the aim of causing the destruction of the fat cells, thus inducing small scale permanent fat loss.

 

The U.S. Food and Drug Administration (FDA) has recently issued warning letters to six medical spas based in America and a company in Brazil who market the online sale of the products used for making false or misleading statements on their websites about drugs they claim will eliminate fat in such procedures or for otherwise misbranding such products. The FDA has issued an import alert against the Brazilian company and its websites to prevent the importation and distribution of unapproved injection lipolysis drug products into the United States.

 

The issue has arisen as the companies involved have made claims that the drugs they use are 'safe and effective'; however, these products have not been evaluated or approved by the FDA for this use (i.e. cosmetic fat removal). Similarly this is the same situation in the UK in relation to the licensing of the drugs through the Medicines and Healthcare products Regulatory Agency (MHRA), whereby a cosmetic licence has not been granted for phosphatidylcholine (Lipostabil®), a drug normally used to treat fat embolisms in arteries which became a popular lipotherapy drug. The FDA is warning about the use of this drug and another called deoxycholate.

 

As well as their use in isolation the FDA is also concerned about their combined use with other substances such as vitamins, minerals and herbal extracts in treatments marketed under the term ‘mesotherapy’, a word which tends to describe a technique rather than a treatment and can be confusing or misleading to consumers. The FDA notes that it is not aware of any credible scientific evidence that supports the effectiveness of any of these substances for fat elimination; and their safety when used alone or in combination is said to be unknown.

 

Each of the companies involved has been cited by the FDA for a variety of regulatory violations in the USA, including making unsupported claims that the products have an outstanding safety record and are superior to other fat loss procedures, including liposuction. Additionally some have made claims that lipodissolve products can be used to treat certain medical conditions, such as male breast enlargement or gynaecomastia and benign fatty growths known as lipomas. Again the FDA makes clear that is not aware of clinical evidence to support any of these claims and is requesting that the companies involved correct these violations or face legal action.

 

In the UK, much controversy was caused when the use of phosphatidylcholine became popular and widely marketed as the Flab Jab™ back in 2005. The MHRA issued warning letters to educate consumers of the dangers it saw with this unlicensed drug.

 

However, Network Lipolysis (www.network-lipolysis.com), a European based physician network which includes 46 UK based practitioners, has issued a statement on its website in response to the FDA which highlights the fact that more than 50 scientific publications are available on the subject of injection lipolysis.

 

The organisation explains; “Some are done on a large scale and include double-blind studies. Therefore scientific evidence is given which defines the new therapy injection lipolysis as an effective therapy with good safety and a low side effect profile as long as the doctors have undergone skilful corresponding training. Many studies included safety as an important aspect of the therapeutic approach. More than 100,000 treatments in total have been documented. The rate of more serious complications is 0.0017%. Compared to many other therapies the complication rate can be called extremely low.”

 

The FDA, like the MHRA claims to have received reports of adverse effects in those who have been treated with the two named drugs for injection lipolysis, including permanent scarring, skin deformation, and deep painful knots under the skin in areas where the products have been injected. It warns consumers who are considering treatment to think twice.

 

The debate over this therapy and the drugs involved is set to run and run...

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