| LIPOLySIS TREATMENTS | ANALYSIS Having said that, the FDA’s comments


on lipodissolve do nothing to stoke the market. The agency makes clear that it: ■ Has not evaluated or approved products for use in lipodissolve ■ Is not aware of evidence supporting the effectiveness of the substances used in lipodissolve for fat elimination ■ Cannot speak for the safety of these substances, when used alone or in combination ■ Is not aware of clinical studies to support medical uses of lipodissolve.


It also lays out the side‑effects as possible permanent scarring (at the injection site or as a result of allergic response), local and generalised bacterial and fungal infections, inflammation, skin deformation and hardening, and contour changes— the deep, painful knots that can appear under the skin if the lipodissolve treatments are injected without due care and attention. The case against the products in France


has been built with the help of side‑effect cases reported in the press. For instance, a leading daily, France Soir, carried articles referring to complications in a young patient injected with hypotonic saline, who went on to experience a subcutaneous trochanteric abscess requiring antibiotic treatment and surgical drainage during a 10‑day hospital stay; and a patient with skin necrosis over a larger area requiring surgery, subsequent pain and scarring. The FDA’s warning letters were issued to


prevent the companies in question from claiming lipodissolve was variously safe and effective, has an outstanding safety record and is superior to other fat‑loss procedures, including liposuction. The FDA may leave the decision‑making


to the consumer, but equally there are lobby groups militating against lipolysis, just as there are groups outraged at France’s unilateral and strong regulatory action.


Lipolysis injections safety questions The compounds most regularly used in lipolysis injections are phosphatidylcholine (PC) and deoxycholate (DC) sodium. Other ingredients — vitamins, minerals and herbal extracts — can also be incorporated. The injections are typically used on many parts of the body — the facial region (double chin, cheeks and neck), thighs, buttocks, 'spare tyres', hips, belly, shoulder/arm joints, arms, knees and back. They are also commonly used for cellulitis treatment and to address lipomas.


The International


Society for Lipolysis Therapy claims that over 80% of patients are very satisfied with their lipolysis, which is used in 60 countries. The lipolysis


treatment In spring 2010,


the FDA alerted consumers about false and misleading claims being made about


protocol is successful because it is effective and safe for both patients and physicians, the Society claims. Others offer a different view. Lipolysis is


products used in lipodissolve, and about other misbranding of these products.


undoubtedly convenient. Taking just minutes using numbing medication and with minimal pain, it allows the recipient to return to work immediately post‑procedure. It is also seen as an attractive alternative to liposuction surgery, which involves anaesthesia, potentially‑scarring major incisions, time off work and recovery time. But US liposuction community forum, Letty’s Liposuction Directory, says there is a paucity of statistics on the frequency of side‑effects of lipodissolve, mainly owing to the fact that injection therapy in general is not regulated at federal level. This also implies a lack of tight governance, and of standards for those performing the procedure and for reporting adverse reactions, it says. It also claims that no scientific studies


are available to confirm that lipodissolve actually reduces fat as effectively as it claims to. In terms of both cost and the potential risk to health, it has not yet been given the official stamp of approval in the US, it observes.


All lipolyis procedures banned The French action does not cover injection lipolysis only, but all forms of non‑surgical fat removal. So carboxytherapy and the use of transcutaneous lasers, ultrasound, infrared and radio frequency are all to suffer the same fate. Although many are non‑invasive, they are all classed by the HAS as equally as dangerous as injection lipolysis.


Natural solution to a growing problem France has not escaped the global obesity trend, though it is not usually in the spotlight. Lipolysis is a solution that many individuals seeking aesthetic treatments would pursue. Now it is no longer an option in France, natural, healthy diets and more exercise may rise up the priority list.


There is good reason,


as France is getting fatter. The fifth national ObÉPI survey, run in 2010, revealed a national obesity rate of 14.5% — 6.5


million


people — based on a sample of 25000 adults. In 1997, the rate was 8.5%,


according to the 3‑yearly surveys, which are sponsored by Roche in association with TNS Healthcare Sofres. Women are as prone to the condition as


men, and all ages are affected, with the highest rates in the 55–64‑year‑old age bracket (20.1% men; 19.5% women); 75–79 years at 16%; and over 80 years at 11%; 22% of low income earners (under €900 per month) are obese; and 32% (14 million) of the population is overweight, including 38.5% of men.


Under pressure There has been pressure on non‑core aesthetic doctors in France for many years. They are denied the right to inject botulinum toxin, which is the province of dermatologists, plastic surgeons and other specialists. A decree banning access to certain aesthetic medicines was mooted in 2008, but the action was shelved. The market would be made more


difficult by a lipolysis ban. It will be interesting to track the behaviour of patients determined to access non‑surgical solutions, the pressure that the profession — seeking a proper risk evaluation — can bring to bear, and the actions of equipment manufacturers. 'This is a completely new dimension,


and we foresee a long battle,' said NGNL’s Mr Handl in Spring this year. Furthermore, the criticism of safety records of lipolyis is without foundation. Out of a total 42 000 cases, only 0.0017% resulted in complications. There have been no deaths, he stresses. Those seeking to overturn the French


decision expected strong opposition as France is not afraid of going it alone. What happened last month was largely unexpected, and potentially puts a whole new complexion on matters.


Turn to page 76 for PRIME's Treatment Guide to lipoplasty and body contouring


prime-journal.com | July 2011 ❚ 15


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