| LIPOLySIS TREATMENTS | ANALYSIS
Potential side-effects The HAS bases its action on certain cases of serious complications, a study of scientific literature and talks with healthcare bodies and dermatology, plastic surgery, patient and other professional organisations in France and abroad. In a discussion document issued by HAS in December 2010, the authority referred to two surveys on the side‑effects of PC/DC lipolysis use conducted in the UK and US. The UK survey of 172 doctors resulted
in a fairly poor return of only 39 replies, covering 10 581 injections: 37.6% of patients described their localised side‑effects as moderate and 5% as severe; 1% described their systemic side‑effects as severe and 8% as moderate; 15 events were described as unexpected by the doctors. These findings implied a minimal risk if the procedure was overseen by well‑trained specialists A 600‑doctor survey authored by
Colorado doctor Diane Irvine Duncan, and coordinated by the German‑based Global Network Lipolysis and AestheticMD (Scottsdale, Arizona), received a similarly poor 75 replies, covering 56 320 injections. To note was that additives (L‑carnitine, aminophylline, vasodilators, lidocaine and multi‑vitamins) were used in 40% of cases. Most secondary effects were predictable and transitory, but pain persisted for up to 3 months in 0.015% of cases. In the week before the JO notice, the
HAS opined that lipolysis — techniques that destroy small pockets of adipose fat by rupturing or dissolving the membrane of the adipocyte — were actually or potentially dangerous for people undertaking the treatment. It concluded this by looking at 23 patients who experienced serious side‑effects after hypoosmolar injections. It backed up its decision with the statement that it believes that such procedures have no therapeutic aim. For Dirk Handl, spokesman at Network
Globalhealth and Network Lipolysis (NGNL), it sets a dangerous precedent. With this action, France has banned the use of CE‑marked devices, some of which have been on the market for two decades. 'This is a breach of EU law, as I see it,' he told PRIME.
Opposition to the ban It is understood that plastic surgeons in France have lobbied strongly against the right of doctors to perform fat‑reducing
prime-journal.com | July 2011
In the week before
the JO notice, the HAS opined that lipolysis — techniques that destroy small pockets of adipose fat by rupturing or dissolving the membrane of the adipocyte — were actually or potentially dangerous for people undertaking the treatment.
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