ANALYSIS | LIPOLySIS TREATMENTS |
regulatory focus back on lipolysis
T
ASHLEY YEO, Principal Analyst, Informa Business Information
email
ashley.yeo@
informa.com
12 ❚
he search for a perfect body may have to be pursued without recourse to the form of liposculpture, known chiefly as lipolysis. France at least, one of the
leading markets in Europe which has a strong record for regulating healthcare products — the recent Mediator case excepted — has passed a decision banning lipolysis treatments on the basis that they have no therapeutic effect and are dangerous. But in a surprising move, on 17 June the French Council of State suspended the ban, pending an investigation into its legality. What happens next is keenly awaited. This article takes us back 3 months to the immediate aftermath of the decision to ban. The tightening of regulations decided
by the French superior heath authority (Haute Authorité de Santé (HAS)) on 12 April is out of line with other countries. It goes significantly further than the US Food and Drug Administration (FDA) and UK Medicines and Healthcare products Regulatory Agency (MHRA) policies, which merely warn about misbranding. The MHRA has stated (most recently in February 2007) that the injectable product Lipostabil is unauthorised for cosmetic/fat
July 2011 |
prime-journal.com treatments: aesthetic
After the FDA’s warning about lipolysis injections, in April the French authorities banned all non‑surgical treatments for aesthetic fat removal. But in a surprise move in June, the ban was suspended
pending an investigation. The industry can be expected to keep up its fight to reinstate these minimally‑invasive alternatives to liposuction
removal uses. Canada and Brazil have also issued alerts about the use of unregistered injectable lipolysis products. Austria sought to have norms for all aesthetic procedures set under CEN (the European Committee for Standardization), but this did not succeed. The French decree (see http://tinyurl.
com/6e94o2b), published in the French official journal (JO), states that all cosmetic lipolysis treatments are banned, no matter who is performing the procedure. It means that there is no longer access to a range of treatments, be they performed by a beautician or fully‑qualified and established doctor: Lipolysis
■ by hypoosmolar,
phosphatidylcholine (PC), or deoxycholate (DC) sodium injections ■ Ultrasound ■ Mesotherapy (injecting microscopic quantities of natural extracts, homoeopathic
agents,
pharmaceuticals and vitamins into the skin to eliminate cellulite and promote weight loss) ■ Carboxytherapy (cutaneous and
subcutaneous administration of CO2 for therapeutic purposes) ■ Radiofrequency ■ Lipolysis by laser.
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