ANALYSIS | LIPOLySIS TREATMENTS | processes. It is the same in the
Netherlands, where action against injection lipolysis is in the news. The French decree has threatened to
throw the market into confusion, and could leave consumers seeking aesthetic treatment the sole option of liposuction surgery, which requires an anaesthetic and is described as a less comfortable and more invasive technique. It is also more costly, at some €2000–
10000 for liposuction against €300–600 per lipolysis session. While cosmetic surgeries and treatments seem, encouragingly, to be holding up well in the current tough economic spell, more pressure on individuals’ discretionary spending power could have negative impact on the market. Despite the claimed risks of lipolysis,
these methods are increasingly used. The French decision to ban is politically motivated, says Dominique du Crest, Vice President of new business development, Europe, at Grey Healthcare Group (Bologne– Billancourt, Paris). Market growth is led by the non‑core aesthetic market, where there is also more innovative surgery. The effect on consumers of the French
action is difficult to assess; GPs will have equipment in their practices with which to perform non‑surgical fat reduction procedure, but will not be covered by insurance. Consumers determined to seek lipolysis will be tempted to visit clinics in neighbouring EU countries. The industry, specialists, private hospitals and GPs can all be expected to oppose the ban, Mr du Crest told PRIME. He believes the market will continue to develop. The profession and specialists have
reacted angrily to the ban, and are assessing what action they can take. The German‑based NETWORK–Globalhealth and NETWORK–Lipolysis describes the decree, which it says prohibits every form of reduction treatment for deposits of fat with the exception of liposuction, as 'a massive restriction on medical freedom'. Together with its French branch,
NETWORK–Globalhealth France, the group is deciding on which countermeasures to pursue to bring about a withdrawal of the ban, and thereby end HAS’s drift into what it calls 'medieval methods'. A position paper signed by members of the international aesthetic medicine community — opinion leaders, members of scientific societies, university professors — can be expected as a first
14 ❚ July 2011 |
prime-journal.com
stage, in a bid to highlight the international shock and indignation at the decree. Whether this is likely to succeed is a
moot point. The French regulatory authorities are not unaccustomed to acting alone. The history of French regulatory activity on breast implants in the last decade, including the healthcare products safety regulator’s (Afssaps) action last year against the manufacturer of a brand of silicone gel‑filled breast implants, bears witness to this. But some 12–13 anti‑ageing societies
have got together in France and hired a well‑know lawyer. However, the lawyer sees some difficulty — though not impossibility — in overturning a law that has already been signed. In France, politics is centralised around the very powerful president. Nevertheless, the fight is on, and 2000
local GPs have signed a petition seeking a legal review. The International Herald Tribune has also begun reporting on the issue, said Mr Handl.
Warnings The US has also felt the need to issue an alert about lipolysis injections — better known locally as lipodissolve — but it has stopped short of an outright ban. In spring 2010, the FDA alerted consumers
about false and misleading claims being made about products used in lipodissolve, and about other misbranding of these products. The promise that the process —
also known variously as injection lipolysis, lipozap, lipotherapy and mesotherapy — will dissolve and permanently remove small pockets of fat from various parts of the body can be a compelling prospect for some people, said the FDA. But it expressed concern that certain firms — six in the US and one in Brazil — were making false or misleading statements on their websites about drugs used in the lipodissolve procedure or were otherwise misbranding products. In April 2010, it sent warning letters to the US operations and a cyber letter (intended for companies whose US online sales of products may be illegal) to the Brazilian company. The stance taken by the US — that any
individual considering this voluntary procedure must be aware that the products used are not approved by the FDA for fat removal — leaves the decision up to the consumer. The French action, on the other hand, removes the decision‑making, and with it potentially a growth market.
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