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ANALYSIS | REGULATION | MACROLANE AND


PIP IMPLANTS: MORE REGULATORY TURBULENCE FOR THE FRENCH MARKET


France’s unilateral ban on Q-Med’s breast augmentation


filler threw the national market into disarray last autumn. And as 2011 drew to a close, a new chapter in the PIP implants saga completed a choppy year


for Afssaps’ cosmetic device regulatory activities. Ashley Yeo reports


ASHLEY YEO, Principal Analyst, Informa Business Information


email ashley.yeo@ informa.com


to plans to reform and rename it. That followed poor regulatory oversight of the diabetes drug Mediator, which was extensively used off-label for weight loss control and led to some 500 deaths over 30 years. This most unprecedented of events for


T 12 ❚


the regulatory body fairly eclipsed a number of controversial regulatory decisions in cosmetic medicine that on any other occasion would have taken a larger share of the headlines themselves. But although pushed down the list, these decisions were significant in their own right.


Macrolane follows lipolysis In spring, Afssaps banned the form of liposculpture known as lipolysis. In doing so, on the grounds that such treatments have no therapeutic effect and are dangerous, France went further than any other market in terms of stringency and brought itself out of line with other countries.


January/February 2012 | prime-journal.com


HE YEAR 2011 WAS THE year that the French healthcare products regulatory body, Afssaps, was publicly chastised and subsequently subject


On 26 August, the agency banned the


use of the hyaluronic body contouring injectable filler, Macrolane, for breast volume augmentation. The product is manufactured by Swedish aesthetic products specialist company Q-Med. Macrolane is used for volume


restoration and contouring of body surfaces, for example breast volume augmentation, sculpting of the chest and on the calves and buttocks. It also smoothes out unevenness and wrinkles in the skin surface, such as those caused by liposuction and surgical scars. It is claimed to be less invasive than


reconstructive or other aesthetic procedures, and has so far been used in 15 000 patients internationally for body contouring or breast augmentation procedures. The French ban was a precautionary


move that was put in place after publication of the preliminary results of a clinical study authorised by Afssaps in 2008. These early findings show that use of the product could have a negative impact on breast cancer screening. The same problem does not arise with breast implants, says Afssaps. Afssaps notes that no serious incidents linked to Macrolane use have been


Macrolane is


used for volume restoration and contouring of body surfaces, for example breast volume augmentation, sculpting of the chest and on the calves and buttocks.


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