| REGULATION | ANALYSIS
reported, in France or across Europe, in the last 3 years. Some 2500 French women have used Macrolane for breast augmentation. These recipients are subject to no special treatment needs, but should now inform their mammographer or imaging specialist prior to examination, says the agency. Other uses of Macrolane are not affected by the regulatory action. France banned silicone injections in
the breast in 2000, which means that demand for this aesthetic procedure in France can now be met only via surgical implants, or via lipofilling; which, however, is also under scientific review (see below). Specifically, the French band on
Macrolane for breast augmentation rests on a number of reasons, but principally that changes in breast anatomy (particularly nodule formation) can make it harder to examine the breast and thereby affect the interpretation of mammograms, possibly causing delays in the diagnosis of breast disease. This is seen in the fact that screening and early diagnosis of breast cancer is a public health priority. A recently published online report in
the Journal of Plastic Reconstructive and Aesthetic Surgery1
requires repeated invasive injections, which can cause undesirable inflammation in the breast tissue, leading to an increased risk of breast cancer. Q-Med notes that no clinical data have been provided. There have also been reports of nodule
formation and scar tissue (capsular contracture) due to fragmentation of the product. Macrolane is currently approved in more than 20 countries, but not the US. Q-Med says it has not applied for a US licence. The product was approved in France in 2007 under a CE-marking, as the product is a NASHA (non-animal-stabilised hyaluronic acid) gel-based technology, and is therefore not classed as a drug. Its first EU approval was for all areas of
the body, except the face and breasts. At the end of 2008 it received a CE mark for breast augmentation. It is highly cross-linked, which slows resorption, and is said to leave long-term waste in place.
Precautionary move Macrolane was proposed as a less invasive alternative to breast implants, but in August 2011, in spite of an absence of 'characterised risk', Afssaps decided to
noted that the treatment
withdraw its breast augmentation use, on a precautionary basis. Based on the 2008 study, Afssaps
said that imaging and breast palpation during clinical analyses could be compromised, which was not shown to be the case with prosthetic breast implants. The agency said that Macrolane was the only product affected by this decision in France (liquid silicone injections having been withdrawn over a decade ago).
However, Q-Med, part of the Galderma
group since early 2011, tells PRIME that Afssaps has decided to ban the use of all injectable products
for breast
augmentation — not just Macrolane. The company, based in Uppsala, Sweden, has informed doctors in France of the regulatory decision, but feels that, as a precautionary measure despite absence of any proven health risk, this is excessive. 'We believe this decision by Afssaps is disproportionate,' says a Q-Med
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