Correspondence and communication| Volume 65, ISSUE 4, P527-528, April 2012

Macrolane is no longer allowed in aesthetic breast augmentation in France. Will this decision extend to the rest of the world?

Published:October 24, 2011DOI:
      In recent years, the market for resorbable fillers has been steadily expanding. In France, the European Community’s (EC) seal of approval is sufficient for distribution. Approval from the AFSSAPS (French Agency for Safety of Health Products), the French equivalent of the US Food and Drug Administration (FDA), is not required to market resorbable fillers, because they are considered to be “implantable medical devices” and not drugs. Macrolane (Q-Med AB, Uppsala, Sweden) is a NASHA (Stabilized Non-Animal Hyaluronic Acid) gel-based technology and has been available on the French market since 2007 as a filler that can be used in all areas of the body except the face. It is highly crosslinked, and this property slows its absorption into the body but can also leave long-lasting residues. At the end of 2008, Macrolane received EC approval for use in breast augmentation.
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        • Nahabedian M.Y.
        Discussion: macrolane for breast enhancement: 12-month follow-up.
        Plast Reconstr Surg. 2011; 127: 861-862
        • Hedén P.
        • Olenius M.
        • Tengvar M.
        Macrolane for breast enhancement: 12-month follow-up.
        Plast Reconstr Surg. 2011; 127: 850-860
        • Crawford R.
        • Shrotria S.
        Macrolane injections for breast enhancement in un-diagnosed breast malignancy: a case report.
        J Plast Reconstr Aesthet Surg. 2011;
      1. Décision de police sanitaire de l’Afssaps: « Portant restriction de la mise sur le marché et de l’utilisation des dispositifs médicaux injectables indiqués dans le comblement et l’augmentation des volumes corporels à visée esthétique »; August 26, 2011.

        • Chaput B.
        • De bonnecaze G.
        • Tristant H.
        • Garrido I.
        • Grolleau J.L.
        • Chavoin J.P.
        Macrolane(®), a too premature indication in breast augmentation. Focusing on current knowledge of the product.
        Ann Chir Plast Esthet. 2011; 56: 171-179