LETTER TO THE EDITOR France Prohibits the Use of Macrolane in Aesthetic Breast Augmentation for Reasons Similar to Criticisms of Autologous Fat Grafting to the Breast B. Chaput • G. De Bonnecaze • J. P. Chavoin • D. Gangloff • I. Garrido Received: 20 November 2011 / Accepted: 9 February 2012 / Published online: 22 March 2012 Ó Springer Science+Business Media, LLC and International Society of Aesthetic Plastic Surgery 2012 Level of Evidence V This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors at www.springer.com/00266. Adipose tissue grafting is a practice that continues to raise questions but is performed by an increasing number of plastic surgeons for breast reconstruction and even for cosmetic breast augmentation. Hyaluronic acid is the most commonly used synthetic filler worldwide. Easy to use, it seduces many patients who prefer minimally invasive procedures under local anesthesia rather than larger surgi- cal procedures under general anesthesia. In France, the resorbable fillers are not classified as drugs and do not require approval of the health authority (AFSSAPS: French agency for the safety of health prod- ucts) to be placed on the market. A European community approval is sufficient for the marketing of these fillers. Macrolane (Q-Med AB, Uppsala, Sweden) is a hyalu- ronic acid gel based on NASHA technology (Stabilized Non-Animal Hyaluronic Acid) that is highly cross-linked to slow down its absorption. Initially used for body shaping and volume restoration except for the breast, Macrolane in 2008 obtained authorization for use in cosmetic breast augmentation. It must be noted that it has not been approved by the U.S. Federal Drug Administration (FDA). This authorization was accorded while the available studies on Macrolane in the literature were few and had low levels of scientific evidence. Inami et al. conducted a study with 1,100 patients, which was published in the Japanese Journal of Plastic and Reconstructive Surgery in 2006 but not indexed in Pubmed. The only available studies to be found in Pubmed were performed by Qmed consultants [1]. Choosing to apply the precautionary principle in accordance with article 14b of European directive 93/42/ EEC, AFSSAPS pronounced the ban on Macrolane for breast augmentation in France on 26 August 2011 [2]. This decision follows four main arguments that are perfectly superimposable for those advanced in the literature against adipose tissue grafting in breast parenchyma [3]. First, this invasive repeated procedure may cause undesirable inflammation to breast tissue, which may increase cancer risk. This is true not only for injection of hyaluronic acid but also for adipose tissue grafting, in which the use of a cannula is traumatic as well. Second, the formation of nodules that may result from injecting masses of Macrolane can interfere with clinical examination. Residual nodules also are frequent in adipose tissue grafting. Third, the resulting perturbations, at both palpation and interpretation of imaging exams, may cause a delay in screening or diagnosis of breast disease [3, 4]. According to Goisis et al. [5], Macrolane is a recent material, unfa- miliar to radiologists, that can mimic cysts and sometimes breast cancers [4, 6]. Fourth, screening and early diagnosis of breast cancer is a public health priority in many countries. For the moment, France is the only country that has banned Macrolane several months after its placement on the market, following a sanitary decision. The arguments advanced by the health Presented at the French Plastic Surgery Meeting in Paris, France, November 2011 B. Chaput (&) Á G. De Bonnecaze Á J. P. Chavoin Á D. Gangloff Á I. Garrido Plastic and Reconstructive Surgery Unit, CHU Toulouse Rangueil, Avenue Jean Poulhe `s, 31059 Toulouse cedex 9, France e-mail: Benoitchaput@aol.com 123 Aesth Plast Surg (2012) 36:1000–1001 DOI 10.1007/s00266-012-9882-5