T Siebert1, B Chaput2, C Vaysse3, T Meresse4, J-P Chavoin4, I Garrido4, J-L Grolleau4. 1. Service de chirurgie plastique reconstructrice, esthétique et des brulés, CHU Rangueil, 1, avenue du Pr-Jean-Poulhès, 31059 Toulouse Cedex, France; Service de chirurgie gynécologique, CHU Rangueil, 1, avenue du Pr-Jean-Poulhès, 31059 Toulouse Cedex, France. 2. Service de chirurgie plastique reconstructrice, esthétique et des brulés, CHU Rangueil, 1, avenue du Pr-Jean-Poulhès, 31059 Toulouse Cedex, France. Electronic address: Benoitchaput31@gmail.com. 3. Service de chirurgie gynécologique, CHU Rangueil, 1, avenue du Pr-Jean-Poulhès, 31059 Toulouse Cedex, France. 4. Service de chirurgie plastique reconstructrice, esthétique et des brulés, CHU Rangueil, 1, avenue du Pr-Jean-Poulhès, 31059 Toulouse Cedex, France.
Abstract
INTRODUCTION: Hyaluronic acid has come to represent the most widely used injectable cosmetic product in the world. Brought into being by the Swedish company Q-Med, in 2007 Macrolane™ was authorized for use in France, and the year after, it received official European approval as a means of breast augmentation. Since then, however, numerous controversies pertaining to its side effects have led to its withdrawal from the worldwide breast augmentation market. The objective of this article is to carry out a review of the literature providing updated information on Macrolane™ and its recent indications. MATERIALS AND METHODS: We carried out a review of the literature on the PubMed and PubMed Central data bases through use of the keywords "Macrolane™", "NASHA", "hyaluronic acid" and "soft filler", and subsequently analyzed the levels of evidence and possible biases of the different publications. The official sites of the French, English, Spanish and American scholarly organizations of plastic surgery were likewise consulted. Perusal of the notifications and recommendations for use brought out by the Q-Med company completed our study. RESULTS: A large majority of the available clinical series on Macrolane™ with regard to not only breast augmentation, but also its other indications, offer an insufficient level of evidence and present a number of conflicts of interest. Since April 2012 Macrolane™ has been temporarily withdrawn by its distributors from the worldwide breast augmentation market. In point of fact, Macrolane™ injections have been found to interfere with breast imaging and screening for breast cancer. As regards the latest indications for this controversial product, it is not yet possible to step back and take stock. CONCLUSIONS: Present-day scientific data fail to justify the market reappearance of Macrolane™ breast augmentation products. Q-Med has shown full awareness of the problem by imposing worldwide restrictions on products aimed at penis as well as breast enlargement. Larger cohorts of female patients are more necessary than ever, as is an approach based on stepping back and taking stock.
INTRODUCTION:Hyaluronic acid has come to represent the most widely used injectable cosmetic product in the world. Brought into being by the Swedish company Q-Med, in 2007 Macrolane™ was authorized for use in France, and the year after, it received official European approval as a means of breast augmentation. Since then, however, numerous controversies pertaining to its side effects have led to its withdrawal from the worldwide breast augmentation market. The objective of this article is to carry out a review of the literature providing updated information on Macrolane™ and its recent indications. MATERIALS AND METHODS: We carried out a review of the literature on the PubMed and PubMed Central data bases through use of the keywords "Macrolane™", "NASHA", "hyaluronic acid" and "soft filler", and subsequently analyzed the levels of evidence and possible biases of the different publications. The official sites of the French, English, Spanish and American scholarly organizations of plastic surgery were likewise consulted. Perusal of the notifications and recommendations for use brought out by the Q-Med company completed our study. RESULTS: A large majority of the available clinical series on Macrolane™ with regard to not only breast augmentation, but also its other indications, offer an insufficient level of evidence and present a number of conflicts of interest. Since April 2012 Macrolane™ has been temporarily withdrawn by its distributors from the worldwide breast augmentation market. In point of fact, Macrolane™ injections have been found to interfere with breast imaging and screening for breast cancer. As regards the latest indications for this controversial product, it is not yet possible to step back and take stock. CONCLUSIONS: Present-day scientific data fail to justify the market reappearance of Macrolane™ breast augmentation products. Q-Med has shown full awareness of the problem by imposing worldwide restrictions on products aimed at penis as well as breast enlargement. Larger cohorts of female patients are more necessary than ever, as is an approach based on stepping back and taking stock.