Search

Summary: Study Purpose: For ten years the market for resorbable fillers has seen a large increase. A CE mark is sufficient for its placing on the market, they do not require AMM because they are not considered drugs. The Macrolane® is a hyaluronic acid NASHA gel-based technology, available on the French market since 2007 as filler used in all areas of the body except face and breasts. It is highly crosslinked, which slows its resorption, leaving in place long-term waste. At end of 2008, Macrolane® received a CE mark for breast augmentation. The aim of this paper is to review current scientific knowledge on the Macrolane™ and list the many uncertainties regarding its recent breast indication. Materials and methods: We reviewed the PubMed literature and study levels of evidence on Macrolane®. All AFFSAPS communication and correspondence with the SOFCPRE on hyaluronic acids and particularly Macrolane™ were collected. Results: At the moment there is no scientific study of high level of evidence which has studied the effects of Macrolane® on breast parenchyma in terms of carcinogenesis or the disruption of radiological monitoring of the breast. The subglandular method of injection remains complex and uncertain especially about the risk of wrong passage. Conclusions: The Macrolane® is proposed as an alternative less invasive than breast implants. Nevertheless the lack of scientific data on this product led to its non approval by the Food and Drug Administration in the United States. Currently there remains too much uncertainty on this filler for reasonable use plebiscite. It would therefore be preferable to return to the manufacturer the burden of proof of Macrolane® safety and security and limit its use in clinical trials yet. [ABSTRACT FROM AUTHOR]

Abstract: Breast augmentation offers a high rate of satisfaction but the local complications remain frequent. These are mainly capsular contracture, malpositions of implant, acute or infraclinical infections. The causes of these complications are multifactorials. The goal of this chapter is to determine the effect of the surgical technique on the result. We think that if no routine procedure can be proposed, a reflexion on the objectives of the breast augmentation and the adaptation of the surgical technique is necessary for each surgeon. We identify twelve aims and discuss them: rigorous preoperative planning, determination of the position of the implant, creation of an adapted implant pocket, as much atraumatic as possible dissection, no bacterial contamination, no foreign particles, respect of the implant, drainage or not, efficient suture, pain and discomfort control, need for contension and clear postoperative advices. These objectives being precised, we integrate them in a chronological surgical process under the form of questions. Each surgeon can then choose his answers by evaluating the arguments, which led to his choices. [Copyright &y& Elsevier]

Summary: 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. [ABSTRACT FROM AUTHOR]