[Macrolane(®), a too premature indication in breast augmentation. Focusing on current knowledge of the product].

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.