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Breast Augmentation – Macrolane Ban
Macrolane hyaluronic acid is banned in France for breast augmentation due to inflammatory risks and screening difficulties.
Heralded over the past three years as a breakthrough in cosmetic breast enhancement, the use of Macrolane®, a highly cross-linked hyaluronic acid gel, has now been officially banned by the French Health Products Safety Agency (AFSSAPS) for use in breast augmentation.
Why Was Macrolane Banned?
The agency cited several potential risks associated with the use of Macrolane for breast enlargement:
- Chronic inflammation of the breast due to the need for regular reinjections, approximately every 18 months
- Product migration as Macrolane is non-encapsulated and can diffuse into the surrounding tissue
- Difficulty interpreting mammograms, which compromises effective breast cancer screening
This decision effectively puts an end to a media frenzy orchestrated by Q-Med Laboratories, which marketed Macrolane as a groundbreaking alternative to traditional silicone breast implants.
A Personal Professional Stance
From the outset, I believed this product was a step backward in terms of safety. Unlike silicone implants, which are housed within a sealed shell, Macrolane lacks structural containment, leading to unpredictable results and safety concerns.For these reasons, we never used Macrolane in our practice.