No more "boob-jab" - Macrolane withdrawn from breast augmentation in UK
Sunday, April 22, 2012
For the past 5 years, there was an injectable filler called Macrolane that was being used in the UK for all sorts of body contouring operations - including breast augmentation. As you might imagine, the idea of a "lunchtime" breast augmentation by injection - in 45 minutes without the need for implants - became quite popular in the U.K.
However, there were significant problems with breast hardness and lumpiness after the treatment. Rather than behaving like a typical soft tissue filler like we might use in the lips or in a facial wrinkle, large deposits of Macrolane seemed to behave more like an actual implant, with potential for capsular contracture formation, and potential for hardness or tissue distortion.
According to the Daily Mail
newspaper, the manufacturers of the product (Q-Med of Sweden) have now decided to withdraw it from use in the breast, due to concerns that it would make mammograms more difficult to read or make a cancer more difficult to detect.
A spokesman for the British equivalent of the FDA, known as the Medicines and Healthcare products Regulatory Agency (MHRA) said: "This is not because of safety concerns with the product itself but because the product may interfere with the reading of mammograms and could make diagnosis more difficult. The product can still be used in its other indications, such as augmenting body contour and correcting soft tissue defects."
The British Association of Aesthetic Plastic Surgeons (BAAPS) said that in a survey of its members, 25% of surgeons reported patient complications after the use of Macrolane.
Macrolane, a thicker cousin of Restylane, is not yet available in the U.S. for any application.
Thomas Fiala, MD
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