Plastic surgeons in the UK have welcomed the withdrawal of a so-called “lunchtime boob job” treatment.
Macrolane, an injectable filler meant to be used for body contouring, had been marketed as a temporary breast enlarger but its manufacturers have now discontinued it for such purposes.
There are not thought to be safety concerns, but it could have an effect on a woman’s mammogram reading.
A spokesman for the Medicines and Healthcare products Regulatory Agency (MHRA) said: “The MHRA is aware that the manufacturer Q-Med has decided to discontinue the injectable dermal filler Macrolane for use in breast augmentation.
“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.”
All customers have been sent a letter by Q-Med, which makes the product in Sweden, and the MHRA has informed other professional bodies and healthcare providers.
The spokesman added: “There are no safety concerns with the product. However, if women have been injected with Macrolane and subsequently had a mammogram, they should contact their GP to see if they need to be referred for further screening.”
The British Association of Aesthetic Plastic Surgeons (BAAPS) said that in a survey of its members, one in four surgeons reported patient complications after the use of Macrolane.
Consultant plastic surgeon and BAAPS president Fazel Fatah said: “Without good long-term studies over five to 10 years it is wise that Macrolane has finally been withdrawn for breast use. At the BAAPS we have been calling for dermal fillers to be reclassified as medicines, which will require further studies into their efficacy and safety similar to the US Food and Drug Administration’s approval process.”
A Q-Med spokesman said: “All breast augmentation procedures, including those involving Macrolane, can interfere with the reading of mammograms. At present, there is a lack of consensus amongst radiologists regarding radiology examination of breasts treated with Macrolane.” They said the decision to discontinue the product for breast augmentation came “after reviewing the current situation and in consultation with the regulatory authorities” and would remain in place until “consensus for best practices in breast radiology following Macrolane treatment has been reached”.