Macrolane withdrawn for breast use
BAAPS repeats calls for fillers to be reclassified as medicines
Quick-fix, non-surgical cosmetic procedures, such as the “lunchtime boob job”, are an attractive and cost-effective alternative for surgery-shy patients who want minimal downtime. But Q-Med, manufacturer of dermal filler Macrolane, has stopped promoting its use in breast enhancement until “consensus has been reached regarding best practice in breast radiology examination following Macrolane treatment”.
Macrolane comprises a stabilised hyaluronic acid injectable gel for providing temporary treatment for volume restoration, body contouring, scar reduction and to fill concavities resulting from liposuction. Apart from the breast, Macrolane has been indicated for a number of areas, including the buttocks, calves and concave deformities.
As with any aesthetic treatment, adverse events can occur, in Macrolane’s case infection, lumps and encapsulation. But as Mr Christopher Inglefield wrote in our special report on implants in our last issue (“Is Macrolane a good alternative?”BL 50) his four years’ experience using the product showed it to be a satisfactory alternative to breast implants. According to Q-Med, a safety reporting system has been in place since the product’s launch and no safety concerns have been identified.
However, Macrolane has been found to interfere with breast mammograms, thereby delaying cancer diagnosis or providing an inaccurate X-ray reading. Following consultation with regulatory authorities, Q-Med has withdrawn its indication for breast enhancement until satisfactory screening procedures can be decided.
The Medicines and Healthcare products Regulatory Agency has advised that women who have undergone Macrolane breast augmentation and a mammogram should contact their GP in case they need further tests. However, Q-Med has made assurances that women who have undergone breast augmentation with the filler do not need any further action other than routine follow-up consultations or as directed by their doctor.
The British Association of Aesthetic Plastic Surgeons (BAAPS) welcomes the decision. The organisation cites a 2009 study published in the International Journal of Plastic, Reconstructive and Aesthetic Surgery which warns that Macrolane could interfere with breast screening and recommended that it should not be used in women with a personal or family history of cancer.
BAAPS president Fazel Fatah says that, while the simple treatment of breast augmentation through injection of a filler may seem appealing, such a procedure can be deemed safe only when the long-term effects on cancer screening are known.
“Without good long-term studies over 5–10 years, it is wise that Macrolane has finally been withdrawn for breast use. At 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,” Mr Fatah says.
Q-Med has conducted a 24-month study in Sweden and France to assess the effectiveness of an alternative screening method using a combination of digital mammography and ultrasonography. The company says preliminary results have shown that an “adequate examination can be performed using these techniques” and the data will be made available to the radiologist community.
Q-Med has recommended women with Macrolane injections should inform their doctor before receiving a mammogram to account for it when screening.