Patients who have had a now discontinued dermal filler injected into their breast are being urged to visit their GP over concerns the substance may impede diagnosis of breast cancer.
Macrolane has been deemed unfit for use during breast enlargement surgery as it has been found to make the diagnosis of breast cancer “more difficult”.
However, the substance can still be used in procedures such as augmenting body contour and correcting soft tissue defects.
The Medicines and Healthcare Regulatory Agency (MHRA) issued a Medical Device Alert (MDA) to healthcare professionals about the discontinuation of the product for breast enhancement.
GPs should consider referral for repeat imaging if a patient is found to have been injected in the breast with Macrolane.
“There are no safety concerns with the product,” said John Wilkinson, MHRA Director of Medical Devices.
“However, if women have been injected with Macrolane in the breast and subsequently had a mammogram, they should contact their GP to see if they need to be referred for further screening.”
The MHRA’s MDA comes after an estimated 47,000 women in the UK were rocked by the banning of French-made Poly Implant Prothese (PIP) breast implants in December 2011 - found to be made with unauthorised silicone gel – developed to fill mattresses among other uses.
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