Clinics told not to use breast filler product

THE IRISH Medicines Board has told cosmetic clinics involved in breast augmentation to stop using a filler that has been found to interfere with the diagnosis of breast cancer.

Macrolane, an injectable non-permanent gel used to augment and contour breasts, interferes with breast diagnostic imaging, particularly mammography. The product makes it difficult for radiologists to interpret mammograms, X-rays of the breast, and detect cancer.

Made by Q-Med AB in Sweden, Macrolane was withdrawn from use in breast augmentation by the manufacturer on April 17th. It is understood there are fewer than 25 clinics in Ireland using the product. The product breaks down in the system after 12-18 months.

A spokeswoman for the board said it had written to all Irish clinics using the product on April 23rd and requested they stop using it for breast augmentation and put in place procedures “to ensure it can no longer be used for this application”.

She said the board also requested that clinics identify all women treated with Macrolane for breast augmentation.

Clinics should ensure the women are advised “of the potential problems that may arise with the interpretation of mammogram images and the importance of informing healthcare professionals of previous Macrolane treatment before they have any breast assessment carried out”, the spokeswoman said.

The board also contacted Irish radiologists to inform them of the issue. The spokeswoman said no safety concerns had been identified with the product.

In a statement, the manufacturer said there was “a lack of consensus amongst radiologists regarding radiology examination of breasts treated with Macrolane”.

“Q-Med has therefore decided to discontinue the indication until consensus for best practices in breast radiology examination following Macrolane treatment has been reached,” it said.

Since no safety concerns had been identified, women who have undergone breast augmentation with Macrolane “do not need to take any additional actions other than the routine follow-up consultations or as directed by their doctors”, the manufacturer said.

It also said it was important to inform the healthcare professional that Macrolane treatment had been given “before any breast assessment is carried out”.

The product had included “very clear information” on the possible need for additional ultrasound examination following a mammogram to obtain adequate information on the breast tissue for screening purposes, the manufacturer said.

Consultant Kambiz Golchin, plastic surgeon at the Beacon Hospital and medical director at the Beacon Face and Dermatology Clinic, said there had been concerns about the product for at least a year. He never used it, he said. While there were problems with breast imaging, there were also other complications, including lumps and nodule formation.

Women who have had the treatment should be made aware the product will break down naturally and disappear, but they should contact their GPs if they have any concerns, he said.