'Serious' Safety Concerns Over Macrolane Cosmetic Filler

Expert Product Liability Lawyers Warn Of Dangers Of ‘Novel’ Cosmetic Procedures


Andrew Robinson, Press Officer | 0113 218 6463

Irwin Mitchell’s specialist product liability lawyers have warned those considering undergoing ‘novel’ cosmetic procedures to be vigilant and seek appropriate advice before proceeding.

The experts were recently contacted by a patient with safety concerns regarding the cosmetic filler Macrolane, who suffered problems with the product following a breast augmentation procedure.

Produced by Q-Med and introduced in the UK in 2008 Macrolane is cosmetic filler comprised of hyaluronic acid for use in body contouring procedures.

Macrolane was offered to women as a safer alternative to traditional breast implants despite a failure to establish the use of Macrolane for breast enhancement.

When introduced into the UK Macrolane was hailed as a non-invasive method of breast enhancement marketed as a “Lunchtime Boob Job” and an estimated 2,000 women in the UK underwent the procedure.

Macrolane is injected under local anaesthetic and intended to dissolve over the course of approximately 12-18 months. Instead of dissolving patients reported that the Macrolane gel was clumping together to form pellet like shapes under the skin. These pellets form as a result of capsular contraction whereby the tissue around the gel identified it as a foreign substance, hardening up to contain the foreign gel.

Concerns arose that these capsules would impact on the effectiveness of radiology examination of breasts previously injected with Macrolane.

In April 2012 as a result of these concerns the UK Medicines and Healthcare products Regulatory Agency issued a medical safety alert recommending that the use of Macrolane in breast augmentation cease as the associated capsule formations can make diagnosis of breast cancer more difficult, particularly during mammography.

Rachel FitzGerald, an expert product liability lawyer, who is investigating the concerns surrounding Macrolane, said: “Any patient considering undergoing a novel elective procedure should ensure that the product has satisfied the required testing and is authorised for the specific use.

“Quick fix non-surgical procedures can seem very appealing however as Macrolane has shown it can result in a long term health issues. Patients who received Macrolane now find themselves in a position whereby their mammograms are unable to distinguish between the un-dissolved gel or signs of breast cancer.

“Unfortunately for many women recourse is very difficult as the product was taken off the market in the UK in 2012 meaning that few patients will now find themselves within the legally required three-year period following injury to allow them to proceed with a claim against Macrolane’s manufacturer Q-Med.

“With the market continuously introducing new wonder products, beauty consumers need to be extra vigilant and should an individual have any concerns arising from a product we would encourage them to contact Irwin Mitchell in due time to ensure that action is taken before the three-year limitation period expires.”

If you've suffered due to negligent cosmetic surgery you might be entitled to claim compensation. See our Cosmetic Surgery Claims or Cosmetic Filler Claims pages for more information.