The French regulatory body ANSM has announced that textured breast implants made by Allergan have been withdrawn from European markets as a result of their association with an increased risk of a rare type of cancer, anaplastic large cell lymphoma (ALCL).
Textured implants are used in breast cancer reconstruction and the very small increase in the risk of ALCL associated with these products has been known for some time. But it has now emerged that one company (Allergan) has lost its approval to market their product in Europe, as its product has been associated with a higher risk of ALCL than those made by other companies.
According to the Association of Breast Surgery, research in Australia and New Zealand estimated that the textured implant from Allergan held the highest risk of ALCL, at approximately 1 case in every 3,817 people who had had the implant – compared to, for example, a risk of 1 in 7,788 found for another company’s product.
Baroness Delyth Morgan, Chief Executive at Breast Cancer Now, said:
The withdrawal from market of a product that can double the very small risk of developing anaplastic large cell lymphoma (ALCL) for patients having implants or breast cancer reconstruction is a very positive step.
While this may be distressing for women concerned they may have had this implant, we’d urge them not to worry. It’s important to remember that the risk of developing ALCL from breast implants is very low and the regulatory body that has withdrawn the marketing authorisation has advised that there is no immediate risk for women with these implants. Professional surgical bodies in the UK have suggested that plastic surgeons had already been moving away from using this brand in recent years.
Crucially, this issue highlights the central importance of all patients being fully informed of the benefits and risks of the possible surgical options, and supported to make the decision that’s right for them.
If you are at all concerned about your implants or reconstruction, we’d encourage you to speak to your surgeon or breast care nurse.