Allergan BIOCELL Breast Implants and BIA-ALCL

In a statement released by the HSE on October 9^th, 2019, 8000 women in Ireland who received Allergan BIOCELL breast implants have been or will be written to regarding the connection between these breast implants and a rare type of cancer.

These letters alert women with these textured implants, created by the company Allergan Pharmaceuticals, to the risk identified between BIOCELL implants and Breast Implant Associated Antiplastic Large Cell Lymphoma (BIA – ALCL). This cancer is a rare type of non-hodgkins lymphoma. It’s not breast cancer but rather a cancer of the immune system.

The World Health Organisation gave BIA-ALCL recognition as type of ALCL in 2016 and Allergan Pharmaceuticals voluntarily recalled all stock of BIOCELL textured implants and tissue expanders, worldwide, on 24^th July 2019. The last time the BIOCELL textured implants and tissue expanders were used in Ireland was in December 2018. So, women who had implants or tissue expanders inserted after this, will not be contacted.

The symptoms of BIA-ALCL include;

• swelling of the affected breast,
• affected breast may feel firmer or more tense than normal,
• A lump or gland present on the breast or in the armpit,
• Collection of fluid on the affected breast.

In the US, the Food and Drug Administration (FDA) were the first to analyze worldwide data on Allergan BIOCELL implants and conclude that continued use of the product could result in detrimental effects to women’s health. The FDA are now recommending the inclusion of a cancer warning on all implant packaging. The Medicine and Healthcare products Agency in the UK issued a Field Safety Notice in August to women who had the implants. Class actions have been filed in the US, UK and Korea, among others.

Lavelle Partners are currently investigating potential legal claims for women who have the Allergan BIOCELL implants.

About the author, Avril Scally, Partner and Head of Clinical Negligence