Allergan Biocell textured breast implants
In July 2019 the US Food and Drug Administration (FDA) requested that Allergan recall its Allergan Natrelle BIOCELL Textured Breast Implants and Tissue Expanders, from sale worldwide. Allergan agreed and a global recall of the products followed.
Background
The FDA acted based on growing data that Allergan Implants are linked with patients developing a rare type of non-Hodgkin’s lymphoma described as Breast Implant Associated Anaplastic Large Cell Lymphoma, or BIA-ALCL.
The UK Medicines and Healthcare Regulatory Authority (MHRA) has provided advice to women who currently have Allergan implants, and who may be affected by the recall.
Recalled products list
The issue
As of October 2021, the MHRA reported that 88 women in the UK had been diagnosed with BIA-ALCL linked to breast implant surgery. As stated by the MHRA, BIA-ALCL is a rare condition, however, as with all cancers if this condition develops it is important for patients to seek medical help quickly. It is therefore vital that all healthcare professionals and patients who have implants know about it.
As it stands the MHRA’s specialist committee does not recommend that patients with Allergan implants have them removed and advises people who are worried about developing BIA-ALCL to seek advice from their GP or surgeon. Despite its low risk, some women with Allergan implants in the UK may remain anxious about developing BIA-ALCL and may wish to access removal and/or replacement surgery, but are unable to do so due to lack of funds.
UK
Hausfeld London is bringing a claim on behalf of one individual who developed BIA-ALCL after her implantation with Allergan Biocell implants. The claim is being progressed under the Consumer Protection Act 1987. We also continue to liaise with lawyers in France who are looking at routes to redress for women affected by Allergan Biocell implants. We are also supporting our Hausfeld colleagues in Amsterdam in their ongoing claim against Allergan. Further details are provided below
Action in the Netherlands
On 1 December 2021, on behalf of the Dutch women’s rights organization Bureau Clara Wichmann, Hausfeld Advocaten in Amsterdam held Allergan liable and requested that it compensate all damages suffered by women in the Netherlands with Allergan biocell breast implants. As Allergan refused, a collective action on behalf of Bureau Clara Wichmann grouping the 60.000 women in the Netherlands who received Allergan biocell breast implants was filed on 12 December 2022. This lawsuit is an initiative of Bureau Clara Wichmann with the support of Stichting SVS/Meldpunt Klachten Siliconen and the Breast Cancer Association of the Netherlands.
For those affected in the Netherlands, the dedicated Dutch claim website 'Siliconen Zaak' offers additional information.