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Breast Implant Associated Anaplastic Large Cell Lymphoma: A Call to Action

Sarah Moore, Associate Solicitor

The history of breast implants internationally is a history of repeated scandals, recalls, and health problems for those women who undergo implantation. Even against that backdrop, the fact that textured breast implants are now associated with a pathognomic form of cancer known as Breast Implant Associated Anaplastic Large Cell Lymphoma, or BIA-ALCL for short, has brought renewed regulatory attention to the issue of breast implants, and renewed concerns for those women with textured breast implants in particular.

In December 2018 sales of one brand of textured implants, Allergan Biocell, were suspended across Europe, following an intervention by the French regulator. The reason for that suspension was due to growing concerns about the association between Allergan Biocell and a rare type of blood cancer, known as BIA-ALCL.

BIA-ALCL is not a new diagnosis, indeed it has been written about in the medical literature since as early as 1997. However, due to problems with international Breast Implant Registries, misdiagnosis, under-diagnosis and the apparent rarity of the disease, until this year BIA-ALCL has largely existed beyond the public eye.

During the course of 2019, BIA-ALCL has been at the centre of robust regulatory interventions overseas, with some countries including France, Canada and Australia making the decision to ban all textured breast implants due to the known link between these types of implants and the relatively low, but potentially serious, health risks posed by BIA-ALCL.

Whilst Allergan textured implants are no longer available in the UK market, due to regulatory activity elsewhere in Europe, all other types of textured implants, including Nagor, remain available to women seeking implantation in the UK. This is in contrast with bans maintained in other countries and despite the fact that British women have been diagnosed with BIA-ALCL linked specifically to Nagor implants. One of the reasons cited by the MHRA for failing to take firmer action in relation to textured breast implants is that BIA-ALCL is an extremely rare form of cancer – and according to the MHRA there are only 57 confirmed cases in the UK.

Since January 2019 Leigh Day have been approached by a growing group of women all of whom have confirmed BIA-ALCL diagnoses. As of October 2019, Leigh Day are working with 46 women, 35 of whom have confirmed diagnoses.

Based upon our work with and on behalf of those whom we represent, we suspect that there has been significant misdiagnosis and under-diagnosis of BIA-ALCL in the UK, such that whilst BIA-ALCL is no doubt a rare form of cancer, it is perhaps less rare than the MHRA’s current data would suggest. Our concerns about the existing clarity regarding diagnostic and treatment pathways for BIA-ALCL are rooted in the fact that many of the women with whom we are working have experienced significantly delayed access to diagnosis and treatment as a result of their clinicians both in the NHS and the private sector being ill-equipped to make the crucial differential diagnosis between seroma, capsular contracture and other more common problems associated with breast implants and the rare but potentially fatal diagnosis of BIA-ALCL.

We are working to ensure that those whom we represent have access to compensation for the significant physical, psychiatric and financial losses that they have suffered as a result of their diagnosis with BIA-ALCL.

In addition, Leigh Day is committed to pushing for substantive changes at a regulatory level in order to facilitate speedier diagnosis and access to better treatment of BIA-ALCL in the UK. One expert has described access to diagnosis and treatment for BIA-ALCL in the UK as a ‘postcode lottery’, that statement is borne out by the experiences of many of our clients. In the coming months Leigh Day will be hosting a series of meetings with key stakeholders, clinicians, experts and patients, with the objective of drafting an Open Letter to the MHRA calling for action on BIA-ALCL. This is important not just for Leigh Day clients, and those with BIA-ALCL diagnoses, but for all women with textured breast implants and the patient community as a whole.

It has taken until 2019 and the spectre of a human caused cancer linked to breast implants, for the FDA, and other international regulators to look again at cosmetic industry – it is vital that we seize this moment to push for real changes in the way that patients access treatments, the information with which they are provided, and their access to care and monitoring thereafter.

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