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Nagor Textured Breast Implants and BIA-ALCL

Solicitor Sarah Moore, who represents women diagnosed with the cancer BIA-ALCL related to textured breast implants, discusses the latest medical findings on the rare disease.

Woman considering breast implants
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Sarah Moore specialises in product liability and claims for groups of people who have suffered an injury because of unsafe products. She has written a number of articles on topics such as drug regulation, cigarette packaging and food safety.

On 18 November 2019 an article in the medical literature provided the first statistical data showing the incidence of BIA-ALCL, a type of cancer, with Nagor textured breast implants.

The article, authored by an Australian team, provides an analysis of all cases of BIA-ALCL reported in Australia since 2007. The team found that the risk of BIA-ALCL for three implant brands, based on sales data and single implant exposure, was as follows: one in 2596 patients with Silimed PU implants; one in 3194 patients with Allergen Biocell implants; and one in 6024 patients with Nagor implants.

This latest data contrasts significantly with the risk incidence published by the MHRA, the UK regulator, which at the moment indicates that BIA-ALCL has an incidence rate of 1:24,000 cases. Importantly, that figure takes account of all implants in the UK and, in contrast to the Australian data, provides no breakdown by brand. That more granular breakdown is important as the available evidence indicates that the risk of BIA-ALCL is significantly higher for some types of breast implants, than others.

The Australian publication is a watershed moment, in that for the first time it provides public access to statistical data which supports the decision by the Australian regulator, in October 2019, to suspend the sale of all higher surface area/textured implants from the Australian market. The authors conclude that their data supports the growing consensus that ‘implants with higher surface area and surface roughness confer significantly higher risk to patients’.

The study analysed 104 individual case reports of BIA-ALCL diagnosed in Australia with exposure to 149 unique breast implants. It used sales data obtained directly from the manufacturers, Allergan, Mentor, Nagor and Silimed for the period 1999 to 2019. These four manufacturers accounted for 87% of all implants used in patients in Australia with BIA-ALCL. The use of sales data, as described by the authors, most likely underestimates the real risk incidence of BIA-ALCL because it presumes that all implants sold were actually implanted, however, by using sales data the publication is able to provide a clear picture of emerging patterns of disease and highlight brands that are associated with higher risk incidence of BIA-ALCL – this includes Nagor textured implants.

The authors explain in their report that the ban on Nagor implants by the Australian regulator is supported by their findings which confirms that the implants are within the same range as other “higher risk devices”.

Yet despite the growing evidence that BIA-ALCL is not just an Allergan Biocell problem, as it stands the UK regulator, the MHRA, has only taken action to ban Allergan Biocell from the UK market.

Contrast the early action by the French regulator, the ANSM, to ban all textured implants, including Nagor, in April 2019; and the decision by the Australian regulator, the TGA, to follow suit and suspend all textured implants, including Nagor, in October 2019.

The MHRA informs the public, via its website, that at present there are 59 confirmed cases of BIA-ALCL in the UK. Leigh Day, to date, have been approached by 40 women who have developed BIA-ALCL: The majority of those women were implanted with Allergan implants, however  four of those working with Leigh Day have been implanted with Nagor textured implants and have developed BIA-ALCL. Notably one of those cases includes implantation of Nagor textured implants, post mastectomy – through the NHS.

If the MHRA has data that contradicts the association between Nagor textured implants and BIA-ALCL, undermining the position taken by the Australians, the French and the latest medical literature, then this may well provide reassurance for other women with Nagor textured implants, and on that basis we call upon the MHRA to put that data into the public domain.

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