Manufacturer Issues Global Recall of Textured Breast Implant at the Request of the US FDA

In 2018, Allergan Biocell implants were removed from European markets, but the UK Medicines and Healthcare products Regulatory Authority (MHRA) has reassured patients that:

‘There is currently no evidence of an increased risk to patients and there is no need for people who have Allergan breast implants to get them removed or have any additional clinical follow-up’.

In edition 279 of BC Disease News (here), we reported that Leigh-Day Solicitors had issued letters of claim on behalf of women who had undergone breast enlargement surgery and allege that the implants are defective. They are allegedly defective because they have caused, or may cause, a rare form of non-Hodgkin lymphoma, called anaplastic large cell lymphoma (ALCL).

Since our last report, the US Food and Drug Administration (FDA) requested a voluntary recall of Allergan's ‘Biocell surface’ models.[i]

The FDA claimed that the specific texture of these implants are associated with a ‘risk’ of ALCL, though Amy Abernethy, Principal Deputy Commissioner of the US FDA, admitted that ‘the overall incidence of BIA-ALCL appears to be relatively low’.

That being said, the FDA claims that the risk of breast implant-associated (BIA) ALCL with Allergan’s textured implants is 6-times higher than in textured implants manufactured by competitors, Sientra Inc and Mentor Worldwide LLC (owned by Johnson & Johnson).

Indeed, worldwide analysis of 573 BIA-ALCL cases, which included 33 patient deaths, revealed that 481 of the patients had Allergan breast implants at the time of their diagnoses.

Jeff Shuren, Director of the FDA’s Center for Devices and Radiological Health, has cautioned that the FDA is still unsure as to whether the increased risk of ALCL is limited to specific models of textured implants or all textured breast implants.

In a material development on Wednesday of this week, Allergan informed the FDA that it was issuing a worldwide recall of its textured Biocell products.[ii]

It appears that Australia’s Therapeutic Goods Administration, which proposed regulatory action to cancel, suspend or recall implants earlier this month, has been leapfrogged by Allergan’s recent activity.[iii]

What effect, if any, will the global recall have on impending Leigh Day claims in the UK?

 

[i] Nivedita Balu and Manas Mishra, ‘Allergan recalls textured breast implants worldwide’ (24 July 2019 Reuters) <https://www.reuters.com/article/us-allergan-recall/allergan-recalls-textured-breast-implants-across-markets-idUSKCN1UJ1N9> accessed 26 July 2019.

[ii] Sabrina Barr, ‘DO BREAST IMPLANTS CAUSE CANCER AND WHY HAS THE FDA RECALLED SOME IMPLANTS?’ (25 July 2019 The Independent) <https://www.independent.co.uk/life-style/health-and-families/breast-implants-cancer-recall-us-fda-allergan-plastic-surgery-cosmetic-a9020676.html> accessed 26 July 2019. 

[iii] ‘Australian ban on textured breast implants recommended over apparent cancer link’ (11 July 2019 The Guardian) <https://www.theguardian.com/australia-news/2019/jul/11/australian-ban-on-textured-breast-implants-recommended-over-apparent-cancer-link> accessed 11 July 2019.